Acipimox

There is only limited experience to date of administration of acipimox to humans therefore epidemiological data is not available. Animal studies have shown reproductive toxicity at high doses. Taking into account the present experience of administration to humans of acipimox and that the safety of acipimox in human pregnancy has not yet been ascertained, it is recommended, therefore, that acipimox not be administered to women who are, or may be pregnant.

In the absence of animal data on the levels of acipimox excreted in milk, acipimox should not be administered to women who are breast-feeding.

Fertility

No human data on the effect of acipimox on fertility are available. In rats, there was no effect on mating or fertility with acipimox treatment.

The effect of acipimox on ability to drive or use machinery has not been studied, but based on its pharmacodynamic properties and overall safety profile it is unlikely to have an effect.

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).

Eye Disorders

Not Known: Eye symptoms (dry or gritty eyes)

Immune System Disorders

Uncommon: Anaphylactoid reaction*

Nervous System Disorders

Very Common: Headache

Vascular Disorders

Very Common: Flushing

Not Known: Vasodilatation**

Respiratory Thoracic and Mediastinal Disorders

Uncommon: Bronchospasm*

Gastrointestinal Disorders

Very Common: Dyspepsia

Common: Abdominal pain upper

Uncommon: Nausea*

Not Known: Diarrhoea**

Skin and Subcutaneous Tissue Disorders

Common: Urticaria

Uncommon: Angioedema*, Pruritus*, Rash*, Erythema*

Musculoskeletal and Connective Tissue Disorders

Uncommon: Myositis*, Myalgia*, Arthralgia*

General Disorders and Administration Site Conditions

Common: Asthenia

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.