Olbetam
Italy
Table of Contents
Package leaflet: Information for the user
OLBETAM 250 mg hard capsules
acipimox
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Olbetam is and what it is used for
- What you need to know before taking Olbetam
- How to take Olbetam
- Possible side effects
- How to store Olbetam
- Contents of the pack and other information
1. What Olbetam is and what it is used for
Olbetam contains the active substance acipimox. Acipimox belongs to a group of medicines called "nicotinic acid and derivatives" and works by reducing levels of triglycerides and cholesterol in the blood.
Olbetam is used in combination with other medicines called statins or fibrates, or it may be used instead of these medicines when they are not suitable, for the treatment of the following conditions:
- high levels of triglycerides in the blood (Fredrickson type IV hyperlipoproteinemia)
- high levels of cholesterol and triglycerides in the blood (Fredrickson type IIb hyperlipoproteinemia)
Olbetam is used after it has been established that an appropriate diet, regular physical exercise, and reduction of body weight have not achieved the desired effect on triglyceride and cholesterol levels in the blood.
Olbetam must not be used to prevent the onset of heart disease.
2. What you need to know before taking Olbetam
Do not take Olbetam:
- if you are allergic to acipimox or to any of the other ingredients of this medicine (listed in section 6);
- if you have a stomach or intestinal ulcer;
- if you have severe kidney problems (severe renal insufficiency with creatinine clearance less than 30 ml/min).
Warnings and precautions
Before starting treatment with Olbetam, you should try to reduce your blood triglyceride and
cholesterol levels by changing your diet and lifestyle (e.g. stopping alcohol consumption, reducing body weight in case of obesity, and regularly engaging in physical exercise).
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Talk to your doctor or pharmacist before taking Olbetam.
Olbetam should not be taken during pregnancy or while breastfeeding. Inform your doctor if
you are or think you may be pregnant, or if you are breastfeeding before taking Olbetam (see section
Pregnancy and breastfeeding).
Before and during treatment with this medicine, your doctor will carry out tests to assess:
- your blood fat levels;
- whether you have liver problems;
- whether you have kidney problems.
Inform your doctor if you are being treated with other medicines called statins to reduce blood triglyceride and cholesterol levels. Combining these medicines with Olbetam may cause muscle damage (see section Other medicines and Olbetam).
Other medicines and Olbetam
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are taking other medicines to reduce triglycerides and cholesterol in the blood, such as medicines called statins or fibrates, because combining these medicines with Olbetam may cause muscle damage (see also section Warnings and precautions).
Olbetam may be used together with medicines for:
- lowering blood glucose levels (hypoglycaemic agents);
- increasing the force of heart contraction (digoxin);
- slowing down or preventing blood clotting (anticoagulants), such as warfarin.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before taking this medicine.
The safety of Olbetam during pregnancy has not been established. Therefore, your doctor may decide not to start or to stop treatment with this medicine if you are pregnant.
It is not known whether Olbetam passes into breast milk. Therefore, your doctor may advise you to stop breastfeeding if treatment with this medicine becomes necessary.
Driving and using machines
It is not known whether Olbetam affects the ability to drive or use machinery. If you have any doubts, consult your doctor or pharmacist.
Olbetam 250 mg hard capsules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.
3. How to take Olbetam
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule 2 or 3 times daily, to be taken after meals. The capsules should be swallowed with a glass of water.
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If you have kidney problems (renal insufficiency), the dose should be reduced to one capsule 1 or 2 times daily, to be taken after meals.
Your doctor will advise you on the most appropriate Olbetam dose for you.
If you take more Olbetam than you should
If you take too many Olbetam capsules, contact your doctor immediately. Generally, doses of Olbetam up to 1200 mg daily are well tolerated.
If you forget to take Olbetam
It is important not to miss a dose. Do not take a double dose to make up for a forgotten one.
If you stop taking Olbetam
Your doctor will tell you how long to take Olbetam. You must not stop treatment unless your doctor tells you to do so. If you stop treatment with Olbetam before your doctor advises, your condition may worsen or recur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the first doses of Olbetam, skin flushing, sensation of warmth, and itching may occur. These effects are due to dilation of blood vessels and usually disappear within the first few days of treatment.
Immediately contact your doctor if you experience any of the following side effects, as they may be serious:
- Uncommon (may affect up to 1 in 100 people):
- severe allergic reaction
- swelling of the face, tongue, and throat, which may cause difficulty swallowing and breathing
Very common side effects (may affect more than 1 in 10 people):
- headache
- hot flushes
- persistent burning and/or discomfort in the upper abdomen
Common side effects (may affect up to 1 in 10 people):
- upper abdominal pain
- hives (urticaria)
- weakness
Uncommon side effects (may affect up to 1 in 100 people):
- narrowing of the bronchi (bronchospasm) causing breathing difficulties
- nausea
- skin rash, itching, redness
- inflammation of muscle tissue, muscle pain, joint pain
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- sensation of warmth, malaise
Side effects with frequency not known (frequency cannot be estimated from the available data):
- dilation of blood vessels (vasodilation)
- diarrhoea
Other side effects
- hypotension
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Olbetam
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Olbetam contains
The active substance is acipimox.
Each capsule contains 250 mg of acipimox.
The other components are: starch, precipitated silica, magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide, yellow iron oxide (E172) and red iron oxide (E172).
Description of the appearance of Olbetam and package contents
Olbetam capsules are hard capsules with a red cap and a red-brown body.
The capsules are available in aluminium/PVC blisters, pack size: 30 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
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