Paracetamol Sandoz 500 mg, tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

PARACETAMOL 500 mg/stuk

זמין מ:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

קוד ATC:

N02BE01

INN (שם בינלאומי):

PARACETAMOL 500 mg/stuk

טופס פרצבטיות:

Tablet

הרכב:

MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570), MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570), MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Paracetamol

leaflet_short:

Hulpstoffen: MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); STEARINEZUUR (E 570);

תאריך אישור:

2012-04-17

עלון מידע

Sandoz B.V.
Page 1/8
Paracetamol Sandoz 500 mg, tabletten
RVG 111619
V9
1.3.1.3 Bijsluiter
April 2022
v
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
PARACETAMOL SANDOZ
®
500 MG, TABLETTEN
paracetamol
_[For medicines available only on prescription:] _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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.
_[For medicines available without a prescription:] _
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.
-
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 5 days for pain or
after 3 days for fever.
[To be completed nationally]
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance paracetamol.
It is a pain relieving, fever
reducing medicine (analgesic and antipyretic).
_ _
_<[Nationally completed na

מאפייני מוצר

Sandoz B.V.
Page 1/10
Paracetamol Sandoz 500 mg, tabletten
RVG 111619
V8
1.3.1.1 Samenvatting van de
Productkenmerken
April 2022
1.
NAAM VAN HET GENEESMIDDEL
Paracetamol Sandoz 500 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
Excipient with known effect:
Each tablet contains up to 1.87 mg of sodium.
Each tablet contains 1000 mg paracetamol.
Excipient with known effect:
Each tablet contains up to 3.74 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_500 mg tablet: _
Tablet.
White, caplet-shaped tablets, debossed “500” on one side and plain
on the other side (17.5 mm x 7.3
mm).
_1000 mg tablet: _
Tablet.
White to off-white, caplet-shaped tablets, debossed with scoreline
between “10” and “00” on one side
and scoreline between “PA” and “RA” on the other side (21.4 mm
x 9.0 mm).
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_<[Nationally completed name] 500 mg, tablets> _
Mild to moderate pain and fever.
[Nationally completed name] is indicated for adults, adolescents and
children aged 9 years and older.
_<[Nationally completed name] 1000 mg, tablets> _
Mild to moderate pain associated with osteoarthritis of the hip and
knee.
[Nationally completed name] is indicated for adults and adolescents
aged 15 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sandoz B.V.
Page 2/10
Paracetamol Sandoz 500 mg, tabletten
RVG 111619
V8
1.3.1.1 Samenvatting van de
Productkenmerken
April 2022
Posology
The lowest effective dose should be used.
Do not exceed the recommended dose because of the risk of serious
liver damage (see sections 4.4 and
4.9)
_<[Nationally completed name] 500 mg, tablets:> _
_Adults and adolescents aged 15 years and older (above 55 kg body
weight) _
Start with 1 tablet (500 mg of paracetamol), if necessary 2 tablets
(1000 mg) at a time, up to a
maximum of 6 tablets (3000 mg of paracetamol) per 24 hours.
_Paediatric population _
_Adolescents betw