Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Olbetam Capsules 250
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Acipimox may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for This medicine contains acipimox, which is used to treat lipid disorders by reducing high blood levels of certain types of fats called triglycerides. Olbetam Capsules should only be used in patients where diet alone or other non-drug measures (weight loss or exercise) failed to correct the levels of these fats. Olbetam Capsules should be used in addition to other medicines, such as medicines called 'statins' or 'fibrates' or instead of these medicines where they may not be appropriate or of expected benefit. Olbetam Capsules prevent the release of fatty acids from fatty tissue and decrease the blood level of triglyceride and cholesterol. Your doctor will advise you whether Olbetam Capsules will be of benefit to you in reducing the level of fat in your blood. Your doctor will prescribe this medicine to you only once it is clear that low fat diets and stopping drinking alcohol are not having the desired effect. You must talk to your doctor if you do not feel better or if you feel worse.
What you need to know before you take it
e Olbetam Capsules Do not take Olbetam Capsules:
- If you are allergic to acipimox or any of the other ingredients of this medicine (listed in section 6).
- If you have an ulcer affecting the stomach or gut.
- If you have a severe kidney problem. Your doctor will tell you if this is the case.
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Warnings and precautions Talk to your doctor or pharmacist before taking Olbetam Capsules.
- This medicine is not effective for all lipid disorders.
- You should have made changes to your diet, alcohol intake and physical exercise before being given this medicine.
- This medicine is for long term use, blood tests should be performed before taking this medicine, and at regular intervals during treatment.
- Your kidney and liver functions should be monitored while you are taking this medicine.
- Tell your doctor if you are taking other medicines to reduce blood fat levels (see Other medicines and Olbetam).
- This medicine is not given to prevent heart disease.
- Your doctor will assess how well this medicine is working for you based on your response to it over time.
- Tell your doctor immediately if you have unexplained muscle pain, muscle tenderness or muscle weakness while you are taking this medicine. Other medicines and Olbetam Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Please tell your doctor if you are taking any other lipid lowering agents. Although no interaction has been shown with other lipid lowering agents, caution should be taken if Olbetam Capsules are used in combination with statins (e.g. simvastatin) or fibrates (e.g. clofibrate). The absorption of Olbetam Capsules is not affected by taking colestyramine (another lipid lowering agent) at the same time. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Olbetam does not affect the ability to drive and operate machines, however please consult your doctor if you wish to drive whilst taking Olbetam Capsules. Olbetam contains sodium This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodiumfree'.
How to take it
Olbetam Capsules Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dosage is one 250 mg capsule 2 or 3 times a day. This should be taken with or after main meals. The capsules should be swallowed with a glass of water. If you have mild kidney problems you may need to take a lower dose and to take your tablets less often. The doctor will advise you how much to take and how often (usually one capsule 1 or 2 times a day). If you take more Olbetam Capsules than you should If you accidentally take more than the recommended dose, your doctor should be contacted immediately. Page 2 of 4
If you forget to take Olbetam Capsules If you forget to take your medicine, take it as soon as you remember. If it is nearly time for the next dose, take it at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Olbetam Capsules Do not stop taking your medicine or alter the dose you are currently taking without seeing your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Please contact your doctor immediately if any of the following side effects occur:
- Serious allergic reaction which causes difficulty in breathing (due to narrowing of the airways), swelling of the tongue, throat, face and / or neck. These effects are uncommon.
- Dilation of blood vessels in the skin causing a feeling of heat, flushing or itching, rash or redness. These reactions usually disappear quickly during the first day of treatment. Other side effects may include: Very common: may affect more than 1 in 10 people
- Headache
- Flushing
- Indigestion Common: may affect up to 1 in 10 people
- Stomach ache
- Weakness
- Hives Uncommon: may affect up to 1 in 100 people
- Serious allergic reaction which causes difficulty in breathing or dizziness
- Difficulty in breathing or wheezing
- Nausea (feeling sick)
- Rash, itching, redness
- Inflammation of muscle tissue causing pain in the muscles and joints
- Feeling hot, malaise (generally not feeling well) Not known: frequency cannot be estimated from the available data
- Eye problems including dry or gritty eye
- Vasodilatation (widening of the blood vessels)
- Diarrhoea Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Olbetam Capsules Keep this medicine out of the sight and reach of children. Page 3 of 4
Do not use this medicine after the expiry date printed on the carton or blister after EXP. The expiry date refers to the last day of that month. Store below 30°C in the original carton to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Olbetam Capsules contains The active substance is acipimox. Each capsule contains 250 mg of acipimox. The other ingredients are corn starch, silicon dioxide, magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171) and red and yellow iron oxides (E172). What Olbetam Capsules look like and contents of the pack This medicine is a hard gelatin self-locking capsule, with a red-brown cap and dark pink body, containing a white to cream powder. The capsules are available in blister packs (strips of 10) packed in cartons of 90 capsules. Marketing Authorisation Holder Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom Manufacturer Pharmacia Italia SpA, Via Del Commercio, Zona Industriale, Ascoli Piceno, 63046, Italy. Company Contact address For further information on your medicine contact Medical Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey, UK, Tel: +44 1304 616161 This leaflet was last revised in 10/2020
Ref: OB 11_0
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Frequently asked questions about Olbetam Capsules 250
How do I take Olbetam Capsules 250?
Olbetam Capsules 250 comes as capsule. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Olbetam Capsules 250?
The active substance in Olbetam Capsules 250 is acipimox.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Olbetam Capsules 250, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Olbetam Capsules 250 without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: acipimox
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Olbetam is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for:
• hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia);
• hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIB hyperlipoproteinaemia).
Olbetam should be used after other measures have been taken such as dietary changes and other non-pharmacological treatment (e.g. exercise, weight reduction).
It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
4.2. Posology and method of administration
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.
4.3. Contraindications
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).
4.4. Special warnings and precautions for use
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.
Excipient Information:
Olbetam contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
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.
Pregnancy
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.
Breast-feeding
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.
4.7. Effects on ability to drive and use machines
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.
4.8. Undesirable effects
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
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.
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. 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.
4.9. Overdose
If toxic effects are observed, supportive care and symptomatic treatment should be administered.
💬 Ask about this leaflet
Ask anything about Olbetam Capsules 250. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.