Migromin

Package leaflet: Information for the patient

Migromin, 250 mg + 250 mg + 65 mg, film-coated tablets
Acidum acetylsalicylicum + Paracetamolum + Coffeinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary. If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for migraine or 4 days for headache, or if your condition worsens, you should consult a doctor.

Leaflet contents:

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

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

2. Important information before using Migromin

When not to use Migromin

• if the patient is allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine, or any of the ingredients of this medicine (listed in section 6);
• if allergic reactions have ever occurred to 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 allergic reaction may include: asthma, shortness of breath or difficulty breathing; skin rash or urticaria; swelling of the face or tongue; nasal congestion. In case of any doubts, consult a doctor or pharmacist;
• in patients with gastric or intestinal ulcers, or if peptic ulcer disease has occurred in the past;
• if there is blood in the stool or black stools (symptoms of gastrointestinal bleeding or perforation);
• in cases of haemophilia or other blood disorders;
• in severe heart, liver or kidney disease;
• during treatment with 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 exceed the recommended dose, as it may cause serious liver damage.
Acetylsalicylic acid may cause bleeding. If unusual bleeding occurs, inform your doctor.
Do not take this medicine together with other products containing acetylsalicylic acid or paracetamol.
Migromin may not be suitable for every patient for the following reasons. Consult a doctor before using the medicine if:

• the patient has not previously been diagnosed with migraine, as other potentially serious neurological conditions should be ruled out before treatment;
• migraine is so severe that bed rest is required, or the pain differs from usual migraines, or if migraine headaches are accompanied by vomiting;
• headaches occur after injury or are caused by head trauma, fatigue, coughing or bending forward;
• headaches are chronic (15 or more days per month for longer than 3 months), or if headaches first occurred after age 50;
• the patient has a severe infection, is severely malnourished, has significant underweight, or chronically abuses alcohol (chronic alcoholism), as this may increase the risk of metabolic acidosis (see description below). Symptoms of metabolic acidosis include: deep, rapid, difficult breathing, general malaise (nausea, vomiting), loss of appetite. If a combination of these symptoms occurs, contact a doctor immediately;
• there is a hereditary deficiency of glucose-6-phosphate dehydrogenase affecting red blood cells. As a result, after consuming certain foods or taking other anti-inflammatory medicines (including acetylsalicylic acid), anaemia, jaundice, enlargement of the spleen or other diseases may develop;
• gastrointestinal disorders have occurred in the past, such as gastric ulcers, gastrointestinal bleeding or black stools. If the patient previously experienced stomach discomfort or heartburn after taking analgesic or anti-inflammatory medicines;
• bleeding disorders or abnormal genital bleeding other than menstrual bleeding (e.g. abnormally heavy and prolonged menstrual bleeding) occur;
• the patient has recently undergone surgery (even minor, such as dental surgery) or has surgery planned within the next 7 days;
• bronchial asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease or allergy symptoms (skin reactions, itching, urticaria) occur;
• gout, diabetes, hyperthyroidism, cardiac arrhythmias, uncontrolled hypertension, kidney or liver dysfunction occur;
• the patient currently uses other medicines containing acetylsalicylic acid or paracetamol, or takes other medicines, as some drugs may interact with the components of Migromin and cause adverse effects (see section Migromin and other medicines);
• there is a risk of dehydration (e.g. due to vomiting, diarrhoea, before or after major surgery);
• the patient is under 18 years of age. A possible association exists between acetylsalicylic acid administered to children and adolescents and the occurrence of Reye's syndrome. Reye's syndrome is a disease causing changes in the brain and liver and, although very rare, may lead to death. Therefore, Migromin should not be given to children and adolescents under 18 years of age.

During treatment with Migromin, inform your doctor immediately if:

• The patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (abnormality of blood and fluids) when taking paracetamol regularly for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Other warnings
As with other medicines used to treat headache, excessive use of Migromin (for 10 days or more per month) in treating chronic headache (for 15 days or more per month) lasting longer than 3 months may worsen headache or migraine. Therefore, this product should not be used for more than 10 days per month for longer than 3 months. If the patient feels this situation applies, medical advice should be sought. Discontinuation of Migromin may lead to improvement.
Migromin may reduce the symptoms of infection (e.g. headache, fever), which may make diagnosis more difficult. Therefore, in case of feeling unwell, remember to inform the doctor about taking Migromin.
Migromin may also affect the results of certain laboratory tests, so if blood, urine or other laboratory tests are to be performed, remember to inform the doctor about 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if any of the following medicines are being taken:

