BRUFENKIDS 20 mg /Ml Oral Suspension

Зміст інструкції

1. BRUFENKIDS FEBBRE E DOLORE 20 mg/ml oral suspension
   1. What is BRUFENKIDS FEBBRE E DOLORE and what is it for
   2. What you need to know before taking BRUFENKIDS FEBBRE E DOLORE
   3. How to take BRUFENKIDS FEVER AND PAIN
   4. Possible side effects
   5. How to store BRUFENKIDS FEVER AND PAIN
   6. Contents of the pack and other information

BRUFENKIDS FEBBRE E DOLORE 20 mg/ml oral suspension

ibuprofen

Read this leaflet carefully before 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 more information or advice, ask your doctor or pharmacist.
• If you experience any side effects, 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 a short period of treatment.

Contents of this leaflet:

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

1. What is BRUFENKIDS FEBBRE E DOLORE and what is it for

BRUFENKIDS FEBBRE E DOLORE 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.
BRUFENKIDS FEBBRE E DOLORE is used to treat:

• fever;
• mild to moderate pain.

BRUFENKIDS FEBBRE E DOLORE can be used in infants and children aged between 3 months and 12
years.

2. What you need to know before taking BRUFENKIDS FEBBRE E DOLORE

Do not take BRUFENKIDS FEBBRE E DOLORE:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic symptoms (such as difficulty breathing, nasal congestion, skin rashes) after taking aspirin or other anti-inflammatory drugs, especially if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a stomach or duodenal ulcer;
• if you have had even one episode of ulcer, perforation or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools) caused by taking medicines;
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• if you have severe liver or kidney problems;
• if you suffer from severe heart failure;
• if you have any condition that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe vomiting, diarrhea or drink very little;
• during the third trimester of pregnancy.

Do not use BRUFENKIDS FEBBRE E DOLORE in children under 3 months of age or weighing less than 5 Kg.

Warnings and precautions
Consult your doctor before taking BRUFENKIDS FEBBRE E DOLORE if:

• you suffer from systemic lupus erythematosus (SLE, known as lupus) 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 diseases of the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis;
• 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 are elderly, as you are more likely to develop adverse events with this medicine;
• you have chickenpox, as pain and inflammation medications (NSAIDs) can worsen the severity of skin lesions caused by it. In such cases, your doctor may advise you not to use this medicine;
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• if you are a child or adolescent or an elderly person and are dehydrated 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 BRUFENKIDS FEBBRE E DOLORE 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
BRUFENKIDS FEBBRE E DOLORE 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 ibuprofen treatment. Stop using BRUFENKIDS FEBBRE E DOLORE and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph

• 4.

Infections
BRUFENKIDS FEBBRE E DOLORE can mask the symptoms of infections such as fever and pain. Therefore,
BRUFENKIDS FEBBRE E DOLORE 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 are taking this medicine while you
have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

CAUTION, as during treatment with all pain and inflammation medications (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 fatal;
• even if very rarely, severe skin reactions have been reported, some of which are fatal, manifesting with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Patients appear to be at higher risk in the early stages of therapy: such reactions occur in most cases within the first month of treatment;
• eye changes may occur if you use BRUFENKIDS FEBBRE E DOLORE for prolonged treatments. Periodic eye checks are necessary during therapy;
• especially if used for prolonged periods and at high doses, headache may occur; in such cases, do not increase the dose of BRUFENKIDS FEBBRE E DOLORE to relieve the pain.

The risk of having undesirable effects can be reduced by using the lowest effective dose and for the shortest duration possible of treatment needed to control the symptoms. Do not exceed the dose of
BRUFENKIDS FEBBRE E DOLORE 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;
• a skin 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.

Other medicines and BRUFENKIDS FEBBRE E DOLORE
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines, even those available without a prescription, as some medicines may
interact with BRUFENKIDS FEBBRE E DOLORE or increase the risk of adverse events, even serious.
BRUFENKIDS FEBBRE E DOLORE can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs and COX-2 selective inhibitors);
• 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);
• medicines containing cortisone (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;
• voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a plant extract used to improve circulation;
• probenecid, a medicine used for gout;
• mifepristone, a medicine used for medical abortion.

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

BRUFENKIDS FEBBRE E DOLORE 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 BRUFENKIDS FEBBRE E
DOLORE.

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

• Do not use BRUFENKIDS FEBBRE E DOLORE in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the heart, lungs or kidneys of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.
• During the first months of pregnancy (up to the sixth month) or if you are breastfeeding, this medicine should be used only when necessary and under the direct supervision of your doctor. If you need treatment during this period or during attempts to conceive, you should use the minimum dose for the shortest possible time. From the 20th week of pregnancy, BRUFENKIDS FEBBRE E DOLORE can cause kidney problems in the fetus if taken for more than a few days, thus reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing 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.
• 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 using machines
BRUFENKIDS FEBBRE E DOLORE can cause side effects that can 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 particularly
important when you drink alcohol during treatment with BRUFENKIDS FEBBRE E DOLORE.

BRUFENKIDS FEBBRE E DOLORE contains:

• Sodium benzoate (E211):this medicine contains 5 mg of sodium benzoate per 5 ml of suspension equivalent to 1 mg/ml. It may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
• Maltitol:if your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine; it may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g.
• Azorubine (E122):may cause allergic reactions.

This medicine contains 8.96 mg of sodium (the main component of table salt) per 2.5
ml dose. This is equivalent to 0.45% of the recommended daily intake of salt for an
adult.
This medicine contains the following amounts of sodium (the main component of table salt) for the
dosages of 5 ml, 7.5 ml, 10 ml and 15 ml.

3. How to take BRUFENKIDS FEVER AND PAIN

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. 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).

Infants and children between 3 months and 12 years of age who weigh more than 5 kg
The daily dose is calculated based on the child's weight. The usual dose is 20 - 30 mg per each kg of body weight per day, to be taken in 3 administrations (every 8 hours), unless specifically indicated by the doctor. The maximum doseis 30 mg per each kg of body weight per day.
Consult the following table, which provides some examples, to take the correct dose:

Duration of treatment
Use the lowest dose for the shortest period of time necessary to relieve symptoms.
Consult your doctor if you do not feel better or feel worse or new symptoms appear after a treatment of:

• 3 days in infants and children over 6 months of age and in adolescents;
• 1 day 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.
Method of administration
BRUFENKIDS FEVER AND PAIN must be taken orally (oral use).
BRUFENKIDS FEVER AND PAIN can be taken on an empty stomach. However, some people may experience some stomach discomfort. If this occurs, take BRUFENKIDS FEVER AND PAIN with food to avoid stomach discomfort.
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 that you find inside the package to take the correct dose. The syringe has markings for the two different dosages: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.
For using the dosing syringe follow these instructions:

• 1. Unscrew the cap by pushing it down and turning it to the left (Fig. 1).
• 2. Fully insert the tip of the syringe into the hole in the sub-cap (Fig. 2).
• 3. Shake well.
• 4. Turn the bottle upside down while holding the syringe firmly; gently pull the plunger down to draw the suspension into the syringe up to the mark corresponding to the desired dose (Fig. 3).
• 5. Return the bottle to the vertical position and remove the syringe by gently rotating it.
• 6. Insert the tip of the syringe into the child's mouth, and apply slight pressure to the plunger to expel the suspension.
• 7. After use, close the bottle by screwing the cap on (Fig. 4). Wash the syringe with warm water and let it dry.

Fig. 1 Fig. 2 Fig. 3 Fig. 4

If you take more BRUFENKIDS FEVER AND PAIN than you should, or 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 on the actions to be taken.
If you take high doses of BRUFENKIDS FEVER AND PAIN 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, 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 (even serious) of breathing, symptoms of depression 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 BRUFENKIDS FEVER AND PAIN
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.

Serious side effects
Stop taking BRUFENKIDS FEBBRE E DOLORE and contact your doctor immediately if any of the following occur:

• serious stomach problems, burning or abdominal pain due to stomach or duodenal ulcers (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), associated with bleeding from the stomach or intestines (gastrointestinal hemorrhage) or unusual fatigue with reduced urine output (due to non-visible bleeding). These conditions are common side effects;
• allergic reactions, even severe, manifesting with more or less sudden skin lesions, for example, color changes in patches or widespread (rash, purpura), hives, itching, swelling (angioedema) of the face, eyes, lips, tongue and throat with possible difficulty breathing and swallowing. Increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis or severe shock) may also occur;
• 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 are very rare;
• difficulty breathing (asthma, bronchospasm, dyspnea or apnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE, known as lupus), a disease that affects connective tissue causing joint or muscle pain, skin changes and problems with other organs. This condition is rare;
• 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 sensitivity to light. This condition is rare;
• 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 BRUFENKIDS FEBBRE E DOLORE 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;
• rash.

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

• inflammation of the nose (rhinitis);
• gastritis, mouth ulcers;
• vertigo, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• ringing in the ears (tinnitus), impaired hearing, visual disturbances;
• appearance of skin lesions following exposure to the sun (photosensitivity);
• alterations in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of liver inflammation (hepatitis);
• hypersensitivity reactions (urticaria, itching);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), impaired 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 racing (palpitations), heart attack, reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs (pulmonary edema);
• kidney damage (acute renal failure, papillary necrosis).

Other side effects with unknown frequency(frequency cannot be estimated on the basis of available data)

• burning sensation in the mouth or throat, 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 varicella;
• stroke;
• hallucinations, malaise, loss of appetite.

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 BRUFENKIDS FEVER AND PAIN

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. After first opening, use the medicine within 6 months.
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 BRUFENKIDS FEBBRE E DOLORE contains
The active ingredient is: ibuprofen.
1 millilitre of oral suspension of BRUFENKIDS FEBBRE E DOLORE contains: 20 mg of ibuprofen.
The other ingredients are: sodium benzoate (E-211),anhydrous citric acid, sodium citrate, sodium saccharin,
sodium chloride, hypromellose, xanthan gum, maltitol syrup, strawberry flavour, azorubine (E-122),
glycerol (E-422), purified water.

Description of the appearance of BRUFENKIDS FEBBRE E DOLORE and contents of the pack
This medicine is available in bottles of 100, 150 or 200 ml of oral solution, equipped with a 5 ml
dosing syringe.

Marketing authorisation holder and manufacturer
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)