Excedrin Migrastop

Leaflet attached to the packaging: Patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Excedrin MigraStop (Excedryn)

250 mg + 250 mg + 65 mg, coated tablets

Acetylsalicylic acid + Paracetamol + Caffeine
Excedrin MigraStop and Excedryn are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

• The leaflet should be kept so that it can be read again if necessary. If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days of treatment for migraine and 4 days of treatment for headache, or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Excedrin MigraStop and what is it used for
• 2. Important information before taking Excedrin MigraStop
• 3. How to take Excedrin MigraStop
• 4. Possible side effects
• 5. How to store Excedrin MigraStop
• 6. Package contents and other information

1. What is Excedrin MigraStop and what is it used for

Each Excedrin MigraStop 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. Excedrin MigraStop is used for the acute treatment of headache and migraine attacks (such as headache, nausea, sensitivity to light and sound, and daily functioning disorders) with or without aura.

2. Important information before taking Excedrin MigraStop

When not to take Excedrin MigraStop

Do not take Excedrin MigraStop:

• if you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine, or any of the other ingredients of Excedrin MigraStop coated tablets listed in section 6.
• if you have ever had allergic reactions to other painkillers, anti-inflammatory, or antipyretic drugs, such as acetylsalicylic acid and salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac or ibuprofen. Symptoms of an allergic reaction may include: asthma, wheezing, or shortness of breath; rash or hives; swelling of the face or tongue; runny nose. If in doubt, consult a doctor or pharmacist.
• if you have stomach or intestinal ulcers, or if you have had ulcers in the digestive system in the past.
• if you have blood in your stool or black stools (symptoms of bleeding or perforation of the gastrointestinal tract).
• if you have hemophilia or other blood diseases.
• if you have severe heart, liver, or kidney disease.
• if you are taking more than 15 mg of methotrexate per week (see section "Excedrin MigraStop and other medicines").
• in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Excedrin MigraStop contains paracetamol. Do not take more than the recommended dose, as it may cause serious liver damage.
Acetylsalicylic acid may cause bleeding. If unusual bleeding occurs, inform your doctor.
Excedrin MigraStop may not be suitable for every patient with the following conditions. Consult your doctor before taking the medicine if:

• the patient has not been diagnosed with migraine, as other potentially serious brain or nervous system disorders must be ruled out before taking the medicine.
• migraine is so severe that it requires bed rest, or the pain is different from the usual migraine, or if the migraine is accompanied by vomiting.
• there are headaches after injury or caused by injury to the head, fatigue, coughing, or bending.
• headaches occur chronically (15 or more days per month for more than 3 months) or if headaches occurred for the first time after the age of 50.
• the patient has liver or kidney problems, is underweight, is malnourished, or regularly consumes alcohol. It may be necessary to completely stop taking the medicine or limit the amount of paracetamol taken.
• the patient has a severe infection, is seriously malnourished, is underweight, or chronically abuses alcohol, as this may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid, difficult breathing, poor condition (nausea, vomiting), loss of appetite. If these symptoms occur, consult a doctor immediately.
• there is a history of gastrointestinal disorders, such as stomach ulcers, gastrointestinal bleeding, or black stools. If the patient has had discomfort in the stomach or heartburn after taking painkillers or anti-inflammatory drugs.
• there are bleeding disorders or abnormal bleeding other than menstrual bleeding (e.g., abnormally heavy and prolonged menstrual bleeding).
• the patient has recently undergone surgery (including minor surgery such as dental surgery) or will 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 disorders.
• there are problems with alcohol abuse (see section "Taking Excedrin MigraStop with food and drink").
• 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 Excedrin MigraStop and cause side effects (see section "Excedrin MigraStop 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 old. 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 it is very rare, can lead to death. Therefore, without a doctor's recommendation, Excedrin MigraStop should not be given to children and adolescents under 18 years old.

