Excedrin 250 mg/ 250 mg/ 65 mg film coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Acetylsalicylic acid; Paracetamol; Caffeine

Dostępny od:

Haleon Ireland Limited

Kod ATC:

N02BE; N02BE51

INN (International Nazwa):

Acetylsalicylic acid; Paracetamol; Caffeine

Dawkowanie:

250/250/65 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product not subject to medical prescription

Dziedzina terapeutyczna:

Anilides; paracetamol, combinations excl. psycholeptics

Status autoryzacji:

Marketed

Data autoryzacji:

2010-06-04

Ulotka dla pacjenta

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.
• have ever had an allergic reaction to other medicines used to
treat pain, inflammation or fever,
such as acetylsalicylic acid and salicylates, or any other
anti-inflammatory medicines known as
NSAIDs

Charakterystyka produktu

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 14
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)
FORHEADACHE:
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, 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.
FORMIGRAINE:
Take 2 tablets when symptoms appear. If needed 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. (see section 4.4).
Drink a full glass of water with each dose. Children and adolescents
(under 18 years ofage)
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 elderly, particularly in elderly patients with low
body weight.
Hepatic and renalimpairment
The effect of hepatic or renal disease on the pharmacokinetics of
Excedrin has not been evaluat