Each tablet contains 200mg of meptazinol (as hydrochloride).

Film-coated tablet. Oval, biconvex, orange, film coated tablets. The tablets are engraved “MPL 023” on one side.

For the short term treatment of moderate pain.

200mg 3-6 hourly as required. Usually one tablet 4 hourly

Meptid Tablets have not been evaluated for use in children

The adult dosage schedule can be used in the elderly.

Patients with the following conditions:

- known hypersensitivity to the active ingredient or to any of the excipients

- acute alcoholism and where there is a risk of paralytic ileus

- raised intracranial pressure or head injury (in addition to interfering with respiration, affect pupillary responses vital for neurological assessment).

Clinical studies have indicated absence of clinically significant respiratory depression but caution should be exercised in patients already severely compromised. A reduced dose may therefore be appropriate.

Patients with moderate to severe renal impairment should be given a reduced dose as the effect in these patients may be prolonged and increased. Cerebral sensitivity may also be increased. Patients with hepatic impairment should be given a reduced dose as opioid analgesics may precipitate coma in these patients.

Safety in long term use is not known, therefore it is recommended that this drug be used in the treatment of moderate pain, for short periods of time. Repeated administration of opioid analgesics may cause dependence and tolerance (severe withdrawal symptoms if withdrawn abruptly).

Safety for use in myocardial infarction has not been established.

Meptazinol should also be used with caution in patients with the following conditions: hypotension, hypothyroidism, asthma (avoid during an attack), prostatic hypertrophy and convulsive disorders.

Sunset yellow FCF (E 110) can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

The following undesirable effects could occur as a result of possible interaction with meptazinol hydrochloride.

Antidepressants: CNS excitation or depression manifesting as hypertension or hypotension may occur if meptazinol is administered to patients receiving monoamine-oxidase inhibitors (MAOIs) (including moclobemide). Avoid concomitant use for two weeks after an MAOI is discontinued. Possible increased sedation if meptazinol is used with tricyclic antidepressants.

Antipsychotics: enhanced sedative and hypotensive effect.

Antivirals: avoid concomitant use with ritonavir as plasma concentration of meptazinol may be increased.

Alcohol: enhanced sedative and hypotensive effect.

Quinolones (ciprofloxacin): Avoid premedication with meptazinol as a reduced plasma-ciprofloxacin concentration may be experienced.

Anxiolytics and hypnotics: enhanced sedative effect.

Drugs used in nausea and vomiting: Concomitant use of metoclopramide or domperidone may result in antagonism of gastro-intestinal side effects.

Ulcer healing drugs: cimetidine may inhibit metabolism of meptazinol resulting in increased plasma concentration.

The most commonly reported adverse reactions after treatment with meptazinol are nausea, vomiting, dizziness, diarrhoea and increased sweating, constipation, abdominal pain, rash, vertigo, headache, drowsiness, somnolence and dyspepsia.

Occasional reports of psychiatric disorders (hallucination, confusion, depression) have been received but any causal relationship with the use of meptazinol has not been established. Other uncommon effects are hypotension and respiratory depression.

A summary of the adverse reactions according to system order class is presented below.

Psychiatric disorders: drowsiness, somnolence, confusion, depression, hallucinations

Nervous system disorders: dizziness, headache, vertigo

Vascular disorders: hypotension

Respiratory, thoracic and mediastinal disorders: respiratory depression

Gastrointestinal disorders: abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting

Skin and subcutaneous tissue disorders: increased sweating, rash

Reactions not already stated which are attributable to opioid analgesics include difficulty with micturition, ureteric or biliary spasm, dry mouth, facial flushing, bradycardia, tachycardia, palpitations, hypothermia, dysphoria, mood changes, miosis, decreased libido or potency, urticaria and pruritus.

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