Prospect: information for the user

Ezetimiba TecniGen 10 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Ezetimibe TecniGen is a medication to reduce elevated levels of cholesterol.

Ezetimibe reduces total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain types of fat called triglycerides that circulate in the blood. Additionally, ezetimibe increases concentrations of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe, the active ingredient of Ezetimibe TecniGen, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimibe TecniGen adds to the effect of lowering cholesterol of statins, a group of medications that reduce cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this accumulation of plaque can cause artery narrowing. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of cardiovascular disease.

It is used in patients who cannot control their cholesterol levels solely with a cholesterol-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

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

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

• A hereditary disease (familial hypercholesterolemia), 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 cardiovascular disease, ezetimibe combined with medications to lower cholesterol called statins, reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimibe TecniGen does not help reduce weight.

If you take Ezetimiba with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba TecniGen if:

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

Do not take Ezetimiba TecniGen with a statin if:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba TecniGen.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimiba 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 Ezetimiba TecniGen with a statin.

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

The safety and efficacy of using ezetimiba and certain cholesterol-lowering medicines, such as fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years old) unless prescribed by a specialist, as the safety and efficacy data are limited.

Do not administer this medicine to children under 6 years old, 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 taken recently, or may need to take any other medicine. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

• Ciclosporin (often used in organ transplant patients).
• Medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestiramine (also used to lower cholesterol), as it affects how ezetimiba works.
• Fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

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

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

The use of ezetimiba with a statin during pregnancy has not been studied. Consult your doctor before using Ezetimiba if you are pregnant.

Do not take Ezetimiba with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, do not take ezetimiba, even without taking a statin. Consult your doctor.

Driving and operating machinery

Ezetimiba is not expected to interfere with your ability to drive or use machines. However, some people may experience dizziness after taking Ezetimiba.

Ezetimiba TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Ezetimiba TecniGen contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Continue taking your other medications to lower cholesterol unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is one Ezetimiba TecniGen 10 mg tablet once a day taken orally.

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

If your doctor has prescribed ezetimiba along with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions on the medication packaging.

If your doctor has prescribed ezetimiba along with another cholesterol-lowering medication that contains the active ingredient cholestyramine or any other medication that contains 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication packaging to the healthcare professional.

If you forgot to take Ezetimiba TecniGen

Do not take a double dose to compensate for the missed doses, simply take your usual amount of Ezetimiba at the usual time the next day.

If you interrupt treatment with Ezetimiba TecniGen

Speak with your doctor or pharmacist as your cholesterol levels may increase again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following terms are used to describe how often side effects have been reported:

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

Contact your doctor immediately if you experience unexplained muscle pain, sensitivity, or weakness. This is because, in rare cases, muscle problems, including muscle degradation that causes kidney damage, can be severe and potentially life-threatening.

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

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

Common:Abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon:Elevation of results from 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 flashes; high blood pressure.

Additionally, when used with a statin, the following side effects have been reported:

Common:Elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity to pressure or weakness.

Uncommon:tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unusual fatigue or weakness; swelling, especially in hands and feet.

When used with fenofibrate, the following common side effect has been reported: abdominal pain.

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; swollen and inflamed skin, sometimes with lesions in the form of a target (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with intense abdominal pain; constipation; reduction in blood cell count, which may cause hematoma/hemorrhage (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist howto dispose of the packaging and the medications that you no longer need. This will help protect the environment.

Composition of Ezetimiba TecniGen

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

Appearance of the product and contents of the packaging

White, oblong-shaped tablets.

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

Only some package sizes may be marketed.

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid) - Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra - Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy:Ezetimiba Tecnigen

Portugal:Ezetimiba Tecnigen

Last review date of this leaflet: August 2021

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)