ASTRAPAIN FORTE TABLETS

Land: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

Fáanlegur frá:

ASTRAL PHARMA (PTY) LTD

Skammtar:

See ingredients

Lyfjaform:

TABLET

Samsetning:

EACH TABLET C ONTAINS CAFFEINE 32 mg CODEINE PHOSPHATE 8 mg MEPROBAMATE 150 mg PARACETAMOL 320 mg

Leyfisstaða:

Registered

Leyfisdagur:

1992-05-11

Upplýsingar fylgiseðill

Applicant: Astral Pharma (Pty) Ltd
Page 1 of 10
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE:
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
SCHEDULING STATUS
S5
PROPRIETARY NAME (and dosage form)
WHAT ASTRAPAIN FORTE TABLETS CONTAINS
•
The active substances are (per tablet):
Paracetamol ……………………………………320 mg
Codeine Phosphate……………………………….8 mg
Caffeine anhydrous………………………………32 mg
Meprobamate……………………………………150 mg
Applicant: Astral Pharma (Pty) Ltd
Page 2 of 10
•
The other ingredients are: Apple Green (CI 19140, CI 44090) Colloidal
Silicone Dioxide
(Aerosil 200), Magnesium Stearate, Nipastat (as preservative) - 0,025%
(m/m), Povidone
K90, Powdered Acacia, Purified Talc, Starch Maize.
Contains Tartrazine
Contains no sugar.
WHAT ASTRAPAIN FORTE TABLETS IS USED FOR
Pain and pain associated with tension.
Short term use in mild to moderate pain associated with anxiety or
tension.
BEFORE YOU TAKE ASTRAPAIN FORTE TABLETS
DO NOT TAKE ASTRAPAIN FORTE TABLETS:
•
if
you
are
hypersensitive
(allergic)
to
paracetamol,
codeine
phosphate,
caffeine,
meprobamate or any of the other ingredients of ASTRAPAIN FORTE TABLETS
as listed
above.
I)
CONTRA-INDICATIONS
ASTRAPAIN FORTE TABLETS should not be used by patients with:
•
acute intermittent porphyria (inherited disorder of blood pigment
metabolism).
•
by patients with kidney or liver insufficiency.
•
Safety of ASTRAPAIN FORTE TABLETS during pregnancy has not been
established.
Applicant: Astral Pharma (Pty) Ltd
Page 3 of 10
•
Asthma, respiratory depression especially in the presence of cyanosis
and excessive
bronchial (relating to air passages in lungs) secre

Vara einkenni

Applicant: Astral Pharma (Pty) Ltd
Page 1 of 14
PACKAGE INSERT
SCHEDULING STATUS:
S5
PROPRIETARY NAME (AND DOSAGE FORM):
ASTRAPAIN FORTE TABLETS
COMPOSITION:
Each tablet contains:
Paracetamol
320 mg
Codeine Phosphate
8 mg
Caffeine anhydrous
32 mg
Meprobamate
150 mg
Preservative: Nipastat
0,025% (m/m)
Contains TARTRAZINE.
Sugar free.
PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations
PHARMACOLOGICAL ACTION:
Applicant: Astral Pharma (Pty) Ltd
Page 2 of 14
Paracetamol has analgesic and antipyretic properties.
Codeine is metabolized to morphine, which in turn, exerts an analgesic
effect.
Caffeine relaxes smooth muscle and stimulates the central nervous
system (CNS).
Meprobamate acts in the central nervous system, has sedative and
hypnotic properties.
PHARMACOKINETICS:
PARACETAMOL:
Absorption
following
oral
administration
is
rapid
and
almost
complete.
Paracetamol is metabolized in the liver primarily by conjugation.
Paracetamol has half-life of 1 to
4 hours, time to peak concentration of 0.5 to 2 hours, time to peak
effect of 1 to 3 hours and the
duration of action of 3 to 4 hours. Paracetamol is renally excreted
primarily as metabolites and
3% of a dose may be excreted unchanged.
CODEINE: Readily absorbed from the gastrointestinal tract. Half-life
is 2.5 to 4 hours. Codeine
is metabolized in the liver. The cytochrome P450 enzyme 2D6 converts
codeine to morphine, one
of its metabolites. About 10% of the dose is demethylated to morphine.
Onset of action is 30 to
45 minutes. The time to peak effect is 1 to 2 hours. Duration of
action is 4 hours. Codeine is
eliminated via the kidneys.
CAFFEINE: Caffeine is readily absorbed after oral administration.
Readily distributed to all body
compartments, readily crosses the placenta and blood brain barrier.
Protein binding is about 25 % - 36 %. It is biotransformed in the
liver. Its half life is 3 to 7 hours.
Peak plasma concentration is reached within 50 to 75 minutes following
oral administration.
Elimination is renally
Applicant: Astral Pharma (Pty) Ltd
Page 3 of 14
M