Excedrin migrastop

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is 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.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again. If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. 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, consult your doctor.

Contents of the leaflet:

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

Each coated tablet of Excedrin MigraStop contains three active substances: acetylsalicylic acid, paracetamol and caffeine.

• Acetylsalicylic acid and paracetamol reduce pain and fever, and acetylsalicylic acid additionally has anti-inflammatory properties.
• Caffeine is a mild stimulant and enhances the effect of acetylsalicylic acid and paracetamol. Excedrin MigraStop is used for the short-term 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 using Excedrin MigraStop

When not to use Excedrin MigraStop
Do not use Excedrin MigraStop:

• if you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine, or any of the ingredients of Excedrin MigraStop listed in section 6;
• if you have ever experienced allergic reactions to other pain-relieving, 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 reaction may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; nasal congestion. If in doubt, consult your doctor or pharmacist;
• in patients with peptic ulcers of the stomach or intestines, or if peptic ulcer disease of the gastrointestinal tract has occurred in the past;
• if there is blood in the stool or black stools (signs 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 Excedrin MigraStop and other medicines);
• during the third trimester of pregnancy (see section Pregnancy, breastfeeding and fertility).

Warnings and precautions
Excedrin MigraStop contains paracetamol. Do not exceed the recommended dose, as this may cause serious liver damage.
Acetylsacetylsalicylic acid may cause bleeding. Inform your doctor if unusual bleeding occurs.
Excedrin MigraStop may not be suitable for every patient for the following reasons. Consult your doctor before using the medicine if:

• migraine has not previously been diagnosed, as other potentially serious neurological or brain conditions must be ruled out before treatment;
• migraine is so severe that bed rest is required, or if the pain differs from your usual migraines, or if migraine headaches are accompanied by vomiting;
• headaches occur after head injury, physical exhaustion, coughing, or bending forward;
• headaches are chronic (occurring on 15 or more days per month for longer than 3 months), or if headaches first occurred after age 50;
• you have liver or kidney problems, are underweight, malnourished, or regularly consume alcohol. It may be necessary to completely discontinue the medicine or reduce the amount of paracetamol taken;
• you have a severe infection, are severely malnourished, have significant weight loss, or chronically abuse alcohol, as this may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid, labored breathing, general malaise (nausea, vomiting), loss of appetite. If a combination of these symptoms occurs, contact your doctor immediately;
• you have 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), haemolytic anaemia, jaundice, enlargement of the spleen, or other diseases may develop;
• you have ever had gastrointestinal disorders, such as stomach ulcers, gastrointestinal bleeding, or black stools. If you previously experienced stomach discomfort or heartburn after taking pain-relieving or anti-inflammatory medicines;
• you have bleeding disorders or abnormal genital bleeding other than menstrual bleeding (e.g. abnormally heavy and prolonged menstrual bleeding);
• you recently underwent surgery (including minor procedures such as dental surgery) or will undergo surgery within the next 7 days;
• you have bronchial asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease (COPD), or symptoms indicating allergy (skin reactions, itching, hives);
• you have gout, diabetes, hyperthyroidism, heart rhythm disorders, uncontrolled hypertension, or impaired kidney or liver function;
• you have problems with alcohol abuse (see section Taking Excedrin MigraStop with food and drink);
• you are currently taking other medicines containing acetylsalicylic acid or paracetamol, or other medications, as some medicines may interact with the components of Excedrin MigraStop and cause adverse effects (see section Excedrin MigraStop and other medicines);
• dehydration is a risk (e.g. due to vomiting, diarrhoea, before or after major surgery);
• you are under 18 years of age. There may be an association between acetylsalicylic acid administered to children and adolescents and the occurrence of Reye’s syndrome. Reye’s syndrome is a disease affecting the brain and liver, which, although very rare, may lead to death. Therefore, Excedrin MigraStop should not be given to children and adolescents under 18 years of age without medical advice.

Other warnings
As with other medicines used to treat headaches, excessive use of Excedrin MigraStop (for 10 days or more per month) in treating chronic headaches (occurring on 15 or more days per month) lasting longer than 3 months may worsen headache or migraine. If you feel this situation applies to you, consult your doctor. Discontinuation of Excedrin MigraStop may lead to improvement.
Excedrin MigraStop may reduce the symptoms of infection (e.g. headache, fever), which may make diagnosis more difficult. Therefore, if you feel unwell, remember to inform your doctor that you are taking Excedrin MigraStop.
Excedrin MigraStop may also affect the results of certain laboratory tests. Therefore, if blood, urine, or other laboratory tests are 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
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
In particular, 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;
• anticoagulants ("blood thinners"), such as oral anticoagulants (e.g. warfarin), heparin, thrombolytic agents (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 cancers and rheumatoid arthritis);
• some 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 for hypertension and heart failure;
• diuretics (used to increase urine production and for fluid removal);
• medicines used to treat gout;
• oral contraceptives;
• zidovudine (treatment of HIV infection);
• medicines delaying gastric emptying, such as propantheline;
• clozapine (treatment of schizophrenia);
• sympathomimetic medicines (to raise low blood pressure and treat nasal congestion);
• antiallergic medicines (to prevent or treat allergies);
• theophylline (treatment of asthma);
• terbinafine (treatment of fungal infections);
• cimetidine (treatment of heartburn and gastrointestinal ulcers);
• disulfiram (treatment of alcohol dependence);
• nicotine (used to help quit smoking);
• cholestyramine (treatment of high blood cholesterol levels);
• flucloxacillin (antibiotic), due to the serious risk of blood and body fluid disorders (metabolic acidosis with a high anion gap), which require urgent treatment and may occur particularly in patients with severe kidney dysfunction, sepsis (a condition in which 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 whether you can take Excedrin MigraStop or other pain-relieving/antipyretic medicines while consuming 3 or more alcoholic drinks daily. Paracetamol and acetylsalicylic acid may cause liver damage and gastrointestinal bleeding.
• Caffeine: The caffeine content in the recommended dose of the medicine is equivalent to approximately one cup of coffee. While taking the medicine, limit intake of caffeine-containing medicines, foods, or drinks, as excessive 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, suspect you may be pregnant, or are planning to become pregnant, you should inform your doctor and not use Excedrin MigraStop.
Pregnancy – third trimester
Do not use this medicine during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both you and your baby and may delay or prolong labour.
Pregnancy – first and second trimester
Due to the presence of acetylsalicylic acid, this medicine should not be used 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 required, use the lowest possible dose for the shortest possible time. Taking acetylsalicylic acid for longer than a few days from week 20 of pregnancy may cause kidney dysfunction in the unborn child, leading to oligohydramnios (low levels of amniotic fluid surrounding the baby) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring.
Do not use this medicine during breastfeeding, as it may be harmful to the infant.
Before taking any medicine, consult your doctor or pharmacist.
Excedrin MigraStop belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which may impair fertility. This effect reverses after discontinuation of NSAIDs.

Driving and operating machinery
There are no data confirming the effect of Excedrin MigraStop 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 Excedrin MigraStop

Excedrin MigraStop should be used according to the instructions in the leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults (aged over 18 years)
Treatment of headache
When headache occurs, take 1 tablet with a full glass of water. If necessary, a second tablet may be taken after 4–6 hours from the first dose.
In case of more intense headache, 2 tablets may be taken at once; if necessary, another 2 tablets may be taken 4–6 hours after the initial dose.

Excedrin MigraStop should not be used for headache for longer than 4 days without consulting a doctor.

Treatment of migraine
When migraine symptoms or migraine aura occur, take 2 tablets with a glass of water. If necessary, another 2 tablets may be taken, maintaining a 4–6 hour interval between doses.

Excedrin MigraStop should not be used for migraine for longer than 3 days without consulting a doctor.

In both headache and migraine treatment, the dose should not exceed 6 tablets per day.

This corresponds to a dose of 1500 mg acetylsalicylic acid, 1500 mg paracetamol, and 390 mg 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 duration.

Children and adolescents
Excedrin MigraStop should not be used in children and adolescents under 18 years of age (see section Warnings and precautions).

Elderly patients
There are no special dosage recommendations for elderly patients. However, in patients with low body weight, consult a doctor or pharmacist.

Patients with kidney or liver function disorders
Inform your doctor about any liver or kidney diseases. The doctor may recommend different intervals between doses or a different treatment duration than recommended for Excedrin MigraStop.

