Paracetamol Teva 500 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Paracetamol

متاح من:

Teva B.V.

ATC رمز:

N02BE01

INN (الاسم الدولي):

Paracetamol

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

paracetamol

الوضع إذن:

Not marketed

تاريخ الترخيص:

2022-04-01

نشرة المعلومات

Paracetamol, DE/H/6508/001, 03.03.22
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL TEVA 500 MG FILM-COATED TABLETS
paracetamol
_RX _
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.
_OTC _
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
PARACETAMOL TEVA
is and what it is used for
2.
What you need to know before you take
PARACETAMOL TEVA
3.
How to take
PARACETAMOL TEVA
4.
Possible side effects
5.
How to store
PARACETAMOL TEVA
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
The active ingredient is paracetamol which is a painkiller and also
reduces your temperature when you
have a fever.
PARACETAMOL TEVA
is used for symptomatic treatment of mild to moderate pain and/or
fever.
PARACETAMOL TEVA
is indicated in adults, adolescents and children aged 6 years and
over.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TEVA
DO NOT T

خصائص المنتج

Health Products Regulatory Authority
20 September 2022
CRN00CVW4
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Teva 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg paracetamol.
Excipients with known effect:
Each film-coated tablet contains 12 µg of glucose and sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval shaped biconvex tablet, breakline on one side
of the tablet and plain on the other. The tablet is
approximately 7.9 x 17.1 mm in size with a height of approximately
5.0-6.5 mm.
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.
Paracetamol Teva is indicated in adults, adolescents and children aged
6 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage is in accordance with the information in the following table.
Dose depends on age and body weight, generally 10 to 15 mg/kg body
weight as a single dose, up to a maximum of 60 mg/kg
body weight as the total daily dose.
In each case, the dosing interval depends on the symptoms and maximum
total daily dose. It should be no less than 4 hours.
For children under the age of 6 years, more suitable formulations are
available.
If symptoms persist beyond 3 days, a doctor should be consulted.
BODY WEIGHT
(AGE)
SINGLE DOSE
(EQUIVALENT
PARACETAMOL
DOSE)
(NUMBER OF
TABLETS)
MAX. DAILY DOSE (24 H) (EQUIVALENT PARACETAMOL DOSE) (NUMBER OF
TABLETS/DOSES
MINIMUM
INTERVAL
BETWEEN
DOSES
22 kg - 30 kg
(children 6 – 9
years
approximately)
250 mg
(1 half tablet)
1,000 – 1,500 mg
(maximum of 2-3 tablets/4-6 doses)
4 - 6 hours
30 kg- 40 kg
(children 9 –
12 years
approximately)
500 mg
(1 tablet)
1,500 – 2,000 mg (maximum of 3-4 tablets/ doses)
4 -6 hours
Health Products Regulatory Authority
20 September 2022
CRN00CVW4
Page 2 of 8
40 kg - 55 kg
(children 12 -
15 years
approx