Excedrin Migrastop

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, 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 using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet so that you can read it again if you need to. If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 3 days of treatment for migraine and 4 days of treatment for headache there is no improvement or 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. Contents of the pack 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 disturbances of daily functioning) 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, caffeineor any of the excipients of Excedrin MigraStop coated tabletslisted in section 6
• if you have ever had an allergic reactionto 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. In case of any doubts, you should consult a doctor or pharmacist.

• in patients with stomach or intestinal ulcers, or if there is a history of gastrointestinal ulcers
• if there is blood 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 "Excedrin MigraStop and other medicines")
• in the third trimester of pregnancy(see "Pregnancy, breastfeeding, and fertility")

Warnings and precautions

Excedrin MigraStop 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, you should inform your doctor.
Excedrin MigraStop may not be suitable for every patient with the following conditions. You should consult a doctor beforetaking the medicine if:

• the patient has not been diagnosed with migraine, as other potentially serious brain or nervous system disorders should be ruled out before taking the medicine
• migraineis so severethat it requires bed rest, or the pain is different from the usual migraines, or if migraine is accompanied by vomiting
• there are headaches after injury or caused by head injury, 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 severely 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 a combination of these symptoms occurs, you should contact your doctor 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 drugs (including acetylsalicylic acid), anemia, jaundice, spleen enlargement, 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 painkillers or anti-inflammatory drugs
• there are bleeding disorders or abnormal bleeding from the reproductive tractother than menstrual bleeding (e.g., abnormally heavy and prolonged menstrual bleeding)
• the patient has recently undergone surgery(even minor, 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, arrhythmias, uncontrolled hypertension, kidney or liver dysfunction
• there are alcohol abuse problems(see "Using 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 "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 development 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, too frequent use of Excedrin MigraStop (for 10 days or longer per month) in the treatment of chronic headache (for 15 days or longer per month) lasting longer than 3 months may cause worsening of headache or migraine. If the patient feels that this situation is occurring, they should consult a doctor. Stopping the use of Excedrin MigraStop may improve the condition.
Excedrin MigraStop may reduce the severity of infection symptoms (e.g., headache, fever), which may make it difficult to diagnose. Therefore, in case of poor condition, you should remember to inform your doctor about 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, you should remember to inform your doctor about 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

You should inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
Particularly, you should 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)
• sulfonylureas 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 propanteline
• 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)
• flucloxacillin(antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which should be treated urgently and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Using Excedrin MigraStop with food and drink

Alcohol:

You should 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 the medicine is equivalent to the amount in about one cup of coffee.
While taking the medicine, you should 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, you should consult your doctor and not take Excedrin MigraStop.

Migraine Stop.

Pregnancy – third trimester
Do not take this medicine if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and baby and cause delayed or prolonged delivery.
Pregnancy – first and second trimester
Due to the presence of acetylsalicylic acid, do not take this medicine during the first 6 months of pregnancy, unless your doctor considers it absolutely necessary. If treatment during the first 6 months of pregnancy or while trying to conceive is necessary, you should use the smallest possible dose of the medicine for the shortest possible time. Taking acetylsalicylic acid from the 20th week of pregnancy for a period longer than a few days may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment for a longer period than a few days is required, your doctor may recommend additional monitoring.
Do not take the medicine during breastfeeding, as it may be harmful to the baby.
Before taking any medicine, you should 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 the NSAID medicine.

Driving and using machines:

There is no data confirming the effect of Excedrin MigraStop coated tablets on the ability to drive and use machines.
In case of dizziness or drowsiness, do not drive vehicles or operate machinery. You should immediately inform your doctor about the occurrence of the above events.

3. How to take Excedrin MigraStop

Excedrin MigraStop should be taken as directed in the leaflet or as directed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.

Adults (over 18 years old):

Treating headache

In case of a headache, 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. In case of more intense headache, 2 tablets can be taken at once, and if necessary, another 2 tablets can be taken after 4-6 hours from the first dose.
Do not take Excedrin MigraStop for headache for more than 4 days without consulting a doctor.

Treating migraine

In case of migraine symptoms or aura, take 2 tablets of the medicine and drink 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.
Both for headache and migraine, do not take a dose greater 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.

Children and adolescents:

Excedrin MigraStop should not be taken by children and adolescents under 18 years old (see "Warnings and precautions").

Older people

There are no special recommendations for dosing in older people. In case of low body weight in this group of patients, you should consult a doctor or pharmacist.

Patients with kidney or liver dysfunction

You should inform your doctor about liver and kidney diseases. Your doctor may recommend using different intervals between doses of the medicine or a different treatment duration with Excedrin MigraStop.
Do not take Excedrin MigraStop in patients with 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 of the medicine and do not take other medicines containing any of its ingredients or other medicines used to treat pain, inflammation, or fever (non-steroidal anti-inflammatory drugs).
In case of taking too much Excedrin MigraStop, you should contact a doctor, pharmacist, or go to the nearest hospital and contact a 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 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, 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 Excedrin MigraStop

You should take the missed dose as soon as possible, but do not take a double dose of the medicine to make up for the missed dose. Do not take a dose greater than 6 tablets in 24 hours.
In case of doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

You should stop taking Excedrin MigraStop and inform your doctor immediately if you experience side effects such as:

• Allergic reactions such as swelling of the face, lips, mouth, tongue, or throat. These symptoms may make swallowing difficult, cause wheezing, breathing difficulties, a feeling of tightness in the chest (symptoms of asthma). It may also cause rash, itching, and 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 treatment with all NSAIDs, at any stage of treatment, and may lead to death. This risk is particularly high in older people.

Yellowing of the skin or eyes(symptoms of liver failure).

• Dizziness or a feeling of "light-headedness" (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 a similar reaction occurs after taking this product.
• Bruises or bleeding of unknown cause.
• Increased frequency of nosebleeds or bruising.
• Swelling or water 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 people. You should consult a doctor if you observe 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, peeling of the skin, or mouth ulcers.
• Decreased appetite, taste disorders
• Anxiety, euphoric mood, feeling tense
• Attention disorders, memory loss, coordination disorders
• Pain in the forehead and cheeks
• Eye pain, vision disorders
• Hot flashes, peripheral vascular disorders (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 unwell

The following side effects have been reported after the medicine was placed on the market. It is difficult to estimate their frequency:

• Anxiety, poor or unusual condition
• Sleepiness, migraine
• Redness of the skin, rash, very rare cases of serious skin reactions have been reported
• Rapid heartbeat, shortness of breath, sudden difficulty breathing, feeling of tightness in the chest, wheezing, or cough (symptoms of asthma)
• 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, you should 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:
Al. Jerozolimskie 181C
02-222 Warsaw;
Phone: +48 (22) 49 21 301;
Fax: +48 (22) 49 21 309;
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Excedrin MigraStop

• Store out of sight and reach of children.
• Do not take Excedrin MigraStop after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. You should 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 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: core of the tablet: hydroxypropylcellulose, microcrystalline cellulose (E 460), 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 contents of the pack

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

Marketing authorization holder in Belgium, the country of export

Haleon Belgium
Da Vincilaan 5
1930 Zaventem
Belgium

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE352493

Parallel import authorization number: 326/24

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: 19.08.2024

[Information about the trademark]