Mig for children forte with strawberry flavor

Patient Information Leaflet

MIG dla dzieci Forte o smaku truskawkowym
40 mg/ml, oral suspension
For use in children weighing 10 kg (from 1 year of age), adolescents, and adults
Ibuprofen
Please read the entire leaflet carefully before using this medicine, as 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 for future reference.
• If you have any questions, consult your pharmacist.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Contact your doctor if there is no improvement or if the patient feels worse:
  • after 3 days in children and adolescents,
  • after 3 days when treating fever and after 4 days when treating pain in adults.

Table of Contents

1. What MIG dla dzieci Forte o smaku truskawkowym is and what it is used for
2. Important information before using MIG dla dzieci Forte o smaku truskawkowym
3. How to use MIG dla dzieci Forte o smaku truskawkowym
4. Possible side effects
5. How to store MIG dla dzieci Forte o smaku truskawkowym
6. Contents of the pack and other information

1. What MIG dla dzieci Forte o smaku truskawkowym is and what it is used for

MIG dla dzieci Forte o smaku truskawkowym is a non-steroidal anti-inflammatory and analgesic drug (NSAID) with antipyretic (fever-reducing) properties.
MIG dla dzieci Forte o smaku truskawkowym is used for short-term symptomatic treatment of:

• Mild to moderate pain
• Fever

MIG dla dzieci Forte o smaku truskawkowym is indicated for use in children weighing 10 kg (from 1 year of age), adolescents, and adults.

2. Important information before using MIG for children Forte strawberry-flavoured

When not to use MIG for children Forte strawberry-flavoured

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• If the patient has previously experienced bronchospasm, asthma attacks, nasal mucosal swelling (rhinitis), angioedema, or skin reactions (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• In cases of unexplained blood disorders
• In active or recurrent history of gastric or duodenal ulcer (peptic ulcers or gastrointestinal bleeding (two or more separate episodes of confirmed ulceration or bleeding))
• In case of a history of gastrointestinal bleeding or perforation related to previous NSAID treatment
• If the patient has cerebral haemorrhage (cerebrovascular bleeding) or any other active bleeding
• In severe hepatic or renal insufficiency
• In severe heart failure
• In severe dehydration (significant loss of body fluids caused, for example, by vomiting, diarrhoea, or inadequate fluid intake)
• If the patient is in the last three months of pregnancy
• In children weighing less than 10 kg (under 1 year of age), as this dosage is not appropriate for this group due to excessive content of the active substance

Warnings and precautions
Before starting treatment with MIG for children Forte strawberry-flavoured, discuss it with a doctor or pharmacist.
If the patient has an infection – see below, section titled "Infections".
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Gastrointestinal safety
Avoid concomitant use of MIG for children Forte strawberry-flavoured with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors).

Elderly patients
The frequency of adverse effects during NSAID treatment, particularly gastrointestinal bleeding and perforation, which may be fatal, is higher in elderly patients. Therefore, particularly careful medical monitoring is recommended during treatment in elderly patients.

Gastrointestinal bleeding, ulceration, and perforation
Gastrointestinal bleeding, gastric and/or duodenal ulceration, and perforation, which may be fatal, have been reported with all NSAIDs, occurring at any time during treatment, with or without warning symptoms, and with or without previous serious gastrointestinal adverse events.
The risk of gastrointestinal bleeding, gastric and/or duodenal ulceration, and gastrointestinal perforation increases with higher NSAID doses, in patients with a history of gastric and/or duodenal ulceration, particularly if complicated by bleeding or perforation (see section 2. "When not to use MIG for children Forte strawberry-flavoured"), and in elderly patients. Such patients should start treatment with the lowest available dose.
In these patients, as well as in patients requiring additional use of low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal adverse effects, concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal adverse effects should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Caution is advised in patients concurrently taking medications that may increase the risk of gastric and/or duodenal ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (used, among others, in the treatment of depression), or antiplatelet drugs such as acetylsalicylic acid (see section 2. "MIG for children Forte strawberry-flavoured and other medicines").
If gastrointestinal bleeding or gastric and/or duodenal ulceration occurs during treatment with MIG for children Forte strawberry-flavoured, treatment must be discontinued and medical advice sought.
NSAIDs should be used with caution in patients with a medical history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4. "Possible side effects").

