Migromin

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Migromin, 250 mg + 250 mg + 65 mg, coated tablets
Acetylsalicylic acid + Paracetamol + Caffeine

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 advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days of treatment for migraine and 4 days of treatment for headache, there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet:

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

1. What is Migromin and what is it used for

Migromin is used for the acute treatment of headache and migraine attacks (symptoms such as headache, nausea, hypersensitivity to light and sound, and disturbances of daily functioning) with or without aura.
Each Migromin coated tablet contains three active substances: acetylsalicylic acid, paracetamol, and caffeine.
Acetylsalicylic acid and paracetamol reduce pain and fever, and acetylsalicylic acid also has an anti-inflammatory effect.
Caffeine is a mild stimulant and increases the effect of acetylsalicylic acid and paracetamol.
Migromin is intended for adults over 18 years of age.

2. Important information before taking Migromin

When not to take Migromin

• If you are allergic(hypersensitive) to acetylsalicylic acid, paracetamol, caffeineor any of the other ingredients of this medicine(listed in section 6).
• If you have ever had allergic reactionsto other analgesic, anti-inflammatory, or antipyretic medicines, such as acetylsalicylic acid and salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac or ibuprofen; symptoms of an allergic reactionmay include: asthma, shortness of breath or difficulty breathing; rash or hives; swelling of the face or tongue; runny nose. If in doubt, consult a doctor or pharmacist;
• in patients with stomach or intestinal ulcers, or if there has been a history of gastrointestinal ulcers;
• if blood is present in the stool or black stools(symptoms of bleeding or gastrointestinal perforation);
• in cases of hemophilia or other blood disorders;
• in severe heart, liver, or kidney disease;
• while taking more than 15 mg of methotrexate per week(see section Migromin and other medicines);
• during the third trimester of pregnancy(see section Pregnancy, breastfeeding, and fertility).

Warnings and precautions

Migromin contains paracetamol. Do not take more than the recommended dose, as this may cause serious liver damage.
Acetylsalicylic acid may cause bleeding. If unusual bleeding occurs, inform your doctor.
Do not take this medicine with other products containing acetylsalicylic acid or paracetamol.
Migromin may not be suitable for every patient with the following conditions. Consult a doctor before taking the medicine if:

• the patient has not been previously diagnosed with migraine, as other potentially serious neurological disorders must be ruled out before taking the medicine;
• migraineis so severethat bed rest is necessary, or the pain is different from the usual migraine, or if migraine is accompanied by vomiting;
• there are headaches after injury or caused by injury, overexertion, coughing, or bending;
• headaches occur chronically(15 or more days per month for more than 3 months) or if headaches have occurred for the first time after the age of 50;
• the patient has severe infection, is seriously malnourished, has significant underweight, or chronically abuses alcohol(chronic alcoholism), as this may increase the risk of metabolic acidosis (see below). Symptoms of metabolic acidosis include: deep, rapid, difficult breathing, poor condition (nausea, vomiting), loss of appetite. If a combination of these symptoms occurs, seek medical attention immediately;
• there is a hereditary deficiency of glucose-6-phosphate dehydrogenase, which affects red blood cells. As a result, after consuming certain foods and taking other anti-inflammatory medications (including acetylsalicylic acid), anemia, jaundice, splenomegaly, or other diseases may develop;
• there have been gastrointestinal disorders, such as stomach ulcers, gastrointestinal bleeding, or black stools. If the patient has previously experienced discomfort in the stomach or heartburn after taking pain or anti-inflammatory medications;
• there are bleeding or coagulation disorders or other bleeding disordersother than menstrual bleeding (e.g., abnormally heavy and prolonged menstrual bleeding);
• the patient has recently undergone surgery(even minor, such as dental surgery) or is scheduled to undergo surgery within the next 7 days;
• there is asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, or symptoms indicating an allergy(skin reactions, itching, hives);
• there is gout, diabetes, hyperthyroidism, heart rhythm disorders, uncontrolled hypertension, kidney or liver dysfunction;
• the patient is currently taking other medicines containing acetylsalicylic acid or paracetamol, or is taking other medicines, as some medicines may interact with the ingredients of Migromin and cause side effects (see section Migromin and other medicines);
• there is a risk of dehydration(e.g., due to vomiting, diarrhea, before or after major surgery);
• the patient is under 18 years of age.There may be a link between acetylsalicylic acid given to children and adolescents and the occurrence of Reye's syndrome. Reye's syndrome is a disease that causes changes in the brain and liver and, although rare, can be fatal. Therefore, Migromin should not be given to children and adolescents under 18 years of age.

During treatment with Migromin, inform your doctor immediately if:

• If you have severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (a blood and fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Other warnings

As with other medicines used to treat headaches, taking Migromin too frequently (for 10 days or more per month) for the treatment of chronic headache (for 15 days or more per month) lasting longer than 3 months may worsen the headache or migraine. Therefore, this product should not be used for more than 10 days per month for more than 3 months. If you feel that this situation is occurring, consult a doctor. Stopping the use of Migromin may improve the condition.
Migromin may reduce the severity of infection symptoms (e.g., headache, fever), making it more difficult to diagnose. Therefore, in case of poor condition, remember to inform your doctor that you are taking Migromin.
Migromin may also affect the results of some laboratory tests, so if a blood, urine, or other laboratory test is to be performed, remember to inform your doctor that you are taking Migromin.
The medicine contains 0.24 mg of propylene glycol and 0.048 mg of benzoic acid in each tablet.

Migromin and other medicines

Tell your doctor about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.
Particularly, inform your doctor if you are taking any of the following medicines:

• other medicines containing paracetamol, acetylsalicylic acid, or any other pain-relieving and/or antipyretic medicines;
• anticoagulant medicines("blood thinners"), such as oral anticoagulants (e.g., warfarin), heparin, thrombolytic medicines (e.g., streptokinase), or other antiplatelet medicines (e.g., ticlopidine, clopidogrel, cilostazol);
• corticosteroids(used to treat inflammatory conditions);
• barbiturates and benzodiazepines(used to treat anxiety and insomnia);
• lithium, selective serotonin reuptake inhibitors, or fluvoxamine(used to treat depression);
• sulfonylureas or insulin(used to treat diabetes);
• methotrexate(used to treat certain types of cancer and arthritis);
• certain medicines used to treat infections(e.g., rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid);
• levothyroxine(used to treat hypothyroidism);
• metoclopramide(used to treat nausea and vomiting);
• medicines used to treat epilepsy;
• medicines used to treat high blood pressure and heart failure;
• diuretics(used to increase urine production and diuretic);
• medicines used to treat gout;
• oral contraceptives;
• zidovudine(used to treat HIV infection);
• medicines that delay gastric emptying, such as propantheline;
• clozapine(used to treat schizophrenia);
• sympathomimetic medicines(used to increase low blood pressure and treat nasal congestion);
• antihistamines(used to prevent or treat allergies);
• theophylline(used to treat asthma);
• terbinafine(used to treat fungal infections);
• cimetidine(used to treat heartburn and stomach ulcers);
• disulfiram(used to treat alcohol dependence);
• nicotine(used to help quit smoking);
• cholestyramine(used to lower high cholesterol levels in the blood);
• flucloxacillin(an antibiotic), due to the serious risk of blood and fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Migromin with food, drink, and alcohol

Alcohol

Ask your doctor if you can take Migromin or other pain-relieving and/or antipyretic medicines.
While taking the medicine, avoid drinking alcoholic beverages, as alcohol in combination with paracetamol and acetylsalicylic acid can cause serious liver damage and stomach bleeding.

Caffeine

The amount of caffeine in the recommended dose of Migromin is equivalent to the amount found in about one cup of coffee.
While taking the medicine, limit the consumption of medicines, foods, or beverages containing caffeine, as excessive intake may cause nervousness, irritability, insomnia, and in some cases, increased heart rate.

Pregnancy, breastfeeding, and fertility

This medicine is not recommended during pregnancy.
The medicine is contraindicated during the last three months of pregnancy, due to the potential risk of harm to the fetus or difficulties during delivery.
If you are pregnant, think you may be pregnant, or plan to have a baby, inform your doctor and do not take Migromin.
If, following the advice of your doctor, you continue or start taking Migromin during pregnancy, take the medicine as directed by your doctor and do not take a dose higher than recommended.

