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PACKAGE LEAFLET: INFORMATION FOR THE USER

EXCEDRIN 250mg / 250mg/ 65mg film-coated tablets Acetylsalicylic acid / Paracetamol / Caffeine

In this leaflet:

1.    What EXCEDRIN is and what it is used for

2.    Before you take EXCEDRIN

3.    How to take EXCEDRIN

4.    Possible side effects

5.    How to store EXCEDRIN

6.    Further information

1. What EXCEDRIN is and what it is used for

Each tablet of EXCEDRIN contains three active substances: acetylsalicylic acid, paracetamol and caffeine.

•    Acetylsalicylic acid and paracetamol reduce pain and fever, and acetylsalicylic acid also reduces inflammation.

•    Caffeine is a mild stimulant and increases the effect of acetylsalicylic acid and paracetamol.

EXCEDRIN is used for the acute treatment of headache and migraine attacks (symptoms such as headache, nausea, and sensitivity to light and sound) with or without aura.

2. Before you take EXCEDRIN Do not take EXCEDRIN if you:

• are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine or any of the other ingredients of EXCEDRIN (see Section 6. Further Information).

Symptoms of an allergic reaction may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose. If you are not sure, ask your doctor or pharmacist.

•    ever had an allergic reaction to other medicines used to treat pain, inflammation or fever, such as diclofenac or ibuprofen.

•    have a stomach or intestinal ulcer, or if you have a history of peptic ulceration.

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

•    are a haemophiliac or suffering from other blood disorders.

•    have severe heart, liver and kidney problems

•    take more than 15 mg methotrexate per week (see Taking other medicines)

•    are in the last 3 months of pregnancy.

Take special care with EXCEDRIN:

The following are reasons why EXCEDRIN may not be suitable for you. Talk to your doctor before you take this medicine if you:

•    have not been diagnosed with migraine before, as potentially serious conditions relating to the brain or nerves need to be excluded before treatment.

•    have a migraine that is so severe as to require bed rest, or a headache different from your usual migraines, or if you have vomiting with your migraine headache.

•    start having headaches after or caused by head injury, exertion, coughing or bending.

•    have daily headaches, or if you experience your first headache after the age of 50.

•    suffer from a hereditary condition called glucose 6-phosphate dehydrogenase deficiency that affects the red blood cells and could cause anaemia, jaundice or enlargement of the spleen when exposed to certain foods, medicinal products such as certain anti-inflammatory drugs (eg., acetylsalicylic acid), or to other diseases.

•    have ever had gastrointestinal problems such as stomach ulcer, bleeding or black stools. If you have had stomach discomfort or heartburn after taking pain relievers or anti-inflammatory medicines in the past.

•    suffer from bleeding disorders or abnormal vaginal bleeding other than your menstrual period (eg., unusually heavy and prolonged menstrual period).

•    have recently undergone a surgical operation (including minor ones such dental surgery) or will undergo one within the next 7 days.

•    have bronchial asthma, hay fever, nasal polyps, a chronic respiratory disease or develop allergic symptoms (eg., skin reaction, itching, urticaria).

•    have gout, diabetes, hyperthyroidism, arrhythmia, uncontrolled hypertension, impaired kidney or liver function.

•    have alcohol problems (see Taking EXCEDRIN with food and drinks).

•    are already taking other medicinal products containing acetylsalicylic acid or paracetamol, or

other medicines, since certain may interfere with EXCEDRIN and cause side effects (see Taking other medicines).

•    are at risk of being dehydrated (e.g. by vomiting, diarrhoea, or before or after major surgery).

•    are less than 18 years of age. There is a possible association between acetylsalicylic acid and Reye’s syndrome when given to children and adolescents. Reye’s syndrome is a rare disease, which affects the brain and liver, and can be fatal. For this reason, EXCEDRIN should not be given to children or adolescents under 18 years unless specifically indicated by your doctor.

Other precautions

Habitual use of analgesics may cause headache, which must not be treated with higher doses of the same analgesic substance. If you think that this may be the case, please contact your doctor for advice.

EXCEDRIN may reduce the symptoms of an infection (e.g. headache, high temperature) and may therefore make it more difficult to detect. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking EXCEDRIN.

EXCEDRIN may affect the results of laboratory tests. If you have been asked to have blood, urine or other laboratory testing, remember to tell that you are taking EXCEDRIN.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    any other medicinal product that contains paracetamol, acetylsalicylic acid or any other pain reliever/fever reducer.

•    medicines used to prevent blood-clotting ("blood thinners") such as oral anticoagulants (eg., warfarin), heparin, thrombolytics (eg., streptokinase), or other antiplatelets (ticlopidine, clopidogrel, cilostazol).

•    corticosteroids (used to provide relief of inflammation).

