Ibunid for children forte

Package leaflet: Information for the user

Ibunid dla dzieci Forte, 200 mg/5 ml, oral suspension
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement within 24 hours in infants aged 3–5 months, or within 3 days in infants over 6 months of age, children, adolescents, or adults, or if the patient feels worse, consult a doctor.

Table of contents

1. What Ibunid dla dzieci Forte is and what it is used for
2. Important information before taking Ibunid dla dzieci Forte
3. How to take Ibunid dla dzieci Forte
4. Possible side effects
5. How to store Ibunid dla dzieci Forte
6. Contents of the pack and other information

1. What Ibunid dla dzieci Forte is and what it is used for

Ibunid dla dzieci Forte contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This medicine helps relieve fever, pain, and inflammation.
Ibunid dla dzieci Forte is intended for use in infants from 3 months of age, children, adolescents, and adults in the following conditions:

• Fever of various causes (including viral infections and post-vaccination reactions),
• Mild to moderate pain of various origins: headache, sore throat, and muscle pain, e.g., during viral infections; muscle, joint, and bone pain due to musculoskeletal injuries (strains, sprains); pain due to soft tissue injuries; postoperative pain; toothache; pain following dental procedures; pain associated with teething; headache; ear pain occurring in middle ear inflammatory conditions.

If there is no improvement within 24 hours in infants aged 3–5 months, or within 3 days in infants over 6 months of age, children, adolescents, or adults, or if the patient feels worse, consult a doctor.

2. Important information before using Ibunid dla dzieci Forte

When not to use Ibunid dla dzieci Forte:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• in patients who have previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma, or angioedema after taking acetylsalicylic acid or other NSAIDs,
• in patients with blood coagulation disorders (ibuprofen may prolong bleeding time),
• in patients with active or past peptic ulcer or duodenal ulcer, or recurrent gastrointestinal bleeding (defined as two or more episodes of ulceration or bleeding),
• in patients with gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active bleeding or blood formation disorders of unknown origin (such as thrombocytopenia),
• in patients with severe hepatic insufficiency,
• in patients with severe renal insufficiency,
• in patients with severe heart failure,
• during the third trimester of pregnancy,
• in patients with haemorrhagic diathesis,
• in infants under 3 months of age,
• in patients with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Warnings and precautions
Before starting treatment with Ibunid dla dzieci Forte, consult a doctor or pharmacist.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms (see section 3 and information below).
Allergic reactions to ibuprofen have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Ibunid dla dzieci Forte immediately and contact a doctor or emergency medical services without delay.
Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been associated with ibuprofen use. If any of these symptoms occur, discontinue Ibunid dla dzieci Forte immediately and seek medical help.
Avoid concomitant use of ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Consult a doctor if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• congenital porphyria metabolism disorders (e.g. acute intermittent porphyria),
• allergic reactions after taking acetylsalicylic acid,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart dysfunction,
• kidney function disorders,
• liver function disorders,
• blood coagulation disorders,
• active or past bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• use of other medications (especially anticoagulants, diuretics, cardiac medications, corticosteroids),
• presence of infection – see below, section titled "Infections".

If any signs of hypersensitivity occur after taking Ibunid dla dzieci Forte (e.g. anaphylactic shock), discontinue use of the medicine and contact a doctor immediately.
Use of anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibunid dla dzieci Forte, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral artery disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker.

Infections
Ibunid dla dzieci Forte may mask objective signs of infection such as fever and pain.
Therefore, Ibunid dla dzieci Forte may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an ongoing infection and symptoms persist or worsen, consult a doctor immediately.
In rare cases, chickenpox may lead to severe, complicated skin and soft tissue infections. Currently, a potential influence of NSAIDs on the worsening of these infections cannot be ruled out. Therefore, it is recommended to avoid using ibuprofen in cases of chickenpox.

Infants, children and adolescents
In dehydrated infants, children, and adolescents, there is a risk of impaired kidney function.

Effect on the circulatory system and cerebral vessels
In some patients, non-steroidal anti-inflammatory drugs (NSAIDs) may cause oedema and fluid retention. Patients who develop oedema after taking Ibunid dla dzieci Forte should consult a doctor.

Effect on the gastrointestinal tract
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with a history of such symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly patients (Ibunid dla dzieci Forte may also be used by adults), should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial phase of treatment.

Elderly patients
Elderly patients have a higher risk of adverse effects associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), particularly gastrointestinal bleeding and ulceration, which may be fatal. Any unusual gastrointestinal symptoms (especially bleeding) should be reported to a doctor, particularly during the initial phase of treatment. These patients should use the lowest possible dose of the medicine.

