Kruidvat Paracetamol 500 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PARACETAMOL 500 mg/stuk

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

N02BE01

INN (Algemene Internationale Benaming):

PARACETAMOL 500 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Paracetamol

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL;

Autorisatie datum:

2014-08-07

Bijsluiter

KRUIDVAT PARACETAMOL 500 MG, TABLETTEN – RVG 114335
MODULE 1.3
Product Information
Version: 2205
MODULE 1.3.3
Patient Information Leaflet
Replaces: 2203
PACKAGE LEAFLET: INFORMATION FOR THE USER
KRUIDVAT PARACETAMOL 500 MG TABLET, TABLETTEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
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.
-
Are your symptoms of pain not less after 5 days or are your symptoms
of fever not less after 3
days or are they worse? Contact your doctor.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol 500 mg tablet is and what it is used for
2.
What you need to know before you use Paracetamol 500 mg tablet
3.
How to use Paracetamol 500 mg tablet
4.
Possible side effects
5.
How to store Paracetamol 500 mg tablet
6.
Contents of the pack and other information
1. WHAT PARACETAMOL 500 MG TABLETS IS AND WHAT IT IS USED FOR
Paracetamol 500 mg tablet belongs to the group of pain relieving and
fever lowering medicines.
Paracetamol 500 mg tablet is used for symptomatic treatment of mild to
moderate pain and/or fever.
Paracetamol 500 mg tablet may be used in adults, adolescents and
children but is not suitable for use
in children below
8 years.
Are your symptoms of pain not less after 5 days or are your symptoms
of fever not less after 3 days or
are they worse? Contact your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL 500 MG TABLET
DO NOT USE PARACETAMOL 500 MG TABLET:
-
if you are allergic to any of the ingredients of this medicine listed
in section 6.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Paracetamol 500 mg
tablet if you suffer from:
-
Hepatic or renal impairment;
-
Moderate to severe renal insufficiency (inadequate activity of the
kidneys)
-
Mild to severe hepatic

Productkenmerken

KRUIDVAT PARACETAMOL 500 MG, TABLETTEN – RVG 114335
MODULE 1.3
Product Information
Version:2205
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2203
1.
NAME OF THE MEDICINAL PRODUCT
Kruidvat Paracetamol 500 mg tablet, tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
(Almost) white, round tablet which is 13 mm in diameter with a score
line on one side and the
inscription “PARACETAMOL” on the other .
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents from 15 years (>50 kg body weight): _
1 to 2 tablets (500-1000 mg) at a time, maximum 6 tablets (3000 mg)
per 24 hours.
_ _
_ _
_Children and adolescents under 15 years: _
The recommended daily dose of paracetamol is about 60 mg/kg which is
divided into 4 or 6
administrations daily, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4
hours.
_Children from 12 to 15 years (43-50 kg): _
1 tablet (500 mg) at a time, every 4 hours, if needed, with a maximum
of 4 tablets per day.
_ _
_Children from 11 to 12 years (34-43 kg): _
1 tablet (500 mg) at a time, every 6 hours, if needed, with a maximum
of 4 tablets per day.
_ _
_Children from 8 to 11 years (26-34 kg): _
½ tablet (250 mg) at a time every 4 hours, or 1 tablet (500 mg) every
6 hours, if needed, with a
maximum of 3 tablets per day. Other pharmaceutical forms containing
paracetamol (i.e. solutions)
exist as an alternative for children who might have difficulties to
swallow a tablet.
_ _
KRUIDVAT PARACETAMOL 500 MG, TABLETTEN – RVG 114335
MODULE 1.3
Product Information
Version:2205
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2203
Indications for use:
-
Not suitable for children below 8 years of age.
-
The dosing interval must be at least 4 hours.
-
Do not use in combination with other