•    barbiturates and benzodiazepines (to treat anxiety and insomnia).

•    lithium, selective serotonin reuptake inhibitors or fluvoxamine (to treat depression).

•    sulphonylureas and insulin (to treat diabetes).

•    methotrexate (to treat some kinds of cancer, arthritis or psoriasis).

•    some medicines used to treat infection (eg., rifampicin, isoniazide, chloramphenicol, ciprofloxacin or pipemidic acid).

•    levothyroxine (to treat hypothyroidism).

•    metoclopramide (to treat nausea and vomiting).

•    epilepsy medication.

•    high blood pressure and heart failure medication.

•    diuretics (to increase urine production and reduce excess fluid).

•    medicines to treat gout.

•    oral contraceptives.

•    zidovudine (to treat HIV).

•    medicines to treat slow gastric emptying such as propantheline.

•    clozapine (to treat schizophrenia).

•    sympathomimetics (to raise low blood pressure or to treat nasal congestion).

•    antiallergics (to prevent or relieve allergies).

•    theophylline (to treat asthma).

•    terbinafine (to treat fungal infections).

•    cimetidine (to treat heartburn and peptic ulcers).

•    disulfiram (to treat alcohol dependence).

•    nicotine (used for smoking cessation)

•    cholestyramin (to treat high cholesterol levels)

Taking EXCEDRIN with food and drinks

•    Alcohol:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take this medicine or other pain relievers/fever reducers. Paracetamol and acetylsalicylic acid may cause liver damage and stomach bleeding.

•    Caffeine:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit your intake of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat.

Pregnancy and breast-feeding

If you are pregnant or think that you may be pregnant, tell your doctor and do not take EXCEDRIN. It is especially important not to take EXCEDRIN during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.

Do not take EXCEDRIN if you are breast-feeding as it might be harmful for your infant.

Ask your doctor or pharmacist for advice before taking any medicine.

EXCEDRIN belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

Driving and using machines

Taking EXCEDRIN is not known to affect your ability to drive and use machines.

If you notice side effects such as dizziness or drowsiness, you should not drive or use machines. Tell your doctor as soon as possible.

3. How to take EXCEDRIN_

For OTC medicine:

Always take EXCEDRIN exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

Adults (18 years of age and older):

•    For headache treatment:

Take 1 tablet with a full glass of water when headache pain appears. If needed, you can take another 1 tablet 4 to 6 hours later.

In case of more intense pain, take 2 tablets with a full glass of water when headache pain appears. If needed, you can take another 2 tablets 4 to 6 hours later.

Do not use EXCEDRIN for more than 4 days for headache without consulting your doctor.

•    For migraine treatment:

Take 2 tablets with a full glass of water when migraine symptoms or migraine aura appear. If needed you can take an additional 2 tablets, with 4 to 6 hours between doses.

If you get no migraine relief within 2 hours from the first 2-tablet dose of EXCEDRIN, you should seek the advice of a doctor.

Do not use EXCEDRIN for more than 3 days for migraine without consulting your doctor.

For both headache and migraine treatment, do not exceed 6 tablets over a period of 24 hours. This corresponds to a dose of 1500 mg acetylsalicylic acid, 1500 mg paracetamol and 390 mg caffeine.

Prolonged use except under medical supervision may be harmful.

Children and adolescents:

EXCEDRIN should not be given to children and adolescents under the age of 18 (see Take special care with EXCEDRIN).

Elderly (over 65 years of age):

There are no special dosage recommendations.

Patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may need to adjust the dose interval or treatment duration. Do not take EXCEDRIN if you suffer from severe liver or kidney problems.

If you take more EXCEDRIN than you should

These tablets contain acetylsalicylic acid, paracetamol and caffeine. Do not take more than the recommended dose and do not take any other products which may contain either of these ingredients or any other non steroidal anti-inflammatory drugs while using EXCEDRIN.

Contact your doctor, pharmacist or go to the nearest hospital as soon as you think you might have taken an overdose. Immediate medical attention is critical, because of the potential risk of irreversible liver damage due to paracetamol. Do not wait for symptoms to appear as the overdose might not, at first, produce any noticeable symptoms.

If symptoms of overdose appear they could be:

•    For acetylsalicylic acid: dizziness, ringing in the ears, deafness, sweating, hyperventilation, fever, nausea, vomiting, headache, confusion or restlessness, circulatory collapse or respiratory failure.

•    For paracetamol: the first symptoms that may appear are nausea, vomiting, lack of appetite, pallor, sleepiness, sweating, and later abdominal pain.

•    For caffeine: anxiety, nervousness, restlessness, insomnia, excitement, muscle twitching, confusion, convulsions, hyperglycemia, tachycardia or cardiac arrhythmia.

Even if these symptoms do not appear or if they vanish, it is essential to seek medical help

immediately.

If you forget to take EXCEDRIN

Take the dose as soon as you remember but do not take a double dose to make up for a forgotten dose. Do

not take more than 6 tablets over a period of 24 hours.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking EXCEDRIN and tell your doctor immediately if you have any of these serious side effects:

•    allergic reaction with swelling of the face, lips, mouth, tongue or throat.

This may cause difficulty in swallowing, wheezing, difficulty in breathing and feelings of tightness in the chest (signs of asthma). You may also have a rash or itching and experience fainting.

•    skin reddening, blistering of lips, eyes or mouth, skin peeling.

•    bleeding in the stomach or intestine, ulcer in stomach or intestine, which may be accompanied by severe stomach pain, bloody or black stools, or vomiting blood. As with all pain relievers and fever reducers, this can happen at any time during the treatment, without prior history, and may be fatal. This side effect is particularly serious in elderly people.

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

•    light-headedness or dizziness (signs of low blood pressure).

•    irregular heart beat.

Below side effects were reported in the 16 clinical trials conducted with EXCEDRIN over 4800 treated

subjects. Tell your doctor if you notice any of these other side effects:

Common (affects 1 to 10 users in 100):

•    nervousness, dizziness

•    nausea, abdominal discomfort

Uncommon (affects 1 to 10 users in 1,000):

•    insomnia, trembling, numbness, headache

•    ringing in the ears

•    dry mouth, diarrhoea, vomiting

•    fatigue, feeling j ittery

•    heart rate increased

Rare (affects 1 to 10 users in 10,000):

•    sore throat, difficulty in swallowing, numbness or tingling around the mouth, too much saliva

•    decreased appetite, altered taste

•    anxiety, euphoric mood, tension

•    disturbance in attention, memory loss, altered coordination

• feeling of pain in the cheeks and forehead

•    eye pain, vision disorder

•    hot flushes, peripheral blood vessels problems (eg., in arms or legs)

•    nose bleeds, slow and shallow breathing, runny nose

•    eructation, flatulence

•    excessive sweating, itching, itchy rash, increased skin sensitivity

•    stiffness in muscles, bones or joints; neck pain, back pain, muscles spasms

•    weakness, chest discomfort

Below side effects have also been reported since marketing EXCEDRIN. In general, frequency in postmarketing surveillance cannot be determined precisely, thus it is indicated as “not known”:

•    restlessness, generally feeling unwell or not normal

•    somnolence, migraine

•    skin reddening, rash

•    palpitations, breathlessness, sudden difficulty breathing and feeling of tightness in chest with wheezing or coughing (asthma)

•    abdominal pain, stomach discomfort after meals

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.

5.    How to store EXCEDRIN

•    Keep out of the reach and sight of children.

•    Do not use EXCEDRIN after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information What EXCEDRIN contains

•    The active substances are: acetylsalicylic acid, paracetamol, caffeine.

Each film-coated tablet contains 250 mg acetylsalicylic acid, 250 mg paracetamol and 65 mg caffeine.

•    The other ingredients are:

Tablet core: hydroxypropyl cellulose low substitution, cellulose microcrystalline (E460), stearic acid. Film-coating: hypromellose (E464), titanium dioxide (E171), propylene glycol, benzoic acid (E210), carnauba wax (E903).

What EXCEDRIN looks like and content of the pack

EXCEDRIN is a white, oblong-shaped, film-coated tablet with the letter “E” debossed on one side.

The tablets are provided in blisters which are packed in boxes containing 10, 16, 20, or 32 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorisation holder:

To be completed nationally.

Manufacturer:

Novartis Consumer Health GmbH, ZielstattstraPe 40, 81379 Munich (Germany).

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Excedrinil 250 mg/250 mg/65 mg - Filmtabletten

Belgium:Excedryn, filmomhulde tabletten

Bulgaria: Excedrin 250mg / 250mg / 65mg OnaMHpaHa TabaeTKa

Czech Republic: Excedrinil

France: Excedrinil 250 mg/250 mg/65 mg comprime pellicule

Germany: Paracetamol/ASS/Coffein Kopfschmerz & Migrane 250 mg/250 mg/65 mg Filmtabletten Greece: Excedrin

Ireland: Excedrin film-coated tablets

Italy: Cibalgina Emicrania Cefalea 250mg/250mg/65mg Compressa Rivestita Con Film

Luxemburg: Excedryn, comprimes pellicules

The Netherlands: Excedrin, filmomhulde tabletten

Poland: Excedrin MigraStop

Portugal: Excedrin

Romania: Excedrinil 250 mg / 250 mg / 65 mg comprimate filmate Slovakia: Excedrin

Spain: Excedrin comprimidos recubiertos con pelicula United Kingdom: Excedrinil tablets

This leaflet was last approved on: <country specific>

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