SNIP 325mg/15mg/1mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N02BE51

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg CHLORPHENAMINE MALEATE 1 mg PARACETAMOL 325 mg

Pharmaceutical form:

TABLET

Composition:

PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg CHLORPHENAMINE MALEATE 1 mg PARACETAMOL 325 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2007-03-22

Patient Information leaflet

PIL-SNIPPOM-2.3-MT
© MEDOCHEMIE LTD
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SNIP 325MG/15MG/1MG TABLETS
Paracetamol/pseudoephedrine hydrochloride/chlorphenamine maleate
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.
WHAT IS IN THIS LEAFLET
1.
What SNIP is and what it is used for
2.
What you need to know before you take SNIP
3.
How to take SNIP
4.
Possible side effects
5.
How to store SNIP
6.
Contents of the pack and other information
1.
WHAT SNIP IS AND WHAT IT IS USED FOR
SNIP is a combination of paracetamol, chlorphenamine, and
pseudoephedrine. Paracetamol is one of a
group of medicines with analgesic (painkiller) and anti-pyretic
(reduces fever) activity.
Pseudoephedrine is a decongestant which helps you to breathe more
easily. Chlorphenamine is an
antihistamine used to relieve respiratory allergies.
SNIP is indicated to relief the symptoms associated with cold and flu,
such as: cough, nasal
congestion, rhinitis, sneeze, fever, light to severe pain of different
origin.
SNIP is also indicated for alleviating symptoms of hay fever and other
allergies of upper respiratory
tract associated with fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SNIP
DO NOT
TAKE SNIP
:
•
if you are allergic to paracetamol, chlorphenamine, pseudoephedrine or
any other ingredients of
this medicine (listed in section 6).
PIL-SNIPPOM-2.3-MT
© MEDOCHEMIE LTD
2
•
if you take monoamine oxidase inhibitors (for treatment of depression
and other psychiatric
disorders). In order to start taking SNIP you should not have been
taking such medicines

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
. NAME OF THE MEDICINAL PRODUCT
SNIP 325mg/15mg/1mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SNIP 325mg/15mg/1mg tablet contains 325 mg of paracetamol, 15 mg
of
pseudoephedrine hydrochloride and 1 mg of chlorphenamine maleate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, round, flat, scored tablets embossed SNIP.
The score line is not intended for breaking the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SNIP is indicated for:
Relief of symptoms associated with cold and flu, such as:
-
Cough
-
Nasal congestion
-
Rhinitis
-
Sneeze
-
Fever
-
Light to severe pain of different origin
Additional, for alleviating symptoms of hay fever and other allergies
of upper respiratory
tract associated with fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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Posology
_Adults _
1-2 tablets every 4-6 hours as needed up to maximum 12 tablets per
day.
_Adolescents (over 12 years old): _
1-2 tablets every 6 hours as needed up to maximum 8 tablets per day
_Paediatric population_
_For children 6 to 11 years old _
1 tablet every 4 to 6 hours, not to exceed 6 tablets per day. For
children between 6 to 8 years
old the maximum recommended dose is 5 tablets per day.
_Children under 6 years old: _
As with any antihistamine-containing product, use of Snip tablets in
children under 6 years of
age should be only under the advice and supervision of a physician.
_Renal/hepatic impairment _
Consideration should be given to a reduced total daily dosage in
patients with hepatic or renal
impairment.
_Elderly_
There is evidence of prolonged half life in the elderly, so reduction
in dosage should be
considered.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Snip is contraindicated in individuals who are taking or have taken
monoaminoxidase
inhibitors within the preceding two weeks.
SPC