Other warnings

As with other medicines used to treat headaches, taking Excedrin MigraStop too frequently (for 10 days or more per month) for chronic headache treatment (for 15 days or more per month) lasting more than 3 months may worsen the headache or migraine. If the patient feels that this is happening, they should consult a doctor. Stopping Excedrin MigraStop may improve the condition.
Excedrin MigraStop may reduce the severity of infection symptoms (e.g., headache, fever), making it difficult to diagnose. Therefore, in case of poor condition, remember to inform your doctor that you are taking Excedrin MigraStop.
Excedrin MigraStop may also affect the results of some laboratory tests, so if a blood test, urine test, or other laboratory test is to be performed, remember to inform your doctor that you are taking Excedrin MigraStop.
Excedrin MigraStop contains 0.03 mg of benzoic acid (E 210) per tablet. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Excedrin MigraStop and other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
Particularly, inform your doctor if you are taking any of the following medicines:

• other medicines containing paracetamol, acetylsalicylic acid, or any other painkillers/antipyretics.
• anticoagulant medicines (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 inflammation).
• barbiturates and benzodiazepines (treatment of anxiety and insomnia).
• lithium, selective serotonin reuptake inhibitors, or fluvoxamine (treatment of depression).
• sulfonylurea or insulin (treatment of diabetes).
• methotrexate (treatment of certain types of cancer and arthritis).
• certain medicines used to treat infections (e.g., rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid).
• levothyroxine (treatment of hypothyroidism).
• metoclopramide (treatment of 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 (treatment of HIV infection).
• medicines that delay gastric emptying, such as propantheline.
• clozapine (treatment of schizophrenia).
• sympathomimetic medicines (increasing low blood pressure and treating nasal congestion).
• antihistamines (preventing or treating allergies).
• theophylline (treatment of asthma).
• terbinafine (treatment of fungal infections).
• cimetidine (treatment of heartburn and stomach ulcers).
• disulfiram (treatment of alcohol dependence).
• nicotine (used to quit smoking).
• cholestyramine (treatment of high cholesterol levels in the blood).
• flucloxacillin (antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.

Taking Excedrin MigraStop with food and drink

• Alcohol:Ask your doctor if you can take Excedrin MigraStop or other painkillers/antipyretics while consuming 3 or more alcoholic beverages per day. Paracetamol and acetylsalicylic acid may cause liver damage and stomach bleeding.
• Caffeine:The amount of caffeine in the recommended dose of Excedrin MigraStop is equivalent to the amount in about one cup of coffee. While taking the medicine, limit the consumption of medicines, foods, 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. If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor and do not take Excedrin MigraStop. It is very important not to take Excedrin MigraStop during the last three months of pregnancy, as it may harm the fetus or cause difficulties during delivery.
Do not take the medicine while breastfeeding, as it may be harmful to the baby.
Before taking any medicine, consult your doctor or pharmacist.
Excedrin MigraStop belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs), which may affect fertility. This effect is reversible after stopping NSAIDs.

Driving and using machines

There is no data confirming the effect of Excedrin MigraStop on the ability to drive and use machines.
If dizziness or drowsiness occurs, do not drive or operate machinery. Inform your doctor immediately if these events occur.

3. How to take Excedrin MigraStop

Excedrin MigraStop should be taken as described in the leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults (over 18 years old):

Treating headache

If a headache occurs, take 1 tablet and drink a full glass of water. If necessary, another tablet can be taken after 4-6 hours from the first dose.
If the headache is more severe, 2 tablets can be taken at once, and if necessary, another 2 tablets can be taken after 4-6 hours from the first 2 tablets.
Do not take Excedrin MigraStop for headache for more than 4 days without consulting a doctor.

Treating migraine

If migraine symptoms or aura occur, take 2 Excedrin MigraStop tablets with a glass of water. If necessary, another 2 tablets can be taken, maintaining a 4-6 hour interval between doses.
Do not take Excedrin MigraStop for more than 3 days for migraine without consulting a doctor.
For both headache and migraine treatment, do not take more 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 health.
Do not exceed the recommended dose. Use the lowest effective dose for the shortest possible time.
Children and adolescents
Excedrin MigraStop should not be taken by children and adolescents under 18 years old (see section "Warnings and precautions").
Elderly
There are no special recommendations for dosing in elderly patients. If the patient has a low body weight, consult a doctor or pharmacist.
Patients with kidney and liver disorders
Inform your doctor about liver and kidney diseases. Your doctor may prescribe different intervals between doses or a different treatment duration with Excedrin MigraStop.
Do not take Excedrin MigraStop if you have severe kidney or liver failure.

Taking a higher dose of Excedrin MigraStop than recommended

The medicine contains acetylsalicylic acid and paracetamol. While taking Excedrin MigraStop, do not take a higher dose than recommended and do not take other medicines containing any of its ingredients or other pain, inflammation, or fever medicines (non-steroidal anti-inflammatory drugs).
If you have taken too much Excedrin MigraStop, 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 unnoticed at first.
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 nervousness, circulatory collapse, or respiratory failure.
• For paracetamol: the first symptoms that may occur are nausea, vomiting, loss of appetite, pallor, lethargy, excessive sweating, later abdominal pain.
• For caffeine: anxiety, nervousness, insomnia, excitement, muscle tremors, confusion, hyperglycemia (increased blood sugar), tachycardia (rapid heart rate), and arrhythmia.

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

Missing a dose of Excedrin MigraStop

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 in doubt about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Excedrin MigraStop can cause side effects, although not everybody gets them.

Stop taking Excedrin MigraStop 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 make swallowing difficult, cause wheezing, shortness of breath, chest tightness (asthma symptoms), rash, itching, or fainting.
• 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 lead to death. This risk is particularly high in the elderly.
• Yellowing of the skin or eyes (symptoms of liver failure).
• Dizziness or feeling lightheaded (symptom of low blood pressure).
• Irregular heartbeat.
• If the patient has experienced breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs and has had a similar reaction to this product.
• Bruises or bleeding of unknown cause.
• Increased incidence of 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 have been reported in 16 clinical trials involving over 4800 patients. Consult a doctor if you experience any of the following symptoms:

Common (occurring in 1 in 10 patients)

• Nervousness, dizziness.
• Nausea, abdominal discomfort.

Uncommon (occurring in 1 in 100 patients)

• Insomnia, tremors, numbness, headache.
• Dry mouth, diarrhea, vomiting.
• Fatigue, feeling anxious.
• 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 tense.
• Attention disorders, memory loss, coordination disorders.
• Pain in the forehead and cheek area.
• Eye pain, vision disorders.
• Hot flashes, peripheral vascular problems (e.g., in 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 unwell.

The following side effects have been reported after the marketing of Excedrin MigraStop. It is difficult to estimate their frequency:

• Anxiety, poor or unusual condition.
• Drowsiness, migraine.
• Redness of the skin, rash, very rare cases of serious skin reactions have been reported.
• Palpitations, shortness of breath, sudden difficulty breathing, feeling of chest tightness, wheezing, or coughing (asthma symptoms).
• Abdominal pain, gastrointestinal disorders occurring after meals.
• Increased liver enzyme activity.
• Nasal congestion and irritation.
• Kidney problems.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Warsaw, Al. Jerozolimskie 181C, 02-222 Warsaw; Tel. +48 (22) 49 21 301; Fax +48 (22) 49 21 309; website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Excedrin MigraStop

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Store below 25°C.
• 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. Package contents and other information

What Excedrin MigraStop 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.
• Other ingredients of the medicine are: tablet core:hypromellose, microcrystalline cellulose, stearic acid, coating:hypromellose (E 464), titanium dioxide (E 171), propylene glycol, benzoic acid (E 210), carnauba wax (E 903).

What Excedrin MigraStop looks like and what the package contains

Excedrin MigraStop is a white, elongated, coated tablet with the letter "E" embossed on one side.
The tablets are packaged in blisters and then in boxes containing 10, 20, or 30 tablets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Haleon Belgium, Da Vincilaan 5, B-1930 Zaventem, Belgium

Manufacturer:

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstrasse 4, 80339 Munich, Germany
Famar Italia S.P.A, Via Zambeletti, 25, 20021 Baranzate (MI), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgian marketing authorization number: BE352493

Parallel import authorization number: 448/22

This medicine has been authorized for marketing in EU member states under the following trade names:

Austria: Excedrinil 250 mg/250 mg/65 mg - Filmtabletten
Belgium: Excedryn, filmomhulde tabletten
Czech Republic: EXCEDRINIL 250 mg/250 mg/65 mg potahované tablety
Germany: Paracetamol/ASS/Coffein Kopfschmerz & Migräne 250 mg/250 mg/65 mg Filmtabletten
Greece: Panmigran
Ireland: Excedrin film-coated tablets
Luxembourg: Excedryn, comprimés pelliculés
Netherlands: Excedrin, filmomhulde tabletten
Portugal: Excedrin
Slovakia: Panadol Migréna
Spain: Excedite 250mg/250mg/65mg comprimidos recubiertos con película

Date of leaflet approval: 20.05.2024

[Information about the trademark]