Kidney function disorders
As with other non-steroidal anti-inflammatory drugs (NSAIDs), prolonged use of Ibunid dla dzieci Forte may lead to renal papillary necrosis and other kidney disorders. Patients with kidney function disorders, heart failure, those taking diuretics or angiotensin-converting enzyme (ACE) inhibitors, and elderly patients are most susceptible to worsening kidney function.

Liver function disorders
Patients treated with Ibunid dla dzieci Forte, especially long-term, should have liver function monitored regularly. If liver enzyme activity, bilirubin levels, or alkaline phosphatase levels increase to twice the normal value, treatment should be discontinued immediately. Re-treatment with ibuprofen should be avoided in such cases.

Appropriate precautions should be taken in patients with kidney, liver, or heart insufficiency and those prone to fluid retention, as NSAIDs may worsen kidney function. In these patients, the dose should be kept as low as possible, and kidney function should be monitored.

Skin reactions
Severe skin reactions, some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported with NSAIDs.
The highest risk of these severe reactions occurs at the beginning of therapy, mostly within the first month of treatment.
Discontinue use of Ibunid dla dzieci Forte immediately upon the first signs of skin rash, mucosal lesions, or other hypersensitivity symptoms.

Other warnings
At the beginning of treatment with Ibunid dla dzieci Forte, as with other NSAIDs, caution should be exercised in patients with significant dehydration.
Ibunid dla dzieci Forte, like other non-steroidal anti-inflammatory drugs (NSAIDs), may inhibit platelet aggregation and prolong bleeding time.
During long-term, high-dose analgesic treatment, headaches may occur, which should not be treated with increased doses of these medicines. In general, chronic use of analgesics, especially in combination with other analgesics, may lead to permanent kidney damage and risk of renal failure (analgesic nephropathy - post-analgesic).
Particular caution should be exercised in patients with bronchial asthma, as Ibunid dla dzieci Forte may induce bronchospasm in these patients.
Avoid alcohol consumption, as it may exacerbate adverse effects of NSAIDs, particularly on the gastrointestinal tract or central nervous system.
Ibunid dla dzieci Forte may temporarily inhibit platelet aggregation and prolong bleeding time. Therefore, patients with coagulation disorders or undergoing anticoagulant therapy should be closely monitored by a doctor. In case of long-term ibuprofen treatment, periodic monitoring of liver and kidney function and blood cell counts is necessary, especially in high-risk patients.
NSAIDs may cause visual disturbances (scotoma, colour vision disturbances). In such cases, discontinue the medicine and perform an ophthalmological examination.
Use of medicines such as Ibunid dla dzieci Forte may be associated with a small increased risk of myocardial infarction or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended. If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms occur, contact a doctor.
In case of heart function disorders, history of stroke, or suspected risk of such disorders (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with a doctor or pharmacist.

Ibunid dla dzieci Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Avoid taking Ibunid dla dzieci Forte with the following medicines:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors,
• acetylsalicylic acid (ASA),
• other analgesics.

Ibunid dla dzieci Forte may affect the action of other medicines, or other medicines may affect the action of Ibunid dla dzieci Forte. For example:

• antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan, potassium-sparing diuretics),
• cardiac glycosides (e.g. digoxin),
• anticoagulant drugs (i.e. blood thinners/preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• antiplatelet drugs,
• selective serotonin reuptake inhibitors (SSRIs),
• sulfonylureas,
• zidovudine,
• probenecid and sulfinpyrazone,
• baclofen,
• phenytoin,
• lithium and methotrexate,
• ritonavir,
• corticosteroids,
• cyclosporine,
• tacrolimus,
• voriconazole and fluconazole,
• cholestyramine,
• aminoglycosides,
• quinolone antibiotics.

Some other medicines may also be affected by or influence treatment with Ibunid dla dzieci Forte. Therefore, always consult a doctor or pharmacist before using Ibunid dla dzieci Forte with other medicines.

Ibunid dla dzieci Forte with food and drink
In patients with sensitive gastrointestinal tract, it is recommended to take the medicine during a meal or with milk.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Ibunid dla dzieci Forte during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprofen may cause kidney and heart disorders in the unborn child. It may increase the tendency to bleed in both the mother and the child and may delay or prolong labour. During the first 6 months of pregnancy, ibuprofen should not be used unless a doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
Ibunid dla dzieci Forte taken for longer than a few days from week 20 of pregnancy may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or constriction of the ductus arteriosus in the child's heart. If prolonged treatment is required, the doctor may recommend additional monitoring.

Ibuprofen may pass into breast milk in small amounts. No cases of adverse effects in breastfed infants have been reported; therefore, in principle, there is no need to discontinue breastfeeding during short-term ibuprofen treatment at doses used for pain and fever relief.
Ibunid dla dzieci Forte belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which may affect fertility in women. This effect is reversible and resolves after discontinuation of the medicine.

Driving and operating machinery
No data are available on adverse effects affecting the ability to drive vehicles, operate machinery, or psycho-motor performance.

Ibunid dla dzieci Forte contains liquid maltitol (E 965), sodium benzoate (E 211), benzyl alcohol, and sodium

Liquid maltitol (E 965)
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking the medicine.

Sodium benzoate (E 211)
The medicine contains 5 mg of sodium benzoate in 5 ml of suspension.

Benzyl alcohol
The medicine contains 0.000826 mg of benzyl alcohol in 5 ml of suspension. Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney diseases should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's recommendation.

Sodium
The medicine contains 28.95 mg of sodium (main component of table salt) in 5 ml of suspension. This corresponds to approximately 1.5% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Ibunid dla dzieci Forte

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest necessary duration to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Using the medicine at the lowest effective dose for the shortest necessary duration reduces the risk of adverse effects (see effects on the gastrointestinal tract and circulatory system).

Recommended dosage of Ibunid dla dzieci Forte:
Infants aged 3 to 6 months (body weight 5–7.6 kg): 3 times 1.25 ml per day (equivalent to 150 mg of ibuprofen per day)
Infants aged 6 to 12 months (body weight 7.7–9 kg): 3 to 4 times 1.25 ml per day (equivalent to 150–200 mg of ibuprofen per day)
Children aged 1 to 3 years (body weight 10–15 kg): 3 times 2.5 ml per day (equivalent to 300 mg of ibuprofen per day)
Children aged 4 to 6 years (body weight 16–20 kg): 3 times 3.75 ml per day (equivalent to 450 mg of ibuprofen per day)
Children aged 7 to 9 years (body weight 21–29 kg): 3 times 5 ml per day (equivalent to 600 mg of ibuprofen per day)
Children aged 10 to 12 years (body weight 30–40 kg): 3 times 7.5 ml per day (equivalent to 900 mg of ibuprofen per day)
Adults and adolescents over 12 years of age: the recommended dose for symptomatic treatment of pain and fever is 3 times 10 ml per day (equivalent to 1200 mg of ibuprofen per day), until symptoms subside.

Elderly patients: Dosage should be individually determined by a doctor. Consideration should be given to reducing the dose. In patients with renal impairment, dosage should take into account the degree of kidney function.

Doses should be administered approximately every 6 to 8 hours.

Patients with renal function disorders
Exercise caution when using this medicine in patients with impaired kidney function.
In patients with mild to moderate renal impairment, consider reducing the dose. Ibuprofen should not be used in patients with acute renal failure.

Patients with hepatic function disorders
Ibuprofen should not be used in patients with acute liver failure.

Method of administration
For oral use only.
Shake well before use. The medicine may be administered directly or diluted in water or juice.
In patients with a sensitive gastrointestinal tract, it is recommended to take the medicine during a meal or with milk.

The package includes an oral dosing syringe (5 ml) with graduated markings to facilitate accurate dosing:

Instructions for use:

1. Before each use, shake the bottle well to ensure no visible sediment remains at the bottom.
2. Unscrew the bottle cap by pressing it down and turning counterclockwise. Firmly insert the oral syringe into the neck of the bottle.
3. To fill the dosing syringe, invert the bottle, then slowly pull the plunger down until the suspension reaches the desired mark on the syringe.
4. Return the bottle to an upright position and carefully remove the syringe by twisting it out.
5. Place the tip of the syringe into the child's mouth and slowly depress the plunger to carefully dispense the contents.
6. After each use, close the bottle with the cap, separate the plunger from the syringe barrel, and wash both parts with warm water. Allow to air dry. Wipe the outside of the syringe with a clean cloth before next use.

Do not exceed the recommended dose.
This medicine is intended for oral use only and for short-term treatment. If symptoms persist or worsen, or if new symptoms appear, consult a doctor.
Infants under 6 months of age should only receive this medicine after consultation with and on the advice of a doctor. This medicine is not intended for use in infants under 3 months of age or weighing less than 5 kg.
Do not use this medicine for longer than 3 days without medical advice.

Use in infants, children, and adolescents
For infants aged 3 to 5 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
For infants over 6 months of age, children, and adolescents, consult a doctor if treatment is needed for more than 3 days or if symptoms worsen.

