BRUFEN 200 mg Film-Coated Tablets

Зміст інструкції

1. BRUFEN ANALGESICO 200 mg film-coated tablets, 400 mg film-coated tablets
   1. What is BRUFEN ANALGESICO and what is it used for
   2. What you need to know before taking BRUFEN ANALGESICO
   3. How to take BRUFEN ANALGESICO
2. BRUFEN ANALGESICO is contraindicated for use in adolescents weighing less than 40 kg or in
   1. Possible side effects
   2. How to store BRUFEN ANALGESICO
   3. Package Contents and Other Information

BRUFEN ANALGESICO 200 mg film-coated tablets, 400 mg film-coated tablets

ibuprofen (as lysine salt)

Read this leaflet carefully before taking this medicine because 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 more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days in case of fever, or after 4 days in case of pain treatment.

Contents of this leaflet:

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

1. What is BRUFEN ANALGESICO and what is it used for

BRUFEN ANALGESICO contains the active substance ibuprofen. It belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief
by modifying the body's response to pain and fever.
BRUFEN ANALGESICO tablets is used for the symptomatic treatment of mild to
moderate pain, such as headache, toothache, menstrual pain and pain and fever associated with the
common cold.

2. What you need to know before taking BRUFEN ANALGESICO

Do not take BRUFEN ANALGESICO:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have had an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue or throat, urticaria, runny and itchy nose, caused by acetylsalicylic acid (ASA) or other NSAIDs
• if you have (or have had two or more episodes of) stomach ulcers or bleeding
• if you have had a gastrointestinal perforation or bleeding while using NSAIDs
• if you suffer from cerebrovascular bleeding or other active bleeding
• if you suffer from disorders of unknown nature of blood formation
• if you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake)
• if you suffer from severe liver, kidney or heart failure
• if you are in the last 3 months of pregnancy.

(Only 200 mg)
BRUFEN ANALGESICO is contraindicated in children under 6 years of age (less than 20 kg of body weight).

(Only 400 mg)
BRUFEN ANALGESICO is contraindicated in adolescents under 40 kg of body weight or in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BRUFEN ANALGESICO:

• if you have recently undergone major surgery
• if you suffer from or have suffered from asthma or an allergic disease, because breathing difficulties may occur
• if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria
• if you suffer from heart problems
• if you have a history of gastrointestinal diseases (such as ulcerative colitis, Crohn's disease)
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (a disease that affects the skin, joints and kidneys)
• if you suffer from certain hereditary diseases of blood formation (e.g. acute intermittent porphyria)
• if you suffer from blood coagulation disorders
• if you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see section “Other medicines and BRUFEN ANALGESICO”, below) and should be avoided
• if you have chickenpox, it is advisable to avoid using BRUFEN ANALGESICO
• if you are elderly
• if you have an infection - see paragraph «Infections» below.

Patients with kidney or liver problems should consult a doctor before taking Ibuprofen tablets.
Anti-inflammatory drugs such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when administered at high doses. Do not exceed the recommended dose or duration of treatment (see paragraph 3).
You should talk to your doctor or pharmacist before taking BRUFEN ANALGESICO, if:

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

Skin reactions
Serious skin reactions have been reported in association with treatment with BRUFEN ANALGESICO.
Stop taking BRUFEN ANALGESICO and consult your doctor immediately if you develop a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See paragraph 4.
Infections
BRUFEN ANALGESICO can mask the symptoms of infections such as fever and pain. Therefore, BRUFEN ANALGESICO may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in 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, consult your doctor immediately.
Adverse effects can be minimized by using the lowest effective dose for the shortest possible period of time. Elderly patients have an increased risk of adverse effects.
In general, the habitual use of analgesics (even of different types) can lead to serious and persistent kidney problems. This risk may increase during exercise associated with salt loss and dehydration. Therefore, this should be avoided. There is a risk of impaired kidney function in dehydrated children and adolescents.
Prolonged use of any type of analgesic for headache can worsen it. If this situation is present or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication-overuse headache should be suspected in patients who have headache despite (or because of) the regular use of headache medications.
Regular monitoring of the liver, kidney function and blood cell count is required with prolonged administration of BRUFEN ANALGESICO. Your doctor may ask you to undergo blood tests during treatment.

Other medicines and BRUFEN ANALGESICO
What you should avoid when taking this medicine?
BRUFEN ANALGESICO can influence or be influenced by other medicines. For example:

• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines may also influence or be influenced by treatment with BRUFEN ANALGESICO. Therefore, you should always ask your doctor or pharmacist for advice before using BRUFEN ANALGESICO with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking:
Because this may increase the risk of ulcers or gastrointestinal bleeding

• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and analgesic drugs)
• Digoxin (for heart failure) Because the effect of digoxin may be increased Because this may increase the risk of ulcers or gastrointestinal bleeding
• Glucocorticoids (medicines containing cortisone or cortisone-like substances)
• Antiplatelet agents Because this may increase the risk of bleeding
• Acetylsalicylic acid (at low dose) Because the blood-thinning effect may be compromised Because ibuprofen may increase the effects of these medicines
• Medicines to make the blood more fluid (such as warfarin)
• Phenytoin (for epilepsy) Because the effect of phenytoin may be increased
• Selective serotonin reuptake inhibitors (medicines used for depression) Because they may increase the risk of gastrointestinal bleeding
• Lithium (a medicine for manic-depressive illness and depression) Because the effect of lithium may be increased
• Probenecid and Sulfinpyrazone (medicines for treating gout)
• Medicines for hypertension and diuretics Because ibuprofen may decrease the effects of these medicines and there may be a possible increased risk to the kidneys
• Potassium-sparing diuretics Because this may lead to hyperkalemia (high levels of potassium in the blood) Because the effect of methotrexate may be increased
• Methotrexate (a medicine for cancer and rheumatism)
• Tacrolimus and cyclosporine (immunosuppressant medicines) Because kidney damage may occur
• Zidovudine: (a medicine for the treatment of HIV/AIDS) Because the use of ibuprofen may cause an increased risk of bleeding in hemophiliacs HIV (+)
• Sulfonylureas (antidiabetic medicines) Interactions are possible
• Quinolone antibiotics Because the risk of seizures may increase Because ibuprofen may reduce the effect of this medicine
• Mifepristone (a medicine prescribed to terminate pregnancy) Because these may increase the risk of ulcers and gastrointestinal bleeding
• Bisphosphonates (medicines prescribed to treat osteoporosis) Because this may increase the risk of gastrointestinal bleeding
• Oxypentifylline (pentoxifylline) (a medicine prescribed to increase blood flow to arms and legs)
• Baclofen, a muscle relaxant Because baclofen toxicity may increase

Low-dose acetylsalicylic acid (ASA)
Do not take this medicine if you are taking ASA at a dose higher than 75 mg per day. If you are being treated with low-dose ASA (up to 75 mg per day), talk to your doctor or pharmacist before taking BRUFEN ANALGESICO.

BRUFEN ANALGESICO with alcohol
Consumption of alcohol should be avoided while using BRUFEN ANALGESICO as it may intensify possible adverse effects.

Pregnancy, breastfeeding and fertility
Do not take BRUFEN ANALGESICO during the last 3 months of pregnancy.
If you are in the first 6 months of pregnancy, if you suspect or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
BRUFEN ANALGESICO belongs to a group of medicines that can alter fertility in women.
This effect is reversible after stopping treatment. It is unlikely that BRUFEN ANALGESICO, used occasionally, will affect the likelihood of becoming pregnant, however, inform your doctor before taking this medicine if you have problems getting pregnant.

Driving and using machines
For short-term use at normal dosage, this medicine does not alter or alters negligibly the ability to drive vehicles or use machines. If adverse effects such as fatigue, dizziness, drowsiness and visual disturbances occur, you should not drive or use machines. Alcohol consumption increases the risk of these effects.

3. How to take BRUFEN ANALGESICO

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
This product is intended for short-term use only. 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 section 2).
Do not take BRUFEN ANALGESICO for more than 3 days in case of fever, or for 4 days for pain relief, unless your doctor tells you to.
If symptoms persist or worsen, consult your doctor.

(200 mg only)

Adults and adolescents weighing over 40 kg (12 years of age or older)
The recommended dose is from 200 mg to 400 mg (1 or 2 tablets) up to three times a day, as needed. Allow at least four hours between 200 mg doses (1 tablet) and at least six hours between 400 mg doses (2 tablets). Do not take more than 1200 mg (6 tablets) in 24 hours.

Use in children over 6 years of age (20 kg – 40 kg body weight)
The recommended daily dose is from 20 mg to 30 mg of ibuprofen per kg of body weight, divided into three or four separate doses, as shown in the following table. Allow at least six to eight hours between doses.

Body weightSingle doseMaximum daily dose
20 kg – 29 kg One 200 mg tablet (equivalent
to 200 mg of ibuprofen)
Three 200 mg tablets
(equivalent to 600 mg of
ibuprofen)
30 kg – 39 kg One 200 mg tablet (equivalent
to 200 mg of ibuprofen)
Four 200 mg tablets
(equivalent to 800 mg of
ibuprofen)
If this medicine is required for more than 3 days in children over 6 years of age and in adolescents, or if symptoms worsen, it is necessary to consult a doctor.

Use in children under 6 years of age (less than 20 kg weight)
BRUFEN ANALGESICO is contraindicated for use in children under 6 years of age (less than 20 kg weight).

(400 mg only)

Adults and adolescents weighing over 40 kg (12 years of age or older)
The recommended dose is 400 mg (1 tablet) up to three times a day, as needed. Allow at least six hours between 400 mg doses (1 tablet). Do not take more than 1200 mg (3 tablets) in 24 hours.
If this medicine is required for more than 3 days in children over 12 years of age and in adolescents, or if symptoms worsen, it is necessary to consult a doctor.

Use in adolescents weighing less than 40 kg or in children under 12 years of age

BRUFEN ANALGESICO is contraindicated for use in adolescents weighing less than 40 kg or in

children under 12 years of age.

Method of administration
BRUFEN ANALGESICO tablets must be swallowed whole with plenty of water. Do not
chew the tablets.
Patients with a sensitive stomach should take the tablets during a meal. Taking the
tablets after a meal may delay the onset of effect on pain or fever. Do not exceed the
recommended dose or take the tablets more frequently than recommended.

If you take more BRUFEN ANALGESICOthan you should
If you have taken more BRUFEN ANALGESICO than you should, or if a child has accidentally taken
this medicine, always contact your doctor or go to the nearest hospital for advice
on the risk and guidance on the actions to be taken.
Symptoms may include nausea, stomach pain, vomiting (may contain blood), headache, ringing
in the ears, confusion and unstable eye movements. At high doses, drowsiness,
chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness
and dizziness, blood in the urine, feeling cold and breathing problems have been reported.

If you forget to take BRUFEN ANALGESICO
Simply refer to the previous instructions on how to take the medicine and do nottake
more than recommended.

Do nottake a double dose to make up for a missed dose.
If you have any doubts 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 will experience them.
Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Elderly patients using this product have an increased risk of developing problems associated with side effects.
Medicines like BRUFEN ANALGESICO may be associated with a small increase in the risk of a heart attack (myocardial infarction) or stroke.
Some of the side effects listed below are less frequent when the maximum daily dose is 1200 mg compared to high-dose therapy in patients with rheumatic diseases.

If you think you have any of the following side effects or symptoms, stop taking this
medicine and seek immediate medical help:

• gastric or intestinal ulcers, sometimes with bleeding and perforation, vomiting with blood or black, tarry stools (common, may affect up to 1 in 10 people)
• kidney problems with blood in the urine, which may be associated with kidney failure (uncommon: may affect up to 1 in 100 people)
• severe allergic reactions (very rare: may affect up to 1 in 10,000) such as:
• difficulty breathing or unexplained wheezing
• dizziness or a fast heartbeat
• a drop in blood pressure causing shock
• swelling of the face, tongue and throat.
• skin rashes potentially life-threatening, with the formation of severe blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson Syndrome) or severe skin reactions that begin with painful red areas, then with large blisters and ultimately detachment of the skin layers. This is accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis) (very rare: may affect up to 1 in
• 10,000)
• severe skin condition that can affect the mouth and other parts of the body with symptoms including red patches, often itchy, similar to a measles rash, starting on the limbs and sometimes on the face and the rest of the body. The spots may swell or may progress to form raised, red spots with a pale center. Affected patients may have fever, sore throat, headache and/or diarrhea (very rare: may affect up to 1 in 10,000)
• severe shedding or peeling of the skin (very rare: may affect up to 1 in
• 10,000)
• a severe skin reaction known as DRESS syndrome may occur. DRESS syndrome includes: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of blood cell) (frequency not known: cannot be estimated based on available data).
• inflammation of the pancreas with severe epigastric pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000)
• nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine, which may be signs of hepatitis or liver failure (very rare: may affect up to 1 in
• 10,000)
• heart disorder with shortness of breath and swelling of the feet or legs due to fluid retention (heart failure) (frequency not known: cannot be estimated based on available data)
• aseptic meningitis (infection around the brain or spinal cord, with symptoms including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light and clouded mental state to the point of not being fully aware of the environment (very rare: may affect up to 1 in 10,000)
• heart attack (myocardial infarction, very rare: may affect up to 1 in 10,000) or stroke (frequency not known: cannot be estimated based on available data)
• severe kidney damage (papillary necrosis, especially with long-term use (rare: may affect up to 1 in 1,000)
• worsening of inflammation related to an infection (e.g. development of “flesh-eating bacteria” syndrome) particularly with the use of other NSAIDs (very rare: may affect up to 1 in 10,000).

Stop takingthe medicine and tell your doctor if you experience:
Very common: (may affect more than 1 in 10 people)

• indigestion or heartburn
• abdominal pain (stomach pain) or other stomach abnormalities

Frequency not known (the frequency cannot be estimated based on the available data)

• visual disturbances
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters mainly located on the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using BRUFEN ANALGESICO if you develop these symptoms and contact your doctor immediately. See also section 2.

Tell your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)

• nausea, flatulence, diarrhea, constipation, vomiting

Common (may affect up to 1 in 10 people)

• headache, drowsiness, dizziness, feeling giddy, fatigue, agitation, inability to sleep, irritability
• gastric and duodenal ulcers, sometimes with bleeding and perforation, occult blood loss that can lead to anemia, a condition in which there is a decrease in red blood cells (symptoms include fatigue, headache, shortness of breath during exercise, dizziness and pallor), black, tarry stools, vomiting blood, mouth ulcers and herpes, inflammation of the colon (symptoms include diarrhea, usually with blood and mucus, stomach pain and fever), worsening of inflammatory bowel disease, inflammation of the intestinal wall

Uncommon (may affect up to 1 in 100 people)

• urticaria, itching, unusual bleeding or bruising under the skin, skin rash, asthma attack (sometimes with hypotension)
• runny or blocked nose, sneezing, facial pain or pressure, difficulty breathing
• inflammation of the stomach (symptoms include: pain, nausea, vomiting, vomiting blood, blood in the stool)
• increased sensitivity of the skin to the sun
• swelling of the face, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing, sometimes with high blood pressure
• fluid retention in body tissues, especially in patients with hypertension or kidney problems

Rare (may affect up to 1 in 1,000)

• a disease affecting the skin, joints and kidneys (lupus erythematosus syndrome)
• depression, confusion, hallucinations, mental illness with strange or disturbing thoughts or mood
• ringing, whistling, hissing, buzzing or other persistent noises in the ears
• increased blood urea, transaminases and alkaline phosphatase, decreased values of hemoglobin and hematocrit, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased uric acid in the serum, all observed with a blood test
• loss of vision

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

• fast or irregular heartbeat (palpitations)
• increased fluid in body tissues
• inflammation of the esophagus, narrowing of the intestine
• liver disorders, liver damage (especially with long-term use), liver failure, yellowing of the skin and/or eyes, also known as jaundice
• severe skin infections, with complications of soft tissues, may occur if you have chickenpox
• fluid accumulation in the lungs, symptoms include shortness of breath, which can be very severe and usually worsens when lying down

Frequency not known (the frequency cannot be estimated based on the available data)

• worsening of an inflammatory disease that can affect any part of the gastrointestinal tract (symptoms include pain, fever, diarrhea and weight loss), worsening of inflammation of the colon (symptoms: diarrhea, usually with blood and mucus, stomach pain, fever).
• high blood pressure
• unusual hair loss or thinning hair
• menstrual disorders

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 the website: 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 ANALGESICO

Keep this medicine out of the sight and reach of children .

Do not usethis medicine after the expiry date which is stated on the blister, bottle and carton
after “Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Bottles: use within 60 days of opening. After opening, keep the bottle tightly closed.
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. Package Contents and Other Information

What BRUFEN ANALGESICO contains
The active ingredient is ibuprofen (as lysine).
Each 200 mg tablet contains 200 mg of ibuprofen (as lysine)
Each 400 mg tablet contains 400 mg of ibuprofen (as lysine)
The other ingredients (excipients) of one tablet are: microcrystalline cellulose, colloidal silicon dioxide
anhydrous, crospovidone, povidone, magnesium stearate, talc (E553b).
The tablet coating contains: hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol
(E1521), talc (E553b). The printing ink contains: shellac, black iron oxide (E172),
ammonium hydroxide (E527).

Description of the appearance of BRUFEN ANALGESICOand package contents
The 200 mg tablet is white to off-white in color, film-coated, round, biconvex, with
beveled edges, imprinted with black ink “M” above “IL1” on one side of the tablet and white
on the other side.
The 400 mg tablet is white to off-white in color, film-coated, oval, biconvex, with beveled
edges, imprinted with black ink “M” above “IL2” on one side of the tablet and white
on the other side.
BRUFEN ANALGESICO is available in blisters of 2, 4, 6, 10, 12, 16, 20, 24, 30, 36, 48, 50, 100, 200
tablets and in bottles of 48, 100, 200 tablets (dispensing pack). Each bottle
also contains silica gel (desiccant) which helps to protect the tablets from moisture.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
via Vittor Pisani, 20
20124 Milan

Manufacturers
McDermott Laboratories Limited T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft., H-2900, Komarom Mylan street 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: