Mig

Leaflet accompanying the packaging: information for the user

MIG

400 mg, coated tablets
Medicine intended for use in children from 6 years of age (from 20 kg) and in adults
Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in children and adolescents or after 3 days of treatment of fever or after 4 days of treatment of pain in adults, there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is MIG and what is it used for

MIG is an anti-inflammatory and analgesic (non-steroidal anti-inflammatory, NSAID) with antipyretic (fever-reducing) effects.
MIG is used for symptomatic treatment

• Mild to moderate pain
• Fever.

2. Important information before taking MIG

When not to take MIG

• If the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• If the patient has a history of asthma, bronchospasm, nasal polyps, angioedema, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
• In unexplained blood formation disorders
• In active or recurrent peptic ulcer disease (gastric and/or duodenal ulcers) or gastrointestinal bleeding (two or more separate episodes of proven ulceration or bleeding)
• In cases of perforation or gastrointestinal bleeding in the history, related to previous NSAID treatment
• If the patient has cerebral hemorrhage (cerebrovascular bleeding) or other active bleeding
• In severe liver or kidney failure
• In severe heart failure
• In severe dehydration (significant loss of body fluids due to, for example, vomiting, diarrhea, or inadequate fluid intake)
• In women in the last 3 months of pregnancy
• In children with a body weight below 20 kg (under 6 years of age), as this dose is not suitable due to the content of the active substance

Warnings and precautions

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

Gastrointestinal safety

Concomitant use of MIG with other NSAIDs, including so-called COX-2 inhibitors, should be avoided.
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, special medical supervision is recommended.
Gastrointestinal bleeding, ulcers, and perforation
There have been reports of gastrointestinal bleeding, gastric and/or duodenal ulcers, and perforations, 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, gastric and/or duodenal ulcers, and perforation increases with increasing NSAID doses in patients with a history of gastric and/or duodenal ulcers, especially if complicated by bleeding or perforation (see section 2, "When not to take MIG") and in the elderly. In such patients, treatment should be started with the lowest available doses.
In such patients and in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal side effects, consideration should be given to concomitant administration 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, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is advised in patients receiving concomitant medications that may increase the risk of developing gastric and/or duodenal ulcers or gastrointestinal 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 and other medicines").
In the event of gastrointestinal bleeding or gastric and/or duodenal ulcers during MIG treatment, treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as they may exacerbate the disease (see section 4, "Possible side effects").

Impact on the cardiovascular system

Taking anti-inflammatory and analgesic medicines like 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 and duration of treatment.
Before taking MIG, 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 coronary artery bypass graft, has peripheral arterial disease (poor 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, has a family history of heart disease or stroke, or smokes

During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain.

In case of noticing any of these symptoms, the patient should immediately stop taking MIG and contact their doctor or emergency medical services immediately.

Skin reactions

Severe skin reactions have been reported with ibuprofen, including 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 and seek medical attention.
During chickenpox (varicella), it is recommended to avoid taking MIG.

Infections

MIG may mask the symptoms of infection, such as fever and pain. As a result, MIG may delay the use of appropriate treatment and consequently lead to increased risk of complications. This has been observed in 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 their doctor.

Respiratory disorders

Caution is advised when administering MIG to patients with asthma or a history of asthma, as NSAIDs have been reported to cause bronchospasm in these patients.

Other notes

MIG 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 and mixed connective tissue disease). An increased risk of aseptic meningitis (aseptic meningitis) has been observed

opon mózgowych (aseptycznego zapalenia opon mózgowo-rdzeniowych) (see section 4, "Possible side effects").
MIG can only be used under strict medical supervision in the following cases:

• If the patient has gastrointestinal disorders or has a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease)
• In cases of high blood pressure or heart failure
• In cases of kidney or liver dysfunction
• In cases of dehydration
• Immediately after major surgery
• In cases of allergies (e.g., skin reactions to other medicines, asthma, hay fever), in mild nasal polyps (nasal polyps), in chronic nasal congestion or in chronic respiratory diseases with airway obstruction

