STOPAYNE Tablet Ref.[50682] Active ingredients: Caffeine Codeine Meprobamate Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Adcock Ingram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685

Product name and form

STOPAYNE TABLETS, tablets.

Pharmaceutical Form

Tablets.

Light green, round biconvex tablets, scored on one side and RIO embossed on the other side.

Qualitative and quantitative composition

Each tablet contains:

Meprobamate 150 mg
Codeine phosphate 8 mg
Paracetamol 320 mg
Caffeine anhydrous 32 mg

Excipients with known effect:

Contains sugar (lactose monohydrate): 1 mg
Contains the colouring agent sunset yellow FCF (E 110)

For full list of excipients, see section 6.1.

Active Ingredient Description
Caffeine

Caffeine is structurally related to the methylxanthines theophylline and theobromine. Caffeine’s main action is as a CNS stimulant.

Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.

Meprobamate

Meprobamate is a carbamate with hypnotic, sedative and some muscle relaxant properties. It is used for the short-term treatment of anxiety states, muscle tension and associated conditions where anxiety is present. In therapeutic doses its sedative effect rather than a direct action may be responsible for muscle relaxation.

Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Brilliant blue FCF (E133)
Gelatine
Lactose monohydrate
Magnesium stearate
Povidone
Pregelatinized starch
Purified talc
Quinoline yellow (E104)
Sodium starch glycolate
Sunset yellow FCF (E110)

Pack sizes and marketing

PVC/PVDC/Aluminium blister strips in an outer carton.

or

White HDPE bottles with white HDPE screw caps in an outer carton.

Pack sizes: 100 or 1 000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock Ingram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685

Marketing authorization dates and numbers

B 866 (Act 101/1965)
Namibia NS3 14/2.8/0417
Botswana S1 B9300805

Date of registration: 19 November 1986

Drugs

Drug Countries
STOPAYNE South Africa

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