Para-Denk 500 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol

Available from:

bene-Arzneimittel GmbH Herterichstrasse 1-3

ATC code:

N02BE01

INN (International Name):

paracetamol

Dosage:

500mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2023-04-08

Patient Information leaflet

Version: 50001024-002 (4744/003)
PARA-DENK 500
Tablet – oral use
Analgesic and antipyretic medicine
Active substance: paracetamol
Suitable for children over 4 years of age, adolescents and adults.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 or your child 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 or your child do not feel better or
feel worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Para-Denk 500 is and what it is used for
2.
What you need to know before you take Para-Denk 500
3.
How to take Para-Denk 500
4.
Possible side effects
5.
How to store Para-Denk 500
6.
Contents of the pack and other information
1. WHAT PARA-DENK 500 IS AND WHAT IT IS USED FOR
Para-Denk 500 is a pain-killing and fever-lowering medicine (analgesic
and antipyretic).
Para-Denk 500 is used in the symptomatic treatment of mild to moderate
pain and/or fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARA-DENK 500
DO NOT TAKE PARA-DENK 500

if you or your child are allergic to paracetamol or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you or your child take
Para-Denk 500.

if you or your child suffer from chronic alcoholism

if you or your child suffer from impaired liver function (such as
inflammation of the liver, Gilbert’s
syndrome)

if you or your child have pre-existing kidney damage

if you or your child are taking medicines that impair liver function

if you or your child suffer from a hereditary deficiency of the enzyme
glucose-6

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Para-Denk 500
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: paracetamol
Each tablet contains 500 mg paracetamol.
Excipient with known effect: Each tablet contains less than 1 mmol
sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biplanar, facetted tablet, one side with breaking notch,
one side with imprint “Para-
Denk 500”.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Para-Denk 500
_ _
is used in the symptomatic treatment of mild to moderate pain and/or
fever.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage is guided by the specifications in the following table.
The dosage of paracetamol administered depends upon body weight and
age. The usual dose is 10 –
15 mg per kg body weight as a single dose and up to a maximum of 60
mg/kg body weight as total
daily dose.
The respective interval between doses depends on the symptoms and the
maximum total daily dose
and should be at least 6 hours.
A doctor should be consulted if symptoms persist for longer than 3
days.
BODY WEIGHT
(AGE)
SINGLE DOSE
(CORRESPONDING PARACETAMOL
DOSE)
MAX. DAILY DOSE (24 HOURS)
(CORRESPONDING PARACETAMOL
DOSE)
17 kg – 20 kg
(children 4 – 6 years)
½ tablet
(equivalent to 250 mg
paracetamol)
2 [4 x ½] tablets
(equivalent to 1,000 mg
paracetamol)
21 kg – 25 kg
(children 6 – 8 years)
½ tablet
(equivalent to 250 mg
paracetamol)
2 ½ [5 x ½] tablets
(equivalent to 1,250 mg
paracetamol)
2
BODY WEIGHT
(AGE)
SINGLE DOSE
(CORRESPONDING PARACETAMOL
DOSE)
MAX. DAILY DOSE (24 HOURS)
(CORRESPONDING PARACETAMOL
DOSE)
26 kg – 31 kg
(children 8 – 11 years)
½ tablet
(equivalent to 250 mg
paracetamol)
3 [6 x ½] tablets
at intervals of at least 4 hours
(equivalent to 1,500 mg
paracetamol)
32 kg – 43 kg
(children 11 – 12 years)
1 tablet
(equivalent to 500 mg
paracetamol)
4 tablets
(equivalent to 2,000 mg
paracetamol)
43 kg or