Mig dla dzieci Forte o smaku truskavkovim

Leaflet accompanying the packaging: information for the user

MIG for children Forte with a strawberry flavor

40 mg/ml, oral suspension

For use in children with a body weight of 10 kg or more (from 1 year of age), in adolescents and in adults
Ibuprofen

You should carefully read the contents of the leaflet before using the 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• You should contact your doctor if there is no improvement or if you feel worse:
• after 3 days in the case of children and adolescents,
• after 3 days in the case of fever treatment and after 4 days in the case of pain treatment in adults.

Table of contents of the leaflet

• 1. What MIG for children Forte with a strawberry flavor is and what it is used for
• 2. Important information before using MIG for children Forte with a strawberry flavor
• 3. How to use MIG for children Forte with a strawberry flavor
• 4. Possible side effects
• 5. How to store MIG for children Forte with a strawberry flavor
• 6. Contents of the pack and other information

1. What MIG for children Forte with a strawberry flavor is and what it is used for

MIG for children Forte with a strawberry flavor is an anti-inflammatory and analgesic medicine (non-steroidal anti-inflammatory drug, NSAID) with antipyretic (fever-reducing) properties.
MIG for children Forte with a strawberry flavor is used for the short-term symptomatic treatment of:

• Mild to moderate pain
• Fever

MIG for children Forte with a strawberry flavor is used in children with a body weight of 10 kg or more (from 1 year of age), in adolescents and in adults.

2. Important information before using MIG for children Forte with a strawberry flavor

strawberry

When not to use MIG for children Forte with a strawberry flavor

• If the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• If the patient has had bronchospasm, asthma, nasal polyps, angioedema, or urticaria (hives) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
• In unexplained blood formation disorders
• In active or recurrent peptic ulcer disease (ulcers or bleeding in the stomach or intestines, with two or more separate episodes of confirmed ulcers or bleeding)
• In patients with a history of gastrointestinal bleeding or perforation related to previous NSAID use
• If the patient has a history of cerebrovascular bleeding (cerebrovascular hemorrhage) or other active bleeding
• In severe liver or kidney impairment
• In severe heart failure
• In severe dehydration (significant loss of body fluids due to vomiting, diarrhea, or inadequate fluid intake)
• If the patient is in the last three months of pregnancy
• In children with a body weight below 10 kg (under 1 year of age), as this dose of the medicine is not suitable for this age group due to the high content of the active substance

Warnings and precautions

Before starting treatment with MIG for children Forte with a strawberry flavor, you should discuss it with your doctor or pharmacist.
If the patient has an infection - see below, section entitled "Infections".
Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to control symptoms.

Gastrointestinal safety

You should avoid taking MIG for children Forte with a strawberry flavor with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase inhibitors-
2).

• 2).

Elderly patients
The frequency of side effects during NSAID treatment, especially gastrointestinal bleeding and perforation, which can be fatal, is higher in the elderly. Therefore, during treatment in the elderly, careful medical monitoring is recommended.
Gastrointestinal bleeding, peptic ulcer disease, and perforation
There have been reports of gastrointestinal bleeding, peptic ulcer disease, and perforation, which can be fatal, with all NSAIDs, occurring at any time during treatment, with or without warning symptoms and with or without a history of severe gastrointestinal side effects.
The risk of gastrointestinal bleeding, peptic ulcer disease, and perforation increases with increasing NSAID doses in patients with a history of peptic ulcer disease, especially if it was complicated by bleeding or perforation (see section 2. "When not to use MIG for children Forte with a strawberry flavor") and in elderly patients. Such patients should start treatment with the lowest available dose.
For these patients, as well as for patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal side effects, consideration should be given to concurrent use of drugs with a protective effect on the gastric mucosa (e.g., misoprostol or proton pump inhibitors).
Patients with a history of gastrointestinal side effects should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is recommended in patients taking concomitant medications that may increase the risk of gastrointestinal ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat depression), or antiplatelet agents (e.g., acetylsalicylic acid) (see section 2. "MIG for children Forte with a strawberry flavor and other medicines").
If gastrointestinal bleeding or peptic ulcer disease occurs during treatment with MIG for children Forte with a strawberry flavor, treatment must be discontinued and medical advice should be sought.
In patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), NSAIDs should be used with caution, as these conditions may worsen (see section 4. "Possible side effects").

Impact on the cardiovascular system

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before using MIG for children Forte with a strawberry flavor, the patient should discuss the treatment with their doctor or pharmacist if:

• The patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, has had a bypass operation, has peripheral arterial disease (poor blood circulation in the legs or feet due to narrowing or blockage of the arteries), or has had a stroke (including "mini-stroke" or transient ischemic attack - "TIA")
• The patient has high blood pressure, diabetes, high cholesterol levels, or has a family history of heart disease or stroke, or smokes

During ibuprofen treatment, allergic reactions to this medicine have been reported, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain.

In case of noticing any of these symptoms, you should immediately stop taking MIG for children Forte with a strawberry flavor and seek medical attention immediately.

Skin reactions

Severe skin reactions have been reported with ibuprofen use, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediatelystop taking MIG for children Forte with a strawberry flavor and seek medical attention.
It is recommended to avoid using MIG for children Forte with a strawberry flavor during chickenpox (varicella).

Infections

MIG for children Forte with a strawberry flavor may mask the symptoms of infection, such as fever and pain. As a result, MIG for children Forte with a strawberry flavor may delay the use of appropriate treatment and consequently lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediatelyconsult a doctor.

Respiratory disorders

Caution should be exercised when administering MIG for children Forte with a strawberry flavor to patients with asthma or a history of asthma, as NSAIDs have been reported to cause bronchospasm in these patients.

Other notes

MIG for children Forte with a strawberry flavor should only be used after careful consideration of the benefit-risk ratio:

• In certain congenital blood disorders (e.g., intermittent porphyria)
• In certain autoimmune disorders (systemic lupus erythematosus or mixed connective tissue disease). It has been observed that there is an increased risk of developing aseptic meningitis (aseptic meningitis) (see section 4. "Possible side effects").

In the following cases, close medical monitoring is required:

• If the patient has gastrointestinal disorders or has 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 dysfunction
• In case of dehydration
• Immediately after major surgery
• In case of allergies (e.g., skin reactions to other medicines, asthma, hay fever), in mild nasal polyps (nasal polyps), in chronic nasal congestion (chronic rhinitis), or in chronic respiratory diseases with airway narrowing

Very rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) have been reported. If the first symptoms of severe hypersensitivity reactions appear after taking MIG for children Forte with a strawberry flavor, treatment should be immediatelydiscontinued and a doctor should be notified.
Ibuprofen, the active substance of MIG for children Forte with a strawberry flavor, may periodically inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
During long-term use of MIG for children Forte with a strawberry flavor, regular monitoring of liver enzyme activity, kidney function, and blood morphology is necessary.
Before surgery, the doctor or dentist should be informed about the use of MIG for children Forte with a strawberry flavor.
Long-term use of any type of pain reliever for headache can worsen it. If this situation occurs or is suspected, the patient should consult a doctor for advice and discontinue treatment. Drug-induced headaches should be suspected in patients who frequently or daily experience headaches despite (or due to) regular use of pain relievers.
Generally, habitual use of pain relievers, especially combinations of several pain relievers at the same time, can lead to permanent kidney damage and is associated with the risk of developing kidney failure (analgesic nephropathy).

Children and adolescents

MIG for children Forte with a strawberry flavor should not be used in children under 1 year of age or with a body weight below 10 kg.
There is a risk of kidney function disorders in dehydrated children and adolescents.

MIG for children Forte with a strawberry flavor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
MIG for children Forte with a strawberry flavor may affect the action of other medicines or other medicines may affect the action of MIG for children Forte with a strawberry flavor. For example:

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

Also, some other medicines may be affected or have an effect on MIG for children Forte with a strawberry flavor treatment. Therefore, before using MIG for children Forte with a strawberry flavor with other medicines, the patient should always consult their doctor or pharmacist.
Particularly, the doctor or pharmacist should be informed if the patient is taking:

• Digoxin (used to strengthen the heart), phenytoin (used to treat epilepsy), or lithium (used to treat certain mental disorders), as the levels of these medicines in the blood may increase. If the medicine is used as recommended (for a maximum of 4 days), it is not generally necessary to monitor the levels of lithium, digoxin, and phenytoin in the blood serum.
• Diuretics (diuretic medicines) and antihypertensive medicines;
• ACE inhibitors (medicines used to treat heart failure and high blood pressure): increased risk of kidney disorders;
• Potassium-sparing diuretics (a type of diuretic): when used at the same time, they may cause an increase in potassium levels;
• Acetylsalicylic acid and other anti-inflammatory pain relievers, including COX-2 inhibitors (non-steroidal anti-inflammatory drugs), selective serotonin reuptake inhibitors (used to treat depression), as well as corticosteroids (medicines containing cortisone): increased risk of gastrointestinal ulcers and bleeding;
• Acetylsalicylic acid in low doses: the effect of inhibiting platelet aggregation may be weakened (see section 2. "Warnings and precautions");
• Anticoagulant medicines, such as warfarin;
• Medicines from the sulfonylurea group (used to lower blood sugar levels): clinical studies have shown interactions between NSAIDs and sulfonylureas. When used concomitantly, it is recommended to monitor blood sugar levels as a precaution;
• Probenecid or sulfinpyrazone (medicines used to treat gout): they may delay the excretion of ibuprofen from the body. This may cause ibuprofen to accumulate in the body and increase its side effects.
• Zidovudine (a medicine used to treat AIDS): increased risk of bleeding into the joints and bruising in people with hemophilia infected with HIV;
• Methotrexate (a medicine used to treat cancer and some rheumatic diseases): MIG for children Forte with a strawberry flavor should not be used within 24 hours before or after taking methotrexate. This may increase the level of methotrexate in the blood serum and increase its side effects;
• Pemetrexed (a medicine used to treat cancer): using pemetrexed with NSAIDs may increase the effect of pemetrexed, so caution should be exercised when administering high doses of NSAIDs;
• Cyclosporin (an immunosuppressive medicine used, for example, after transplants and in the treatment of rheumatism): there is a risk of kidney damage;
• Tacrolimus (a medicine used to prevent transplant rejection): there is a risk of kidney damage;
• Quinolone antibiotics, such as ciprofloxacin: when these medicines are 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 increase the exposure of the body to ibuprofen (a CYP2C9 substrate). In a study using voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S(+)-ibuprofen by about 80-100% was found. When concomitantly administering strong CYP2C9 inhibitors, consideration should be given to reducing the dose of ibuprofen, especially if high doses of ibuprofen are administered concomitantly with voriconazole or fluconazole.
• Deferasirox (a medicine given to patients receiving long-term blood transfusions for certain types of anemia): concomitant use of deferasirox with NSAIDs (e.g., ibuprofen) may increase the risk of gastrointestinal side effects. Therefore, medical monitoring is necessary during concomitant use of deferasirox with NSAIDs;
• Mifepristone (used to terminate pregnancy): if NSAIDs are used during days 8-12 after mifepristone administration, they may reduce the effectiveness of mifepristone;
• Ginkgo biloba (a herbal medicine) in combination with NSAIDs: may increase the risk of bleeding.

MIG for children Forte with a strawberry flavor and alcohol

During treatment with MIG for children Forte with a strawberry flavor, you should avoid drinking alcohol. Some side effects, especially those related to the gastrointestinal tract or central nervous system, are more likely to occur when consuming alcohol and MIG for children Forte with a strawberry flavor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Do not take MIG for children Forte with a strawberry flavor if you are in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first six months of pregnancy, do not use MIG for children Forte with a strawberry flavor unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, MIG for children Forte with a strawberry flavor may cause narrowing of the blood vessel (ductus arteriosus) in the baby's heart or kidney problems in the unborn baby, which can lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios), if used for more than a few days. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk.
Since no harmful effects have been found in infants to date, breastfeeding does not usually need to be discontinued during short-term use. However, during longer use or when using high doses, breastfeeding should be considered for discontinuation.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is temporary and reverses after treatment is stopped.

Driving and using machines

Since large doses of MIG for children Forte with a strawberry flavor may cause side effects from the central nervous system, such as fatigue and dizziness, reaction time may be altered and the ability to actively participate in traffic and operate machinery may be impaired. This is especially true in combination with alcohol. The patient may then lose the ability to react quickly and appropriately to unexpected or sudden situations. In this case, do not drive a car or other vehicles! Do not operate tools or machines! Do not work without a secure footing for your feet!