Pregnancy – third trimester

Migromin contains acetylsalicylic acid in a dose greater than 100 mg per day, so do not take Migromin during the last 3 months of pregnancy, as it may harm the unborn baby or cause difficulties during delivery. Taking Migromin during the last 3 months of pregnancy may cause kidney or heart problems in the unborn baby. It may also affect your and your baby's tendency to bleed and may cause delayed or prolonged delivery.

Pregnancy – first and second trimester

Do not take Migromin during the first 6 months of pregnancy, unless absolutely necessary and advised by your doctor. If treatment is necessary during this period or when trying to conceive, use the smallest possible dose for the shortest possible time. If Migromin is taken for several days in the later stages of pregnancy, starting from the 20th week, it may cause kidney problems in the unborn baby, leading to a decrease in the level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If treatment is necessary for more than a few days, your doctor may recommend additional tests.

Breastfeeding

Do not take the medicine while breastfeeding, as it may be harmful to the baby.
Migromin belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs), which may affect fertility. This effect is reversible after stopping the NSAID.

Driving and using machines

There is no data confirming the effect of Migromin tablets on the ability to drive and use machines.
If you experience dizziness or drowsiness, do not drive or operate machinery. Inform your doctor immediately if you experience any of these events.

3. How to take Migromin

Always take this medicine exactly as described in this patient leaflet, or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults (over 18 years of age):

Treating headache

When a headache occurs, the recommended dose is usually 1 tablet. The tablet should be swallowed with a full glass of water. If necessary, a second tablet can be taken 4-6 hours after the first tablet.
In cases of more intense headache, 2 tablets can be taken at once, swallowed with a full glass of water. If necessary, another 2 tablets can be taken 4-6 hours after the first 2 tablets.
Do not take Migromin for headache for more than 4 days without consulting a doctor.

Treating migraine

When migraine symptoms or aura occur, take 2 tablets of Migromin, swallowed with a full glass of water. If necessary, another 2 tablets can be taken, maintaining a 4-6 hour interval between doses. If there is no improvement 2 hours after taking the first dose of 2 tablets, consult a doctor.
Do not take Migromin for more than 3 days for migraine without consulting a doctor.
Both for headache and migraine, do not exceed a dose higher than 6 tablets in 24 hours. This corresponds to a dose of 1500 mg of acetylsalicylic acid, 1500 mg of paracetamol, and 390 mg of caffeine.
Long-term use of the medicine without medical supervision may be harmful to your health.
Do not exceed the recommended dose. Use the lowest effective dose for the shortest possible time.

Use in children and adolescents:

Do not take Migromin in children and adolescents under 18 years of age (see section Warnings and precautions).

Elderly patients:

In accordance with general medical recommendations, in elderly patients, the medicine should be used with caution. In cases of low body weight in this patient group, consult a doctor or pharmacist.

Patients with kidney or liver dysfunction:

Inform your doctor about liver and kidney diseases. Your doctor may prescribe a different dosage regimen or interval between doses of Migromin.
Do not take Migromin in patients with severe kidney or liver failure.

Taking a higher dose of Migromin than recommended

The medicine contains acetylsalicylic acid, paracetamol, and caffeine. While taking Migromin, do not take a higher dose than recommended and do not take other medicines containing any of its ingredients or other pain-relieving, anti-inflammatory, or antipyretic medicines (non-steroidal anti-inflammatory drugs).
If you have taken too much Migromin, consult a doctor, pharmacist, or go to the nearest hospital and contact the poison control center. Immediate medical attention is necessary due to the risk of irreversible liver damage from paracetamol. Do not wait for overdose symptoms to appear, as they may be initially unnoticed.
If overdose symptoms occur, they may include:

• For acetylsalicylic acid: dizziness, ringing in the ears, hearing loss, excessive sweating, hyperventilation, fever, nausea, vomiting, headache, confusion, or circulatory collapse or respiratory failure.
• For paracetamol: the first symptoms that may occur are: nausea, vomiting, loss of appetite, pallor, lethargy, excessive sweating, abdominal pain.
• For caffeine: anxiety, nervousness, insomnia, excitement, tremors, confusion, hyperglycemia (elevated blood sugar), tachycardia (rapid heart rate), and arrhythmias.

Even if the above symptoms do not occur or have disappeared, immediate medical attention is necessary.

Missing a dose of Migromin

Take the missed dose as soon as possible, but do not take a double dose to make up for the missed dose. Do not take more than 6 tablets in 24 hours.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Migromin and inform your doctor immediately if you experience any of the following side effects:

• Allergic reactions such as swelling of the face, lips, mouth, tongue, or throat. These symptoms may cause difficulty swallowing, wheezing, breathing difficulties, a feeling of chest tightness (symptoms of asthma), or hives and itching.
• Redness of the skin, blisters on the lips, conjunctiva, or mouth, peeling of the skin, or mouth ulcers.
• Bleeding from the stomach or intestines, stomach or intestinal ulcers. These symptoms may be accompanied by severe abdominal pain, bloody or black stools, or bloody vomiting. These symptoms may not be preceded by warning signs and may occur during the use of all NSAIDs, at any stage of treatment, and may be fatal. This risk is particularly high in the elderly.
• Yellowing of the skin or eyes (symptoms of liver failure).
• Dizziness or a feeling of lightheadedness (symptom of low blood pressure).
• Irregular heartbeat.
• If you have experienced breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs and a similar reaction occurs after taking this product.
• Bruises or bleeding of unknown cause.
• Increased nosebleeds or bruising.
• Swelling or fluid retention.
• Ringing in the ears or temporary hearing loss.
• Changes in behavior, nausea, and vomiting (may be a sign of Reye's syndrome).

The following side effects are also reported. Inform your doctor if you experience any of the following:

Common (occurring in 1 in 10 patients)

• Nervousness, dizziness.
• Nausea, abdominal discomfort.

Uncommon (occurring in 1 in 100 patients)

• Insomnia, tremors, numbness, headache.
• Ringing in the ears.
• Dry mouth, diarrhea, vomiting.
• Fatigue, feeling of anxiety.
• Rapid heartbeat.

Rare (occurring in 1 in 1000 patients)

• Sore throat, difficulty swallowing, numbness and tingling around the mouth, excessive salivation.
• Decreased appetite, taste disorders.
• Anxiety, euphoric mood, feeling of tension.
• Attention disorders, memory loss, coordination disorders.
• Pain in the forehead and cheek area.
• Eye pain, vision disturbances.
• Hot flashes, peripheral vascular problems (e.g., in the hands or feet).
• Nosebleeds, slow breathing, runny nose.
• Bloating, belching.
• Excessive sweating, itching, itchy rash, increased skin sensitivity.
• Muscle stiffness, bone or joint pain, neck pain, back pain, muscle cramps.
• Weakness, feeling of discomfort in the chest.

The following side effects have been reported after the medicine containing paracetamol, acetylsalicylic acid, and caffeine was placed on the market.

Frequency not known (cannot be estimated from available data)

• Anxiety, poor or unusual condition.
• Drowsiness, migraine.
• Redness of the skin, rash, very rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.
• Rapid heartbeat, shortness of breath, sudden difficulty breathing, feeling of chest tightness, wheezing, or cough (symptoms of asthma).
• Abdominal pain, gastrointestinal disorders occurring after meals.
• Increased liver enzyme activity.
• Nasal congestion and irritation.
• Kidney problems.
• A serious disease that can cause acidosis (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Migromin

Store in a temperature below 25°C. The medicine should be stored in its original packaging to protect it from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and label.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Migromin contains

• The active substances of the medicine are acetylsalicylic acid, paracetamol, and caffeine. Each coated tablet contains 250 mg of acetylsalicylic acid, 250 mg of paracetamol, and 65 mg of caffeine.
• The other ingredients are: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, stearic acid, hypromellose E6 (type 2910, 6 mPa s), titanium dioxide (E 171), propylene glycol, benzoic acid (E 210), Carnauba wax.

What Migromin looks like and contents of the pack

White, elongated tablets with a smooth surface, without spots or damage, approximately 17.3 mm long and 8.8 mm wide.
The tablets are packaged in blisters, and then in cardboard boxes containing 10, 16, 20, 24, or 32 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

COLFARM Pharmaceutical Works S.A., ul. Wojska Polskiego 3, 39-300 Mielec.
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder.
COLFARM Pharmaceutical Works S.A., ul. Wojska Polskiego 3, 39-300 Mielec, tel.: 17 788 58 11, tel.: 17 788 58 13, e-mail: [email protected]

Date of last revision of the leaflet: