Absorcol 10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
ABSORCOL 10 mg Tablets
ezetimibe
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What ABSORCOL is and what it is used for
- What you need to know before taking ABSORCOL
- How to take ABSORCOL
- Possible side effects
- How to store ABSORCOL
- 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 the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ABSORCOL increases the levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in ABSORCOL, works by reducing the cholesterol absorbed in the gastrointestinal tract.
ABSORCOL adds to the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.
Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your 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 interruption in blood flow may cause a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another type of fat in your blood that may increase the risk of heart disease.
It is used in patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
ABSORCOL is used together with a cholesterol-lowering diet if you have:
- elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
- need additional cholesterol reduction along with a statin when your cholesterol level is not well controlled with a statin alone
- need treatment alone when statin therapy is inappropriate or not tolerated
- a hereditary condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may additionally be prescribed other treatments
- a hereditary condition (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
If you have heart disease, ABSORCOL, when combined with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
ABSORCOL does not help you lose weight.
2. What you need to know before taking ABSORCOL
If you are taking ABSORCOL together with a statin, please read the package leaflet of that 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 further 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 starting to take ABSORCOL.
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Inform your doctor about all your medical conditions, including allergies.
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Your doctor will perform a blood test before you start taking ABSORCOL with a statin. This is to check that your liver is functioning properly.
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Your doctor may also want to carry out further blood tests to monitor your liver function after you start taking ABSORCOL with a statin.
ABSORCOL is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining ABSORCOL with certain cholesterol-lowering medicines, fibrates, have not been studied.
Children and adolescents
Do not give this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist, as data on safety and efficacy are limited.
Do not give this medicine to children under 6 years of age, as there is no information available for this age group.
Taking ABSORCOL with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking medicines containing any of the following active substances:
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cyclosporine (often used in organ transplant patients)
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medicines containing an active substance to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
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cholestyramine (also used to lower cholesterol), as it affects how ABSORCOL works
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fibrates (also used to lower cholesterol)
Pregnancy and breastfeeding
Do not take ABSORCOL with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ABSORCOL with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of ABSORCOL with a statin during pregnancy. Consult your doctor before using ABSORCOL if you are pregnant.
Do not take ABSORCOL with a statin while breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, you should not take ABSORCOL, even without taking a statin. Consult your doctor.
Talk to your doctor or pharmacist before using any medicine.
Driving and using machines
ABSORCOL is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking ABSORCOL.
ABSORCOL contains lactose
ABSORCOL tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
ABSORCOL contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., it is essentially “sodium-free”.
3. How to take ABSORCOL
Follow exactly the instructions for use of this medicine given by your doctor. Continue taking your other cholesterol-lowering medications unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist again.
- Before starting to take ABSORCOL, you should already be following 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 orally.
Take ABSORCOL at any time of day. You may take it 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, please read the dosing instructions in the statin’s package leaflet.
If your doctor has prescribed ABSORCOL together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, 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, pharmacist, or call the Toxicology Information Service immediately at 91.562.04.20, indicating the medicine and the amount taken.
It is recommended to bring the medicine package and package leaflet to the healthcare professional.
If you forget to take ABSORCOL
Do not take a double dose to make up for missed doses. Simply take your normal dose of ABSORCOL at the usual time the next day.
If you stop taking ABSORCOL
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following terms are used to describe how frequently adverse 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, in rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and potentially life-threatening.
In general use, 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 adverse effects have been reported:
Common: abdominal pain; diarrhoea; gas and feeling of tiredness.
Uncommon: increased results in certain liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasm; neck pain; decreased appetite; pain; chest pain, hot flush.
Additionally, when used in combination with a statin, the following adverse effects have been reported:
Common: increased results in certain liver function tests (transaminases); headache; muscle pain; tenderness to pressure 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 in hands and feet.
When used in combination with fenofibrate, the following common adverse effect has been reported: abdominal pain.
Additionally, in general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised and red rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness to pressure or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.
Reporting of adverse effects: If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ABSORCOL
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton or container after EXP. The expiry date refers to the last day of the month indicated.
- Do not store ABSORCOL above 30°C.
Blister packs: Store in the original packaging. Bottles: Keep bottles tightly closed. These measures will protect the product from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of ABSORCOL
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.
Appearance of the product and contents of the pack
ABSORCOL tablets are capsule-shaped, white or off-white, engraved with "414" on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in press-through blisters or single-dose peelable blisters;
84 or 90 tablets in press-through blisters;
50, 100 or 300 tablets in single-dose press-through blisters;
100 tablets in a bottle.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized under the name Ezetimibe Organon 10 mg Tabletten in Germany.
Date of the most recent review of this leaflet: 08/2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/