MIG for children Forte with a strawberry flavor contains liquid maltitol (E 965)

If the patient or their child has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

MIG for children Forte with a strawberry flavor contains sodium

The medicine contains 6 mg of sodium (the main component of table salt) per 1 ml. This corresponds to 0.3% of the maximum recommended daily sodium intake in the diet for adults.

MIG for children Forte with a strawberry flavor contains sodium benzoate (E 211)

The medicine contains 1 mg of sodium benzoate per 1 ml.

MIG for children Forte with a strawberry flavor contains benzyl alcohol

The medicine contains 0.0002 mg of benzyl alcohol per 1 ml.
Benzyl alcohol may cause allergic reactions.
Do not give to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women and patients with kidney or liver dysfunction should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called "metabolic acidosis").

3. How to use MIG for children Forte with a strawberry flavor

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
Use the smallest effective dose for the shortest duration necessary to control symptoms. If the patient feels that the pain-relieving effect is too weak, they should not increase the dose without consulting their doctor.
If the patient has used a larger dose of MIG for children Forte with a strawberry flavor than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.

Dosage

The recommended dose is:

In children and adolescents, the dosage of MIG for children Forte with a strawberry flavor depends on body weight, with a single dose usually being 7-10 mg/kg of body weight, up to a maximum daily dose of 30 mg/kg of 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").

Kidney or liver dysfunction

In mild to moderate kidney or liver dysfunction, dose reduction is not required.

Method of administration

Oral administration.
The packaging includes an oral dosing syringe with a capacity of 5 ml (with a scale every 0.25 ml).
The oral suspension can be taken independently of meals. Patients with sensitive stomachs are advised to take MIG for children Forte with a strawberry flavor during meals.

• 1. Before use, the bottle should be shaken.
• 2. To open the bottle, the cap should be pressed and turned in the direction indicated by the arrows.
• 3. Then, the oral dosing syringe should be placed in the bottle opening.
• 4. The bottle should be turned upside down, holding the oral dosing syringe, and the plunger should be pulled until the required amount of medicine is obtained.
• 5. The bottle should be turned right side up and the oral dosing syringe should be removed, turning it gently.
• 6. To administer the suspension, the tip of the syringe should be placed in the child's mouth and the plunger should be pushed slowly

in accordance with the child's swallowing speed.
After use, the bottle should be closed with the cap. Then, the plunger should be removed from the cylinder of the oral dosing syringe, washed with warm water, and left to dry. The oral dosing syringe should be stored out of sight and reach of children.
If the patient feels that MIG for children Forte with a strawberry flavor is too strong or too weak, they should talk to their doctor.

Treatment duration

The medicine is intended for short-term use only.
If children and adolescents need to take this medicine for more than 3 days or if symptoms worsen, they should consult a doctor.
If adults experience worsening symptoms or need to take this medicine for more than 3 days for fever or more than 4 days for pain treatment, they should consult a doctor.

Using a higher dose of MIG for children Forte with a strawberry flavor than recommended

MIG for children Forte with a strawberry flavor should be used as directed by the doctor or according to the dosage instructions in this leaflet. If the patient feels that the pain-relieving effect is too weak, they should not increase the dose without consulting their doctor.
If the patient has used a larger dose of MIG for children Forte with a strawberry flavor than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.

Possible symptoms of overdose are:

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. Additionally, gastrointestinal bleeding is possible. After taking a large dose, drowsiness, a feeling of impending fainting, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, liver dysfunction, kidney dysfunction, respiratory depression, decreased blood pressure, cyanosis (blue discoloration of the skin and mucous membranes), feeling of cold, and breathing difficulties. There is no specific antidote.

Missing a dose of MIG for children Forte with a strawberry flavor

Do nottake a double dose to make up for a missed dose.
In case of any further 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.

Possible side effects

The following side effects are all those reported during ibuprofen use, including those reported during long-term use of ibuprofen in high doses in patients with rheumatic diseases.
Side effects more frequent than very rare are those that occur during short-term use in daily doses not exceeding the maximum dose of 1200 mg of ibuprofen (= 30 ml of MIG for children Forte with a strawberry flavor maximum daily dose for adults and adolescents with a body weight over 40 kg) in the case of oral medicines and a maximum dose of 1800 mg of ibuprofen in the case of suppositories.
Regarding the side effects listed below, it should be taken into account that they mostly show a dose-dependent relationship and are characterized by significant individual variability.
The most common side effects are related to the gastrointestinal tract.
Gastrointestinal ulcers and perforation, which can be fatal, especially in the elderly (see section 2. "Warnings and precautions"), may occur.

