EXCEDRIN

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL

Tersedia dari:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

Kode ATC:

N02BE51

Bentuk farmasi:

CAPLETS

Komposisi:

PARACETAMOL 250 MG; ACETYLSALICYLIC ACID 250 MG; CAFFEINE 65 MG

Rute administrasi :

PER OS

Jenis Resep:

Not required

Diproduksi oleh:

GSK CONSUMER HEALTHCARE SARL, SWITZERLAND

Kelompok Terapi:

PARACETAMOL, COMBINATIONS EXCL. PSYCHOLEPTICS

Area terapi:

PARACETAMOL, COMBINATIONS EXCL. PSYCHOLEPTICS

Indikasi Terapi:

For temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual descomfort and pain accompanied by fever.

Tanggal Otorisasi:

2014-10-31

Selebaran informasi

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor's prescription
Excedrin caplets, 250 mg/250 mg/65 mg
Active ingredients and their amounts:
Each caplet contains:
Acetylsalicylic acid
250 mg
Paracetamol
250 mg
Caffeine
65 mg
For a list of inactive ingredients and allergens - see section 6.
Read the entire leaflet carefully before using the medicine.
This leaflet contains
concise information about the medicine. If you have any other
questions, refer to the
doctor or the pharmacist.
Take the preparation according to the instructions in section 3 - How
should you use
the medicine. Consult the pharmacist if you need more information.
Refer to the
doctor if signs of the ailment (symptoms) worsen or do not improve
after 5 days of
pain treatment or after 3 days of treatment of pain accompanied by
fever (see
section 3 - How should you use the medicine).
1. What is the medicine intended for?
The medicine is intended for temporary relief of headaches, mild to
moderate pain
related to migraines, pain of menstrual discomfort and pain
accompanied by fever.
Therapeutic class:
Acetylsalicylic acid -
non-steroidal anti-inflammatory drug (NSAIDs)
Paracetamol -
analgesic and antipyretic
Caffeine -
xanthine alkaloid, central nervous system stimulant
2. Before using the medicine
Do not use this medicine if:

You are sensitive
(allergic)
to the active ingredients
or
to any of the
additional components the medicine contains
(see section 6).
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 unsure, ask your doctor or pharmacist.

You had an allergic reaction in the past
to other
medicines used to
treat pain, inflammation or fever
, such as diclofenac or ibuprofen.

You have
a stomach or intestinal ulcer
, or if you have a
history of
peptic ulceration
.

You have
observed blood in the stool or black stool
(symptoms of
bleeding or pe

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Excedrin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One caplets contains 250 mg acetylsalicylic acid, 250 mg paracetamol
and 65 mg caffeine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Caplets.
White, oblong-shaped, caplet with the letter “E” debossed on one
face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For temporary relief of the pain of headache, mild to moderate pain
associated with migraine
headache, pain of menstrual discomfort and pain accompanied by fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
FOR HEADACHE, PAIN OF MENSTRUAL DISCOMFORT AND PAIN ACCOMPANIED BY
FEVER:
Adults and Adolescents above 12 years: The usual recommended dosage is
2 caplets every
6 hours.
Pain relief may be felt within 15 minutes of administration the dose.
FOR MIGRAINE HEADACHE:
Adults- 2 caplets. If Excedrin is taken for migraine headache, and
there is no improvement or
there is an exacerbation after the first dose, reconsider the
treatment.
Do not use Excedrin for Migraine headache more than 24 hours
Intake should be limited for 8 caplets in 24 hours.
Intake period should be limited for up to 5 days for pain relief and
up to 3 days for
pain accompanied by fever.
Drink a full glass of water with each dose.
Do not score or crush the capsule.
Do not lie down for 15-30 minutes after administration the capsule.
Children and adolescents
Excedrin is not indicated for children and adolescents under 12 years
old.
Elderly
Based on general medical considerations, caution should be exercised
in the elderly, particularly
in elderly patients with low bodyweight.
4.3 CONTRAINDICATIONS
• Hypersensitivity to acetylsalicylic acid, paracetamol, caffeine or
to any of the excipients listed
in section 6.1. Patients in whom attacks of asthma, urticaria, or
acute rhinitis are precipitated
by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
such as diclofenac
or ibuprofen.
• Active gastric or intestinal ulcer, gast