MIDRID

For oral administration Adults: 2 capsules at once, then 1 capsule every hour until relief obtained up to a maximum of 5 capsules within a 12 hour period.

Children:

Not recommended.

Transient dizziness may appear in hypersensitive patients. This can usually be eliminated by reducing the dose. Circulatory disturbances may occur. Adverse effects of paracetamol are rare but hypersensitivity reactions including skin rashes may occur.

Anaphylaxis, angioedema, urticaria and very rare cases of fixed drug eruption have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura and agranulocytosis, but these were not necessarily causally related to paracetamol.

Blood disorders have also been reported with isometheptene-containing products.

Metabolism and nutrition disorders:

High anion gap metabolic acidosis with frequency “Not known” (cannot be estimated from the available data). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Cardiovascular disease, diabetes mellitus, hyperthyroidism. When used in patients with high spinal cord lesions, isometheptene, like other sympathomimetics may cause autonomic dysreflexia. Women who have recently given birth may be at increased risk of developing cerebral vasospasm following use of vasospastic agents.

Women should not take Midrid during the post-partum period as there have been several reports of life- threatening cerebral vasoconstriction or intracranial haemorrhage occurring after ingestion of therapeutic doses of isometheptene during the first few weeks after childbirth.

Care is advised in the administration of this product to patients with renal or hepatic impairment. The hazards of paracetamol overdose are greater in those with non- cirrhotic alcoholic liver disease. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Do not exceed the recommended dose. If symptoms persist consult your doctor. Keep out of the sight and reach of children. Patient information leaflet warning. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Label warning:

Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well

Severe cardiac, hepatic or renal impairment, severe hypertension, glaucoma. Patients on monoamine oxidase inhibitor therapy. Porphyria. Hypersensitivity to paracetamol and/or other constituents.