OLBETAM

Posology The daily dosage should be adjusted individually depending on plasma triglyceride and cholesterol levels. The recommended dosage is one 250 mg capsule 2 or 3 times daily to be taken with or after meals. The lower dose is advised in type IV and the higher dose in type IIB hyperlipoproteinaemias.

Daily dosages of up to 1200 mg have been safely administered for long periods. Improvement in the plasma lipid's picture is usually seen within the first month of therapy. Renal impairment In patients with slight renal impairment (creatinine clearance values > 60 ml/min) no dose reduction is required.

For patients with moderate to severe renal impairment (creatinine clearance values between 60 and 30 ml/min) the dose needs to be reduced accordingly to one 250 mg capsule 1 or 2 times daily to be taken with or after meals. Acipimox is eliminated entirely through the kidneys, therefore, accumulation can be expected and is related to the degree of renal impairment.

It is advised that longer intervals are left between doses of the drug in patients with renal impairment. Method of administration To be given orally.

The following undesirable effects have been observed from the clinical and post- marketing experience and reported during treatment with acipimox with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Not Known (cannot be estimated from the available data).

MedDRA System Organ Class Frequency Undesirable Effects Eye Disorders Not Known Eye symptoms (dry or gritty eyes) Immune System Disorders Uncommon Anaphylactoid reaction* Nervous System Disorders Very Common Headache Very Common FlushingVascular Disorders Not Known Vasodilatation** Respiratory Thoracic and Mediastinal Disorders Uncommon Bronchospasm* Very Common Dyspepsia Common Abdominal pain upper Uncommon Nausea* Gastrointestinal Disorders Not Known Diarrhoea** Common UrticariaSkin and Subcutaneous Tissue Disorders Uncommon Angioedema*, Pruritus*, Rash*, Erythema* Musculoskeletal and Connective Tissue Disorders Uncommon Myositis*, Myalgia*, Arthralgia* Common AstheniaGeneral Disorders and Administration Site Conditions Uncommon Feeling hot*, Malaise* * AE frequency estimated from post-marketing safety database ** AE frequency cannot be estimated from the available data The drug may induce skin vasodilatation giving rise to a sensation of heat, flushing or itching, especially at the beginning of therapy and also rash and erythema.

These reactions usually disappear rapidly during the first day of treatment. 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.

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Modification of hyperlipidaemia is recommended only for patients with hyperlipoproteinaemia of a degree and type considered appropriate for treatment. Low cholesterol and low-fat diets, together with cessation of alcohol consumption, exercise and weight loss, in case of obesity are preferable therapeutic approaches to be tried before starting treatment with acipimox.

Since long term administration of acipimox is recommended, all baseline values, including lipid profile, should be measured before treatment and periodic determinations of serum lipids should be obtained to confirm that the desired therapeutic effect has been achieved.

Acipimox is structurally related to nicotinic acid. e. a 3- hydroxy-3- methylglutaryl coenzyme A [HMG-CoA] reductase inhibitor). In one study, Chinese patients taking nicotinic acid plus laropiprant concomitantly with simvastatin were reported to have a higher incidence of myopathy and rhabdomyolysis compared to Caucasians.

Hepatic and renal functions should be monitored. The absorption of acipimox is not affected by the concomitant administration of colestyramine Evidence of clinical efficacy in the prevention of heart disease has not been established.

The possible beneficial and adverse, long-term consequences of some drugs used in the hyperlipidaemias are still the subject of scientific discussion.

Excipient Information:

Olbetam contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

1. Acipimox should not be given to patients with severe renal impairment (creatinine clearance < 30 ml/min).