Paracetamol Genmed 500 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL

Available from:

Genmed B.V.

ATC code:

N02BE; N02BE01

INN (International Name):

PARACETAMOL

Dosage:

500 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Not marketed

Authorization date:

2010-06-18

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2019
CRN009DDN
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Genmed 500 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, biconvex, round tablets.
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:_
For oral use only.
Doses depend on body weight and age; a single dose ranges from 10 to
15 mg/kg body weight (= b.w.) to a maximum of 60
mg/kg b.w. for total daily dose (also see section 4.4).
Adolescents 12 to 15 years of age (40 – 55 kg):
500 mg per intake, maximum 4-6 times per 24 hours, with an interval
between administrations of minimum 4 hours.
The lower dosage frequency is intended for the adolescents at the
lower limit of the age category.
Adults:
500 to 1000 mg per intake, maximum 3000 mg per 24 hours, with an
interval between administrations of minimum 4 hours.
In cases of chronic alcoholism, the maximum dose should not exceed
2000 mg per 24 hours.
Paracetamol Genmed 500 mg tablets is not recommended in children below
12 years of age or who weigh less than 40 kg.
_Method of administration:_
The tablet should be swallowed with a large amount of water or, if
desired, left to dissolve in plenty of water, which should be
stirred well before drinking.
Instructions for use:
- The specific dose interval depends on the symptoms and the maximum
daily dose. Depending on the reoccurrence of
symptoms (fever and/or pain), repeated administration is allowed. It
should, however, never fall below 4 hours.
- In cases of severe renal insufficiency (creatinine clearance lower
than 10 ml/min.), the minimum interval between 2
administrations should be 8 hours.
- The daily effective dose must be considered, without exceeding 60
mg/kg/day (without exceeding 2 g/day) in the following
situations: