SNIP 325mg/15mg/1mg tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE, PARACETAMOL

Tersedia dari:

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

Kode ATC:

N02BE51

INN (Nama Internasional):

PARACETAMOL 325 mg PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg CHLORPHENAMINE MALEATE 1 mg

Bentuk farmasi:

TABLET

Komposisi:

PARACETAMOL 325 mg PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg CHLORPHENAMINE MALEATE 1 mg

Jenis Resep:

OTC

Area terapi:

ANALGESICS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2007-03-22

Selebaran informasi

PIL-SNIPOTC-2.3-MT
© MEDOCHEMIE LTD
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SNIP 325 MG/15 MG/1 MG 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.
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.
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.
Content 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 relieves
the pain and reduces the fever. Chlorphenamine maleate relieves the
following symptoms: snuffles,
swelling of the nasal mucosa, redness and/or hypersensitivity of the
eyes. Pseudoephedrine
hydrochloride reduces the oedema of the mucosa of the upper
respiratory tract.
SNIP is indicated to relief the symptoms associated with cold and flu,
such as nasal congestion,
rhinitis, sneeze, fever, and light to severe pain of different origin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SNIP
DO NOT
TAKE SNIP:
-
If you are allergic to paracetamol, chlorphenamine, pseudoephedrine or
any of the other
ingredients of this medicine (listed in section 6). The allergic
reaction could be recognised by the
presence of rash, itching, redness of the skin or difficulties in
breathing.
PIL-SNIPOTC-2.3-MT
© MEDOCHEMIE LTD
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-
If you take monoamine oxidase inhibitors (for treatment of depression
and other psychiatric
disorders). In order to start taking

Karakteristik produk

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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:
- paracetamol 325 mg,
- pseudoephedrine hydrochloride 15 mg
- chlorphenamine maleate 1 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, round, flat tablets, scored on one side embossed SNIP on the
other
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:
-
Nasal congestion
-
Rhinitis
-
Sneeze
-
Fever
-
Light to severe pain of different origin
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1-2 tablets every 4-6 hours as needed maximum up to 4 doses per day.
_Paediatric population _
_For children over 12 years old _
12-16 years: 1-2 tablets every 4-6 hours (maximum 4 doses in 24 hours)
16-18 years: 1-2 tablets every 4-6 hours (maximum 4 doses in 24 hours)
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_Children under 11years old _
Not recommended
_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
Oral administration.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•
In patients with severe heart, kidney and liver diseases, diabetes,
glaucoma, high blood pressure,
bronchial asthma should not use this medicine.
•
SNIP is contraindicated in individuals who are taking or have taken
monoaminoxidase
inhibitors within the preceding two weeks. The treatment with MAO
inhibitors should be
discontinued at least 2 weeks prior the initiation of SNIP.
•
The concomitant use of pseudoephedrine and SNIP may occasionally cause
a rise in blood
pressure,