Ezetimibe Pensa 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimiba Pensa 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, consult 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.

Leaflet contents

1. What Ezetimiba Pensa is and what it is used for
2. What you need to know before taking Ezetimiba Pensa
3. How to take Ezetimiba Pensa
4. Possible adverse effects
5. How to store Ezetimiba Pensa
6. Contents of the pack and other information

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

Ezetimiba Pensa is a medicine used to reduce elevated cholesterol levels. Ezetimiba Pensa lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and blood fat substances called triglycerides. In addition, Ezetimiba Pensa increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Ezetimiba Pensa, works by reducing the amount of cholesterol absorbed in the digestive tract.

Ezetimibe 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 consists 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 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 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.

Ezetimiba Pensa 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.

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

• elevated blood cholesterol levels (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 disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and may receive other treatments as well.

If you have heart disease, Ezetimiba Pensa, when combined with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, and hospitalization due to chest pain.

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

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

Do not take Ezetimiba Pensa:

• 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 Ezetimiba Pensa together with a statin:

• if you currently have liver problems.
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ezetimiba Pensa.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba Pensa with a statin. This is to check whether 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 Pensa with a statin.

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

The safety and efficacy of combining Ezetimiba Pensa with certain cholesterol-lowering medicines called fibrates have not been established.

Children and adolescents

Do not give this medicine to children and adolescents aged between 6 and 17 years 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 Ezetimiba Pensa 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:

• ciclosporin (often used in organ transplant patients)
• medicines containing an active substance used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• colestyramine (also used to lower cholesterol), because it affects how Ezetimiba Pensa works
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimiba Pensa is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Ezetimiba Pensa.

Ezetimiba Pensa contains lactose

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

3. How to take Ezetimiba Pensa

Follow exactly the instructions for use of this medicine provided by your doctor.

Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is one Ezetimiba Pensa 10 mg tablet once daily, taken orally. Take Ezetimiba Pensa at any time of day. You may take it with or without food.

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

If you take more Ezetimiba Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating 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 Pensa

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of Ezetimiba Pensa at the usual time the next day.

If you stop taking Ezetimiba Pensa

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 often the 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, on rare occasions, muscle problems, including muscle breakdown leading to kidney damage, can be serious and become a potentially life-threatening condition.

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

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

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

Uncommon: increased results of 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 flushes; high blood pressure.

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

Common: increased results of certain 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 together 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 and red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness 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 type of 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Pensa

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba Pensa

• The active substance is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components (excipients) are monohydrate lactose, microcrystalline cellulose pH101, povidone, sodium croscarmellose, sodium lauryl sulfate, sodium stearyl fumarate.

Appearance of the product and contents of the pack

Ezetimiba Pensa are white, uncoated, oblong tablets without a score line, marked with the logo “EZ1” and measuring 8.2 x 4.1 ± 0.5 mm.

The tablets are presented in aluminum/aluminum blisters containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Polígono Industrial Areta

31620 Huarte (Pamplona),

Spain

or

Laboratorios Cinfa, S.A.

Avda. Roncesvalles s/n

31699 Olloki (Navarra)

Spain

Date of the most recent review of this leaflet: June 2016

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