(and dosage form)
Each tablet contains:
A.3.3. Anti-Gout Preparations.
ALLOMARON is a combination of two active principles, allopurinol and benzbromarone, a xanthine oxidase inhibitor and uricosuric agent, interfering simultaneously in two pathways of the body s handling of uric acid.
ALLOMARONis indicated for the treatment of hyperuricaemia.
ALLOMARON should not be used for the treatment of an acute attack of gout.
Additionally, ALLOMARON therapy should not be initiated for any purpose during an acute attack.
Hypersensitivity to any of the ingredients of the product.
Safety in pregnancy and lactation has not been established.
Contra-indicated in porphyria.
Treatment should be stopped if any skin reactions or other signs of hypersensitivity develop. A cautious re-introduction at a lower dose may be attempted when mild skin reactions have cleared. ALLOMARON should not be re-introduced to those patients who have experienced other forms of hypersensitivity reactions.
The metabolism of azathioprine and mercaptopurine is inhibited by allopurinol and their doses should be reduced to one-quarter or one-third of the usual dose when either of them is given with allopurinol.
DOSAGE AND DIRECTIONS FOR USE:
Adults: One tablet daily after breakfast or lunch.
An adequate fluid intake is recommended during ALLOMARON treatment to prevent possible precipitation of urinary urate and oxypurines.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of allopurinol is skin rash. Rashes are generally maculopapular or pruritic, but more serious hypersensitivity reactions may occur and include exfoliative rashes, the Stevens-Johnson syndrome and toxic epidermal necrolysis. It is therefore recommended that allopurinol be withdrawn immediately if a rash occurs. Further symptoms of hypersensitivity include fever, chills, leucopenia or leucocytosis, eosinophilia and arthralgia and vasculitis leading to renal and hepatic damage. These hypersensitivity reactions may be severe, even fatal, and patients with hepatic or renal impairment are at special risk.
Hepatotoxicity and signs of altered liver function may be found in patients not exhibiting hypersensitivity.
Many other side-effects, usually of a less of serious nature, have been noted and include peripheral neuritis, alopecia, nausea, vomiting, abdominal pain, diarrhoea, headache, drowsiness and vertigo. In addition to these adverse effects patients may experience an increase in acute gouty attacks during the first few months of treatment. Benzbromarone may cause gastrointestinal side-effects, especially diarrhoea.
It may precipitate an acute attack of gout and renal symptoms of urate deposits.
ALLOMARON should be administered with care to patients with renal or hepatic impairment and doses may need to be reduced.
In all patients receiving allopurinol it is advisable to maintain a urinary output of not less than 2 litres per day and for the urine to be neutral or slightly alkaline.
An increase in hypersensitivity reactions, and possibly also other adverse effects, has been reported in patients receiving allopurinol with thiazide diuretics, particularly in patients with impaired renal function. There have also been reports of allopurinol enhancing the activity of, and possibly increasing the toxicity of, a number of other agents including some antibacterials, some anticoagulants, some antineoplastics, captopril, theophylline and vidarabine. A number of drugs increase uric acid concentrations and may require that the dose of allopurinol be adjusted.
Benzbromarone should be used with caution in patients with impaired renal function.
Salicylates antagonise the effect of benzbromarone.
Benzbromarone in doses in excess of those normally used therapeutically, may increase the anticoagulant activity of coumarin oral anticoagulants.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions” above.
Treatment is symptomatic and supportive.
White, biconvex film-coated tablets, scored on both sides.
Blister packs containing 30 film-coated tablets.
Protect from light and store in a cool place between 15°C and 25°C.
Keep out of reach of children.