OLBETAM 250 mg Hard Capsule

Зміст інструкції

1. OLBETAM 250 mg hard capsules
   1. What is Olbetam and what is it used for
   2. What you need to know before taking Olbetam
   3. How to take Olbetam
   4. Possible side effects
   5. How to store Olbetam
   6. Contents of the pack and other information

OLBETAM 250 mg hard capsules

acipimox

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olbetam is and what it is used for
• 2. What you need to know before you take Olbetam
• 3. How to take Olbetam
• 4. Possible side effects
• 5. How to store Olbetam
• 6. Contents of the pack and other information

1. What is Olbetam and what is it used for

Olbetam contains the active ingredient acipimox. Acipimox belongs to a group of medicines called
“nicotinic acid and derivatives” and works by reducing triglyceride and cholesterol levels in the blood.
Olbetam is used in association with other medicines called statins or fibrates or may be used instead of them
when these medicines are not suitable, for the treatment of the following diseases:

• elevated levels of triglycerides in the blood (Frederickson type IV hyperlipoproteinemia)
• elevated levels of cholesterol and triglycerides in the blood (Frederickson type IIb hyperlipoproteinemia)

Olbetam is used after verifying that an adequate diet, regular physical exercise and weight reduction
have not produced the desired effect on triglyceride and cholesterol levels in the blood.
Olbetam should 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 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 must try to lower your triglyceride and
cholesterol levels in the blood by changing your diet and lifestyle (e.g. stopping drinking
alcoholic beverages, reducing body weight in case of obesity and exercising regularly).
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Consult your doctor or pharmacist beforetaking 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 taking this medicine, your doctor will perform tests to evaluate:

• fat levels in the blood
• if you have liver problems
• if you have kidney problems. Inform your doctor if you are being treated with other medicines called statins to reduce triglyceride and cholesterol levels in the blood. The combination of these medicines with Olbetam can cause muscle damage (see section Other medicines and Olbetam).

Other medicines and Olbetam
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking other medicines to reduce triglycerides and cholesterol in the
blood, such as medicines called statins or fibrates, because the combination of these medicines with
Olbetam can cause muscle damage (see also section Warnings and precautions).
Olbetam can be combined with medicines for:

• lowering blood glucose levels (hypoglycemic agents);
• increasing the force of heart contraction (digoxin);
• slowing down or stopping the blood clotting process (anticoagulants), such as warfarin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 it is necessary to start treatment with this medicine.

Driving and using machines
It is not known whether Olbetam alters the ability to drive vehicles or use machines. If you have doubts, consult
your doctor or pharmacist.

Olbetam 250 mg hard capsules contains 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule 2 or 3 times a day, to be taken after meals. The capsules must
be swallowed with a glass of water.
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If you have kidney problems (renal insufficiency) the dose must be reduced to one capsule 1 or 2 times a day,
to be taken after meals .
Your doctor will advise you on the most suitable dose of Olbetam 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 per day are well tolerated.

If you forget to take Olbetam
It is important that you do not miss a dose. Do not take a double dose to make up for a missed dose.

If you stop taking Olbetam
Your doctor will tell you how long to take Olbetam. You should not stop treatment until your
doctor tells you to. If you stop taking Olbetam before your doctor tells you to, your
condition may worsen or reappear.
If you have any doubts about the use of this medicine, ask 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 administrations of Olbetam, redness of the skin, a sensation of
warmth and itching may occur. These effects are due to the dilation of blood vessels and normally disappear
during the first few days of treatment.
Immediatelyconsult your doctor if you experience any of the following side effects because
they can be serious:

• Uncommon(may affect up to 1 in 100 people):
• severe allergic reaction
• swelling of the face, tongue and throat, which can cause problems with swallowing and breathing

Very commonside effects (may affect more than 1 in 10 people):

• headache
• hot flashes
• burning and/or persistent discomfort in the upper abdomen

Commonside effects (may affect up to 1 in 10 people):

• pain in the upper abdomen
• urticaria
• weakness

Uncommonside effects (may affect up to 1 in 100 people):

• narrowing of the bronchi (bronchospasm) with difficulty breathing
• nausea
• skin rash, itching, redness
• inflammation of muscle tissue, muscle pain, joint pain

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• feeling of warmth, malaise

Side effects with unknown frequency(frequency cannot be estimated from available data):

• dilation of blood vessels (vasodilation)
• diarrhea

Other side effects

• hypotension

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 package or blister after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Olbetam contains
The active ingredient is acipimox.
Each capsule contains 250 mg of acipimox.
The other ingredients 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 contents of the pack
Olbetam capsules are hard capsules with a red cap and a red-brown body.
The capsules are available in aluminum/PVC blisters in packs of 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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