Excedrin Migrastop

Leaflet accompanying the packaging: Patient information

Excedrin MigraStop, 250 mg + 250 mg + 65 mg, coated tablets
Acetylsalicylic acid + Paracetamol + Caffeine

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 you can read it again if you need to. If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should 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, you should contact your 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 packaging 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 (symptoms such as headache, nausea, sensitivity to light and sound, and disturbances in 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 analgesic, 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 you have any doubts, you should consult your doctor or pharmacist.

• in patients with stomach or intestinal ulcers, or if you have had ulcers of the digestive tract in the past.
• if you have blood in your 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 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 this may cause serious liver damage.
Acetylsalicylic acid may cause bleeding. If you experience unusual bleeding, you should inform your doctor.
Excedrin MigraStop may not be suitable for every patient with the following conditions. You should consult your doctor beforetaking the medicine if:

• you have not been diagnosed with migraine, as you should rule out other potentially serious brain or nervous system disorders before taking the medicine.
• migraineis so severethat you need to go to bed, or if the pain is different from your usual migraines, or if migraine is accompanied by vomiting.
• you have headaches after injury or caused by head injury, fatigue, cough, or bent position.
• 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.
• you have liver or kidney problems, are underweight, are malnourished, or regularly drink alcohol. It may be necessary to completely stop taking the medicine or limit the amount of paracetamol taken.
• you have hereditary glucose-6-phosphate dehydrogenase deficiency, which affects red blood cells. As a result, after consuming certain foods and taking other anti-inflammatory drugs (including acetylsalicylic acid), anemia, jaundice, splenomegaly, or other diseases may occur
• you have ever had gastrointestinal disorders, such as stomach ulcers, gastrointestinal bleeding, or black stools. If you have ever experienced discomfort in the stomach or heartburn after taking painkillers or anti-inflammatory drugs.
• you have bleeding disorders or abnormal bleeding from the reproductive tractother than menstrual bleeding (e.g., abnormally heavy and prolonged menstrual bleeding).
• you have recently undergone surgery(even minor, such as dental surgery) or will undergo surgery within the next 7 days.
• you have asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, or symptoms indicating an allergy(skin reactions, itching, hives).
• you have gout, diabetes, hyperthyroidism, arrhythmias, uncontrolled hypertension, kidney or liver disorders.
• you have alcohol abuse problems(see section Using Excedrin MigraStop with food and drink) .
• you are currently taking other medicines containing acetylsalicylic acid or paracetamol, or if you are 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).
• you are 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.

While taking Excedrin MigraStop, you should immediately inform your doctor if:
you have severe diseases, including severe kidney disorders or
sepsis (when bacteria and their toxins are present in the blood, leading to organ damage)or malnutrition, chronic alcoholism, or if you are taking
flucloxacillin (an antibiotic). There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients in situations where they take paracetamol in regular doses for a longer period or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include:

Other warnings

As with other pain medications, taking Excedrin MigraStop too frequently (for 10 days or longer in a month) for chronic headache (for 15 days or longer in a month) lasting longer than 3 months may worsen the headache or migraine. If you think this is happening to you, you should consult your doctor. Stopping Excedrin MigraStop may improve the situation.
Excedrin MigraStop may reduce the severity of infection symptoms (e.g., headache, fever), making it more difficult to diagnose. Therefore, if you feel unwell, you should remember to inform your doctor that you are taking Excedrin MigraStop.
Excedrin MigraStop may also affect the results of some laboratory tests, so if you are having a blood test, urine test, or other laboratory test, you should 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

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 pain-relieving/antipyretic medicines.
• anticoagulant medicines("blood-thinning" medicines), 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 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 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(an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Using Excedrin MigraStop with food and drink

• Alcohol:You should ask your doctor if you can take Excedrin MigraStop or other pain-relieving/antipyretic medicines 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 found in about one cup of coffee. While taking Excedrin MigraStop, you should limit your intake of medicines, foods, or drinks containing caffeine, as too much caffeine 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

MigraStop.

Pregnancy – last trimester
You should 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 you and your baby and cause delayed or prolonged delivery.
Pregnancy – first and second trimester
Due to the presence of acetylsalicylic acid, you should 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 oligohydramnios (low levels of amniotic fluid surrounding the baby) or narrowing of the arterial duct (a blood vessel in the heart) in the baby. If treatment for a longer period than a few days is required, your doctor may recommend additional monitoring.
You should not take Excedrin MigraStop while 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 NSAID treatment.

Driving and using machines

There is no data confirming the effect of Excedrin MigraStop tablets on the ability to drive and use machines.
In case of dizziness or drowsiness, you should not drive or operate machinery. You should immediately inform your doctor if you experience any of these events.

3. How to take Excedrin MigraStop

Excedrin MigraStop should be taken as directed in the leaflet or as advised by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Adults (over 18 years old):

Treating headache

In case of a headache, you should take 1 tablet and wash it down with a full glass of water. If necessary, you can take another tablet after 4-6 hours from the first dose.
In case of more intense headache, you can take 2 tablets at once, and if necessary, you can take another 2 tablets after 4-6 hours from the first dose.
You should not take Excedrin MigraStop for headache for more than 4 days without consulting your doctor.

Treating migraine

In case of migraine symptoms or migraine aura, you should take 2 tablets of Excedrin MigraStop, washing them down with a glass of water. If necessary, you can take another 2 tablets, maintaining a 4-6 hour interval between doses.
You should not take Excedrin MigraStop for more than 3 days for migraine without consulting your doctor.
Both for headache and migraine, you should 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 your health.
You should not exceed the recommended dose. You should use the lowest effective dose of the medicine 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 Excedrin MigraStop in elderly patients. In case of low body weight in this group of patients, you should consult your doctor or pharmacist.
Patients with kidney and liver disorders
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.
You should 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, you should not take more than the recommended dose of the medicine and should 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 an overdose of Excedrin MigraStop, you should contact your 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. You should 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, and later abdominal pain.
• For caffeine:anxiety, nervousness, insomnia, excitement, muscle tremors, confusion, hyperglycemia (elevated blood sugar levels), 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 you should not take a double dose of the medicine to make up for the missed dose. You should not take more than 6 tablets in 24 hours.
In case of doubts about taking the medicine, you should consult your 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 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, chest tightness (asthma symptoms), and may also include 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 elderly patients.
• 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 you have experienced breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs and have experienced a similar reaction after taking this product.
• Bruises 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 (may be a sign of Reye's syndrome).

The following side effects have been reported in 16 clinical trials involving over 4800 patients. You should consult your 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
• 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 uncomfortable in the chest

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

• Anxiety, feeling unwell or unusual
• 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 cough (asthma symptoms)
• Abdominal pain, gastrointestinal disorders occurring after meals
• Increased liver enzyme activity
• Nasal congestion and irritation
• Kidney problems
• A serious disease that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or 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
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 the medicine.

5. How to store Excedrin MigraStop

• Store in a place out of sight and reach of children.
• Do not take Excedrin MigraStop after the expiry date stated on the blister 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 no longer required. This will help protect the environment.

6. Contents of the packaging 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: o tablet core:hypromellose, microcrystalline cellulose, stearic acid, o coating:Opadry YS-1-7086 (hypromellose 3 cP, hypromellose 6 cP, hypromellose 50 cP, titanium dioxide (E171), propylene glycol), benzoic acid (E210), carnauba wax.

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, and then in cartons containing 10, 16, 20, 30, or 32 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer:

Famar Italia S.P.A
Via Zambeletti, 25
20021 Baranzate (MI)
Italy

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

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

Austria: Excedrinil 250 mg/250 mg/65 mg - Filmtabletten
Belgium: Excedryn, film-coated tablets
Czech Republic: EXCEDRINIL 250 mg/250 mg/65 mg coated tablets
Germany: Paracetamol/ASS/Coffein Kopfschmerz & Migräne 250 mg/250 mg/65 mg Filmtabletten
Greece: Panmigran
Ireland: Excedrin film-coated tablets
Luxembourg: Excedryn, coated tablets
Netherlands: Excedrin, film-coated tablets
Portugal: Excedrin
Slovakia: Panadol Migraine
Spain: Excedite 250mg/250mg/65mg film-coated tablets
Date of leaflet approval:January 2025