BRUFEN 600 mg Granulki Musujące

Treść ulotki

1. BRUFEN 400 mg coated tablets
   1. What is BRUFEN and what is it used for
   2. What you need to know before taking BRUFEN
   3. How to take BRUFEN
   4. Possible side effects
   5. How to store BRUFEN
   6. Contents of the pack and other information
2. BRUFEN 600 mg coated tablets
   1. What is BRUFEN and what is it used for
   2. What you need to know before taking BRUFEN
   3. How to take BRUFEN
   4. Possible side effects
   5. How to store BRUFEN
   6. Contents of the pack and other information
3. BRUFEN 600 mg effervescent granules
   1. What is BRUFEN and what is it used for
   2. What you need to know before taking BRUFEN
   3. How to take BRUFEN
   4. Possible side effects
   5. How to store BRUFEN
   6. Contents of the pack and other information
4. BRUFEN 800 mg prolonged-release coated tablets
   1. What is BRUFEN and what is it used for
   2. What you need to know before taking BRUFEN
   3. How to take BRUFEN
   4. Possible side effects
   5. How to store BRUFEN
   6. Contents of the pack and other information
5. BRUFEN 20 mg/ml oral suspension
   1. What is BRUFEN and what is it used for
   2. What you need to know before taking BRUFEN
   3. How to take BRUFEN
   4. Possible side effects
   5. How to store BRUFEN
   6. Contents of the pack and other information

BRUFEN 400 mg coated tablets

ibuprofen

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BRUFEN is and what it is used for
• 2. What you need to know before you take BRUFEN
• 3. How to take BRUFEN
• 4. Possible side effects
• 5. How to store BRUFEN
• 6. Contents of the pack and other information

1. What is BRUFEN and what is it used for

BRUFEN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain and inflammation.
BRUFEN is used to treat pain due to, for example:

• trauma (e.g. caused by sport), toothache (e.g. after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (e.g. caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthrosis of the shoulder, radiculoneuritis, tenosynovitis, myositis, fibrosis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis) such as cervical, dorsal, lumbar, shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that mainly affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking BRUFEN

Do not take BRUFEN:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other medicines for pain, fever, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding in the stomach or intestine caused by taking medicines in the past;
• if you have had two or more distinct episodes of bleeding or lesion of the wall of the stomach or intestine;
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea, or drink very little;
• after the sixth month of pregnancy.

Do not use BRUFEN in children under 12 years of age.

Warnings and precautions
Talk to your doctor before taking BRUFEN if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing pain in the joints or muscles, changes in the skin and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below PAY ATTENTION to gastrointestinal risks and “Do not take BRUFEN”);
• you have reduced kidney function;
• you have liver problems;
• you have blood coagulation problems;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or respiratory diseases that last a long time (chronic);
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforations of the stomach and intestine which can be life-threatening (see the section below PAY ATTENTION to gastrointestinal risks);
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• if you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems.
• you have an infection - see section “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking BRUFEN if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop BRUFEN immediately and contact your doctor or emergency health service immediately if you notice any of these signs.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using BRUFEN and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections
BRUFEN can mask the symptoms of infections such as fever and pain. Therefore, BRUFEN may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, see your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation:

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take BRUFEN”). If you are elderly or have had these problems in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, the doctor will tell you to start treatment with the lowest available dose and may also prescribe a medicine to protect the stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to be taken together with BRUFEN;
• although very rarely, severe skin reactions have been reported, some of which are fatal, which manifest with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of developing these reactions is greater in the early stages of treatment, especially within the first month;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) can occur;
• changes in the eyes can occur if you use BRUFEN. Periodic eye examinations are necessary during therapy, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of BRUFEN to relieve the pain.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, especially in the case of prolonged treatments, and will prescribe the lowest effective dose and for the shortest duration of treatment necessary to control the symptoms.
The risk of having adverse effects can be reduced by using the lowest effective dose and for the shortest duration of treatment necessary to control the symptoms. Do not exceed the dose of BRUFEN and do not take it for long periods; always carefully follow your doctor's instructions.
STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are an elderly patient or if you have had gastrointestinal problems in the past;
• a rash, mucous membrane lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears;
• you experience vision problems;
• you experience liver problems.

Children
Do not use BRUFEN in children under 12 years of age. If necessary, ask your doctor for advice, as specific (lower) dosages are available for these patients.

Other medicines and BRUFEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
BRUFEN can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs) including medicines called COX-2 selective inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart disease;
• sulfonylureas, medicines used for diabetes;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used for HIV infections;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a herbal extract used to improve circulation;
• probenecid, a medicine used for gout;
• phenytoin, a medicine used for epilepsy;
• bisphosphonates, medicines used to treat osteoporosis;
• oxpentifylline, a medicine used for blood vessel problems;
• baclofen, a medicine used to relax muscles;
• mifepristone, a medicine used for medical abortion;
• moclobemide, a medicine used for the treatment of depression.

Even some other medicines can influence or be influenced by the treatment with BRUFEN. Therefore, always consult your doctor or pharmacist before taking BRUFEN with other medicines.

BRUFEN with alcohol
Some side effects, such as those affecting the stomach and intestines or the nervous system, may be more likely when you drink alcohol during treatment with BRUFEN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Do not use BRUFEN in the last 3 months of pregnancy, as such treatment can cause problems with the heart, lungs or kidneys of the fetus and complications during delivery (see section 2 “Do not take BRUFEN”). It may affect your and the baby's tendency to bleed and delay or prolong labor more than expected.
• During the first 6 months of pregnancy, take this medicine only if absolutely necessary and under the direct supervision of your doctor, as treatment may negatively affect pregnancy and fetal development. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, BRUFEN can cause kidney problems in the fetus, if taken for more than a few days, leading to a reduction in the levels of amniotic fluid surrounding the baby (oligohydramnios) or to the narrowing of

a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than
a few days, the doctor may recommend additional monitoring.
Breastfeeding

• Avoid taking BRUFEN if you are breastfeeding as the medicine can pass into breast milk in small amounts. Fertility
• If you want to become pregnant or have difficulty conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
BRUFEN can cause side effects that may worsen your reactivity to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do not suffer from any of these side effects before driving vehicles or using machinery or doing anything that requires attention. This is especially important when you drink alcohol during treatment with BRUFEN.

BRUFEN contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

BRUFENcontains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take BRUFEN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, see your doctor immediately if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and children over 12 years of age
The recommended dose is 2-4 tablets per day as directed by your doctor. The maximumdose is 4
tablets per day.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, possibly reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take BRUFEN”).

Elderly
If you are elderly, your doctor will decide the most appropriate dose for you, possibly reducing the dosages indicated above.
Method of administration
BRUFEN should be taken by mouth (oral use) with plenty of water. Take the tablets whole, without
chewing, breaking, crushing, or sucking them.
If you are using BRUFEN for rheumatic diseases, take the first dose in the morning upon waking and subsequent doses with
meals.

If you take more BRUFEN than you shouldor if your child has taken this medicine by mistake, always contact
your doctor or go to the nearest hospital to get advice on the risk and what action to take.
If you take high doses of BRUFEN you may experience: nausea, stomach pain, vomiting (possibly with
traces of blood), blood in the urine, low potassium levels in the blood, diarrhea, pain in the abdomen or
chest, bleeding in the stomach or intestines (see also section 4 below), heart problems such as
low blood pressure or irregular heartbeat, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion and oscillatory and uncontrolled eye movements (nystagmus), decreased
blood pH (metabolic acidosis), weakness and dizziness, fainting, seizures (especially in
children), disorientation, a state of excitement, breathing problems (even serious), symptoms of depression
of the central nervous system such as drowsiness, feeling cold (hypothermia), loss of
consciousness, deep sleep (lethargy), coma.

If you forget to take BRUFEN
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Stop taking BRUFEN and contact your doctor immediately if any of the
following conditions occur:

• serious stomach problems, burning or abdominal pain due to injury to the wall of the stomach or intestine (peptic ulcer), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal hemorrhage). These conditions are common side effects;
• allergic reactions, even serious, which manifest with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a serious allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma, even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, changes in the skin and problems with other organs. This condition occurs rarely;
• worsening of infections such as, for example, the onset of necrotizing fasciitis which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and discomfort to light. This condition occurs rarely;
• a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters

localized mainly in the skin folds, on the trunk and upper limbs accompanied by fever
at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN if
you develop these symptoms and contact your doctor immediately. See also paragraph 2;

• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, flatulence, difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reaction following exposure to sunlight (photosensitivity);
• alterations in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects(may affect up to 1 in 1,000 people)

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or due to problems with the bone marrow (aplastic anemia);
• depression, confusion;
• altered vision due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in the throat (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to edema in the lungs.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be defined based on available data);
• worsening of skin infections caused by varicella;
• stroke;
• hallucinations, malaise.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store BRUFEN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRUFEN contains
The active ingredient is: ibuprofen.
One BRUFEN coated tablet contains: 400 mg of ibuprofen.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hydroxypropylmethylcellulose,

lactose, sodium lauryl sulfate, magnesium stearate, Opaspray M-1-7111B White, colloidal anhydrous silica, talc.

Description of the appearance of BRUFEN and contents of the pack
This medicine is available in packs of 30 tablets in blisters.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer
Famar A.V.E. – Anthoussa Avenue 7, Anthousa Attiki, 153 49 (Greece)
AbbVie S.r.l. – S.R. 148 Pontina, Km 52 snc 04011 Campoverde di Aprilia (LT) (only alternative batch release)
Mylan Hungary Kft. Mylan utca 1, Komárom, 2900 (Hungary)

BRUFEN 600 mg coated tablets

ibuprofen

Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BRUFEN is and what it is used for
• 2. What you need to know before you take BRUFEN
• 3. How to take BRUFEN
• 4. Possible side effects
• 5. How to store BRUFEN
• 6. Contents of the pack and other information

1. What is BRUFEN and what is it used for

BRUFEN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain and inflammation.
BRUFEN is used to treat pain due to, for example:

• trauma (e.g. caused by sport), toothache (e.g. after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (e.g. caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthrosis of the shoulder, radiculoneuritis, tenosynovitis, myositis, fibrosis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, osteoarthritis of the shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that mainly affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking BRUFEN

Do not take BRUFEN:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other medicines for pain, fever, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding in the stomach or intestine caused by taking medicines in the past;
• if you have had two or more distinct episodes of bleeding or lesion of the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea or drink very little;
• after the sixth month of pregnancy.

Do not use BRUFEN in children under 12 years of age.

Warnings and precautions
Talk to your doctor before taking BRUFEN if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below PAY ATTENTION to gastrointestinal risks and “Do not take BRUFEN”);
• you have reduced kidney function;
• you have liver problems;
• you have blood coagulation problems;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or respiratory diseases that have lasted a long time (chronic);
• you have had swelling of the face, throat, lips or other parts of the body (angioedema) in the past;
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforation of the stomach and intestine which can be life-threatening (see the section below PAY ATTENTION to gastrointestinal risks);
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• if you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems.
• you have an infection - see section “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking BRUFEN if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
BRUFEN immediately and contact your doctor or emergency medical service immediately if you notice
any of these signs.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using BRUFEN and contact your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.

Infections
BRUFEN can mask the symptoms of infections such as fever and pain. Therefore, BRUFEN may
delay adequate treatment of the infection, which could increase the risk of complications. This has been
observed in bacterial pneumonia and skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact
your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs
for pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take BRUFEN”). If you are elderly or have had these problems in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, the doctor will tell you to start treatment with the lowest available dose and may also prescribe a medicine to protect the stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to be taken together with BRUFEN;
• although very rarely, severe skin reactions have been reported, some of which have been fatal, manifesting with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of you developing these reactions is greater in the early stages of treatment, especially within the first month;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) may occur;
• changes in the eyes may occur if you use BRUFEN. Periodic eye checks are necessary during therapy, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of BRUFEN to relieve the pain.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly in the case of prolonged treatments,
and will prescribe the most effective dose for the shortest possible duration of treatment needed to
control the symptoms.
The risk of having undesirable effects can be reduced by using the lowest effective dose and for the shortest
possible duration of treatment needed to control the symptoms. Do not exceed the dose of BRUFEN and
do not take it for long periods; always carefully follow your doctor's instructions.
STOP the treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are elderly or if you have had gastrointestinal problems in the past;
• a rash, mucosal lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears;
• you experience vision problems;
• you experience liver problems.

Children
Do not use BRUFEN in children under 12 years of age. If necessary, ask your doctor for advice, as
specific (lower) dosages are available for these patients.

Other medicines and BRUFEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
BRUFEN can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs), including medicines called COX-2 selective inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart disease;
• sulfonylureas, medicines used for diabetes;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used for HIV infections;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a herbal extract used to improve circulation;
• probenecid, a medicine used for gout;
• phenytoin, a medicine used for epilepsy;
• bisphosphonates, medicines used to treat osteoporosis;
• oxpentifylline, a medicine used for blood vessel problems;
• baclofen, a medicine used to relax muscles;
• mifepristone, a medicine used for medical abortion.

Even some other medicines can affect or be affected by treatment with BRUFEN. Therefore,
always consult your doctor or pharmacist before taking BRUFEN with other medicines.

BRUFEN with alcohol
Some side effects, such as those affecting the stomach and intestines or the nervous system, may
be more likely when you drink alcohol during treatment with BRUFEN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Do not use BRUFEN in the last 3 months of pregnancy, as this treatment can cause problems with the heart, lungs or kidneys of the fetus and complications during childbirth (see section 2 “Do not take BRUFEN”). It may affect your and the baby's tendency to bleed and delay or prolong labor more than expected.
• During the first 6 months of pregnancy, take this medicine only if necessary and under the direct supervision of your doctor, as the treatment may negatively affect pregnancy and fetal development. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, BRUFEN can cause kidney problems in the fetus, if taken for more than a few days, leading to a reduction in the levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby's heart.

If treatment is needed for more than a few days, the doctor may recommend
additional monitoring.
Breastfeeding

• Avoid taking BRUFEN if you are breastfeeding as the medicine may pass into breast milk in small amounts.

Fertility

• If you want to become pregnant or have difficulty conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and operating machinery
BRUFEN can cause side effects that can worsen your responsiveness to stimuli, such as
headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do
not suffer from any of these side effects before driving vehicles or operating machinery or doing anything
that requires attention. This is especially important when you drink alcohol during treatment
with BRUFEN.

BRUFEN contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

BRUFENcontains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take BRUFEN

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor
or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if symptoms (such as fever and pain) persist
or worsen (see paragraph 2).

Adults and children over 12 years of age
The recommended dose is 1-3 tablets per day as directed by your doctor. The maximum doseis 3
tablets (1800 mg) per day.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, possibly reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take BRUFEN”).

Elderly
If you are elderly, your doctor will decide the most appropriate dose for you, possibly reducing the dosages indicated above.
Method of administration
BRUFEN should be taken orally (oral use) with plenty of water. Take the tablets whole, without
chewing, breaking, crushing or sucking them.
If you are using BRUFEN for rheumatic diseases, your doctor will tell you to take the first dose upon waking and the
subsequent doses with meals.

If you take more BRUFEN than you shouldor if your child has taken this medicine by mistake, always contact
your doctor or go to the nearest hospital to get advice on the risk and recommendations
regarding actions to be taken.
If you take high doses of BRUFEN you may experience: nausea, stomach pain, vomiting (possibly with
traces of blood), blood in the urine, low potassium levels in the blood, diarrhea, pain in the
abdomen or chest, bleeding in the stomach or intestines (see also paragraph 4 below), heart problems, such as
low blood pressure or altered heartbeats (bradycardia, tachycardia), and blood circulation
problems, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion and oscillating and uncontrolled eye movements (nystagmus), decreased blood pH (metabolic acidosis),
weakness and dizziness, fainting, seizures (especially in children), disorientation, excited state,
problems (including severe) with breathing, including apnea, symptoms of central nervous system depression such as
drowsiness, feeling of coldness in the body (hypothermia), loss of consciousness, deep sleep (lethargy),
coma.

If you forget to take BRUFEN
Do not take a double dose to make up for a missed dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Stop taking BRUFEN and contact your doctor immediately if any of the
following conditions occur:

• serious stomach problems, burning or abdominal pain due to injury to the stomach or intestines (peptic ulcers), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal bleeding). These conditions are common side effects;
• allergic reactions, even serious, which manifest with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, edema of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a serious allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blister formation (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, changes in the skin and problems with other organs. This condition occurs rarely.
• worsening of infections such as, for example, the onset of necrotizing fasciitis which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, lethargy and sensitivity to light. This condition occurs rarely;
• a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, flatulence, constipation, indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reactions following exposure to sunlight (photosensitivity);
• changes in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects(may affect up to 1 in 1,000 people)

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• altered vision due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart racing (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BRUFEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store this medicine at a temperature below 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRUFEN contains
The active ingredient is: ibuprofen.
One BRUFEN coated tablet contains: 600 mg of ibuprofen.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hydroxypropylmethylcellulose,

lactose, sodium lauryl sulfate, magnesium stearate, Opaspray M-1-7111B White, anhydrous colloidal silica, talc.

Description of the appearance of BRUFEN and contents of the pack
This medicine is available in packs of 30 tablets in blisters.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer
Famar A.V.E. – Anthoussa Avenue 7, Anthousa Attiki 153 49 (Greece)
AbbVie S.r.l. – S.R. 148 Pontina, Km 52 snc 04011 Campoverde di Aprilia (LT) (only alternative batch release)
Mylan Hungary Kft. Mylan utca 1, Komárom, 2900 (Hungary)
Famar Italia S.p.A. – Via Zambeletti 25, 20021, Baranzate (MI )

BRUFEN 600 mg effervescent granules

ibuprofen

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BRUFEN is and what it is used for
• 2. What you need to know before you take BRUFEN
• 3. How to take BRUFEN
• 4. Possible side effects
• 5. How to store BRUFEN
• 6. Contents of the pack and other information

1. What is BRUFEN and what is it used for

BRUFEN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain and inflammation.
BRUFEN is used to treat pain due to, for example:

• trauma (for example caused by sport), toothache (for example after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (for example caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (scapulo-humeral periarthritis, radiculo-neuritis, tenosynovitis, myositis, fibrositis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, osteoarthritis of the shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that primarily affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking BRUFEN

Do not take BRUFEN:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), or other medicines for pain, fever, or other anti-inflammatory drugs (NSAIDs), especially if associated with polyps in the nose, swelling of the face (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had in the past an episode of perforation or bleeding in the stomach or intestine caused by taking medicines;
• if you have had two or more distinct episodes of bleeding or lesion of the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea or drink very little;
• after the sixth month of pregnancy.

Do not use BRUFEN in children under 12 years of age.

Warnings and precautions
Talk to your doctor before taking BRUFEN if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing pain in the joints or muscles, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below PAY ATTENTION to gastrointestinal risks and “Do not take BRUFEN”);
• you have reduced kidney function;
• you have problems with the liver;
• you have problems with blood coagulation;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or respiratory diseases that last a long time (chronic);
• if you have had in the past swelling of the face, throat, lips or other parts of the body (angioedema);
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforations of the stomach and intestine which can be life-threatening (see the section below PAY ATTENTION to gastrointestinal risks);
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• if you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems;
• you have an infection - see paragraph “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking BRUFEN if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
BRUFEN immediately and contact your doctor or emergency health service immediately if you notice
any of these signs.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using BRUFEN and contact your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.

Infections
BRUFEN can mask the symptoms of infections such as fever and pain. It is therefore possible that BRUFEN may
delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, see
your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs
for pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, injury (ulceration) or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take BRUFEN”). If you are elderly or have had this type of problem in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, the doctor will tell you to start treatment with the lowest available dose, and may also prescribe a medicine to protect the stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to be taken together with BRUFEN;
• although very rarely, severe skin reactions, some of which are fatal, have been reported, manifesting with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of you developing these reactions is greater in the early stages of treatment, especially within the first month;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) may occur;
• changes in the eyes may occur if BRUFEN is used for prolonged treatments. During therapy, periodic eye examinations are necessary;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of BRUFEN to relieve pain.

If you have impaired heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, especially in the case of prolonged treatments,
and will prescribe the most effective lowest dose and for the shortest possible duration of treatment necessary to
control the symptoms.
The risk of having undesirable effects can be reduced by using the lowest effective dose and for the shortest
duration of treatment necessary to control the symptoms. Do not exceed the dose of BRUFEN and
do not take it for long periods; always carefully follow the doctor's instructions.
STOP the treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are elderly or if you have had gastrointestinal problems in the past;
• a rash, mucosal lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure);
• you experience vision problems;
• you experience liver problems.

Children
Do not use BRUFEN in children under 12 years of age. If necessary, ask your doctor for advice, as
specific (lower) dosages are available for these patients.

Other medicines and BRUFEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
BRUFEN can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs) including medicines called selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart diseases;
• sulfonylureas, medicines used for diabetes;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used for HIV infections;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a herbal extract used to improve circulation;
• probenecid, a medicine used for gout;
• phenytoin, a medicine used for epilepsy;
• bisphosphonates, medicines used to treat osteoporosis;
• oxpentifylline, a medicine used for blood vessel problems;
• baclofen, a medicine used to relax muscles;
• mifepristone, a medicine used for medical abortion;
• moclobemide, a medicine used to treat depression.

Some other medicines may also affect or be affected by treatment with BRUFEN. Therefore,
always consult your doctor or pharmacist before taking BRUFEN with other medicines.

BRUFEN with alcohol
Some side effects, such as those affecting the stomach and intestines or the nervous system, may
be more likely when you drink alcohol during treatment with BRUFEN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Do not use BRUFEN in the last 3 months of pregnancy, as this treatment may cause problems with the heart, lungs or kidneys of the fetus and complications during childbirth (see section 2 “Do not take BRUFEN”). It may affect your and the baby's tendency to bleed and delay or prolong labor more than expected.
• During the first 6 months of pregnancy, take this medicine only if absolutely necessary and under the direct control of your doctor, as treatment may have a negative impact on pregnancy and fetal development. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, BRUFEN may cause kidney problems in the fetus, if taken for more than a few days, leading to a reduction in the levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of

a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than
a few days, the doctor may recommend additional monitoring.
Breastfeeding

• Avoid taking BRUFEN if you are breastfeeding as the medicine may pass into breast milk in small amounts.

Fertility

• If you want to become pregnant or have problems conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and operating machinery
BRUFEN can cause side effects that may impair your reactivity, such as
headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do not
suffer from any of these side effects before driving vehicles or operating machinery or doing anything that requires attention. This is particularly important when drinking alcohol during treatment
with BRUFEN.

BRUFEN contains sucrose and sodium:
Sucrose
Sucrose is a sugar. If you have been diagnosed with an intolerance to some sugars, contact
your doctor before taking this medicine. Each sachet contains 3.33 g of sucrose. To be taken into
consideration in people affected by diabetes mellitus.

Sodium
This medicine contains 198 mg of sodium per sachet (the main component of table salt). This
is equivalent to 9.9% of the recommended maximum daily intake with the diet of an adult. Talk to
your doctor or pharmacist if you need 2 or more sachets a day for a prolonged period, especially
if you have been advised to follow a low-sodium diet.

3. How to take BRUFEN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, see your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and children over 12 years of age
The recommended dose is 1-3 sachets per day as directed by your doctor. The maximum doseis 3 sachets
(1800 mg) per day.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, even reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take BRUFEN”).

Elderly
If you are elderly, your doctor will decide the most appropriate dose for you, even reducing the dosages indicated above.
Method of administration
BRUFEN should be taken orally (for oral use). Dissolve the contents of the sachet in plenty of water. You may
experience some burning in the mouth or throat after taking it.
If you are using BRUFEN for rheumatic diseases, take the first dose in the morning upon waking and subsequent doses with
meals.

If you take more BRUFEN than you shouldor if your child has taken this medicine by mistake, always contact
your doctor or go to the nearest hospital to get advice on the risk and recommendations for
action.
If you take high doses of BRUFEN you may experience: nausea, stomach pain, vomiting (possibly with
traces of blood), blood in the urine, low potassium levels in the blood, diarrhea, pain in the abdomen or
chest, bleeding in the stomach or intestines (see also section 4 below), heart problems, such as
low blood pressure or irregular heartbeat (bradycardia, tachycardia), and blood circulation problems, liver or
kidney problems, headache, ringing in the ears (tinnitus), confusion and involuntary, jerky eye movements (nystagmus), decreased blood pH (metabolic acidosis),
weakness and dizziness, fainting, seizures (especially in children), disorientation, excited state,
problems (including severe) with breathing (including apnea), depression, reduced activity of the central nervous
system such as drowsiness, feeling cold (hypothermia), loss of consciousness, deep sleep
(lethargy), coma.

If you forget to take BRUFEN
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
Stop taking BRUFEN and contact your doctor immediately if any of the following occur:

• serious stomach problems, burning or abdominal pain due to injury to the wall of the stomach or intestine (peptic ulcer), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting blood (hematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal bleeding). These conditions are common side effects;
• allergic reactions, even severe, manifesting with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a severe allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blister formation (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, changes in the skin and problems with other organs. This condition occurs rarely;
• worsening of infections such as, for example, the onset of necrotizing fasciitis which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the neck, nausea, vomiting, confusion, lethargy and discomfort to light. This condition occurs rarely.
• a severe skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, flatulence, difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reaction following exposure to sunlight (photosensitivity);
• changes in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects(may affect up to 1 in 1,000 people)

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• visual impairment due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in the throat (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be defined based on available data);
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store BRUFEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRUFEN contains
The active ingredient is: ibuprofen.
One sachet of BRUFEN contains: 600 mg of ibuprofen.
The other ingredients are: malic acid, orange flavour, microcrystalline cellulose, sodium croscarmellose,
povidone, saccharose, sodium bicarbonate, anhydrous sodium carbonate, sodium lauryl sulfate, sodium saccharin.

Description of the appearance of BRUFEN and contents of the pack
This medicine is available in packs of 10 or 30 sachets.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milano

Manufacturer
AbbVie S.r.l. – S.R 148 Pontina Km 52 snc, 04011 Campoverde di Aprilia (LT)

BRUFEN 800 mg prolonged-release coated tablets

ibuprofen

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BRUFEN is and what it is used for
• 2. What you need to know before you take BRUFEN
• 3. How to take BRUFEN
• 4. Possible side effects
• 5. How to store BRUFEN
• 6. Contents of the pack and other information

1. What is BRUFEN and what is it used for

BRUFEN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain and inflammation.
BRUFEN is used to treat pain due to, for example:

• trauma (e.g. caused by sport), toothache (e.g. after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (e.g. caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (scapulo-humeral periarthritis, radiculo-neuritis, tenosynovitis, myositis, fibrosis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, osteoarthritis of the shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that mainly affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking BRUFEN

Do not take BRUFEN:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other medicines for pain, fever, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding in the stomach or intestine caused by taking medicines;
• if you have had two or more distinct episodes of bleeding or injury to the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have serious problems with the liver or kidneys;
• if you suffer from serious heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea, or drink very little;
• after the sixth month of pregnancy.

Do not use BRUFEN in children under 12 years of age.

Warnings and precautions
Talk to your doctor before taking BRUFEN if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below PAY ATTENTION to gastrointestinal risks and “Do not take BRUFEN”);
• you have reduced kidney function;
• you have liver problems;
• you have problems with blood coagulation;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or respiratory diseases that last a long time (chronic);
• you have had swelling of the face, throat, lips or other parts of the body (angioedema) in the past;
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforations of the stomach and intestine which can be life-threatening (see the section below PAY ATTENTION to gastrointestinal risks);
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• if you are a dehydrated adolescent or are elderly as you are more likely to have kidney problems:
• you have an infection - see paragraph “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking BRUFEN if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
BRUFEN immediately and contact your doctor or emergency health service immediately if you notice
any of these signs.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using BRUFEN and contact your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.

Infections
BRUFEN can mask the symptoms of infections such as fever and pain. Therefore, it is possible that BRUFEN may
delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in
pneumonia caused by bacteria and bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, see
your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs
for pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, injury (ulceration) or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take BRUFEN”). If you are elderly or have had this type of problem in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, the doctor will tell you to start treatment with the lowest available dose, and may also prescribe a medicine to protect the stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to be taken together with BRUFEN;
• although very rarely, serious skin reactions have been reported, some of which have been fatal, which manifest with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of you developing these reactions is greater in the early stages of treatment, especially within the first month;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) may occur;
• changes in the eyes may occur. Periodic eye checks are necessary during therapy, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of BRUFEN to relieve the pain.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly in the case of prolonged treatments,
and will prescribe the lowest effective dose and for the shortest duration of treatment necessary to
control the symptoms.
The risk of having undesirable effects can be reduced by using the lowest effective dose and for the shortest
duration of treatment necessary to control the symptoms. Do not exceed the dose of BRUFEN and
do not take it for long periods; always carefully follow the doctor's instructions.
STOP the treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are an elderly patient or if you have had gastrointestinal problems in the past;
• a rash, mucosal lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears;
• you experience vision problems;
• you experience liver problems.

Children
Do not use BRUFEN in children under 12 years of age. If necessary, ask your doctor for advice, as
specific dosages (lower) are available for such patients.

Other medicines and BRUFEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
BRUFEN can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs), including medicines called selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart disease;
• sulfonylureas, medicines used for diabetes;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used for HIV infections;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a herbal extract used to improve circulation;
• probenecid, a medicine used for gout;
• phenytoin, a medicine used for epilepsy;
• bisphosphonates, medicines used to treat osteoporosis;
• oxpentifylline, a medicine used for blood vessel problems;
• baclofen, a medicine used to relax muscles;
• mifepristone, a medicine used for medical abortion.

Some other medicines may also affect or be affected by treatment with BRUFEN. Therefore,
always consult your doctor or pharmacist before taking BRUFEN with other medicines.

BRUFEN with alcohol
Some side effects, such as those affecting the stomach and intestines or the nervous system, may
be more likely when you drink alcohol while taking BRUFEN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Do not use BRUFEN in the last 3 months of pregnancy, as such treatment may cause problems with the heart, lungs or kidneys of the fetus and complications during childbirth (see section 2 “Do not take BRUFEN”). It may affect your and the baby's tendency to bleed and delay or prolong labor longer than expected.
• During the first 6 months of pregnancy, take this medicine only if absolutely necessary and under the direct supervision of your doctor, as treatment may negatively affect pregnancy and fetal development. If you need treatment during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, BRUFEN may cause kidney problems in the fetus, if taken for more than a few days, leading to a reduction in the levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby's heart.

If you need treatment for more than a few days, your doctor may recommend
additional monitoring.
Breastfeeding

• Avoid taking BRUFEN if you are breastfeeding as the medicine may pass into breast milk in small amounts.

Fertility

• If you want to become pregnant or have difficulty conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
BRUFEN can cause side effects that may worsen your reactivity to stimuli, such as
headache, drowsiness, dizziness, vertigo, fatigue and vision disturbances. Make sure you do
not suffer from any of these side effects before driving vehicles or using machinery or doing anything
that requires attention. This is particularly important when you drink alcohol while taking
BRUFEN.

3. How to take BRUFEN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, see your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and children over 12 years of age
The recommended dose is 2 tablets per day, to be taken in a single dose.
In more severe cases, your doctor may increase this dose up to a maximumof 3 tablets (2400 mg) per day
in divided doses.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, even reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take BRUFEN”).

Elderly
If you are elderly, your doctor will decide the most appropriate dose for you, even reducing the dosages indicated above.
Method of administration
BRUFEN should be taken by mouth (oral use), preferably in the evening, well before bedtime and with
plenty of water. Take the tablets whole, without chewing, breaking, crushing or sucking them.

If you take more BRUFEN than you shouldor if your child has taken this medicine by mistake, always contact
your doctor or go to the nearest hospital to obtain advice on the risk and recommendations on what actions to take.
If you take high doses of BRUFEN you may experience: nausea, stomach pain, vomiting (possibly with
traces of blood), blood in the urine, low potassium levels in the blood, diarrhea, pain in the abdomen or
chest, bleeding in the stomach or intestines (see also section 4 below), heart problems, such as
low blood pressure or altered heartbeats (bradycardia, tachycardia), and blood circulation problems, liver or
kidney problems, headache, ringing in the ears (tinnitus), confusion and involuntary, jerky eye movements (nystagmus), decreased blood pH (metabolic acidosis),
weakness and dizziness, fainting, seizures (especially in children), disorientation, excited state,
problems (including severe) with breathing (including apnea), reduced activity of the central nervous system such as
drowsiness, feeling cold to the body (hypothermia), loss of consciousness, deep sleep (lethargy),
coma.

If you forget to take BRUFEN
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop taking BRUFEN and contact your doctor immediately if you experience any of the
following conditions:

• serious stomach problems, burning or abdominal pain due to injury to the stomach or intestines (peptic ulcers), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal bleeding). These conditions are common side effects;
• allergic reactions, even serious, which manifest with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a serious allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, changes in the skin and problems with other organs. This condition occurs rarely.
• worsening of infections such as, for example, the onset of necrotizing fasciitis which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, lethargy and discomfort to light. This condition occurs rarely:
• a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and on the upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reaction following exposure to sunlight (photosensitivity);
• changes in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects(may affect up to 1 in 1,000 people)

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• visual impairment due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in the throat (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be defined based on available data);
• worsening of skin infections caused by varicella;
• stroke;
• hallucinations, malaise.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store BRUFEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRUFEN contains
The active ingredient is: ibuprofen.
One BRUFEN prolonged-release coated tablet contains: 800 mg of ibuprofen.
The other ingredients are: stearic acid, anhydrous colloidal silicon dioxide, xanthan gum, hydroxypropylmethylcellulose,
Opaspray M-1-7111B White, povidone, talc.

Description of the appearance of BRUFEN and contents of the pack
This medicine is available in packs of 20 tablets in blisters.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milano

Manufacturer
Famar A.V.E – Anthoussa Avenue 7, Anthousa Attiki, 153 49 (Greece)
AbbVie S.r.l. – S.R. 148 Pontina, Km 52 snc 04011 Campoverde di Aprilia (LT) (only alternative batch release)

BRUFEN 20 mg/ml oral suspension

ibuprofen

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your doctor or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See your doctor if your symptoms do not improve or get worse after a short period of treatment.

Contents of this leaflet:

• 1. What BRUFEN is and what it is used for
• 2. What you need to know before you take BRUFEN
• 3. How to take BRUFEN
• 4. Possible side effects
• 5. How to store BRUFEN
• 6. Contents of the pack and other information

1. What is BRUFEN and what is it used for

BRUFEN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain, fever and inflammation.
BRUFEN is used for:

• the short-term treatment of fever and pain in children;
• the treatment of symptoms due to juvenile rheumatoid arthritis.

2. What you need to know before taking BRUFEN

Do not take BRUFEN:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other pain relievers, fever reducers or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding of the stomach or intestine in the past caused by taking drugs;
• if you have had two or more distinct episodes of bleeding or injury to the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea or drink very little;
• after the sixth month of pregnancy.

Do not use BRUFEN in children weighing less than 7 Kg.

Warnings and precautions
Consult your doctor before taking BRUFEN if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below “PAY ATTENTION” on gastrointestinal risks and “Do not take BRUFEN”);
• you have reduced kidney function;
• you have liver problems;
• you have blood clotting problems;
• you have or have had allergies (e.g. hay fever);
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you are elderly, as you are more likely to develop adverse events with this medicine;
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• if you are a child or adolescent in a state of dehydration as you are more likely to have kidney problems.
• you have an infection - see paragraph “Infections” below.
• you have recently undergone major surgery

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking BRUFEN if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
BRUFEN immediately and contact your doctor or emergency health service immediately if you notice
any of these signs.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using BRUFEN and contact your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in paragraph 4.

Infections
BRUFEN can mask the symptoms of infections such as fever and pain. Therefore, BRUFEN may
delay adequate treatment of the infection, which could increase the risk of complications. This has been
observed in bacterial pneumonia and skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact
your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs
for pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, injury (ulceration) or perforation of the stomach or intestine have been reported, which can be life-threatening (see paragraph “Do not take BRUFEN”) and fatal in the elderly;
• although very rarely, severe skin reactions have been reported, some of which are fatal, which manifest with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of you developing these reactions is greater in the early stages of treatment, especially within the first;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) can occur;
• eye changes can occur if you use BRUFEN. Periodic eye checks are necessary during therapy, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache can occur; in this case, do not increase the dose of BRUFEN to relieve the pain. If you experience recurrent headache despite using BRUFEN, consult your doctor.
• especially if used for prolonged periods and at high doses, signs and symptoms of meningitis can occur.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe you periodic specific tests, especially in the case of prolonged treatments,
and will prescribe you the lowest effective dose and for the shortest possible duration of treatment necessary to
control the symptoms.
The risk of having adverse effects can be reduced by using the lowest effective dose and for the shortest
possible duration of treatment necessary to control the symptoms. Do not exceed the dose of BRUFEN and
do not take it for long periods; always carefully follow your doctor's instructions.
STOP the treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are an elderly patient or if you have had gastrointestinal problems in the past;
• a rash, mucous membrane lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).
• you experience vision problems;
• you experience liver problems.

Other medicines and BRUFEN
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines.
Due to the potential increase in adverse effects, the use of BRUFEN should be avoided in
combination with:

• acetylsalicylic acid;
• other pain relievers anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors

BRUFEN should be used with caution in combination with:

• cardiac glycosides (e.g. digoxin), drugs used for heart diseases; NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides.
• antidiabetics: possible increase in the hypoglycemic effect of sulfonylureas.
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine) whose effect may be increased;
• cyclosporine and tacrolimus, drugs that reduce immune defenses. May increase the risk of kidney damage.
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics), whose effect may be reduced. These medicines may also increase the risk of kidney function changes. Diuretics may also increase the risk of nephrotoxicity associated with NSAIDs. increased risk of kidney function changes.
• potassium-sparing diuretics (some diuretics): in case of concomitant use, an increase in potassium levels may occur;
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids) which may increase the risk of ulceration or gastrointestinal bleeding;
• antiplatelet agents that may induce an increased risk of gastrointestinal bleeding;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants, which may increase the risk of gastrointestinal bleeding;
• aminoglycoside drugs (a type of antibiotic). Concomitant use may increase the risk of toxicity
• quinolone drugs, a type of antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
• zidovudine, a drug used in HIV infections. In hemophilic patients with HIV infection there is an increased risk of bleeding into the joints and hematoma
• antiviral drugs, such as ritonavir: possible increase in the concentration of NSAIDs
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis. Concomitant use may determine an increased risk of toxicity.
• cholestyramine, a drug used to lower cholesterol levels in the blood, which may reduce the absorption of ibuprofen in the gastrointestinal tract
• lithium, used in depression. Concomitant use may increase its plasma levels;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, drugs used in fungal infections. Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen.
• Ginkgo Biloba, a herbal extract used to improve circulation. May increase the risk of bleeding.
• probenecid, a drug used in gout;
• phenytoin, a drug used for epilepsy. Concomitant use may increase its plasma levels; bisphosphonates, drugs used to treat osteoporosis. May potentiate gastrointestinal side effects and the risk of bleeding and ulcer.
• oxpentifylline, a drug used for blood vessel problems. May potentiate gastrointestinal side effects and the risk of bleeding and ulcer.
• baclofen, a drug used to relax muscles. May potentiate gastrointestinal side effects and the risk of bleeding and ulcer.
• mifepristone, a drug used for medical abortion. A decrease in the effectiveness of the medicine may occur.
• moclobemide, a drug used for the treatment of depression, which increases the effect of ibuprofen.

Even some other medicines can influence or be influenced by the treatment with BRUFEN. Therefore,
always consult your doctor or pharmacist before taking BRUFEN with other medicines.

BRUFEN with alcohol
Some side effects, such as those affecting the stomach and intestines or the nervous system, may
be more likely when you drink alcohol during treatment with BRUFEN.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Do not use BRUFEN in the last 3 months of pregnancy, as such treatment may cause problems with the heart, lungs or kidneys of the fetus and complications during delivery (see paragraph 2 “Do not take BRUFEN”). It may affect your and the baby's tendency to bleed and delay or prolong labour more than expected.
• During the first 6 months of pregnancy, take this medicine only if absolutely necessary and under the direct supervision of your doctor, as treatment may negatively affect pregnancy and fetal development. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, BRUFEN may cause kidney problems in the fetus if taken for more than a few days, leading to a reduction in the amount of amniotic fluid surrounding the baby (oligohydramnios) or to the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

• Avoid taking BRUFEN if you are breastfeeding as the medicine may pass into breast milk in small amounts.

Fertility

• If you want to become pregnant or have problems conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and operating machinery
BRUFEN can cause side effects that may worsen your reactivity to stimuli, such as
headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do not
suffer from any of these side effects before driving vehicles or operating machinery or doing anything
that requires attention. This is particularly important when drinking alcohol during treatment
with BRUFEN.

BRUFENcontainssucrose, sorbitol,yelloworange,methylparahydroxybenzoateand
propylparahydroxybenzoate and sodium benzoate

Sucrose
This medicine contains 3 g of sucrose per 5 ml dose. If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine. To be considered in people affected by diabetes mellitus. May be harmful to teeth.

Sorbitol
This medicine contains 500 mg of sorbitol per 5 ml dose. Sorbitol is a source of fructose.
If your doctor has told you that you (or your child) are intolerant to certain sugars or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize
fructose, talk to your doctor before you (or your child) take this medicine.

Methylparahydroxybenzoate and propylparahydroxybenzoate
This medicine contains the preservatives methylparahydroxybenzoate and propylparahydroxybenzoate which
may cause allergic reactions (including delayed reactions).

Yellow orange
This medicine contains yellow orange which may cause allergic reactions;

Sodium benzoate
This medicine contains 12.5 mg of sodium benzoate per 5 ml dose. Sodium benzoate may increase
jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take BRUFEN

Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Children under 12 years of age and weighing more than 7 kg
The recommended daily dose is calculated based on the child's weight. The usual dose is 20 mg (1 ml of solution) per each kg of body weight per day, to be taken in 3 - 4 administrations.
Consult the following table, which provides some examples, to take the correct dose:

For intermediate weights, calculate the dose considering that 1 kg of body weight corresponds to 1 ml of BRUFEN (equal to 20 mg of ibuprofen), for example, for a child weighing 8 kg, administer 8 ml of suspension per day, equal to 160 mg of ibuprofen).
Do not use Brufen in children weighing less than 7 kg.
Duration of treatment
Use the lowest dose for the shortest period of time necessary to relieve symptoms.
Consult your doctor in the following cases:

• need for treatment for more than 3 days in infants and children over 6 months of age and in adolescents or worsening of symptoms;
• persistence of symptoms for a period longer than 24 hours in infants between 3 and 5 months of age.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, even by reducing the dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see “Do not take BRUFEN”).
Method of administration
BRUFEN must be taken by mouth (oral use). It is possible that after taking it you may experience some burning in the mouth or throat.
Shake the bottle well before each use.
Use the dosing syringe found inside the package to take the correct dose.
For using the dosing syringe, follow these instructions:
1 Shake the bottle well before use;
2 Unscrew the cap and insert the tip of the syringe into the hole in the sub-cap;
3 Turn the bottle upside down, holding the syringe firmly; gently pull the plunger down, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose (Fig. 1);
4 Return the bottle to the vertical position, remove the syringe and close the bottle;
5 Insert the tip of the syringe into the child's mouth, and apply slight pressure on the plunger to allow the suspension to flow (Fig. 2);
6 Wash the syringe with water (Fig. 3).

Fig. 1 Fig. 2 Fig. 3

If you take more BRUFEN than you shouldor if your child has taken this medicine by mistake, always contact your doctor or go to the nearest hospital to get an opinion on the risk and advice on the actions to be taken.
If you take high doses of BRUFEN you may notice: nausea, stomach pain, vomiting (possibly with traces of blood), blood in the urine, low levels of potassium in the blood, diarrhea, pain in the abdomen or chest, bleeding in the stomach or intestines (see also section 4 below), heart problems, such as low blood pressure or altered heartbeats (bradycardia, tachycardia), and blood circulation problems, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion and oscillatory and uncontrolled eye movements (nystagmus), decreased blood pH (metabolic acidosis), weakness and dizziness, fainting, seizures (especially in children), disorientation, excited state, problems (even serious) of breathing (including apnea), reduction of the activity of the central nervous system such as drowsiness, feeling of cold to the body (hypothermia), loss of consciousness, deep sleep (lethargy), coma.

If you forget to take BRUFEN
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Stop taking BRUFEN and contact your doctor immediately if any of the
following occur:

• severe stomach problems, burning or abdominal pain due to lesions of the stomach or intestine (peptic ulcers), severe and sudden pain in the epigastrium or abdomen (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal hemorrhages). These conditions are common side effects;
• allergic reactions, even severe, manifesting with more or less sudden skin lesions, for example with widespread or patchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a severe allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reactions, anaphylaxis);
• severe skin rashes with redness, exfoliation and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing joint or muscle pain, skin changes and problems with other organs. This condition occurs rarely.
• worsening of infections such as the appearance of necrotizing fasciitis, which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and discomfort to light. This condition occurs rarely.
• a severe skin reaction known as DRESS syndrome. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects
Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)

• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reaction following exposure to sunlight (photosensitivity);
• alterations in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

Rare side effects(may affect up to 1 in 1,000 people)

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• altered vision due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in the throat (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs.

Other side effects

• pain or burning (pyrosis) in the epigastrium, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be defined based on available data);
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store BRUFEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
After first opening, use the medicine within 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRUFEN contains
The active ingredient is: ibuprofen.
1 ml of oral suspension of BRUFEN contains: 20 mg of ibuprofen.
The other ingredients are: methylparahydroxybenzoate, propylparahydroxybenzoate, citric acid monohydrate,
glycerol, liquid sorbitol, sucrose, sodium benzoate (E211), yellow orange (E110),orange essence
D717 BBA, polysorbate 80, Agar powder, purified water.

Description of the appearance of BRUFEN and contents of the pack
This medicine is available in bottles of 100 or 200 ml of oral solution, equipped with a dosing syringe of
5 ml.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milano

Manufacturer
AbbVie S.r.l. – S.R 148 Pontina Km 52 snc, 04011 Campoverde di Aprilia (LT)