EZETIMIBE TECNIGEN 10 mg TABLETS

1. What is Ezetimibe TecniGen and what is it used for

Ezetimibe TecniGen is a medicine to lower high levels of cholesterol.

Ezetimibe reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that circulate in the blood. In addition, ezetimibe increases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Ezetimibe TecniGen, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe TecniGen adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by your own body.

Cholesterol is one of the fatty substances that are found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this can lead to a narrowing of the arteries. This narrowing can slow down or block the blood flow to vital organs such as the heart and brain. This blocking of the 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 type of fat in your blood that can increase the risk of heart disease.

It is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should follow a cholesterol-lowering diet.

Ezetimibe TecniGen is used in combination with a cholesterol-lowering diet if you have:

• High levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial])
• • in combination with a statin, when your cholesterol level is not well controlled with a statin alone.
  • alone, when treatment with a statin is not appropriate or is not tolerated.

• A hereditary disease (homozygous familial hypercholesterolaemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have heart disease, ezetimibe in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe TecniGen does not help you lose weight.

2. What you need to know before you take Ezetimibe TecniGen

If you are taking Ezetimibe with a statin, please read the package leaflet for that medicine.

Do not take Ezetimibe TecniGen if:

• You are allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6).

Do not take Ezetimibe TecniGen with a statin if:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe TecniGen.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe TecniGen with a statin. This is to check that your liver is in good condition.
• Your doctor may also want to do blood tests to check your liver again after you start taking Ezetimibe TecniGen with a statin.

If you have moderate or severe liver problems, Ezetimibe TecniGen is not recommended.

The safety and efficacy of the combined use of ezetimibe and certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy data are limited.

Do not give this medicine to children under 6 years of age as there is no information in this age group.

Taking Ezetimibe TecniGen with other medicines

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 medicines with any of the following active substances:

• Ciclosporin (often used in patients with transplanted organs).
• Medicines with an active substance to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol or fluindione (anticoagulants).
• Colestyramine (also used to lower cholesterol), as it affects how ezetimibe works.
• Fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take ezetimibe with a statin if you are pregnant, if you are trying to become pregnant or if you think you may be pregnant. If you become pregnant while taking ezetimibe with a statin, stop taking both medicines immediately and tell your doctor.

There is no experience of the use of ezetimibe with a statin during pregnancy. Ask your doctor for advice before taking Ezetimibe if you are pregnant.

Do not take Ezetimibe with a statin if you are breastfeeding because it is not known if the medicines pass into breast milk. If you are breastfeeding, do not take ezetimibe, even without taking a statin. Ask your doctor.

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Ezetimibe.

Ezetimibe TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ezetimibe TecniGen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ezetimibe TecniGen

Follow the instructions for administration of this medicine exactly as told by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If you are in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimibe, you should follow a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Ezetimibe.

The recommended dose is one Ezetimibe TecniGen 10 mg tablet once a day by mouth.

Take Ezetimibe at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimibe in combination with a statin, both medicines can be taken at the same time. In this case, please read the dosing instructions in the package leaflet of the other medicine.

If your doctor has prescribed ezetimibe in combination with another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, you should take Ezetimibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe TecniGen than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe TecniGen

Do not take a double dose to make up for forgotten doses, simply take your normal dose of Ezetimibe at the usual time the next day.

If you stop taking Ezetimibe TecniGen

Talk to your doctor or pharmacist as your cholesterol levels may increase again.

If you have any further questions on 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 are 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 muscle pain, tenderness or weakness. This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

In general use, allergic reactions, including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (requiring immediate treatment), have been reported.

When used alone, the following side effects have been reported:

Common: abdominal pain; diarrhoea; gas and feeling tired.

Uncommon: elevated results of some liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain, hot flushes; high blood pressure.

In addition, when used in combination with a statin, the following side effects have been reported:

Common: elevated results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon: tingling sensation; dry mouth; itching; rash; hives; 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 side effect has been reported: abdominal pain.

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions including rash and hives; blistering and reddening skin eruptions, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe TecniGen

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 after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information Composition of Ezetimibe TecniGen

Composition of Ezetimibe TecniGen

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, hypromellose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose and sodium stearyl fumarate.

Appearance and packaging

White, oblong tablets.

Ezetimibe TecniGen is available in blister packs of 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid) - Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra - Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Italy: Ezetimiba Tecnigen

Portugal: Ezetimiba Tecnigen

Date of last revision of this leaflet: August 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)