• other medicines containing paracetamol, acetylsalicylic acid or any other analgesics and (or) antipyretics;
• anticoagulants ("blood thinners"), such as oral anticoagulants (e.g. warfarin), heparin, thrombolytic agents (e.g. streptokinase), or other antiplatelet agents (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 cancers and rheumatoid arthritis);
• some 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 for hypertension and heart failure;
• diuretics (used to increase urine production and for dehydration);
• medicines used to treat gout;
• oral contraceptives;
• zidovudine (used to treat HIV infection);
• medicines delaying gastric emptying, such as propantheline;
• clozapine (used to treat schizophrenia);
• sympathomimetic medicines (used to raise low blood pressure and treat nasal mucosal congestion);
• antiallergic medicines (used to prevent or treat allergies);
• theophylline (used to treat asthma);
• terbinafine (used to treat fungal infections);
• cimetidine (used to treat heartburn and gastrointestinal ulcers);
• disulfiram (used to treat alcohol dependence);
• nicotine (used to stop smoking);
• cholestyramine (used to lower high blood cholesterol levels);
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Migromin with food, drink and alcohol

• Alcohol Ask your doctor whether you can take Migromin or other analgesic and (or) antipyretic medicines. During treatment, avoid drinking alcoholic beverages, as alcohol combined with paracetamol and acetylsalicylic acid may cause severe liver damage and gastrointestinal bleeding.
• Caffeine The caffeine content in the recommended dose of the medicine corresponds to approximately one cup of coffee. During treatment, limit intake of medicines, food or drinks 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 risk of fetal harm or complications during delivery.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should inform her doctor and not use Migromin.
If, following advice from the treating doctor, the patient continues or starts taking Migromin during pregnancy, the medicine should be used strictly according to the doctor's recommendations and the dose should not exceed the recommended amount.

Pregnancy – third trimester
Migromin contains acetylsalicylic acid in a dose exceeding 100 mg per day; therefore, Migromin should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Use of Migromin during the last three months of pregnancy may cause kidney or heart dysfunction in the unborn child. It may also affect the tendency to bleed in both mother and child and may delay or prolong labour.

Pregnancy – first and second trimester
Do not take Migromin during the first six months of pregnancy unless absolutely necessary and prescribed by the treating doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. If Migromin is taken for several days or longer during pregnancy, starting from week 20, it may cause kidney problems in the unborn child, leading to reduced amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Do not use the medicine during breastfeeding, as it may be harmful to the infant.
Migromin belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which may impair fertility. This effect is reversible after discontinuation of NSAIDs.

Driving and using machines
There are no data confirming the effect of Migromin coated tablets on the ability to drive or operate machinery.
If dizziness or drowsiness occurs, do not drive or operate mechanical equipment. Inform your doctor immediately if any of the above symptoms occur.

3. How to use Migromin

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

Adults (aged over 18 years):

Treatment of headache
When headache occurs, the usual recommended dose is 1 tablet. The tablet should be taken with a full glass of water. If necessary, a second tablet may be taken 4–6 hours after the first dose.

In the case of more intense headache, 2 tablets may be taken at once, with a full glass of water. If needed, another 2 tablets may be taken 4–6 hours after the initial dose of 2 tablets.

Do not use Migromin for headache for longer than 4 days without consulting a doctor.

Treatment of migraine
When symptoms of migraine or migraine aura occur, take 2 tablets with a full glass of water. If necessary, another 2 tablets may be taken, maintaining a 4–6 hour interval between doses. If there is no improvement within 2 hours after taking the first dose of 2 tablets, consult your doctor.

Do not use Migromin for migraine for longer than 3 days without consulting a doctor.

In both headache and migraine treatment, do not exceed a maximum of 6 tablets per day. This corresponds to a daily dose of 1500 mg acetylsalicylic acid, 1500 mg paracetamol, and 390 mg caffeine.

Long-term use of this medicine without medical supervision may be harmful to health.

Do not exceed the recommended dose. Use the lowest effective dose for the shortest possible time.

Use in children and adolescents:
Migromin should not be used in children and adolescents under 18 years of age (see section Warnings and precautions).

Elderly patients:
In accordance with general medical recommendations, this medicine should be used with particular caution in elderly patients. If patients in this age group have low body weight, consult your doctor or pharmacist.

Patients with impaired kidney and/or liver function:
Inform your doctor if you have liver or kidney disease. Your doctor may recommend a different dosing regimen, longer intervals between doses, or a different duration of treatment with Migromin.

Do not use Migromin in patients with severe renal or hepatic impairment.

Use of a higher than recommended dose of Migromin
Migromin contains acetylsalicylic acid, paracetamol, and caffeine. While taking Migromin, do not exceed the recommended dose and avoid taking other medicines containing any of these ingredients or other medicines used to treat pain, inflammation, or fever (non-steroidal anti-inflammatory drugs).

If an overdose of Migromin is taken, contact your doctor, pharmacist, or go immediately to the nearest hospital and contact a poison control centre. Immediate medical attention is essential due to the risk of irreversible liver damage caused by paracetamol. Do not wait for symptoms of overdose to appear, as they may initially be unnoticeable.

Symptoms of overdose may include:

• For acetylsalicylic acid: dizziness, tinnitus, hearing loss, excessive sweating, hyperventilation, fever, nausea, vomiting, headache, confusion or restlessness, circulatory collapse, or respiratory failure.
• For paracetamol: early symptoms may include nausea, vomiting, loss of appetite, pallor, drowsiness, excessive sweating, followed by abdominal pain.
• For caffeine: anxiety, nervousness, insomnia, excitement, muscle tremors, confusion, hyperglycaemia (increased blood sugar), tachycardia (rapid heartbeat), and cardiac arrhythmias. Even if the above symptoms do not occur or resolve, immediate medical assistance is required.

Missed 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 exceed a maximum of 6 tablets per day.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking Migromin immediately and contact your doctor if any of the following adverse effects occur:

• Allergic reactions such as swelling of the face, lips, mouth, tongue, or throat. These symptoms may cause difficulty swallowing, wheezing, breathing difficulties, or a feeling of tightness in the chest (asthma-like symptoms). Skin rash, itching, and fainting may also occur.
• Redness of the skin, blisters on the lips, conjunctivae, or inside the mouth, skin peeling, or oral ulceration.
• Bleeding from the stomach or intestines, or stomach or intestinal ulcers. These may be accompanied by severe abdominal pain, bloody or black stools, or vomiting blood. These symptoms may occur without warning signs and can happen at any stage of treatment with all NSAIDs, and may lead to death. This risk is particularly high in elderly patients.
• Yellowing of the skin or eyes (signs of liver failure).
• Dizziness or a feeling of "light-headedness" (symptom of low blood pressure).
• Irregular heartbeat.
• If the patient has previously experienced breathing problems after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, and a similar reaction occurs after taking this product.
• Bruising or bleeding of unknown cause.
• Increased frequency of nosebleeds or bruising.
• Swelling or fluid retention.
• Ringing in the ears or temporary hearing loss.
• Changes in behavior, nausea, and vomiting (these may be signs of Reye's syndrome).

The adverse effects listed below have been reported. You should contact your doctor if you notice any of the following symptoms:
Common (affects 1 in 10 patients)

• Nervousness, dizziness.
• Nausea, abdominal discomfort.

Uncommon (affects 1 in 100 patients)

• Insomnia, tremor, numbness, headache.
• Tinnitus (ringing in the ears).
• Dry mouth, diarrhoea, vomiting.
• Fatigue, feeling of uneasiness.
• Rapid heartbeat.

Rare (affects 1 in 1000 patients)

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

The following adverse effects have been reported after the medicine containing paracetamol, acetylsalicylic acid, and caffeine was introduced to the market.
Frequency unknown (cannot be estimated from available data)

• Restlessness, feeling unwell or feeling different than usual.
• Drowsiness, migraine.
• Skin redness, rash; very rare cases of serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
• Palpitations, shortness of breath, sudden breathing difficulty, chest tightness, wheezing, or cough (asthma symptoms).
• Abdominal pain, gastrointestinal discomfort occurring after meals.
• Increased liver enzyme activity.
• Nasal swelling and irritation.
• Kidney problems.
• Serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

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

5. How to store Migromin

Store below 25°C. Keep the medicine in the original packaging
to protect 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Migromin contains

• The active substances in this 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.
• Other ingredients are: microcrystalline cellulose, low-substituted hydroxypropylcellulose, 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, oblong coated tablets with a smooth surface, free from spots and defects, approximately
17.3 mm in length and 8.8 mm in width.
The tablets are packed in blisters, then placed in cardboard boxes containing 10, 16, 20, 24 or 32
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne COLFARM S.A.
ul. Wojska Polskiego 3
39-300 Mielec
For further information on this medicine, please contact the Marketing Authorisation Holder.
Zakłady Farmaceutyczne COLFARM S.A.
ul. Wojska Polskiego 3
39-300 Mielec
tel.: 17 788 58 11
tel.: 17 788 58 13
e-mail: [email protected]