ABSORCOL 10 mg Coated Tablet

Зміст інструкції

1. ABSORCOL 10 mg tablets
   1. What is ABSORCOL and what is it used for
   2. What you need to know before taking ABSORCOL
   3. How to take ABSORCOL
   4. Possible side effects
   5. How to store ABSORCOL
   6. Contents of the pack and other information

ABSORCOL 10 mg tablets

ezetimibe

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 their symptoms are the same as yours, as it could 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 ABSORCOL is and what it is used for
• 2. What you need to know before you take ABSORCOL
• 3. How to take ABSORCOL
• 4. Possible side effects
• 5. How to store ABSORCOL
• 6. Contents of the pack and other information

1. What is ABSORCOL and what is it used for

ABSORCOL is a medicine used to reduce elevated cholesterol levels.
ABSORCOL lowers total cholesterol levels, “bad” cholesterol (LDL cholesterol) and
fats called triglycerides in the blood. ABSORCOL also increases levels of “good”
cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of ABSORCOL, works by decreasing the absorption of cholesterol
within the digestive system.
The decrease in cholesterol levels due to ABSORCOL is added to that due to
statins, a group of medicines that work by reducing cholesterol production by the
body itself.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is composed mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can accumulate in the walls of the
arteries forming plaques. Over time, this accumulation in the form of plaque can
lead to narrowing of the arteries. This narrowing can slow down or block the flow of
blood to vital organs such as the heart and brain. This blockage of blood flow can cause a
heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat present in the blood that can increase the risk of heart
disease.
It is used for patients who cannot control cholesterol levels by reducing cholesterol levels with diet alone. You should follow a diet to reduce cholesterol during
therapy with this medicine.

ABSORCOL is used in addition to your cholesterol-lowering dietif you

have:

• an elevated blood cholesterol level (primary hypercholesterolemia  familial and non-familial heterozygous  )
• together with a statin, when your cholesterol level is not adequately controlled with a statin alone
• alone, when treatment with statins is not appropriate or is not tolerated
• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and you may be prescribed other treatments
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood. If you have heart disease, ABSORCOL in combination with medicines to reduce cholesterol called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

ABSORCOL does not help with weight loss.

2. What you need to know before taking ABSORCOL

specific medicinale prescribed.

Do not take ABSORCOL if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6: Contents of the pack and other information).

Do not take ABSORCOL together with a statin if:

• you currently have liver problems
• you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking ABSORCOL.

• Tell your doctor about all medical conditions you have, including allergies.
• Your doctor should prescribe a blood test before starting therapy with ABSORCOL together with a statin. This is to check how your liver is functioning.
• Your doctor may also ask you to have blood tests to check how your liver is functioning after starting to take ABSORCOL together with a statin.

If you have moderate or severe liver problems, the use of ABSORCOL is not recommended.
The safety and efficacy of ABSORCOL administered in combination with
certain medicines that lower cholesterol, the fibrates, have not been established.

Children and adolescents
Do not give this medicine to children and adolescents (from 6 to 17 years of age) unless it has been
prescribed by a specialist because there are limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age because there is no information in
this age group.

Other medicines and ABSORCOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. In particular, tell your doctor if you are taking any medicine(s) with
one of the following active ingredients:

• cyclosporine (often used in patients with organ transplant)
• medicines with an active ingredient that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it alters the effectiveness of ABSORCOL
• fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding
Do not take ABSORCOL together with a statin if you are pregnant, if you suspect or are
planning a pregnancy. If you become pregnant while taking ABSORCOL
together with a statin, you should immediately stop both treatments and contact your doctor.
There is no experience with the use of ABSORCOL without a statin during pregnancy. If you are pregnant, consult
your doctor for advice before
using ABSORCOL.
Do not take ABSORCOL together with a statin if you are breastfeeding, as it is not known whether the two
medicines are excreted in human milk. ABSORCOL, even when taken alone without a statin,
should not be used during breastfeeding. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No effects of ABSORCOL on the ability to drive or use machines are expected. However, you
should bear in mind that some people may experience dizziness after
taking ABSORCOL.

ABSORCOL contains lactose
ABSORCOL tablets contain a sugar called lactose. If your doctor has
diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take ABSORCOL

Take this medicine following the instructions of your doctor exactly. Continue to take
other medicines to reduce cholesterol, unless your doctor tells you to stop

• Before starting to take ABSORCOL, you must follow a diet to lower cholesterol.
• You must continue to follow this cholesterol-lowering diet while taking ABSORCOL.

The recommended dose is one 10 mg ABSORCOL tablet once a day to be taken
orally.
You can take ABSORCOL at any time of the day and independently of meals.
If your doctor has prescribed ABSORCOL together with a statin, the two medicines can be taken
at the same time. In this case, consult the specific dosage instructions contained in the
If your doctor has prescribed ABSORCOL together with another medicine to reduce cholesterol
containing the active ingredient colestyramine or any other medicine containing bile acid sequestrants,
you must take ABSORCOL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more ABSORCOL than you should
Contact your doctor or pharmacist.

If you forget to take ABSORCOL
Do not take a double dose to make up for the missed tablet, it is sufficient to resume
the usual dose of ABSORCOL at the usual time the next day.

If you stop taking ABSORCOL
Consult your doctor or pharmacist because cholesterol levels may increase again.
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.
The following terms are used to describe how often side effects have been reported:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people including isolated cases).

Contact your doctor immediately in case of unexplained muscle pain, tenderness or
muscle weakness. This is because, in rare cases, muscle problems, including muscle tissue injury
resulting in kidney damage, can be serious and potentially life-threatening.
Allergic reactions, including swelling of the
face, lips, tongue, and/or throat which can cause difficulty breathing or swallowing
(requiring immediate treatment) have been reported with common use of the medicine.
The following side effects have been reported when used alone:
Common: abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon: increases in the values of some liver tests (transaminases) or muscle function (CK); cough; indigestion; heartburn; nausea; pain
in the joints; muscle spasms; neck pain; decreased appetite;
pain; chest pain; hot flushes; high blood pressure.
In addition, the following side effects have been reported when the medicine is used together with a statin:
Common: increases in the values of some liver function tests
(transaminases); headache; muscle pain, tenderness or weakness.
Uncommon: sensation of tingling; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially of the hands and feet.
When used together with fenofibrate, the following common side effect has been reported:
abdominal pain.
In addition, the following side effects have been reported with the general use of the medicine: dizziness;
muscle aches; liver problems; allergic reactions including rash and
hives; raised, red rash sometimes with target-like lesions (erythema
multiforme); muscle pain, tenderness or weakness; muscle tissue injury;
gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea,
vomiting); inflammation of the pancreas often accompanied by severe abdominal pain; constipation;
reduction in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia);
sensation of tingling; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. 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 ABSORCOL

• 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 container after “EXP”. The expiry date refers to the last day of that month.
• Do not store ABSORCOL at a temperature above 30°C.

Blisters: store in the original container.
Bottles: keep the bottles tightly closed. These measures will help to protect the medicine from moisture.
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 ABSORCOL contains

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of ABSORCOL and contents of the pack
ABSORCOL tablets are white/off-white in colour, capsule-shaped with “414” imprinted
on one side.
Packs:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in blister packs with press-through opening or unit dose blisters with peel-off foil;
84 or 90 tablets in blister packs with press-through opening;
50, 100 or 300 tablets in blister packs with press-through opening for unit dose;
100 tablets in bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ADDENDA PHARMA S.r.l.
Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Sales Representative
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SP Labo N.V.
Industriepark 30 – Zone A
B-2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in other EEA member states with the following names:
Italy: Absorcol
Germany: Viemm