Excedrin MigraStop should not be used in patients with severe renal or hepatic impairment.

Use of a higher than recommended dose of Excedrin MigraStop
The medicine contains acetylsalicylic acid and paracetamol. During treatment with Excedrin MigraStop, do not exceed the recommended dose or take other medicines containing either of its active ingredients or other medicines used to treat pain, inflammation, or fever (non-steroidal anti-inflammatory drugs).

If an overdose of Excedrin MigraStop is taken, contact a doctor, pharmacist, or go to the nearest hospital and contact a poison control center immediately.

Immediate medical attention is necessary 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, hyperglycemia (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 Excedrin MigraStop
Take the missed dose as soon as possible, but do not take a double dose to make up for the missed one. Do not exceed a total of 6 tablets per day.

If you have any doubts regarding the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Excedrin MigraStop may cause adverse reactions, although not everyone will experience them.
Immediately discontinue use of Excedrin MigraStop and contact your doctor if any of the following adverse symptoms 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 symptoms). Skin rash, itching, and fainting may also occur.
• Skin redness, blisters on the lips, conjunctiva, or inside the mouth, skin peeling, or oral ulcers.
• 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, at any stage of treatment, and may be fatal. The risk is particularly high in elderly patients.
• Yellowing of the skin or eyes (signs of liver failure).
• Dizziness or a "light-headed" feeling (symptom of low blood pressure).
• Irregular heartbeat.
• Breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs), and a similar reaction after using this product.
• Unexplained bruising or bleeding.
• Increased frequency of nosebleeds or bruising.
• Swelling or fluid retention.
• Ringing in the ears or temporary hearing loss.
• Changes in behavior, nausea, and vomiting (which may indicate Reye's syndrome).

The following adverse reactions have been observed in 16 clinical trials involving over 4800 individuals. Contact your doctor if you experience any of the following symptoms:
Common (occur in 1 out of 10 patients)

• Nervousness, dizziness
• Nausea, abdominal discomfort

Uncommon (occur in 1 out of 100 patients)

• Insomnia, tremor, numbness, headache
• Dry mouth sensation, diarrhea, vomiting
• Fatigue, feeling of unease
• Rapid heartbeat

Rare (occur in 1 out of 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, vision 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, chest discomfort

The following adverse reactions have been reported after Excedrin MigraStop was introduced to the market. The frequency of these reactions is difficult to determine:
Restlessness, feeling unwell or different from usual

• Drowsiness, migraine
• Skin redness, rash; very rare cases of serious skin reactions have been reported
• Palpitations, shortness of breath, sudden breathing difficulty, chest tightness, wheezing or coughing (asthma symptoms)
• Abdominal pain, gastrointestinal discomfort after meals
• Increased liver enzyme activity
• Nasal swelling and irritation
• Kidney problems

Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the 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 specified month.
• Store below 25°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Excedrin MigraStop contains

• The active substances 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 components of the medicine are:
  • Tablet core: low-substituted hydroxypropyl cellulose, microcrystalline cellulose, stearic acid,
  • Coating: hypromellose (E 464), titanium dioxide (E 171), propylene glycol, benzoic acid (E 210), 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 packed in blisters, then placed in cartons containing 10 or 20 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Belgium, the country of export:
Haleon Belgium
Da Vincilaan 5, B-1930 Zaventem, Belgium

Manufacturer:
Haleon Germany GmbH
Barthstrasse 4, 80339 Munich, Germany
Famar Italia S.P.A
Via Zambeletti, 25, 20021 Baranzate (MI), Italy

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorization number in Belgium, the country of export: BE352493
Marketing authorization number for parallel import: 286/22

This medicinal product has been authorised in the European Union Member States under the following trade names:
Belgium: Excedryn, filmomhulde tabletten
Cyprus: Panmigran
Germany: Paracetamol/ASS/Coffein Kopfschmerz & Migräne 250 mg/250 mg/65 mg Filmtabletten
Greece: Panmigran
Ireland: Excedrin film-coated tablets
Luxembourg: Excedryn, comprimés pelliculés
Malta: Panmigran
Netherlands: Excedrin, filmomhulde tabletten
Portugal: Excedrin
Slovakia: Panadol Migréna
Spain: Excedite 250mg/250mg/65mg comprimidos recubiertos con película