Pinex 500mg granules in sachets (strawberry/vanilla flavoured)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 500 mg

Pharmaceutical form:

GRANULES

Composition:

PARACETAMOL 500 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2010-05-20

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PINEX 500 MG GRANULES IN SACHETS
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, pharmacist or nurse
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
WHAT IS IN THIS LEAFLET:
1.
What Pinex is and what it is used for
2.
What you need to know before you take Pinex
3.
How to take Pinex
4.
Possible side effects
5.
How to store Pinex
6.
Contents of the pack and other information
1. WHAT PINEX IS AND WHAT IT IS USED FOR
Paracetamol belongs to the pharmacotherapeutic group of analgesics
(pain-reducing agents) which
are acting simultaneously as antipyretics (fever-reducing agents) with
weak anti-inflammatory
effects.
Pinex is used to reduce fever and for the relief of mild to moderate
pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PINEX
DO NOT TAKE PINEX
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in
section 6)
-
if you have severe kidney problems
-
if you have hepatitis
-
if you are taking other paracetamol containing medicines, as it may
severely damage your
liver
-
if you have alcohol problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pinex
-
if you suffer from liver or kidney disease
-
if you have glucose-6-phosphatedehydrogenase deficiency (an enzyme)
-
if you have haemolytic anaemia (abnormal reduction of red blood cells)
-
if you have Gilbert’s syndrome (familial non-haemolytic jaundice)
-
if you are asthmatic and at the same time sensitive to acetylsalicylic
acid
Page 2 of 7
Prolonged or frequent use i

Summary of Product characteristics

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Pinex 500 mg granules in sachets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains 500 mg paracetamol.
Excipients with known effect:
Contains sorbitol (E420) 801 mg/ sachet.
Contains sucrose 0.14 mg/sachet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules in sachets
White or almost white granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pinex is used for symptomatic treatment of mild to moderate pain and
fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses depend on body weight and age; a single dose ranges from 10 to
15 mg/kg body weight to a
maximum of 60-75 mg/kg for total daily dose.
The specific dose interval depends on the symptoms and the maximum
daily dose. It should,
however, not fall below 4 hours.
Don`t use Pinex longer than three days without medical advice.
500 mg sachets
Body
weight
(age)
single dose [sachet]
max. daily dose [sachets]
26 kg – 40 kg
(8
years
-12
years)
500 mg Paracetamol (1 sachet)
1500 mg Paracetamol (3 sachets)
> 40 kg
(children over 12
years and adults)
500 - 1000 mg Paracetamol (1 – 2
sachets)
3000 mg Paracetamol ( 6 sachets of 500
mg)
Special groups of patients:
_Impaired liver or kidney function _
Page 2 of 9
In patients with impaired hepatic or renal function or Gilbert’s
syndrome, the dose must be reduced
or the dosing interval prolonged.
_Patients with impaired renal function_
In patients with severe renal insufficiency (creatinine clearance < 10
ml/min), a dosing interval of at
least 8 hours must be maintained.
_Chronic alcoholism_
Chronic alcohol consumption may lower the paracetamol toxicity
threshold. In these patients, the
length of time between two doses should be a minimum of 8 hours. 2 g
paracetamol per day should
not be exceeded.
_Elderly patients_
Dose adjustment is not required in the elderly.
_Children and adolescents with small body weight_
Paracetamol 500 mg sachets
Paracetamol 500 mg sachets are not suitable for children under 8 11
years of