Paracetamol Neogen 500 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PARACETAMOL 500 mg/stuk

Beschikbaar vanaf:

Neogen N.V. Marie Curie Square 1070 ANDERLECHT (BELGIË)

ATC-code:

N02BE01

INN (Algemene Internationale Benaming):

PARACETAMOL 500 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Paracetamol

Product samenvatting:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-04-26

Bijsluiter

1
PACKAGE LEAFLET - 500 MG
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL NEOGEN 500 MG FILMOMHUDE TABLETTEN
Paracetamol
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 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.
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 take /.../
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 active substance paracetamol which belongs to a group
of medicines called analgesics
(painkillers).
/.../ is used to relieve pain and help reduce fever. The tablets can
treat mild to moderate pain and/or fever.
/.../ may be used in adults and children weighing more than 30 kg
(i.e. about 9 years). This medicinal product
is not suitable for use in children below 6 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE /.../
DO NOT TAKE /.../:
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in section 6).
-
if you are below 6 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking /.../:
-
if you are taking other paracetamol containing medicines, as it may
severely damage the liver.
-
if you have liver problems (including Gilbert’s syndrome or acute
hepatitis).
-
if you have impaired kidney function.
-
if you have a deficiency of a certain enzyme called
glucose-6-phosphatase.
-
if you have haemolytic anaemia (abnormal breakdown of red blood
cells).
-
if you have a poo

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol Neogen 500 mg filmomhulde tabletten
Paracetamol Neogen 1000 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
500 mg:
Each film-coated tablet contains 500 mg paracetamol
1000 mg:
Each film-coated tablet contains 1000 mg paracetamol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
500 mg:
White, film-coated, oval tablet, scored and marked "P 500" on one
side.
1000 mg:
White, film-coated, oval tablet that has a break line on one side and
is plain on the other
side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
_FOR THE 500 MG STRENGTH_
This product is indicated in adults and children weighing more than 30
kg (i.e. about 9 years).
_FOR THE 1000 MG STRENGTH_
This product is indicated in adults and children weighing more than 55
kg (i.e. about 15 years).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
_FOR THE 500 MG STRENGTH: _
_ _
_Adults and children over 15 years (> 55 kg body weight) _
1 to 2 tablets of 500 mg at a time, up to 6 tablets (3000 mg) per 24
hours. The dosing interval should be at
least 4 hours.
_Paediatric population_
Children from 9 to 15 years
This pharmaceutical form is not considered suitable for children below
the age of 6.
The posology depends on the child’s bodyweight. The recommended dose
is 60 mg/kg/day, not more than
3000 mg (3 g) per day:
3
-
30-40 kg (about 9-12 years): 1 tablet at a time (i.e. 500 mg), up to
3-4 times in 24 hours, with a dosing
interval of 6-8 hours.
-
40-55 kg (about 12-15 years): 1 tablet at time (i.e. 500 mg), up to
4-6 times per 24 hours, with a
dosing interval of 4-6 hours.
The lower frequency of administration is intended for children in the
lower limit of the relevant weight
group. Systematic administration, including during the night, helps to
avoid pain and fever oscillations.
_ _
_FOR THE 1000 MG ST