Mig

Patient Information Leaflet: Information for the User

MIG
400 mg, coated tablets
Medicinal product intended for use in children from the age of 6 (from 20 kg) and adults
Ibuprofenum
Please read this leaflet carefully before taking 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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement in children and adolescents after 3 days of treatment for fever, or in adults after 3 days of fever treatment or 4 days of pain treatment, or if the patient feels worse, consult a doctor.

Table of Contents

1. What MIG is and what it is 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 MIG is and what it is used for

MIG is a non-steroidal anti-inflammatory and analgesic medicine (NSAID) with antipyretic (fever-reducing) properties.
MIG is used for symptomatic treatment of:

• Mild to moderate pain
• Fever.

2. Important information before using MIG

When not to use MIG

• 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, inflammation of the nasal mucosa (rhinitis), angioedema, or skin reactions (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• In blood disorders of unknown cause
• In active or recurrent history of gastric or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more separate episodes of confirmed ulceration or bleeding)
• In case of gastrointestinal perforation or bleeding in the patient's history related to previous NSAID treatment
• If the patient has cerebral haemorrhage (cerebrovascular bleeding) or any other active bleeding
• In severe liver or kidney failure
• In severe heart failure
• In severe dehydration (significant loss of body fluids caused, for example, by vomiting, diarrhoea, or inadequate fluid intake)
• In women during the last three months of pregnancy
• In children with body weight below 20 kg (under 6 years of age), as this dosage is not appropriate due to the content of the active substance

Warnings and precautions
Before starting to take MIG, consult your doctor or pharmacist.

If the patient has an infection – see below, section titled "Infections".
Adverse effects can be minimized by using the lowest 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 (selective cyclooxygenase-2 inhibitors), should be avoided.

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

Gastrointestinal bleeding, peptic ulcer disease, and perforation
Gastrointestinal bleeding, gastric and/or duodenal ulcer disease, and perforations, which may be fatal, have been reported with all NSAIDs. These events may occur 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 ulcer disease, and perforation increases with higher NSAID doses, in patients with a history of gastric and/or duodenal ulcer disease, especially if complicated by bleeding or perforation (see section 2. "When not to use MIG"), and in elderly patients. In such patients, treatment should be initiated with the lowest available doses.

In such patients and in patients requiring additional low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal adverse effects, concomitant administration with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

Patients with a history of gastrointestinal adverse effects, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.

Caution is advised in patients receiving concomitant medications that may increase the risk of gastric and/or duodenal ulcer disease or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors used, among others, in the treatment of depression, or antiplatelet agents such as acetylsalicylic acid (see section 2, "MIG and other medicines").

If gastrointestinal bleeding or gastric and/or duodenal ulcer disease occurs during treatment with MIG, treatment should be discontinued.

NSAIDs should be used cautiously in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4. "Possible side effects").

Cardiovascular effects
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 at high doses. Do not exceed the recommended dose or duration of treatment.

Before using MIG, the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart diseases such as heart failure, angina pectoris (chest pain), history of 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, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during ibuprofen use.

If any of these symptoms occur, discontinue MIG 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 generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient experiences any of the symptoms related to these severe skin reactions described in section 4, discontinue MIG immediately and seek medical help.

During chickenpox (varicella), use of MIG should be avoided.

Infections
MIG may mask symptoms of infection such as fever and pain. Therefore, MIG 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 infection symptoms persist or worsen, seek immediate medical advice.

Respiratory disorders
Caution should be exercised when administering MIG to patients with bronchial asthma or a history of bronchial asthma, as NSAIDs have been reported to cause bronchospasm in such patients.

Other considerations
MIG should be used only after careful consideration of the benefit-risk ratio

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

MIG may be used only under strict medical supervision 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 impaired kidney or liver function
• In case of dehydration
• Immediately after major surgical procedures
• In case of allergies (e.g. skin reactions to other medicines, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa, or chronic respiratory diseases with airway constriction

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. After the first symptoms of severe hypersensitivity following MIG administration, treatment must be immediately discontinued and the doctor informed.

Ibuprofen, the active substance in MIG, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be carefully monitored during treatment.

During long-term use of MIG, regular monitoring of liver enzymes, kidney function, and blood morphology is required.

Before surgical procedures, inform the doctor or dentist about taking MIG.

Long-term use of painkillers for headache treatment may lead to worsening of headache. If such a situation is observed or suspected, medical advice should be sought and treatment discontinued. Consider the possibility of medication-overuse headache in patients suffering from frequent or daily headaches despite regular use (or due to use) of painkillers.

Generally, habitual use of painkillers, especially combinations of several painkillers, may lead to permanent kidney damage and is associated with the risk of kidney failure (analgesic nephropathy).

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

MIG and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and about any medicines planned for use.

MIG may affect the action of other medicines or other medicines may affect the action of MIG. 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 MIG treatment. Therefore, always consult a doctor or pharmacist before using MIG with other medicines.

In particular, inform your doctor or pharmacist if the patient is taking:

• Digoxin (used to strengthen the heart), phenytoin (used to treat epileptic seizures), or lithium (used to treat certain psychiatric disorders), as blood levels of these medicines may increase. Monitoring of serum lithium, digoxin, and phenytoin levels is generally not required if ibuprofen is used according to recommendations (see section 3. "How to use MIG");
• Diuretics (medicines increasing fluid excretion) and antihypertensive medicines (medicines used for high blood pressure);
• 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): concomitant use may lead to 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 levels): 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. This may lead to ibuprofen accumulation and increased adverse effects;
• Zidovudine (used to treat AIDS): increased risk of haemarthrosis and bruising in HIV-infected haemophiliacs;
• Methotrexate (used to treat cancer and certain rheumatic diseases): MIG should not be used within 24 hours before and after methotrexate administration. This may increase methotrexate serum levels and intensify its adverse effects;
• Pemetrexed (used to treat cancer): concomitant use of pemetrexed 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 (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 for fungal infections): concomitant use of ibuprofen and CYP2C9 inhibitors may increase body exposure time to ibuprofen (a CYP2C9 substrate). In a study using voriconazole and fluconazole (CYP2C9 inhibitors), exposure time 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 concomitantly with voriconazole or fluconazole;
• Deferasirox (administered 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 supervision is required during concomitant 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 and alcohol
Avoid alcohol consumption during MIG treatment. Some adverse effects, especially on the gastrointestinal tract or central nervous system, are more likely when alcohol is consumed concomitantly with MIG.

Pregnancy, breastfeeding, and 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 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 should not be used during the first six months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
From week 20 of pregnancy, MIG may cause narrowing of the blood vessel (ductus arteriosus) in the baby'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 during short-term use. However, during prolonged use or when high doses are used, discontinuation of breastfeeding should be considered.

Fertility
This medicine belongs to a group of medicines that may reduce fertility in women (NSAIDs). 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, 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 pronounced with concomitant alcohol use. The patient may then 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 machinery! Do not work without secure foot support!

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

3. How to use MIG

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

Dosage
Recommended dose:

| Body weight | Single dose | Maximum daily dose | |-----------------|-----------------|------------------------| | (Age) | (24 hours) | | | 20 kg - 29 kg | ½ coated tablet (corresponding to 200 mg of ibuprofen) | 1½ coated tablets (corresponding to 600 mg of ibuprofen) | | (Children aged: 6 - 9 years) | | | | 30 kg - 39 kg | ½ coated tablet (corresponding to 200 mg of ibuprofen) | 2 coated tablets (corresponding to 800 mg of ibuprofen) | | (Children aged: 10 - 11 years) | | | | ≥ 40 kg | ½ - 1 coated tablet (corresponding to 200 - 400 mg of ibuprofen) | 3 coated tablets (corresponding to 1200 mg of ibuprofen) | | (Adolescents from 12 years and adults) | | |

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").

Renal or hepatic impairment
Dose reduction is not required in mild to moderate renal or hepatic impairment.

Use in children and adolescents
If this medicine needs to be used for longer than 3 days in children and adolescents, or if symptoms worsen, consult a doctor.

Method of administration
For oral use.
Coated tablets should be swallowed whole with a large amount of liquid (e.g. a glass of water), during or after a meal.

Information on tablet splitting
The tablet may be divided into equal doses. Holding the tablet between the index finger and thumb of both hands, with the break line facing upwards, break the tablet in half along the break line by pressing downwards with the thumbs.

Duration of treatment
This medicine is intended for short-term use only. Do not use this medicine for longer than 3 days in children and adolescents, 3 days for fever, or 4 days in adults for pain, unless advised by a doctor.

If the effect of MIG seems too strong or too weak, consult a doctor.

Taking more MIG than recommended
MIG should be taken according to the doctor's instructions or the dosage recommendations in this leaflet. If the pain-relieving effect seems too weak, do not increase the dose without consulting a doctor.
If a patient has taken more than the recommended dose of MIG, or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on necessary actions.

Symptoms of overdose may include:
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. Gastrointestinal bleeding may also 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 dysfunction, breathing difficulties (respiratory depression), low blood pressure, bluish-red discoloration of the skin and mucous membranes (cyanosis), cold sensation, and breathing problems may occur.
There is no specific antidote.

If a dose of MIG is missed
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Possible side effects
The side effects listed below include all adverse reactions reported during ibuprofen use, including those reported during long-term use of high-dose ibuprofen in patients with rheumatic diseases. Side effects more common than very rare are those occurring during short-term use at daily doses not exceeding the maximum dose of 1200 mg ibuprofen (= 3 tablets of MIG) for oral medicines, and the maximum dose of 1800 mg ibuprofen for suppositories.
Regarding the side effects listed below, it should be noted that in most cases they are dose-dependent and show considerable individual variability.
The most commonly observed side effects are those affecting the gastrointestinal tract. Peptic ulceration of the stomach and/or duodenum, gastrointestinal perforation or bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2. "Warnings and precautions").
After administration of the medicine, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, haematemesis, oral mucosal inflammation with ulceration (ulcerative stomatitis), exacerbation of intestinal disorders, ulcerative colitis and Crohn's disease have been reported (see section 2. "Warnings and precautions").
Gastritis (gastric irritation) has been observed less frequently. The risk of gastrointestinal bleeding is particularly dependent on the dose used and the duration of treatment.
Treatment with NSAIDs has been associated with oedema, hypertension and heart failure.
Use of medicines such as MIG may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
You should IMMEDIATELY STOP taking this medicine and seek medical help if the patient or child experiences any of the following side effects:
Not 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, vomiting blood 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 oedema with bronchospasm, shortness of breath, 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 circular skin lesions on the trunk, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genital organs 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 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 generalised exanthematous pustulosis).

Talk to your 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 bleeding, which in isolated cases may lead to anaemia.

Not 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 your doctor and discontinue MIG.
• Central nervous system disturbances such as headache, dizziness, insomnia, excessive excitation, irritability or fatigue.
• Visual disturbances: in such cases, discontinue treatment and inform your doctor.
• Peptic ulceration of the stomach and/or duodenum, potentially with bleeding and perforation, oral mucosal inflammation with ulceration (ulcerative stomatitis), exacerbation of ulcerative colitis and Crohn's disease, gastric mucosal inflammation (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 narrowing of airway muscles causing breathing difficulties (bronchospasm), shortness of breath (dyspnoea).
• Exacerbation of infection-related inflammation (e.g. development of necrotising fasciitis) has been observed during treatment with certain anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, including MIG). Symptoms of aseptic meningitis (non-infectious inflammation of the meninges) such as severe headache, nausea, vomiting, fever, neck stiffness or altered consciousness have also been observed. Patients with certain immune system disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be at higher risk. If signs of infection (e.g. redness, swelling, excessive warmth, pain, fever) appear or worsen during treatment with MIG, seek medical advice immediately.
• Blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include: fever, sore throat, oral mucosal erosions, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, discontinue the medicine immediately and consult a doctor. Do not attempt self-treatment with painkillers or antipyretics.
• Severe generalised hypersensitivity reactions.
• Psychotic reactions, depression.
• Palpitations, heart failure, heart attack (myocardial infarction).
• 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 prolonged treatment, liver failure, acute hepatitis. During long-term treatment, liver function tests should be performed regularly.
• Hair loss (alopecia).
• Increased fluid retention (oedema), particularly in patients with hypertension or impaired kidney function, nephrotic syndrome (fluid retention [oedema] and proteinuria), inflammatory kidney disease (interstitial nephritis), which may be accompanied by acute renal failure. Kidney damage (papillary necrosis) and increased serum uric acid levels may also occur.

Reduced urine output, fluid accumulation in tissues (oedema), as well as general malaise may indicate impaired kidney function or even renal failure. If any of the above symptoms occur or worsen, discontinue MIG and seek medical advice immediately.
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 infection (chickenpox), severe skin infections and soft tissue complications may occur (see also "very rare" regarding "exacerbation of infection-related inflammation").
Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store the medicinal product MIG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister after "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. Such measures will help
protect the environment.

6. Contents of the pack and other information

What MIG contains
The active substance is ibuprofen.
Each coated tablet contains 400 mg of ibuprofen.
The other ingredients are:
Tablet core
Corn starch, colloidal anhydrous silica, sodium carboxymethyl starch (type A), magnesium stearate.
Tablet coating
Hypromellose 6 mPa·s, macrogol 4000, povidone K 30, titanium dioxide (E 171).

What MIG looks like and contents of the pack
White or almost white, elongated coated tablets with a score line on both sides, marked with the letter “E” on both sides of the score line.
Blister packs (child-resistant packaging) made of white rigid PVC foil and paper-laminated soft aluminum foil or soft aluminum foil, in a cardboard box containing 10, 20, or 50 coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany

For further information about this medicine, 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 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