Paracetamol Zentiva 500 mg tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Paracetamol

제공처:

Zentiva k.s.

ATC 코드:

N02BE01

INN (International Name):

Paracetamol

약제 형태:

Tablet

치료 영역:

paracetamol

승인 상태:

Not marketed

승인 날짜:

2023-02-10

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL ZENTIVA 500 MG TABLETS
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
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 3 days (in case
of fever) or 5 days (in case of pain).
•
Do not give the product to children for more than 3 days without
consulting a doctor.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Zentiva is and what it is used for
2.
What you need to know before you take Paracetamol Zentiva
3.
How to take Paracetamol Zentiva
4.
Possible side effects
5.
How to store Paracetamol Zentiva
6.
Contents of the pack and other information
1.
WHAT IS PARACETAMOL AND WHAT IS IT USED FOR_ _
The name of your medicine is Paracetamol Zentiva 500mg tablets (called
Paracetamol Zentiva
throughout this leaflet).
This product contains paracetamol, active substance relieving fever
and pain.
Paracetamol Zentiva tablets are used for short-term symptomatic
treatment of mild to moderate
pain such as headache, toothache, menstrual pain, muscle and joint
pain during flu and cold,
and/or fever.
Paracetamol Zentiva 500mg is intended for adults, adolescents and
children with body weight
above 21 kg (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 ( for fevers)
or 5 days (for pain).
Do not give the product to children for more than 3 days without
consulting a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL ZENTIVA_ _
DO NOT TAKE PARACETAMOL ZENTIVA IF YOU:
•
are allergic to paracetamol or any of the other ingredie

제품 특성 요약

Health Products Regulatory Authority
11 December 2023
CRN00DKJV
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Zentiva 500 mg tablets
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.
White capsule shaped tablet with flat edges, dimensions approx. 17×7
mm, S score line 1 (S|1) on one side. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of mild to moderate pain and/or
fever.
Paracetamol Zentiva 500 mg tablets are intended for adults,
adolescents and children with body weight above 21 kg (aged 6
years and over).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest time
possible. The maximum daily dose must not be exceeded.
Paracetamol is dosed depending on body weight and age, usually 10 –
15 mg/kg body weight as a single dose, up to a
maximum daily dose of 60 mg/kg body weight. For dosing according to
the body weight and age see the tables.
Paracetamol Zentiva 500 mg tablets are not intended for children less
than 6 years of age with body weight less than 21 kg.
APPROXIMATE AGE
BODY WEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE
6 – 8 years
21 – 24 kg
250 mg (½ tablet)
1 g (2 tablets)
9 – 10 years
25 – 33 kg
250 mg (½ tablet)
1.5 g (3 tablets)
10 – 12 years
34 ‒ 41 kg
500 mg (1 tablet)
2 g (4 tablets)
12 – 15 years
42 ‒ 49 kg
500 mg (1 tablet)
2.5 g (5 tablets)
> 15 years
50 ‒ 60 kg
500 mg (1 tablet)
3 g (6 tablets)
​
> 60 kg
500 – 1000 mg (1 – 2 tablets)
3 g (6 tablets)*
* Only after medical consultation, the maximum daily dose in patients
with body weight > 60 kg can be increased to 4 g of
paracetamol.
Single dose may be repeated as needed, with an interval of at least 4
– 6 hours.
_Renal impairment_
Health Products Regulatory Authority
11 December 2023
CRN00DKJV
Page 2 of 6
Paracetamol should be u