Excedrin migrastop

Patient Information Leaflet

Warning! Keep this leaflet – the packaging information 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 brand names for the same medicine.
Please read this leaflet carefully before taking 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 so that you can read it again if necessary. If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any possible side effects 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 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 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 also has anti-inflammatory effects.
• Caffeine is a mild stimulant and enhances the effects 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 other ingredients of Excedrin MigraStop coated tablets listed in section 6

• if you have ever experienced allergic reactions to 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 urticaria; swelling of the face or tongue; nasal congestion. If in doubt, consult your doctor or pharmacist.

• in patients with gastric or intestinal ulcers, or if peptic ulcer disease has occurred in the past

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

• in case of haemophilia or other blood disorders

• in severe heart, liver or kidney disease

• when taking more than 15 mg of methotrexate weekly (see section “Excedrin MigraStop with 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 it may cause serious liver damage.
Acetylsalicylic acid may cause bleeding. Inform your doctor if you experience unusual bleeding.
Excedrin MigraStop may not be suitable for every patient for the following reasons. Consult your doctor before using the medicine if:

• you have not previously been diagnosed with migraine, as other potentially serious neurological or brain 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 migraine headaches are accompanied by vomiting,
• you have headaches following head injury, fatigue, coughing or bending forward,
• headaches are chronic (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, underweight, are malnourished, or regularly consume alcohol. It may be necessary to completely discontinue the medicine or limit the amount of paracetamol taken,
• you have a severe infection, are seriously malnourished, have severe underweight, or chronically abuse alcohol, as this may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid, laboured breathing, feeling unwell (nausea, vomiting), loss of appetite. If a combination of these symptoms occurs, contact your doctor immediately,
• you have hereditary glucose-6-phosphate dehydrogenase deficiency, which affects red blood cells. This may lead to anaemia, jaundice, enlargement of the spleen, or other disorders after consuming certain foods or taking other anti-inflammatory medicines (including acetylsalicylic acid),
• you have ever had gastrointestinal disorders, such as gastric ulcers, gastrointestinal bleeding or black stools. If you have previously experienced stomach discomfort or heartburn after taking analgesic or anti-inflammatory medicines,
• you have bleeding disorders or abnormal bleeding from the genital tract 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 or symptoms indicating allergy (skin reactions, itching, urticaria),
• you have gout, diabetes, hyperthyroidism, heart rhythm disorders, uncontrolled hypertension, or impaired kidney or liver function,
• you have problems with alcohol abuse (see section “Using 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 with 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 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 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 headache, too frequent use of Excedrin MigraStop (for 10 days or more per month) to treat chronic headache (occurring for 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 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 with 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 treatment of anxiety and insomnia),
• lithium, selective serotonin reuptake inhibitors or fluvoxamine (for treatment of depression),
• sulfonylureas or insulin (for treatment of diabetes),
• methotrexate (for treatment of certain cancers and rheumatoid arthritis),
• some medicines used to treat infections (e.g. rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid),
• levothyroxine (for treatment of hypothyroidism),
• metoclopramide (for 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 (for treatment of HIV infection),
• medicines delaying gastric emptying, such as propantheline,
• clozapine (for treatment of schizophrenia),
• sympathomimetic medicines (to raise low blood pressure and treat nasal congestion),
• antiallergic medicines (to prevent or treat allergies),
• theophylline (for treatment of asthma),
• terbinafine (for treatment of fungal infections),
• cimetidine (for treatment of heartburn and gastrointestinal ulcers),
• disulfiram (for treatment of alcohol dependence),
• nicotine (used to help quit smoking),
• cholestyramine (for treatment of high blood cholesterol levels),
• flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (metabolic acidosis with a high anion gap), which requires 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.

Using 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 per day. Paracetamol and acetylsalicylic acid may cause liver damage and gastrointestinal bleeding.
• Caffeine: The caffeine content in the recommended dose of the medicine corresponds 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 plan 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 also increase the risk of bleeding in both mother and child 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 is required during the first 6 months of pregnancy or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. 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 levels 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 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 upon 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 machinery. 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 (over 18 years of age):

Treatment of headache
At the onset of headache, 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 headaches, 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 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.

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.

Prolonged 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 impaired kidney or liver function
Inform your doctor if you have liver or kidney disease. Your 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.

Use of a higher than recommended dose of Excedrin MigraStop
Excedrin MigraStop contains acetylsalicylic acid and paracetamol. While taking 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 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: nervousness, anxiety, 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 dose. Do not exceed 6 tablets in one day.

If in doubt about how to use the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Excedrin MigraStop may cause adverse reactions, although not everyone experiences them.
You must immediately stop using 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-like symptoms). Skin rash, itching, and fainting may also occur.

• Redness of the skin, blisters on the lips, conjunctiva, or inside the mouth, skin peeling, or oral ulceration.

• 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, may appear at any stage of treatment, and may lead to death. This risk is particularly high in elderly patients.

• Yellowing of the skin or eyes (signs of liver failure).

• Dizziness or feeling "lightheaded" (symptom of low blood pressure).

• Irregular heartbeat.

• If the patient has previously experienced breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs, and a similar reaction occurs 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 (these may be signs of Reye's syndrome).

The following adverse reactions were observed during 16 clinical trials involving over 4800 individuals. Contact your doctor if you experience any of the symptoms listed below:
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 anxious
• 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, flatulence, and slowed breathing, nasal congestion
• Bloating, belching
• Excessive sweating, itching, itchy rash, increased skin sensitivity
• Stiffness of muscles, bones, or joints, neck pain, back pain, muscle cramps
• Weakness, chest discomfort

The following adverse reactions have been reported after Excedrin MigraStop became available on the market. The frequency of these reactions is difficult to determine:

• Restlessness, feeling unwell or different than 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 cough (asthma symptoms)
• Abdominal pain, gastrointestinal discomfort after meals
• Increased liver enzyme activity
• Nasal swelling and irritation
• Kidney problems

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 also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw;
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 this medicine.

5. How to store Excedrin MigraStop

• Keep the medicine out of sight and reach of children.
• Do not use Excedrin MigraStop after the expiry date stated on the blister pack and cardboard box. The expiry date refers to the last day of the specified month.
• Do not store above 25°C.
• Medicines should 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 the medicine 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:
  For the tablet core: low-substituted hydroxypropylcellulose, microcrystalline cellulose (E 460), stearic acid.
  For the 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 within cardboard boxes containing 10, 20, or 30 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or the 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization Number in Belgium, the country of export: BE352493
Parallel Import Authorization Number: 326/24
This medicine has been authorized in the European Union 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