PARACETAMOL CLONMEL 600 Milligram Powder for Oral Solution

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

PARACETAMOL

Dostupné s:

Clonmel Healthcare Ltd

ATC kód:

N02BE01

INN (Mezinárodní Name):

PARACETAMOL

Dávkování:

600 Milligram

Léková forma:

Powder for Oral Solution

Druh předpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Analgesics and antipyretics

Stav Autorizace:

Authorised

Datum autorizace:

2017-09-26

Informace pro uživatele

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL CLONMEL 600MG POWDER FOR ORAL SOLUTION IN SACHET
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 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, pharmacist or nurse.
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 Clonmel is and what it is used for
2.
What you need to know before you take Paracetamol Clonmel
3.
How to take Paracetamol Clonmel
4.
Possible side effects
5.
How to store Paracetamol Clonmel
6.
Contents of the pack and other information
1. WHAT PARACETAMOL CLONMEL IS AND WHAT IT IS USED FOR
CONTAINS PARACETAMOL
Paracetamol Clonmel is a medicine used for relief of symptoms of
influenza and feverish colds (incl.
headache, aches and pains) menstrual pain and toothache.
For children aged 12 years or older, adolescents and adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL CLONMEL
DO NOT TAKE PARACETAMOL CLONMEL

if you 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 taking Paracetamol Clonmel if
you:

suffer from chronic alcoholism

suffer from impaired liver function (liver inflammation, Gilbert’s
syndrome)

have existing kidney damage

are using other medicines that are known to affect the liver

have a deficiency of a certain enzyme called
glucose-6-phosphatedehydrogenase

have haemolytic anaemia (abnormal breakdown of red blood cells)

suffer from reduced glutathione levels

are dehydrated or have impaired nut

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Clonmel 600 mg Powder for oral solution in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 600 mg paracetamol.
Excipients with known effect
Each sachet contains 3.8 g sucrose and 0.095 g aspartame (E951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet
White to slightly yellow powder with the smell of lemon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief of symptoms of influenza and feverish colds (incl.
headache, aches and pains), menstrual pain and toothache.
For children aged 12 years or older, adolescents and adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Single dose: 1 sachet (600 mg paracetamol); maximum of 4 doses in 24
hours with at least 6 hours between doses.
A single dose of 1 sachet may not be exceeded.
If other paracetamol-containing medicines are taken concomitantly, the
maximum recommended daily dose of
paracetamol must not be exceeded.
Dosing after meals may lead to a delayed onset of action.
_Special populations_
Elderly people
No specific dose adjustment is required.
Hepatic impairment and mild renal impairment
Dose must be reduced by prolongation of dosing interval in patients
with impaired hepatic or renal function and
Gilbert's syndrome.
Severe renal impairment
In cases of severe renal impairment (creatinine clearance < 10
ml/min), an interval of at least 8 hours must be respected
between doses.
Patients weighing less than 40 kg
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