Effects on the circulatory system
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before using MIG for children Forte strawberry-flavoured, the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart disease, such as heart failure, angina (chest pain), a history of heart attack, bypass surgery, peripheral arterial disease (poor blood circulation in legs or feet due to narrowed or blocked arteries), or has had any stroke (including "mini-stroke" or transient ischaemic attack – "TIA")
• The patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes

Symptoms of allergic reaction to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have occurred during treatment.
If any of these symptoms occur, discontinue MIG for children Forte strawberry-flavoured immediately and contact a doctor or emergency medical services without delay.

Skin reactions
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient develops any symptoms related to these severe skin reactions described in section 4, discontinue MIG for children Forte strawberry-flavoured immediately and seek medical help.
Avoid using MIG for children Forte strawberry-flavoured during chickenpox (varicella).

Infections
MIG for children Forte strawberry-flavoured may mask symptoms of infection, such as fever and pain. Therefore, MIG for children Forte strawberry-flavoured may delay appropriate treatment and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, seek medical advice immediately.

Respiratory disorders
Exercise caution when administering MIG for children Forte strawberry-flavoured to patients with bronchial asthma or a history of bronchial asthma, as NSAIDs have been reported to cause bronchospasm in these patients.

Other considerations
MIG for children Forte strawberry-flavoured should be used only after careful consideration of benefit versus risk:

• In certain inherited blood disorders (e.g. acute intermittent porphyria)
• In certain autoimmune disorders (systemic lupus erythematosus or mixed connective tissue disease). An increased risk of aseptic meningitis (inflammation of the meninges) has been observed (see section 4. "Possible side effects").

Close medical supervision is required in the following cases:

• If the patient has gastrointestinal disorders or a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease)
• In case of high blood pressure or heart failure
• In case of kidney or liver function impairment
• In case of dehydration
• Immediately after major surgical procedures
• In case of allergies (e.g. skin reactions to other medicines, asthma, hay fever), nasal mucosal hypertrophy (nasal polyps), chronic nasal mucosal oedema, or chronic respiratory diseases with airway narrowing

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been reported. At the first sign of a severe hypersensitivity reaction after taking MIG for children Forte strawberry-flavoured, discontinue treatment immediately and notify a doctor.

Ibuprofen, the active substance in MIG for children Forte strawberry-flavoured, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
During prolonged use of MIG for children Forte strawberry-flavoured, regular monitoring of liver enzyme activity, kidney function, and blood morphology is necessary.
Before surgical procedures, inform the doctor or dentist about taking MIG for children Forte strawberry-flavoured.
Prolonged use of any pain-relieving medicine for headache may worsen the headache. If this occurs or is suspected, the patient should consult a doctor and discontinue treatment. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of pain-relieving medicines.
Generally, habitual use of pain-relieving medicines, especially combinations of several painkillers taken simultaneously, may lead to permanent kidney damage and is associated with the risk of kidney failure (analgesic nephropathy).

Children and adolescents
MIG for children Forte strawberry-flavoured must not be used in children under 1 year of age or weighing less than 10 kg.
There is a risk of impaired kidney function in dehydrated children and adolescents.

MIG for children Forte strawberry-flavoured and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
MIG for children Forte strawberry-flavoured may affect the action of other medicines or other medicines may affect the action of MIG for children Forte strawberry-flavoured. For example:

• Anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• Medicines lowering blood pressure (ACE inhibitors, such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or affect treatment with MIG for children Forte strawberry-flavoured. Therefore, always consult a doctor or pharmacist before using MIG for children Forte strawberry-flavoured with other medicines.
In particular, inform the doctor or pharmacist if the patient is taking:

• Digoxin (used to strengthen the heart), phenytoin (used to treat epilepsy), or lithium (used to treat certain psychiatric disorders), as blood levels of these medicines may increase. If the medicine is used as recommended (for up to 4 days maximum), monitoring of serum lithium, digoxin, and phenytoin levels is generally not necessary.
• Medicines increasing fluid excretion (diuretics) and medicines used for hypertension (antihypertensives);
• Angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure and hypertension): increased risk of kidney function disorders;
• Potassium-sparing diuretics (a type of diuretic): concurrent use may cause increased potassium levels;
• Acetylsalicylic acid and other anti-inflammatory painkillers, including COX-2 inhibitors (non-steroidal anti-inflammatory drugs), selective serotonin reuptake inhibitors (medicines used to treat depression), and corticosteroids (medicines containing cortisone): increased risk of gastrointestinal ulceration and bleeding;
• Low-dose acetylsalicylic acid: antiplatelet effect may be weakened (see section 2. "Warnings and precautions");
• Anticoagulants such as warfarin;
• Sulfonylurea derivatives (used to lower blood glucose): clinical studies have shown interactions between NSAIDs and sulfonylurea derivatives. Blood glucose monitoring is recommended as a precaution during concomitant use;
• Probenecid or sulfinpyrazone (medicines used to treat gout): may delay ibuprofen elimination from the body, potentially leading to ibuprofen accumulation and increased adverse effects;
• Zidovudine (medicine used to treat AIDS): increased risk of haemarthrosis and bruising in HIV-infected individuals with haemophilia;
• Methotrexate (medicine used to treat cancer and certain rheumatic diseases): do not use MIG for children Forte strawberry-flavoured within 24 hours before and after methotrexate administration, as this may increase methotrexate serum levels and intensify its adverse effects;
• Pemetrexed (medicine used to treat cancer): concomitant use with NSAIDs may enhance pemetrexed effects; therefore, caution is advised when administering higher NSAID doses;
• Cyclosporine (an immunosuppressive medicine used, for example, after transplants and in rheumatism treatment): risk of kidney damage;
• Tacrolimus (medicine used to prevent transplant rejection): risk of kidney damage;
• Quinolone antibiotics, such as ciprofloxacin: when used concomitantly, the risk of seizures may increase;
• CYP2C9 inhibitors such as voriconazole and fluconazole (medicines used to treat fungal infections): concomitant use of ibuprofen and CYP2C9 inhibitors may prolong ibuprofen exposure (CYP2C9 substrate). In a study using voriconazole and fluconazole (CYP2C9 inhibitors), exposure to S(+)-ibuprofen increased by approximately 80–100%. When co-administering strong CYP2C9 inhibitors, consider reducing the ibuprofen dose, especially if high ibuprofen doses are given with voriconazole or fluconazole.
• Deferasirox (medicine given to patients receiving long-term blood transfusions in certain types of anaemia): concomitant use of deferasirox with NSAIDs (e.g. ibuprofen) may increase the risk of gastrointestinal adverse effects. Therefore, medical monitoring is required during combined use of deferasirox with NSAIDs;
• Mifepristone (used to terminate pregnancy): if NSAIDs are used 8–12 days after mifepristone administration, they may reduce mifepristone's effectiveness;
• Ginkgo biloba (herbal medicine) in combination with NSAIDs: may increase the risk of bleeding.

MIG for children Forte strawberry-flavoured and alcohol
Alcohol consumption should be avoided during treatment with MIG for children Forte strawberry-flavoured. Some adverse effects, especially gastrointestinal or central nervous system effects, are more likely when alcohol is consumed concomitantly with MIG for children Forte strawberry-flavoured.

Pregnancy, breastfeeding, and effects on fertility
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.

Pregnancy
Do not take MIG for children Forte strawberry-flavoured if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. MIG for children Forte strawberry-flavoured should not be used during the first six months of pregnancy 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. From week 20 of pregnancy, MIG for children Forte strawberry-flavoured may cause narrowing of the blood vessel (ductus arteriosus) in the child's heart or kidney function disorders in the unborn child, which may lead to reduced amniotic fluid volume (oligohydramnios) if used for longer than a few days. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Since no harmful effects have been observed in infants to date, discontinuation of breastfeeding is usually not necessary with short-term use. However, discontinuation should be considered during prolonged use or when high doses are administered.

Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Since undesirable effects on the central nervous system, such as fatigue and dizziness, may occur during use of high doses of MIG for children Forte strawberry-flavoured, reaction time may be altered and the ability to actively participate in road traffic and operate machinery may be limited in individual cases. This is particularly relevant when combined with alcohol. The patient may lose the ability to react quickly and appropriately to unexpected or sudden situations. In such cases, do not drive a car or other vehicles! Do not operate tools or machinery! Do not work without secure foot support!

MIG for children Forte strawberry-flavoured contains liquid maltitol (E 965)
If intolerance to certain sugars has previously been diagnosed in the patient or their child, consult a doctor before taking this medicine.

MIG for children Forte strawberry-flavoured contains sodium
The medicine contains 6 mg of sodium (main component of table salt) in each 1 ml. This corresponds to 0.3% of the maximum recommended daily sodium intake in the diet for adults.

MIG for children Forte strawberry-flavoured contains sodium benzoate (E 211)
The medicine contains 1 mg of sodium benzoate per 1 ml.

MIG for children Forte strawberry-flavoured contains benzyl alcohol
The medicine contains 0.0002 mg of benzyl alcohol per 1 ml.
Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's recommendation.

Pregnant or breastfeeding women and patients with impaired kidney or liver function 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").

3. How to use MIG dla dzieci Forte o smaku truskawkowym

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to control symptoms should be used.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Dosage
The recommended dose is:

In children and adolescents, the dosage of MIG dla dzieci Forte o smaku truskawkowym depends on body weight, with a single dose usually being 7–10 mg/kg body weight, up to a maximum daily dose of 30 mg/kg body weight.
The interval between consecutive doses should be at least 6 hours.
Do not exceed the recommended dose.
Elderly patients
No special dose adjustment is required (see section 2: "Warnings and precautions").
Renal or hepatic impairment
In mild to moderate renal or hepatic impairment, dose reduction is not required.
Method of administration
Oral administration.
The package contains an oral dosing syringe with a capacity of 5 ml (graduated every 0.25 ml).
The oral suspension can be taken independently of meals. For patients with sensitive stomachs, it is recommended to take MIG dla dzieci Forte o smaku truskawkowym during meals.

1. Shake the bottle well before use.

2. To open the bottle, press down on the cap and turn it in the direction indicated by the arrows.
3. Insert the oral syringe into the bottle opening.
4. Turn the bottle upside down, holding the oral syringe securely, and pull the plunger until the required amount of medication is drawn.
5. Turn the bottle upright and remove the oral syringe, gently rotating it.
6. To administer the suspension, place the tip of the syringe into the child's mouth and slowly push the plunger into the barrel. Adjust the injection speed to the child's swallowing rate.

After use, close the bottle with the cap. Then remove the plunger from the syringe barrel, wash both parts with warm water, and leave them to dry. Store the oral syringe out of sight and out of reach of children.
If the patient feels that MIG dla dzieci Forte o smaku truskawkowym is too strong or too weak in effect, they should discuss this with their doctor.
Duration of treatment
This medicine is intended for short-term use only.
If in children and adolescents it becomes necessary to administer this medicine for longer than 3 days or if symptoms worsen, medical advice should be sought.
If in adults symptoms worsen or it becomes necessary to administer this medicine for longer than 3 days in case of fever or longer than 4 days in case of pain treatment, medical advice should be sought.
Use of a higher than recommended dose of MIG dla dzieci Forte o smaku truskawkowym
MIG dla dzieci Forte o smaku truskawkowym should be used according to the doctor's recommendations or the dosing instructions contained in this leaflet. If the patient feels that the pain-relieving effect is too weak, the dose should not be increased without consulting a doctor.
If the patient has taken a higher than recommended dose of MIG dla dzieci Forte o smaku truskawkowym or if a child has accidentally ingested the medicine, medical advice should always be sought from a doctor or the nearest hospital to assess potential health risks and receive guidance on actions to be taken.
Possible symptoms of overdose:
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood traces), headache, tinnitus, disorientation, and nystagmus. Additionally, gastrointestinal bleeding may occur. After ingestion of a large dose, drowsiness, feeling of impending fainting, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, liver and kidney function disorders, breathing difficulties (respiratory depression), drop in blood pressure, cyanosis (bluish-red discoloration of skin and mucous membranes), feeling of cold, and breathing problems may occur.
There is no specific antidote.
Missed dose of MIG dla dzieci Forte o smaku truskawkowym
Do not use a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Possible side effects
The adverse reactions listed below include all side effects reported during ibuprofen use, including those reported during long-term use of high-dose ibuprofen in patients with rheumatic diseases.
Adverse reactions more common than very rare are those occurring during short-term use at daily doses not exceeding the maximum daily dose of 1200 mg ibuprofen (= 30 ml of MIG dla dzieci Forte o smaku truskawkowym, the maximum daily dose for adults and adolescents with body weight above 40 kg) for oral formulations, and the maximum dose of 1800 mg ibuprofen for suppositories.
The adverse reactions listed below are generally dose-dependent and show considerable individual variability.
The most commonly observed adverse reactions involve the gastrointestinal tract.
Gastric and/or duodenal ulceration, gastrointestinal perforation, or gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2. "Warnings and precautions").
After ibuprofen administration, cases of nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, haematemesis, oral mucositis with ulceration (ulcerative stomatitis), exacerbation of intestinal disorders, ulcerative colitis, and Crohn's disease have been reported (see section 2. "Warnings and precautions").
Gastric mucositis (gastritis) has been reported less frequently. The risk of gastrointestinal bleeding is particularly dependent on the dose used and duration of treatment.
Edema, hypertension, and heart failure have been reported in association with NSAID therapy.
Use of drugs such as MIG dla dzieci Forte o smaku truskawkowym may be associated with a slightly increased risk of myocardial infarction ("heart attack") or stroke.

You should IMMEDIATELY STOP USING this medicine and seek medical help if the patient or child experiences any of the following side effects:

Not very common: may affect up to 1 in 100 patients

• Symptoms of gastrointestinal bleeding, such as severe upper abdominal pain, blood in stool and/or black tarry stools, haematemesis, or coffee-ground-like vomit.

Very rare: may affect up to 1 in 10,000 patients

• Symptoms of severe allergic reactions, such as facial swelling, tongue swelling, laryngeal edema with bronchospasm, dyspnea, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. These symptoms may occur even after a single dose of the medicine.
• Red, flat, target-like or round skin lesions on the trunk, often with blisters in the center, skin peeling, and 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).

Frequency not known: frequency cannot be estimated from available data

• Widespread rash, high fever, enlarged lymph nodes, and increased eosinophil count (a type of white blood cell) (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

You should talk to a doctor and also read the instructions below if the patient or child experiences any of the following side effects:

Common: may affect up to 1 in 10 patients

• Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, and minor gastrointestinal blood loss, which in individual cases may lead to anaemia.

Not very common: may affect less than 1 in 100 patients

• Hypersensitivity reactions with skin rash and itching, and asthma attacks (possibly accompanied by sudden drop in blood pressure): in such cases, immediately inform the doctor and discontinue MIG dla dzieci Forte o smaku truskawkowym.
• Central nervous system disturbances such as headache, dizziness, insomnia, psychomotor agitation, irritability, or fatigue.
• Visual disturbances: in such cases, discontinue treatment and inform the doctor.
• Peptic ulcer disease of the stomach and/or duodenum, potentially with bleeding and perforation, oral mucositis with ulceration (ulcerative stomatitis), exacerbation of ulcerative colitis and Crohn's disease, gastric mucositis (gastritis).
• Various skin rashes.

Rare: may affect less than 1 in 1,000 patients

• Tinnitus, hearing loss.

Very rare: may affect less than 1 in 10,000 patients

• Asthma, abnormal constriction of airway muscles causing breathing difficulties (bronchospasm), shortness of breath (dyspnea).
• Exacerbation of infection-related inflammation (e.g., development of necrotizing fasciitis) has been reported during treatment with certain anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, including MIG dla dzieci Forte o smaku truskawkowym). Cases of aseptic meningitis (non-infectious inflammation of the meninges) have been observed, with symptoms such as severe headache, nausea, vomiting, fever, neck stiffness, and altered consciousness. Patients with certain immunological disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be at higher risk. If, during treatment with MIG dla dzieci Forte o smaku truskawkowym, symptoms of infection appear or worsen (e.g., redness, swelling, excessive warmth, pain, fever), immediately contact a doctor.
• Blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms of these disorders may include fever, sore throat, mucosal lesions in the mouth, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, immediately discontinue the medicine and consult a doctor. Do not attempt self-treatment with painkillers or antipyretics.
• Severe systemic hypersensitivity reactions.
• Psychotic reactions, depression.
• Palpitations, heart failure, myocardial infarction (heart attack).
• High blood pressure (hypertension), vasculitis.
• Oesophagitis, pancreatitis, formation of fibrous strictures in the small and large intestine (intestinal fibrous strictures).
• Liver function disorders, liver damage, especially during long-term treatment, liver failure, acute hepatitis. During long-term treatment, liver function tests should be performed regularly.
• Hair loss (alopecia).
• Increased fluid retention (edema), particularly in patients with hypertension or impaired kidney function, nephrotic syndrome (fluid retention [edema] and proteinuria), inflammatory kidney disease (transient nephritis), which may be accompanied by acute renal failure. Kidney damage (papillary necrosis) and increased serum uric acid levels may also occur. Decreased urine output, fluid accumulation in tissues (edema), and general malaise may indicate kidney dysfunction or even renal failure. If any of the above symptoms occur or worsen, discontinue MIG dla dzieci Forte o smaku truskawkowym and immediately consult a doctor.

Frequency not known: frequency cannot be estimated from available data

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Skin becomes sensitive to light.

In exceptional cases, during varicella (chickenpox) infection, severe skin infections and soft tissue complications may occur (see also "very rare" regarding "exacerbation of infection-related inflammation").

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store MIG dla dzieci Forte o smaku truskawkowym

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
bottle after: "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions. After first opening the product,
do not store at temperatures above 30°C.
After opening, the medicine may be used for 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What MIG dla dzieci Forte o smaku truskawkowym contains
The active substance is ibuprofen.
1 ml of oral suspension contains 40 mg of ibuprofen.
Other ingredients are:
Sodium benzoate (E 211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose 15 cP, xanthan gum, liquid maltitol (E 965), glycerol (E 422), thaumatin (E 957), strawberry flavour (substances identical to natural flavours, natural flavours, corn maltodextrin, triethyl citrate [E 1505], propylene glycol [E 1520] and benzyl alcohol), purified water.

What MIG dla dzieci Forte o smaku truskawkowym looks like and contents of the pack
MIG dla dzieci Forte o smaku truskawkowym, oral suspension is a viscous suspension, white to cream in colour.
MIG dla dzieci Forte o smaku truskawkowym, 40 mg/ml oral suspension is available in plastic bottles of 30 ml, 100 ml, 150 ml and 200 ml, with a child-resistant closure.
Not all pack sizes may be marketed.
An oral syringe made of polypropylene, graduated in 0.25 ml increments up to 5 ml, is included in the pack to facilitate accurate dose measurement.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturers
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares - Madrid
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
Fax: +48 22 566 21 01

This medicinal product is authorised in the European Economic Area under the following names:
Bulgaria МИГ джуниър
Estonia Ibustar forte
Germany Eudorlin Ibuprofen 40 mg/ml Suspension zum Einnehmen
Latvia Ibustar bērniem 200 mg/5 ml suspensija iekšķīgai lietošanai
Lithuania Ibustar 40 mg/ml geriamoji suspensija, vaikams
Poland MIG dla dzieci Forte o smaku truskawkowym
Slovakia MIG 4% perorálna suspenzia
Spain EUDORLIN 40 mg/ml suspensión oral