ASPIRIN 500

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACETYLSALICYLIC ACID

Available from:

BAYER ISRAEL LTD

ATC code:

B01AC06

Pharmaceutical form:

TABLETS

Composition:

ACETYLSALICYLIC ACID 500 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

BAYER BITTERFELD, GERMANY

Therapeutic group:

ACETYLSALICYLIC ACID

Therapeutic area:

ACETYLSALICYLIC ACID

Therapeutic indications:

Pain relief, fever reduction .

Authorization date:

2021-09-30

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ASPIRIN® 500
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 500 mg acetylsalicylic acid.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Pain relief
-
Fever reduction
Please note the instructions for children and adolescents (see section
4.4).
4.2
POSOLOGY, METHOD AND DURATION OF ADMINISTRATION
Unless otherwise prescribed, the usual dose is:
AGE
SINGLE DOSE
TOTAL DAILY DOSE
Children from 12 years
1 tablet
(equivalent to 500 mg
acetylsalicylic acid)
UP TO 3 tablets
(equivalent to 1,500 mg
acetylsalicylic acid)
Adolescents and
adults
1–2 tablets
(equivalent to
500–1.000 mg
acetylsalicylic acid)
8 tablets
(equivalent to
4000 mg acetylsalicylic
acid)
A single dose can be taken at intervals of 4 to 6 hours if necessary.
Patients with hepatic impairment
Acetylsalicylic acid should be used with caution in patients with
hepatic impairment (see
section 4.4).
Patients with renal impairment
Acetylsalicylic acid should be used with caution in patients with
renal impairment (see
section 4.4).
Take the tablets with plenty of liquid (e.g. a glass of water).
Patients with swallowing
difficulties can dissolve the tablets in a spoonful of water.
Do not take on an empty stomach.
Aspirin should not be used for more than 4 days without consulting a
doctor.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to acetylsalicylic acid or other salicylates or to
any other ingredient
listed in section 6.1.
2
-
A history of asthma attacks induced by the administration of
salicylates or substances
with a similar action, in particular non-steroidal anti-inflammatory
drugs.
-
Acute gastrointestinal ulcers.
-
Haemorrhagic diathesis.
-
Hepatic and renal failure.
-
Severe, uncontrolled heart failure.
-
In combination with methotrexate at doses of 15 mg or more per week
(see section
4.5).
-
The last trimester of pregnancy (see section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR US