Absorcol

Package leaflet: Information for the patient

ABSORCOL 10 mg tablets

ezetimibe
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 others, even if their symptoms are the same as yours, because it could 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:

1. What ABSORCOL is and what it is 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

1. What ABSORCOL is and what it is used for

ABSORCOL is a medicine used to lower elevated cholesterol levels.
ABSORCOL reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. ABSORCOL also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active component of ABSORCOL, works by reducing the absorption of cholesterol in the digestive tract.
The cholesterol-lowering effect of ABSORCOL adds to that provided by statins, a group of medicines that work by reducing the body's own production of cholesterol.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow 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 building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
It is used in patients who cannot control their cholesterol levels by reducing cholesterol through diet alone. You must follow a cholesterol-lowering diet during treatment with this medicine.
ABSORCOL is used in addition to your cholesterol-lowering diet if you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
• in combination with a statin, when your cholesterol level is not adequately controlled with a statin alone
• alone, when treatment with statins is not appropriate or 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 also be given additional treatment
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood. If you have heart disease, ABSORCOL, when used together with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

ABSORCOL does not help with weight loss.

2. What you should know before taking ABSORCOL

If you have been prescribed ABSORCOL together with a statin, please read the package leaflet of that specific prescribed medicine.

Do not take ABSORCOL if:

• you are allergic (hypersensitive) to ezetimibe or to 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.

• Inform your doctor about all medical conditions you have, including allergies.
• Your doctor should perform a blood test before starting treatment with ABSORCOL together with a statin, to check how well your liver is functioning.
• Your doctor may also request periodic blood tests to monitor liver function after you start taking ABSORCOL in combination with a statin.

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

Children and adolescents
Do not give this medicine to children and adolescents (aged 6 to 17 years) unless specifically prescribed by a specialist, as there is limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age, as there is no information available for this age group.

Other medicines and ABSORCOL
Inform 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 a medicine containing any of the following active substances:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• colestyramine (also used to lower cholesterol), as it may alter 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, suspect you may be pregnant, or are planning to become pregnant. If you become pregnant while taking ABSORCOL together with a statin, you must stop both treatments immediately 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 appropriate advice before using ABSORCOL.
Do not take ABSORCOL together with a statin while breastfeeding, as it is not known whether these medicines are excreted in human milk. ABSORCOL, even when taken alone without a statin, should not be used during breastfeeding. Consult your doctor for appropriate advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
ABSORCOL is not expected to affect the ability to drive or use machinery. However, you should be aware 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 an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take ABSORCOL

Take this medicine exactly as your doctor has told you. Continue taking any other medicines to lower cholesterol, unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist.

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

The recommended dose is one 10 mg ABSORCOL tablet once daily, taken by mouth.
You may take ABSORCOL at any time of day, with or without food.
If your doctor has prescribed ABSORCOL together with a statin, both medicines may be taken at the same time. In this case, refer to the dosing instructions provided in the package leaflet of the other prescribed medicine.
If your doctor has prescribed ABSORCOL together with another cholesterol-lowering medicine containing the active substance 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 forgotten tablet. Simply take your usual dose at the next scheduled time the following day.

If you stop taking ABSORCOL
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

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 everyone 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 if you experience unexplained muscle pain, tenderness, or weakness.
This is because, on rare occasions, muscle problems, including injury to muscle tissue, can lead to
kidney damage and may be serious and potentially life-threatening.
With common use of the medicine, allergic reactions have been reported, including swelling of the
face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring
immediate treatment).
When used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon: increases in the values of certain liver laboratory tests (transaminases) or muscle
function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain;
loss of appetite; pain; chest pain; hot flushes; high blood pressure.
Additionally, when the medicine is used in combination with a statin, the following side effects have
been reported:
Common: increases in the values of certain liver function laboratory tests (transaminases); headache;
muscle pain, tenderness, or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain
in arms and legs; unusual tiredness or weakness; swelling, especially of the hands and feet.
When used in combination with fenofibrate, the following common side effect has been reported:
abdominal pain.
Furthermore, with general use of the medicine, the following side effects have been reported: dizziness;
muscle aches; liver problems; allergic reactions including rash and urticaria; raised red rash, sometimes
with target-like lesions (erythema multiforme); muscle pain, tenderness, or weakness; injury to muscle
tissue; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea,
vomiting); inflammation of the pancreas, often accompanied by severe abdominal pain; constipation;
reduction in the number of blood cells, which may cause bruising/bleeding (thrombocytopenia);
tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly via the national reporting system at the following
website: 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 carton or container after “EXP”. The expiry date refers to the last day of that month.
• Do not store ABSORCOL at temperatures above 30°C.

Blister packs: store in the original container.
Bottles: keep bottles tightly closed. These measures will help protect the medicine from moisture.
Do not dispose of any medicine via 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 substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other components are: monohydrate lactose, microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of ABSORCOL and contents of the pack
ABSORCOL tablets are white or almost white, capsule-shaped, with "414" engraved on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in press-through blisters or unit-dose blisters with peelable foil;
84 or 90 tablets in press-through blisters;
50, 100 or 300 tablets in unit-dose press-through blisters;
100 tablets in bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ADDENDA PHARMA S.r.l.
Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Selling Agent
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 authorized in other EEA member states under the following names:
Italy: Absorcol
Germany: Viemm