EXCEDRIN MIGRASTOP

Package leaflet: Information for the user

Caution! Keep the leaflet. Information on the immediate packaging in a foreign language.
Excedrin MigraStop (Excedryn Migraine & Hoofdpijn)
250 mg + 250 mg + 65 mg, film-coated tablets
Acetylsalicylic acid + Paracetamol + Caffeine
Excedrin MigraStop and Excedryn Migraine & Hoofdpijn 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
your 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 possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days of treatment for migraine or after 4 days of treatment for headache, or if your condition worsens, consult your doctor.

Leaflet contents:

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

• Acetylsalicylic acid and paracetamol reduce pain and fever, and acetylsalicylic acid additionally has anti-inflammatory effects.
• Caffeine is a mild stimulant and enhances the effects 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 using Excedrin MigraStop

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

• if you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine, or any of the ingredients of Excedrin MigraStop coated tablets listed in section 6.

• if you have ever experienced allergic reactions 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 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 your doctor or pharmacist.

• in patients with gastric or intestinal ulcers, or if gastrointestinal ulceration has occurred in the past.

• if you have blood in your stool or black stools (symptoms of gastrointestinal bleeding or perforation).

• in case of hemophilia or other blood disorders.

• in severe heart, liver or kidney disease.

• during treatment with more than 15 mg of methotrexate weekly (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.
Acetylsalicylic acid may cause bleeding. If unusual bleeding occurs, inform your doctor.
Excedrin MigraStop may not be suitable for all patients for the following reasons. Consult your doctor before taking this medicine if:

• you have not previously been diagnosed with migraine, as other potentially serious neurological or brain-related conditions should be ruled out before treatment.
• your migraine is so severe that bed rest is required, or the pain differs from your usual migraines, or if nausea and vomiting accompany the migraine pain.
• you have headaches following head injury, trauma, fatigue, coughing or bending forward.
• headaches are chronic (occurring on 15 or more days per month for longer than 3 months), or if headaches began for the first time 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 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 or taking anti-inflammatory medicines (including acetylsalicylic acid), anemia, jaundice, enlargement of the spleen, or other disorders 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 analgesic 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 alcohol abuse problems (see section Taking Excedrin MigraStop with food and drink).
• you are currently taking other medicines containing acetylsalicylic acid or paracetamol, or other medicines, as some drugs 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, diarrhea, before or after major surgery).
• you are under 18 years of age. A possible association exists between acetylsalicylic acid administered to children and adolescents and the development of Reye’s syndrome. Reye’s syndrome is a condition causing changes in the brain and liver and, 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.

While taking Excedrin MigraStop, inform your doctor immediately if:
you have serious conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients taking paracetamol regularly over a long period or taking paracetamol together 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 Excedrin MigraStop (for 10 days or more per month) in treating chronic headache (occurring on 15 or more days per month for longer than 3 months) may worsen headache or migraine. If you feel this situation applies to you, consult your doctor. Discontinuing 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 obtained 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 analgesic/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 (for treating anxiety and insomnia).
• lithium, selective serotonin reuptake inhibitors, or fluvoxamine (for treating depression).
• sulfonylureas or insulin (for treating diabetes).
• methotrexate (for treating certain cancers and joint inflammation).
• some medicines used to treat infections (e.g., rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid).
• levothyroxine (for treating hypothyroidism).
• metoclopramide (for treating 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 (for treating HIV infection).
• medicines delaying gastric emptying, such as propantheline.
• clozapine (for treating schizophrenia).
• sympathomimetic medicines (to raise low blood pressure and treat nasal congestion).
• antiallergic medicines (to prevent or treat allergies).
• theophylline (for treating asthma).
• terbinafine (for treating fungal infections).
• cimetidine (for treating heartburn and gastrointestinal ulcers).
• disulfiram (for treating alcohol dependence).
• nicotine (used to help quit smoking).
• cholestyramine (for treating high blood cholesterol levels).
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

Taking Excedrin MigraStop with food and drink

• Alcohol: Ask your doctor whether you can take Excedrin MigraStop or other analgesic/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 this medicine, limit consumption 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. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, you should inform your doctor and not take Excedrin MigraStop.
Pregnancy – third trimester
Do not take 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 also increase the risk of bleeding in both you and your baby, and may delay or prolong labor.
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 required, use the lowest possible dose for the shortest possible time. Taking acetylsalicylic acid from week 20 of pregnancy for longer than a few days may cause kidney dysfunction in the unborn child, leading to oligohydramnios (low level of amniotic fluid surrounding the baby) or narrowing of a 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 take this medicine while 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 upon discontinuation of NSAIDs.

Driving and using machines
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 4–6 hours after the first dose.
For more intense headache, 2 tablets may be taken at once; if needed, another 2 tablets may be taken 4–6 hours after the initial dose.

Do not use Excedrin MigraStop for headache for more than 4 days without consulting a doctor.

Treatment of migraine
When symptoms of migraine 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.

Do not use Excedrin MigraStop for migraine for more than 3 days without consulting a doctor.

In both headache and migraine treatment, do not exceed a total 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 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 renal or hepatic impairment
Inform your doctor of any kidney or liver disease. The doctor may recommend longer intervals between doses or a different treatment duration than recommended.
Do not use Excedrin MigraStop in patients with severe renal or hepatic impairment.

Overdose of Excedrin MigraStop
Excedrin MigraStop contains acetylsalicylic acid and paracetamol. During treatment with Excedrin MigraStop, do not exceed the recommended dose or take other medicines containing any of its components, 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 essential due to the risk of irreversible liver damage from 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: initial 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. However, do not take a double dose to make up for a missed dose. Do not exceed 6 tablets per day.

If in doubt about how to use 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.
You must stop using Excedrin MigraStop immediately 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-like symptoms). A rash, itching, or fainting may also occur.
• Skin redness, blisters on the lips, conjunctiva, or inside the mouth, skin peeling, or oral ulceration.
• Gastrointestinal bleeding or ulcers. These may be accompanied by severe abdominal pain, bloody or black stools, or vomiting blood. These symptoms may occur without prior warning signs, at any stage of treatment, and may lead to death. The risk is particularly high in elderly patients.
• Yellowing of the skin or eyes (signs of liver failure).
• Dizziness or a feeling of "light-headedness" (symptoms of low blood pressure).
• Irregular heartbeat.
• Breathing difficulties after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs), if a similar reaction occurred 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 behaviour, nausea, and vomiting (these may be signs of Reye's syndrome).

The following adverse reactions were observed during 16 clinical trials involving over 4,800
individuals. Contact your doctor if you notice 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, diarrhoea, vomiting.
• Fatigue, feeling of uneasiness.
• Rapid heartbeat.

Rare (occur in 1 out of 1,000 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, shallow and slow breathing, nasal discharge.
• 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 events is difficult to determine:

• Restlessness, malaise, or unusual feelings.
• 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 cough (asthma-like symptoms).
• Abdominal pain, gastrointestinal discomfort after meals.
• Increased liver enzyme activity.
• Nasal swelling and irritation.
• Kidney problems.
• A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Poland; Tel. +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 this medicine out of 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 how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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 (E 903).

What Excedrin MigraStop looks like and contents of the pack
Excedrin MigraStop is a white, elongated, film-coated tablet with the letter "E" embossed on one side.
The tablets are packed in blisters and then placed in cartons containing 10, 20, or 30 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Belgium, 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, Poland

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

Marketing Authorisation Number in Belgium, country of export: BE352493
Parallel Import Licence Number: 448/22

This medicine has been authorised for sale in the European Union member states under the following trade names:
Austria: Excedrinil 250 mg/250 mg/65 mg - Filmtabletten
Belgium: Excedryn Migraine & Hoofdpijn
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