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OLBETAM 250 MG CAPSULES

Active substance(s): ACIPIMOX

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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.

Pratyush Bhartiya at 2:53 pm, Jul 30, 2012
How long should you take your By
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
Leaflet date: 12.09.2011
OLBETAM is a registered trademark of Pharmacia Limited.

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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