ASTRAPAIN SYRUP

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

ASTRAL PHARMA (PTY) LTD

Dosage:

See ingredients

Pharmaceutical form:

SYRUP

Composition:

EACH 5 ML SYRUP CONTAINS CODEINE PHOSPHATE 5 MG PARACETAMOL 120 MG PROMETHAZINE HYDROCHLORIDE 6,5 MG

Authorization status:

Registered

Authorization date:

1996-02-01

Patient Information leaflet

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INITIAL AND DATE
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S2
ASTRAPAIN SYRUP (SYRUP)
PARACETAMOL 120 MG, CODEINE PHOSPHATE 5 MG, PROMETHAZINE HYDROCHLORIDE
6,5 MG.
CONTAINS SUGAR:
Sucrose 2.0 g / 5 ml
Liquid glucose 2.0 g / 5 ml
Invert syrup 600 mg / 5 ml
CONTAINS SWEETENER:
Sodium saccharin: 1,5 mg / 5 ml
Sodium cyclamate: 30 mg / 5 ml
ASTRAPAIN SYRUP is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless, you still need to use ASTRAPAIN SYRUP carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ASTRAPAIN SYRUP with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
a few days.
WHAT IS IN THIS LEAFLET
1. What ASTRAPAIN SYRUP is and what it is used for.
2. What you need to know before you take ASTRAPAIN SYRUP.
3. How to take ASTRAPAIN SYRUP.
4. Possible side effects.
5. How to store ASTRAPAIN SYRUP.
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INITIAL AND DATE
6. Contents of the pack and other information.
1.
WHAT ASTRAPAIN SYRUP IS AND WHAT IT IS USED FOR
ASTRAPAIN SYRUP is used for the relief of mild to moderate pain,
associated with fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASTRAPAIN SYRUP
DO NOT TAKE ASTRAPAIN SYRUP :
•
if
you
are
hypersensitive
(allergic)
to
paracetamol,
codeine
phosphate,
promethazine
hydrochloride or any other ingredients of ASTRAPAIN SYRUP (listed in
section 6).
•
if you are hypersensitive (allergic) to opiates or phenothiazines
•
if you are sensitive to one antihistamine and may be sensitive to
others
•
if you suffer from kidney or liver problems
•
if you have an attack of bronchial asthma, respiratory depression,
especially in the presence of
cyanosis (bluish discolouration of skin due to lack of oxygen) and
excessive bronchial (relating
to air passages in the lungs) secretion.
•
If you are an alcoholic.
•
If

Summary of Product characteristics

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____________ _ INITIAL/ DATE
PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
ASTRAPAIN SYRUP
2 QUALITIVE AND QUANTITIVE COMPOSITION
Each 5 ml contains: Paracetamol 120 mg
Codeine Phosphate 5 mg
Promethazine hydrochloride 6,5 mg
Preservatives: Methylparaben 0,10 % m/v
Propylparaben 0,01 % m/v
Contains alcohol: Alcohol content 12,5 % v/v
Contains sugar: Sucrose 2,0 g/ 5 ml
Liquid glucose 2,0 g/ 5 ml
Invert syrup 600 mg/ 5 ml
Contains sweetener: Sodium Saccharin 1,5 mg/ 5 ml
Sodium Cyclamate 30 mg/ 5 ml
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
Mauve to maroon-coloured clear syrup with a distinctive flavour of
blackcurrant.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain, associated with fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
DO NOT EXCEED THE RECOMMENDED DOSE
2 to 5 years: One medicine measure full (5 ml) three times a day.
6 to 12 years: One to two medicine measure full (5 to 10 ml) three
times a day.
Do not use continuously for more than 5 days for pain and 3 days for
fever.
PAEDIATRIC POPULATION
Not recommended for children under the age of 2 years.
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METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
•
Sensitivity to paracetamol, opiates or phenothiazines.
•
Patients sensitive to one antihistamine may be sensitive to others.
•
During
an
attack
of
bronchial
asthma,
patients
with
obstructive
airway
disease,
respiratory
depression, especially in the presences of cyanosis and excessive
bronchial secretion.
•
Heart failure secondary to chronic lung disease and after operations
on the biliary tract.
•
Patients with severe liver or kidney complications.
•
Head injuries and where intracranial pressure is raised.
•
Acute alcoholism.
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Convulsive disorder.
•
Premature infants or neonates.
•
Children under the age of two years.
•
Pregnancy and lactation