TENSOPYN Tablet Ref.[51217] Active ingredients: Caffeine Codeine Doxylamine Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Product name and form

TENSOPYN tablets.

Pharmaceutical Form

Tablets.

Yellow, slightly mottled, practically odourless flat faced bevelled edged round tablets embossed with a triangle on one side.

Qualitative and quantitative composition

Each tablet contains:

Paracetamol 450 mg
Codeine phosphate 10 mg
Caffeine anhydrous 30 mg
Doxylamine succinate 5 mg

Sugar free

For the 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

Quinoline yellow supra
Magnesium stearate
Microcrystalline cellulose
Povidone
Silicon dioxide
Sodium croscarmellose

Pack sizes and marketing

TENSOPYN is packed in:

  • Blister strips of 10 tablets packed in a carton containing 20 or 40 tablets.
  • 40 tablets packed into white plastic containers with white plastic caps.

Not all pack sizes may be marketed.

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Marketing authorization dates and numbers

T/2.9/79

8 July 1988

Drugs

Drug Countries
TENSOPYN South Africa

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