EXCEDRIN 250/250/65 Milligram Film Coated Tablet

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

ACETYLSALICYLIC ACID, PARACETAMOL, CAFFEINE

Διαθέσιμο από:

Novartis Consumer Health UK Limited

Φαρμακολογική κατηγορία (ATC):

N02BE51

INN (Διεθνής Όνομα):

ACETYLSALICYLIC ACID, PARACETAMOL, CAFFEINE

Δοσολογία:

250/250/65 Milligram

Φαρμακοτεχνική μορφή:

Film Coated Tablet

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Analgesics and antipyretics

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2010-06-04

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
EXCEDRIN
 film coated tablets
Aspirin 250 mg, Paracetamol 250 mg and Caffeine 65 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet
or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must talk to a doctor if you do not feel better or your
symptoms worsen or do not improve after 3 days for migraine
and 4 days for headache.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What
EXCEDRIN
 is and what it is used for
2. What you need to know before you take
EXCEDRIN
3. How to take
EXCEDRIN
4. Possible side effects
5. How to store
EXCEDRIN
6. Contents of the pack and other information
1. WHAT EXCEDRIN IS AND WHAT IT IS USED FOR
Each tablet of
EXCEDRIN
 contains three active substances:
acetylsalicylic acid (aspirin), paracetamol and caffeine.
• Acetylsalicylic acid (aspirin) and paracetamol reduce pain and
fever, and acetylsalicylic acid (aspirin) also reduces
inflammation.
• Caffeine is a mild stimulant and increases the effect
of acetylsalicylic acid (aspirin) and paracetamol.
EXCEDRIN
 is used for the acute treatment of headache and
migraine attacks (symptoms such as headache, nausea,
sensitivity to light and sound and functional disability) with or
without aura.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EXCEDRIN
DO NOT TAKE
EXCEDRIN
 IF YOU:
• ARE ALLERGIC (hypersensitive) TO ACETYLSALICYLIC ACID
(ASPIRIN),
PARACETAMOL, CAFFEINE OR any of the OTHER INGREDIENTS
OF
EXCEDRIN
 listed in section 6.
SYMPTOMS OF AN ALLERGIC REACTION may include: asthma,
wheezing or shortness of breath; skin rash or hives; swelling
of the face or

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Excedrin 250 mg/ 250 mg/ 65 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 250 mg acetylsalicylic acid (aspirin), 250 mg paracetamol and 65 mg caffeine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong-shaped, film-coated tablet with the letter “E” debossed on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Excedrin is indicated in adults for the acute treatment of headache and of migraine attacks with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (18 years and older)
FOR HEADACHE:
The usual recommended dosage is 1 tablet_; _an additional TABLET can be taken, with 4 to 6 hours between doses. IN CASE
OF MORE INTENSE PAIN, IT IS POSSIBLE TO TAKE 2 TABLETS. IF NEEDED, AN ADDITIONAL 2 TABLETS CAN BE TAKEN, WITH 4 TO 6
HOURS BETWEEN DOSES.
Excedrin is intended for episodic use, up to 4 days for headache.
FOR MIGRAINE:
Take 2 tablets when symptoms appear. If needed an additional 2 tablets can be taken, with 4 to 6 hours between doses.
Excedrin is intended for episodic use, up to 3 days for migraine.
For both headache and migraine, intake must be limited to 6 tablets in 24 hours. The medicinal product must not be
used for a longer period or at a higher dosage without first consulting a doctor.
Drink a full glass of water with each dose.
Children and adolescents (under 18 years of age)
Safety and efficacy of Excedrin in children and adolescents have not been evaluated. Use of Excedrin in children and
adolescents is therefore not recommended (see section 4.4).
Elderly
Based on general medical considerations, caution
should be exercised in the elder