Overdose of Ibunid dla dzieci Forte
If a patient takes more than the recommended dose of Ibunid dla dzieci Forte or if a child accidentally ingests the medicine, always seek medical advice from a doctor or go to the nearest hospital for assessment of potential health risks and guidance on necessary actions. Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures may rarely occur in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms is possible. Additionally, low blood pressure and breathing difficulties may occur.

Missed dose of Ibunid dla dzieci Forte
Do not take a double dose to make up for a missed dose.

Stopping treatment with Ibunid dla dzieci Forte
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects listed below have been observed during short-term use of ibuprofen at doses available without a prescription. Other adverse effects may occur when ibuprofen is used for other indications or for prolonged periods.

Frequently occurring adverse effects (may affect up to 1 in 10 patients):

• feeling of fatigue.

Uncommonly occurring adverse effects (may affect up to 1 in 100 patients):

• indigestion, abdominal pain, nausea;
• headache;
• urticaria and itching;
• visual disturbances.

Rarely occurring adverse effects (may affect up to 1 in 1,000 patients):

• diarrhoea, flatulence, constipation, vomiting, inflammation of the gastric mucosa;
• dizziness, insomnia, restlessness, irritability and feeling of fatigue (depression, psychotic reactions and tinnitus have also been reported);
• oedema;
• toxic optic neuropathy;
• swelling.

Very rarely occurring adverse effects (may affect up to 1 in 10,000 patients):

• tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, sometimes with fatal outcome, particularly in elderly patients, perforation may occur;
• decreased urine output, renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
• liver function disorders (particularly during long-term use);
• blood count abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - a haematological disorder characterised by deficiency of all normal blood cells: erythrocytes, leukocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds);
• erythema multiforme, bullous reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis; severe skin and soft tissue infections may exceptionally occur as complications during chickenpox;
• facial, tongue and laryngeal swelling, dyspnoea, tachycardia - cardiac arrhythmia, hypotension - low blood pressure, shock. Asthma exacerbation and bronchospasm. In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), symptoms typical of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, and disorientation have been reported during ibuprofen treatment;
• oedema, hypertension, heart failure associated with high-dose use of NSAIDs. Cases of oedema, hypertension and heart failure have been reported with NSAID use. Use of drugs such as ibuprofen may be associated with a small increased risk of myocardial infarction (heart attack) or stroke; severe skin and soft tissue infections during chickenpox. Exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis) has been reported.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• skin becomes sensitive to light,

• drug reaction with eosinophilia and systemic symptoms. Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell),

• red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, treatment with Ibunid dla dzieci Forte should be discontinued immediately and medical help should be sought without delay. See also section 2,

• chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

If any of the following symptoms occur in a patient, ibuprofen use should be stopped immediately and medical help should be sought:

• Red, flat, non-elevated, target-like or circular lesions on the trunk, often with blisters in the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Red, peeling rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibunid dla dzieci Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton: Expiry
date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Shelf-life after first opening of the container: 6 months
After first opening of the container: Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Ibunid dla dzieci Forte contains

• The active substance is ibuprofen. 5 ml of the medicine contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: sodium benzoate (E 211), citric acid (E 330), sodium citrate (E 331), sodium saccharin (E 954), sodium chloride, hypromellose 15 cP, xanthan gum, maltitol liquid (E 965), glycerol, thaumatin (E 957), strawberry flavour

(substances identical to natural flavours, natural flavours, corn maltodextrin,
triethyl citrate, propylene glycol and benzyl alcohol), purified water.
What Ibunid dla dzieci Forte looks like and contents of the pack
The medicine is a white or almost white, viscous suspension, free from foreign particles, with a strawberry taste.
The packaging consists of an orange-coloured PET bottle with a capacity of 30 ml, 100 ml, 150 ml or 200 ml, closed with a child-resistant HDPE cap and an LDPE adapter for the syringe, together with an oral syringe with graduations, with a capacity of 5 ml (PP cylinder, HDPE plunger), packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
„Polski Lek – Dystrybucja” Sp. z o.o.
ul. Chopina 10
34-100 Wadowice
Telephone number: +48 33 870 83 01
Manufacturer
Farmasierra Manufacturing S.L.
Ctra. Irún, Km. 26,200
San Sebastián de los Reyes, 28709 Madrid
Spain
EDEFARM, S.L.
Polígono Industrial Enchilagar del Rullo
117 Villamarchante, 46191 Valencia
Spain
Farmalider S.A.,
C/ Aragoneses, 2
28108 Alcobendas, Madrid
Spain