Olbetam 250 Mg Capsules
Assessed against UK PIL dated February 2012
PACKAGE LEAFLET: INFORMATION FOR THE USER
Olbetam® 250mg Capsules
(acipimox)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
The name of your medicine is Olbetam 250mg Capsules, but it will be referred to as Olbetam Capsules throughout the remainder of this leaflet.
In this leaflet:
1. What Olbetam Capsules are and what they are used for
2. Before you take Olbetam Capsules
3. How to take Olbetam Capsules
4. Possible side effects
5. How to store Olbetam Capsules
6. Further information
1. What Olbetam Capsules are and what they are used for
This medicine is used to treat lipid disorders characterised by high blood levels of certain types of fats, for example triglycerides and/or cholesterol. Olbetam Capsules should only be used for patients where diet alone failed to correct the levels of these fats.
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.
2. Before you take Olbetam Capsules Do not take Olbetam Capsules if you:
• are hypersensitive (allergic) to acipimox or any of the other ingredients of Olbetam Capsules
• have an ulcer affecting the stomach or gut
• have a severe kidney problem. Your doctor will tell you if this is the case.
Taking other medicines
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 cholestyramine (another lipid lowering agent) at the same time.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and Breast-feeding
You should not take Olbetam Capsules if you are pregnant, trying to become pregnant, or likely to want to become pregnant in the future.
You should not take Olbetam Capsules if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Olbetam does not affect the ability to drive and operate machinery, however please consult your doctor if you wish to drive whilst taking Olbetam Capsules.
3. How to take Olbetam Capsules
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.
If you take more Olbetam Capsules than you should
If you accidentally take more than the recommended dose, your doctor should be contacted immediately.
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 any extra doses to make up for it.
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How long should you take your medicine
Keep taking your medicine until your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, Olbetam Capsules 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 side affects which may affect 1 user in 10:
- Headache
- Flushing
- indigestion
Common side affects which may affect 1 to 10 users in 100:
- Stomach ache
- Weakness
- Hives
Uncommon side affects may affect 1 to 10 users in 1,000:
- 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)
Frequency of the following side affects cannot be estimated from the available date:
- Eye problems including dry or gritty eye
- Vasodilatation (widening of the blood vessels)
- Diarrhoea
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store Olbetam Capsules
You should not use your medicine after the expiry date printed on the box or the label.
Do not store above 30°C. Store in the original package.
Keep your medicine out of reach and sight of children.
If your capsules become discoloured or show any other signs of deterioration, seek the advice of your pharmacist who will tell you what to do.
6. Further information
What Olbetam Capsules contains
The capsules contain 250 mg of acipimox.
The other ingredients are pregelatinised starch, silica gel, magnesium stearate, sodium lauryl sulphate, gelatin, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
What Olbetam Capsules look like and contents of the pack
This medicine is a hard gelatin capsule with a red-brown cap and dark pink body, containing a white to cream powder.
Your medicine is available in blister packs of 30 capsules (3 blister strips of 10 capsules each).
Manufactured by: Pfizer Itaila S.r.l.: Via del Commercio 25/27, 63046 Marino del Tronto (AP)
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Olbetam® 250mg Capsules PLPI NO: 18799/0288 |POM|
Leaflet date: 12.09.2011
OLBETAM is a registered trademark of Pharmacia Limited.