Brufenkids for fever and pain

Package leaflet: Information for the patient

BRUFENKIDS FEVER AND PAIN 20 mg/ml oral suspension

ibuprofen
Please 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What BRUFENKIDS FEVER AND PAIN is and what it is used for
2. What you need to know before taking BRUFENKIDS FEVER AND PAIN
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

1. What BRUFENKIDS FEVER AND PAIN is and what it is used for

BRUFENKIDS FEVER AND PAIN contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are medications used to relieve pain, fever, and inflammation.
BRUFENKIDS FEVER AND PAIN is used to treat:

• fever;
• mild to moderate pain.

BRUFENKIDS FEVER AND PAIN can be used in infants and children aged between 3 months and 12 years.

2. What you should know before taking BRUFENKIDS FEVER AND PAIN

Do not take BRUFENKIDS FEVER AND PAIN:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced allergic symptoms (e.g. difficulty breathing, nasal congestion, skin rash) after taking aspirin or other anti-inflammatory medicines, particularly if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a stomach or duodenal ulcer;
• if you have ever had a single episode of stomach or intestinal ulcer, perforation, or bleeding (including blood in vomit or stool, or black, tarry stools) caused by taking medicines;
• if you have had two or more separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or stool, 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 severely dehydrated, for example due to severe episodes of vomiting, diarrhoea, or very low fluid intake;
• during the third trimester of pregnancy.

Do not use BRUFENKIDS FEVER AND PAIN in children under 3 months of age or weighing less than 5 kg.
Warnings and precautions
Talk to your doctor before taking BRUFENKIDS FEVER AND PAIN if:

• you suffer from systemic lupus erythematosus (SLE, commonly known as lupus) or mixed connective tissue disease, conditions affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs;
• you have had stomach or intestinal disorders, such as ulcer, Crohn’s disease, or ulcerative colitis;
• you have reduced kidney function;
• you have liver problems;
• you have blood clotting disorders;
• you have or have had allergies (e.g. hay fever);
• you have nasal inflammation (chronic rhinitis) or nasal polyps;
• you are elderly, as you are more likely to experience adverse effects from this medicine;
• you have chickenpox, as pain and inflammation medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• you are a child, adolescent, or elderly person and are dehydrated, as you are at higher risk of kidney problems;
• you have an infection – see section “Infections” below.

Heart attack and stroke
Anti-inflammatory/pain medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking BRUFENKIDS FEVER AND PAIN if you:

• have heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack);
• have 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 difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking BRUFENKIDS FEVER AND PAIN immediately and contact your doctor or emergency medical services if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using BRUFENKIDS FEVER AND PAIN and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Infections
BRUFENKIDS FEVER AND PAIN may mask symptoms of infections such as fever and pain. Therefore, BRUFENKIDS FEVER AND PAIN could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
BE CAREFUL, because during treatment with all pain and anti-inflammatory medicines (NSAIDs):

• at any time, with or without warning symptoms, even in patients without prior serious gastrointestinal problems (stomach or intestine), bleeding, ulceration, or perforation of the stomach or intestine may occur, which can be fatal;
• although very rarely, serious skin reactions, some of which have been fatal, may occur, manifesting as redness, blistering, and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial phase of therapy, patients appear to be at higher risk: such reactions usually occur within the first month of treatment;
• eye disorders may occur if BRUFENKIDS FEVER AND PAIN is used for prolonged treatment. Regular eye examinations are necessary during therapy;
• headache may occur, especially if used for prolonged periods and at high doses; in such cases, do not increase the dose of BRUFENKIDS FEVER AND PAIN to relieve pain.

The risk of adverse effects may be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not exceed the recommended dose of BRUFENKIDS FEVER AND PAIN or take it for long periods; always follow your doctor's instructions carefully.
STOP treatment and contact your doctor if:

• you notice any gastrointestinal symptoms (stomach or intestine), especially bleeding;
• a skin 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).

Other medicines and BRUFENKIDS FEVER AND PAIN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as some medicines may interact with BRUFENKIDS FEVER AND PAIN or increase the risk of adverse effects, even serious ones.
BRUFENKIDS FEVER AND PAIN may affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs and selective COX-2 inhibitors);
• cardiac glycosides (e.g. digoxin), medicines used for heart conditions;
• sulfonylureas, medicines used for diabetes;
• medicines with anticoagulant effect (i.e. substances that thin the blood, preventing clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that suppress the immune system;
• medicines that lower high 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;
• zidovudine and ritonavir, medicines used in HIV infections;
• methotrexate, used in cancer treatment and for certain immune system disorders, e.g. rheumatoid arthritis;
• colestyramine, a medicine used to lower blood cholesterol levels;
• lithium, used in depression;
• voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a herbal extract used to improve circulation;
• probenecid, a medicine used for gout;
• mifepristone, a medicine used for medical termination of pregnancy.

Other medicines may also affect or be affected by treatment with BRUFENKIDS FEVER AND PAIN. Therefore, always consult your doctor or pharmacist before taking BRUFENKIDS FEVER AND PAIN with other medicines.
BRUFENKIDS FEVER AND PAIN and alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may be more likely when consuming alcohol during treatment with BRUFENKIDS FEVER AND PAIN.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• Do not use BRUFENKIDS FEVER AND PAIN during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause problems with the baby’s heart, lungs, or kidneys. It may affect your or your baby’s tendency to bleed and delay or prolong labour more than expected.
• During the first months of pregnancy (up to the sixth month) or if you are breastfeeding, this medicine should only be used when strictly necessary and under direct medical supervision. If treatment is needed during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, BRUFENKIDS FEVER AND PAIN may cause kidney problems in the unborn baby if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing 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.
• If you are planning a pregnancy or have difficulty conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the medicine.

Driving and using machines
BRUFENKIDS FEVER AND PAIN may cause side effects that could impair your reaction to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue, and visual disturbances. Make sure you do not experience any of these side effects before driving, operating machinery, or doing anything that requires alertness. This is particularly important when consuming alcohol during treatment with BRUFENKIDS FEVER AND PAIN.
BRUFENKIDS FEVER AND PAIN 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 them 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 (a main component of table salt) per 2.5 ml dose. This corresponds to 0.45% of the maximum daily dietary intake recommended for an adult.
This medicine contains the following amounts of sodium (a main component of table salt) for 5 ml, 7.5 ml, 10 ml, and 15 ml doses.

3. How to take BRUFENKIDS FEVER AND PAIN

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Infants and children aged between 3 months and 12 years, weighing more than 5 kg
The daily dose is calculated based on the child's body weight. The usual dose is 20–30 mg per kg of body weight per day, divided into 3 doses (every 8 hours), unless otherwise directed by the doctor. The maximum dose is 30 mg per kg of body weight per day.
Refer to the table below, 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, if you feel worse, or if new symptoms appear after treatment for:

• 3 days in infants and children over 6 months of age and in adolescents;
• 1 day in infants aged between 3 and 5 months.

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 doses indicated above.
Method of administration
BRUFENKIDS FEVER AND PAIN must be taken by mouth (oral use).
BRUFENKIDS FEVER AND PAIN may be taken on an empty stomach. However, some people may experience stomach discomfort. If this occurs, take BRUFENKIDS FEVER AND PAIN with food to avoid stomach disturbances.
You may experience a slight burning sensation in the mouth or throat after taking the medicine.
Shake the bottle well before each use.
Use the dosing syringe provided inside the package to take the correct dose. The syringe has markings for two different dosages: the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen.
To use the dosing syringe, follow these instructions:

1. Unscrew the cap by pushing down and turning to the left (Fig. 1).
2. Insert the tip of the syringe fully into the opening of the inner cap (Fig. 2).
3. Shake well.
4. Invert the bottle, 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 an upright position and remove the syringe by gently rotating it.
6. Insert the tip of the syringe into the child's mouth, and gently press the plunger to dispense the suspension.
7. After use, close the bottle by screwing the cap back on (Fig. 4). Wash the syringe with warm water and allow it to 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 accidentally taken this medicine, always contact your doctor or go to the nearest hospital to obtain advice on the risk and what actions to take.
If you take excessive doses of BRUFENKIDS FEVER AND PAIN, you may experience: nausea, stomach ache, vomiting (possibly with traces of blood), blood in the urine, low potassium levels in the blood, diarrhea, abdominal or chest pain, 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 uncontrolled, oscillating eye movements (nystagmus), decreased blood pH (metabolic acidosis), weakness and dizziness, fainting, seizures (especially in children), disorientation, agitation, breathing problems (even severe), symptoms of central nervous system depression such as drowsiness, feeling cold (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 the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects
Stop taking BRUFENKIDS FEVER AND PAIN and contact your doctor immediately if you experience any of the following conditions:

• severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal ulcers (peptic ulcers), sudden and severe pain in the upper abdomen or stomach area (gastrointestinal perforation). These side effects are uncommon;
• vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestines (gastrointestinal haemorrhage), or unusual fatigue with reduced urine output (due to non-visible bleeding). These conditions are common side effects;
• allergic reactions, even severe ones, appearing more or less suddenly with skin lesions, such as discoloured spots or widespread rash (rash, purpura), urticaria, itching, swelling (angioedema) of the face, eyes, lips, tongue and throat, possibly causing difficulty breathing or swallowing. Increased heart rate and sudden drop in blood pressure may also occur (anaphylactic reaction, anaphylaxis or severe shock);
• severe skin rashes with redness, peeling and/or blister formation (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and bullous dermatitis). These conditions occur very rarely;
• difficulty breathing (asthma, bronchospasm, dyspnoea or apnoea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE, commonly known as lupus), a disease affecting connective tissue causing joint or muscle pain, skin changes and problems in other organs. This condition occurs rarely;
• worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, 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) presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely;
• a severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using BRUFENKIDS FEVER AND PAIN if you develop these symptoms and contact your doctor immediately. See also section 2;
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin reactions 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 severe 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, diarrhoea, intestinal gas (flatulence), difficulty passing stools (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;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensation (paraesthesia);
• ringing in the ears (tinnitus), impaired hearing, vision disturbances;
• development of skin lesions after sun exposure (photosensitivity);
• changes in liver function, yellowing 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), changes in function (renal failure).

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

• decrease in the number of white blood cells (leucopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decrease in platelet count (thrombocytopenia), decrease in red blood cells due to destruction (haemolytic anaemia) or bone marrow problems (aplastic anaemia);
• depression, confusion;
• vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (oedema).

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

• reduced liver function, inflammation of the pancreas (pancreatitis);
• sensation of heart pounding (palpitations), heart attack, reduced heart function (heart failure), high blood pressure (hypertension);
• breathing difficulties due to lung oedema;
• kidney damage (acute renal failure, papillary necrosis).

Other side effects with unknown frequency (frequency cannot be estimated from available data)

• burning sensation in the mouth or throat, pain or burning in the upper stomach (pyrosis), inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise, reduced appetite.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps 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 stated on the packaging. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions. After first opening, use the medicine within 6 months.
Do not dispose of any medicine via 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 BRUFENKIDS FEVER AND PAIN contains
The active substance is: ibuprofen.
1 millilitre of BRUFENKIDS FEVER AND PAIN oral suspension contains: 20 mg of ibuprofen.
The other components 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 FEVER AND PAIN and contents of the pack
This medicine is available in bottles of 100, 150 or 200 ml of oral solution, supplied with a 5 ml dosing syringe.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan
Manufacturer
AbbVie S.r.l. – S.R 148 Pontina Km 52 snc, 04011 Campoverde di Aprilia (LT)