Ezetimibe Tecnigen 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe TecniGen 10 mg tablets EFG

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 others, even if they have the same symptoms as you, because it could 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.

Package leaflet contents

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

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

Ezetimiba TecniGen is a medicine used to reduce elevated cholesterol levels.

Ezetimiba lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of blood fats called triglycerides. In addition, ezetimiba increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba TecniGen, works by reducing the cholesterol absorbed from the gastrointestinal tract.

Ezetimiba TecniGen 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 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such disruption in blood flow may lead to 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 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.

Ezetimiba TecniGen is used together with a cholesterol-lowering diet if you have:

• High levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])

  • together with a statin, when your cholesterol level is not well controlled with a statin alone.
  • alone, when treatment with a statin 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.

If you have heart disease, ezetimiba, 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.

Ezetimiba TecniGen does not help you to lose weight.

2. What you need to know before starting to take Ezetimiba TecniGen

If you are taking Ezetimiba together with a statin, please read the package leaflet of that medicine.

Do not take Ezetimiba TecniGen if:

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

Do not take Ezetimiba TecniGen 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 you start taking Ezetimiba TecniGen.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba TecniGen with a statin. This is to check that your liver is functioning properly.
• Your doctor may also want to carry out further blood tests to monitor your liver function after you start taking Ezetimiba TecniGen with a statin.

Ezetimiba TecniGen is not recommended if you have moderate or severe liver problems.

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

Children and adolescents

Do not administer 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 administer this medicine to children under 6 years of age, as there is no information available for this age group.

Taking Ezetimiba TecniGen with other medicines

Inform 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:

• Cyclosporine (often used in organ transplant patients).
• Medicines containing an active substance to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestyramine (also used to reduce cholesterol), as it affects how ezetimibe works.
• Fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

There is no experience with the use of ezetimibe with a statin during pregnancy. Consult your doctor before using Ezetimibe if you are pregnant.

Do not take Ezetimibe with a statin while breastfeeding, as it is unknown whether these medicines pass into breast milk. If you are breastfeeding, you should not take ezetimibe, even without a statin. Consult your doctor.

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Ezetimiba.

Ezetimiba TecniGen contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Ezetimiba TecniGen contains sodium

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

3. How to take Ezetimiba TecniGen

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

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

The recommended dose is one 10 mg Ezetimiba TecniGen tablet once daily, taken orally.

Take Ezetimiba at any time of day. You may take it with or without food.

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

If your doctor has prescribed ezetimiba together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba TecniGen than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ezetimiba TecniGen

Do not take a double dose to make up for missed doses. Simply take your normal dose of Ezetimiba at the usual time on the following day.

If you stop taking Ezetimiba TecniGen

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 will experience 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; flatulence; and feeling tired.

Uncommon: increased results in certain 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.

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; muscle 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 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 hives; raised, red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Ezetimiba TecniGen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which appears on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information Composition of Ezetimiba TecniGen

Composition of Ezetimiba TecniGen

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

Appearance of the medicinal product and contents of the container

White, oblong tablets.

Ezetimiba TecniGen is available in blister packs containing 28 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy: Ezetimiba Tecnigen

Portugal: Ezetimiba Tecnigen

Date of the most recent review of this summary: August 2021

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