BETAPYN Tablet Ref.[51189] Active ingredients: Caffeine Codeine Doxylamine Paracetamol

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

Product name and form

BETAPYN TABLETS.

Strength:

Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine anhydrous 50 mg

Pharmaceutical form: Tablets.

Pharmaceutical Form

Tablets.

Round, yellow, flat tablets, bisected on one side of 12,7 mm and embossed with “BETAPYN” on reverse side.

Qualitative and quantitative composition

Each BETAPYN tablet contains:

Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine anhydrous 50 mg

Sugar free.

For a 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.

Doxylamine

Doxylamine, an ethanolamine, first-generation antihistamine crosses the blood-brain barrier and exerts an antiemetic action by selectively binding to H1 receptors in the brain. Doxylamine is an antihistamine commonly used as a sleep aid. This drug is also used to relieve symptoms of hay fever (allergic rhinitis), hives (rash or itching), and other allergic reactions. Doxylamine is also a potent anticholinergic.

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

Colour yellow 14037
Hydrogenated cottonseed oil
Magnesium stearate
Microcrystalline cellulose
Nipastat/salistat (total parabens) 0,124% m/m
Pregelatinized starch
Starch maize
Sodium starch glycollate

Pack sizes and marketing

PVC/Aluminium foil blister packs of 18, 20 and 40 tablets.

All pack sizes may not be marketed simultaneously.

Marketing authorization holder

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

Marketing authorization dates and numbers

BETAPYN: F/2.8/7

Date of Registration: 6 May 1974

Drugs

Drug Countries
BETAPYN South Africa

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