Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Hypersensitivity to the active substance or to any of the excipients and those with peptic ulceration listed in section 6.1.
Acipimox should not be given to patients with severe renal impairment (creatinine clearance <30 ml/min).
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. The risk of muscle toxicity is increased when nicotinic acid is administered concomitantly with a statin (i.e. a 3hydroxy-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.
Olbetam contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
No interaction has been shown with other lipid lowering agents. However, the combination with statins or fibrates should be used with caution due to reports of an increased risk of musculoskeletal events with nicotinic acid (a structural analogue of acipimox) when used in combination with such lipid-lowering agents.
No interaction has been shown with digoxin and warfarin.
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.
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 (see section 5.3). 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.
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).
Not Known: Eye symptoms (dry or gritty eyes)
Uncommon: Anaphylactoid reaction*
Very Common: Headache
Very Common: Flushing
Not Known: Vasodilatation**
Uncommon: Bronchospasm*
Very Common: Dyspepsia
Common: Abdominal pain upper
Uncommon: Nausea*
Not Known: Diarrhoea**
Common: Urticaria
Uncommon: Angioedema*, Pruritus*, Rash*, Erythema*
Uncommon: Myositis*, Myalgia*, Arthralgia*
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
