Acetylsalicylzuur ratiopharm 500 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ACETYLSALICYLZUUR 500 mg/stuk

INN (Algemene Internationale Benaming):

ACETYLSALICYLZUUR 500 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, GEPOEDERD (E 460) ; MAÏSZETMEEL

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-02-15

Bijsluiter

Acetylsalicylic acid 500 mg, NL/H/5055/001-28.10.2021
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACETYLSALICYLZUUR RATIOPHARM 500 MG, TABLETTEN
acetylsalicylic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days (for fever) or 3 - 4
days (for pain).
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains acetylsalicylic acid. Acetylsalicylic acid is
an analgesic (pain-relief) and an
antipyretic (fever-reducer).
is used for the symptomatic treatment of fever and/or
mild to moderate pain such as
headaches, flu symptoms, dental pain and muscular pain.
is indicated for adults and adolescents 12 years of age
and older.
Ask your doctor or pharmacist about other forms of acetylsalicylic
acid for patients weighing less than 40 kg.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days (for fever) or 3 - 4 days
(for pain).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE IF YOU:
•
are allergic to acetylsalicylic acid or other salicylates, or any of
the other ingredients of this medicine
(listed in section 6).
•
have a history of asthma or allergic reactions caused by
acetylsalicylic acid or to a related medicine
(notably non-st

Productkenmerken

Acetylsalicylic acid 500 mg, NL/H/5055/001, 17.11.2021
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Acetylsalicylzuur ratiopharm 500 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg acetylsalicylic acid (Ph.Eur.).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablet with cross break score on one side,
diameter approx. 12 mm and height
approx. 5.5 mm.
The tablet can be divided into equal halves.
The cross break score is only to facilitate breaking for ease of
swallowing and not to divide into equal
quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment for fever and/or mild to moderate pain.
500 mg tablets is indicated in adults and adolescents
from 12 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents (aged 16 and older):
1 to 2 tablets with each dose to be repeated as needed after a minimum
period of 4 hours. The
maximum daily dose should not exceed 6 tablets.
Elderly patients (aged 65 and older):
1 tablet with each dose to be repeated as needed after a minimum
period of 4 hours. The maximum
daily dose should not exceed 4 tablets.
Adolescents aged 12 – 15 years (40 - 50 kg):
1 tablet with each dose to be repeated as needed after a minimum
period of 4 hours. The maximum
daily dose should not exceed 4 tablets.
Acetylsalicylic acid should not be taken for more than 3 days (for
fever) respectively for more than 3 -
4 days (for pain) unless directed by a physician.
Acetylsalicylic acid 500 mg, NL/H/5055/001, 17.11.2021
2
Paediatric patients
This medicinal product is not suitable for children under 12 years
(under 40 kg).
Other formulations are available which may be more appropriate for
this patient group.
Hepatic impairment/ renal impairment
Acetylsalicylic acid should be used with caution in patients with
impaired hepatic or renal function or
cardiovascular problems (see sections 4.3 and 4.4).
Method of administratio