You should immediately STOP using this medicine and seek medical attention if you or your child experience any of the following side effects:

Uncommon: may affect up to 1 in 100 people

• Symptoms of gastrointestinal bleedingsuch as relatively severe pain in the upper abdomen, blood in the stool, and (or) black tarry stools, bloody vomiting, or vomiting that looks like coffee grounds.

Rare: may affect up to 1 in 10,000 people

• Symptoms of severe allergic reactionssuch as swelling of the face, swelling of the tongue, swelling of the larynx with airway constriction, difficulty breathing, rapid heartbeat, sudden drop in blood pressure to life-threatening shock. These symptoms may occur even after a single use of the medicine.
• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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 the available data

• Widespread rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) (DRESS syndrome).
• A red, peeling rash with nodules under the skin and blisters, mainly located in skin folds, on the torso, and upper limbs, with fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

You should talk to your doctor and also read the instructions below if you or your child experience any of the following side effects:

Common: may affect up to 1 in 10 people

• Gastrointestinal disorders, such as heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (with possible accompanying sudden drop in blood pressure): in this case, you should immediatelynotify your doctor and discontinue MIG for children Forte with a strawberry flavor.
• Central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• Visual disturbances: in this case, treatment should be discontinued and a doctor consulted.
• Peptic ulcer disease and (or) duodenal ulcer, potentially with bleeding and perforation, oral mucosal ulceration (ulcerative stomatitis), worsening of inflammatory bowel diseases, ulcerative colitis, and Crohn's disease (see section 2. "Warnings and precautions"), gastritis (gastritis).

Varying skin rashes.

• Ringing in the ears, hearing loss.

Rare: may affect up to 1 in 1,000 people

• Asthma, abnormal narrowing of the airways causing breathing difficulties (bronchospasm), shortness of breath (dyspnea).

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

• Panic attacks, depression.
• Palpitations, heart failure, heart attack (myocardial infarction).
• High blood pressure (hypertension), vasculitis (inflammation of blood vessels).
• Esophagitis and pancreatitis, formation of membranous strictures in the small and large intestines (membranous intestinal 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).
• Fluid retention (edema), especially in patients with hypertension or kidney dysfunction, nephrotic syndrome (fluid retention [edema] and proteinuria), kidney disease with inflammation (interstitial nephritis), which may be accompanied by acute kidney failure. Kidney damage (renal papillary necrosis) and increased uric acid levels in the blood may also occur. Reduced urine output, fluid retention, as well as general malaise may be signs of kidney dysfunction or even kidney failure. If any of the above symptoms occur or worsen, MIG for children Forte with a strawberry flavor should be discontinued and medical attention should be sought immediately.

5. How to store MIG for children Forte strawberry flavor

Store the medicine in a place invisible and inaccessible to children. Do not use this medicine after the expiry date stated on the carton and bottle after: "EXP". The expiry date refers to the last day of the specified month. This medicine does not require special storage conditions. After first opening the product, do not store it at a temperature above 30°C. After opening, the medicine can be used for 6 months. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What MIG for children Forte strawberry flavor contains

The active substance is ibuprofen. 1 ml of oral suspension contains 40 mg of ibuprofen. The 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 flavor (substances identical to natural flavors, natural flavors, corn maltodextrin, triethyl citrate [E 1505], propylene glycol [E 1520], and benzyl alcohol), purified water.

• strawberry flavor (substances identical to natural flavors, natural flavors, corn maltodextrin, triethyl citrate [E 1505], propylene glycol [E 1520], and benzyl alcohol), purified water.

What MIG for children Forte strawberry flavor looks like and what the package contains

MIG for children Forte strawberry flavor, oral suspension is a viscous suspension with a color from white to creamy. MIG for children Forte strawberry flavor, 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. To facilitate accurate dosing, an oral syringe made of polypropylene with a scale of 0.25 ml to 5 ml is included with the package.

Marketing authorization holder and manufacturer

Marketing authorization holder Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany. Manufacturer 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 more detailed information on this medicinal product, please contact the local representative of the marketing authorization 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 authorized in the Member States of 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

Date of last revision of the leaflet:01/2025