Very rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. After the first symptoms of severe hypersensitivity after taking MIG, treatment should be immediatelydiscontinued and the doctor informed.
Ibuprofen, the active substance of MIG, may periodically inhibit platelet aggregation. Therefore, during treatment, patients with coagulation disorders should be closely monitored.
During long-term use of MIG, regular monitoring of liver enzymes, kidney function, and blood morphology is required.
Before surgery, the doctor or dentist should be informed about the use of MIG.
Long-term use of painkillers for headache treatment may lead to worsening of the headache. If this situation is detected or suspected, medical advice should be sought and treatment discontinued. The possibility of medication-overuse headache should be considered in patients suffering from frequent or daily headaches despite regular use (or due to the use) of painkillers.
Generally, habitual use of painkillers, especially combinations of several painkillers, can lead to permanent kidney damage and increase the risk of kidney failure (analgesic nephropathy).

Children and adolescents

There is a risk of kidney function disorder in dehydrated children and adolescents.

MIG 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 may affect the action of other medicines or other medicines may affect the action of MIG. For example:

• Anticoagulant medicines (e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)

Also, some other medicines may be affected or have an effect on MIG treatment. Therefore, before taking MIG with other medicines, the patient should always consult their doctor or pharmacist.
Particularly, the patient should inform their doctor or pharmacist if they are taking:

• Digoxin (used to strengthen the heart), phenytoin (used to treat seizures), or lithium (used to treat certain mental disorders), as the levels of these medicines in the blood may increase. Monitoring of lithium, digoxin, and phenytoin levels in the blood is generally not required if ibuprofen is used as recommended (see section 3, "How to take MIG");
• Diuretics and antihypertensive medicines;
• Angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure and high blood pressure): increased risk of kidney function disorders;
• Potassium-sparing diuretics (some diuretics): may cause an increase in potassium levels;
• Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines, including COX-2 inhibitors, selective serotonin reuptake inhibitors (used to treat depression), as well as corticosteroids: increased risk of gastric and/or duodenal ulcers and gastrointestinal bleeding;
• Low-dose acetylsalicylic acid: the antiplatelet effect may be weakened (see section 2, "Warnings and precautions");
• Anticoagulant medicines, such as warfarin;
• Sulfonylurea derivatives (used to lower blood sugar levels): clinical studies have shown interactions between NSAIDs and sulfonylurea derivatives. When used concomitantly, blood sugar levels should be monitored as a precaution;
• Probenecid or sulfinpyrazone (medicines used to treat gout): may delay the excretion of ibuprofen from the body. This may lead to accumulation of ibuprofen in the body and intensification of its side effects.
• Zidovudine (a medicine used to treat AIDS): increased risk of hemorrhages and bruising in people with hemophilia infected with HIV;
• Methotrexate (a medicine used to treat cancer and certain rheumatic diseases): MIG should not be used within 24 hours before or after methotrexate administration. This may lead to an increase in methotrexate levels in the blood and intensification of its side effects;
• Pemetrexed (a medicine used to treat cancer): concomitant use of pemetrexed with NSAIDs may enhance the effect of pemetrexed, so caution is advised when administering high doses of NSAIDs;
• Cyclosporine (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 used concomitantly, the risk of seizures may increase;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (antifungal medicines): 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 observed. 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 in certain types of anemia): concomitant use of deferasirox with NSAIDs (e.g., ibuprofen) may increase the risk of gastrointestinal side effects. Therefore, medical supervision is necessary during concomitant use of deferasirox with NSAIDs;
• Mifepristone (used to terminate pregnancy): if NSAIDs are used during the period 8-12 days 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 and alcohol

Alcohol consumption should be avoided during MIG treatment. Some side effects, especially those related to the gastrointestinal tract or central nervous system, are more likely to occur when consuming alcohol and taking MIG.

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 taking this medicine.
Pregnancy
MIG should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolongation or prolongation of labor. During the first 6 months of pregnancy, MIG should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or during attempts to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, MIG may cause constriction of the fetal ductus arteriosus or kidney problems in the unborn child, which may lead to reduced amniotic fluid (oligohydramnios) if taken for more than a few days. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

• From the 20th week of pregnancy, MIG may cause constriction of the fetal ductus arteriosus or kidney problems in the unborn child, which may lead to reduced amniotic fluid (oligohydramnios) if taken 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 metabolites pass into breast milk.
Since no harmful effects have been observed in infants to date, breastfeeding does not usually need to be discontinued during short-term use. However, during long-term use or when taking high doses, breastfeeding should be considered for discontinuation.
Fertility
This medicine belongs to a group of medicines that may reduce fertility in women (NSAIDs). This effect is temporary and disappears after the end of treatment.

Driving and using machines

Since large doses of MIG may cause side effects from the central nervous system, such as fatigue and dizziness, the reaction time may change, and the ability to actively participate in traffic and operate machinery may be impaired. This is especially true for interactions with alcohol. The patient may then lose the ability to react quickly and appropriately to unexpected or sudden situations. In this case, they should not drive a car or other vehicles! They should not operate machinery! They should not work without secure support for their feet!

MIG contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take MIG

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The smallest effective dose should be used for the shortest duration necessary to control symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should immediatelyconsult their doctor (see section 2).

Dosage

The recommended dose is:

Body weight (age)

Maximum daily dose (24 hours)

20 kg - 29 kg

(Children aged 6-9 years)

Single dose

½ coated tablet (equivalent to 200 mg ibuprofen)
1½ coated tablets (equivalent to 600 mg ibuprofen)
2 coated tablets (equivalent to 800 mg ibuprofen)
≥ 40 kg
(Adolescents from 12 years and adults)
½ coated tablet (equivalent to 200 mg ibuprofen)

30 kg - 39 kg

(Children aged 10-11 years)
3 coated tablets (equivalent to 1200 mg ibuprofen)
After taking the maximum single dose, the next dose should not be taken earlier than 6 hours later.

Elderly patients

No special dose adjustment is required (see section 2, "Warnings and precautions").

Kidney or liver function disorders

In mild and moderate kidney or liver function disorders, dose reduction is not required.

Use in children and adolescents

If children and adolescents need to take this medicine for more than 3 days or if symptoms worsen, they should consult their doctor.

Method of administration

Oral administration.
The coated tablets should be swallowed whole, washed down with a large amount of liquid (e.g., a glass of water) during or after a meal.

Information on tablet division

The tablet can be divided into equal doses. Holding the tablet with the index fingers and thumbs of both hands, with the break line facing upwards, the tablet should be broken in half along the break line by pressing the thumbs downwards.

Treatment duration

The medicine is intended for short-term use only. This medicine should not be used without consulting a doctor for more than 3 days in children and adolescents, 3 days in the case of fever, and 4 days in adults with pain.
If the patient feels that the effect of MIG is too strong or too weak, they should consult their doctor.

Taking a higher dose of MIG than recommended

MIG should be taken as recommended by the doctor or according to the dosage instructions in this leaflet. If the pain-relieving effect seems too weak, the dose should not be increased without consulting a doctor.
½ - 1 coated tablet (equivalent to 200 - 400 mg ibuprofen)
If the patient has taken a higher dose of MIG than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to obtain an opinion on the possible risk to their health and advice on what actions to take.

Overdose symptoms may include:

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 and kidney function disorders, respiratory depression, decreased blood pressure, cyanosis, and coldness and breathing difficulties.

Missing a dose of MIG

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their 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 treatment, including side effects reported during long-term use of ibuprofen in high doses in patients with rheumatic diseases. Side effects more frequent than very rare are those occurring during short-term use in daily doses not exceeding the maximum dose of 1200 mg ibuprofen (= 3 MIG tablets) in the case of oral medicines and a maximum dose of 1800 mg ibuprofen in the case of suppositories.
Regarding the side effects listed below, it should be noted that they mostly show a dose-dependent relationship and are characterized by significant individual variability.
The most commonly observed side effects are gastrointestinal disorders. Gastric and/or duodenal ulcers, perforation, or gastrointestinal bleeding may occur, sometimes leading to death, especially in the elderly (see section 2, "Warnings and precautions").
After taking the medicine, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, and bloody vomiting have been reported, as well as stomatitis (stomatitis with ulcers), exacerbation of inflammatory bowel diseases, ulcerative colitis, and Crohn's disease (see section 2, "Warnings and precautions").
Less frequently, gastritis (gastritis) has been observed. The risk of gastrointestinal bleeding is dose-dependent and duration-dependent.

Stop taking MIG and seek medical attention immediately if the patient or child experiences any of the following side effects:

Uncommon: may affect up to 1 in 100 people

• Symptoms of gastrointestinal bleedingsuch as severe abdominal pain, blood in the stool, and/or black tarry stools, bloody vomiting or vomiting resembling coffee grounds.

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

• Symptoms of severe allergic reactionssuch as facial edema, tongue edema, laryngeal edema with bronchospasm, dyspnea, tachycardia, and a sudden drop in blood pressure to life-threatening shock. These symptoms may occur even after a single dose 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 reactions 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 bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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 people

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

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity reactions with skin rash and itching and asthma attacks (with possible accompanying sudden drop in blood pressure): in such cases, the patient should immediatelyinform their doctor and discontinue MIG.
• Central nervous system disorders such as headache, dizziness, insomnia, overexcitement, irritability, or fatigue.
• Visual disturbances: in such cases, treatment should be discontinued and the doctor informed.
• Gastric and/or duodenal ulcers, potentially with bleeding and perforation, stomatitis with ulcers (stomatitis with ulcers), exacerbation of inflammatory bowel diseases, ulcerative colitis, and Crohn's disease, gastritis (gastritis).
• Various skin rashes.

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

• Tinnitus, hearing impairment.

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

• Asthma, abnormal narrowing of the airways causing breathing difficulties (bronchospasm), shortness of breath (dyspnea).
• Exacerbation of infections (e.g., development of necrotizing fasciitis) has been observed during treatment with some anti-inflammatory medicines (non-steroidal anti-inflammatory medicines, including MIG). Symptoms of aseptic meningitis (aseptic meningitis) such as severe headache, nausea, vomiting, fever, stiff neck, or altered consciousness have been observed. Patients with certain immune system diseases (systemic lupus erythematosus, mixed connective tissue disease) seem to be more susceptible. If symptoms of infection (e.g., redness, swelling, excessive heat, pain, fever) appear or worsen during MIG treatment, the patient should immediatelycontact their doctor.
• Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of these disorders may be: fever, sore throat, mouth ulcers, flu-like symptoms, significant fatigue, nosebleeds, and skin bleeding. In such cases, the patient should immediatelydiscontinue the medicine and consult their doctor. They should not attempt to treat themselves with painkillers or antipyretics.
• Severe general hypersensitivity reactions.
• Psychotic reactions, depression.
• Palpitations, heart failure, heart attack (myocardial infarction).
• High blood pressure (hypertension), vasculitis.
• Esophagitis, pancreatitis, formation of membranous strictures in the small and large intestines (membranous strictures of the intestines).
• 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 function disorders, nephrotic syndrome (edema and proteinuria), interstitial nephritis (inflammation of the kidney tissue), which may be accompanied by acute kidney failure. Kidney damage (papillary necrosis) and increased uric acid levels in the blood may also occur.

Decreased urine output, fluid retention, as well as general malaise may be signs of kidney function disorders or even kidney failure. If any of the above symptoms occur or worsen, the patient should discontinue MIG and immediatelyconsult their doctor.

Frequency not known: frequency cannot be estimated from the available data

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

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store MIG

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
This medicine does not require special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What MIG contains

The active substance of MIG is ibuprofen.
Each coated tablet contains 400 mg of ibuprofen.

Other ingredients are:

Core
Cornstarch, anhydrous colloidal silica, sodium carboxymethylcellulose (type A),
magnesium stearate.
Coating
Hypromellose 6 mPas, macrogol 4000, povidone K 30, titanium dioxide (E 171).

What MIG looks like and contents of the pack

White or almost white, oblong, coated tablets with a break line on both sides, with the letters "E" on either side of the break line on one side.
Child-resistant blisters (packaging) made of white, rigid PVC film and soft aluminum foil coated with paper or soft aluminum foil in a cardboard box containing 10, 20, and 50 coated tablets.
Not all pack sizes may be marketed.

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
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
MIG-400
Estonia
IBUSTAR
Germany
EUDORLIN Extra Ibuprofen-Schmerztabletten
Hungary
IBUSTAR 400 mg coated tablets
Latvia
IBUSTAR 400 mg coated tablets
Poland
MIG
Romania
MIG-400
Slovakia
MIG-400
Date of last revision of the leaflet:01/2025