Ezetimibe/atorvastatin Pensa 10 mg/20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Atorvastatin pensa 10 mg/20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 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

1. What Ezetimibe/Atorvastatin pensa is and what it is used for
2. What you need to know before taking Ezetimibe/Atorvastatin pensa
3. How to take Ezetimibe/Atorvastatin pensa
4. Possible side effects
5. How to store Ezetimibe/Atorvastatin pensa
6. Contents of the pack and other information

1. What Ezetimiba/Atorvastatina pensa is and what it is used for

Ezetimiba/Atorvastatina pensa is a medicine that lowers high cholesterol levels. Ezetimiba/Atorvastatina pensa contains ezetimibe and atorvastatin.

Ezetimiba/Atorvastatina is used in adults to reduce levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, this medicine increases levels of “good” cholesterol (HDL cholesterol).

Ezetimiba/Atorvastatina works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the gastrointestinal tract, as well as the 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 trigger a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps prevent bad cholesterol from accumulating 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.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

This medicine is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):
  • that are not well controlled with a statin alone
  • for whom a statin and ezetimibe have been used as separate tablets
• an inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• heart disease; in these patients, ezetimiba/atorvastatina reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba/Atorvastatina does not help you lose weight.

2. What you need to know before taking Ezetimiba/Atorvastatina pensa

Do not take Ezetimiba/Atorvastatina pensa

• if you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have ever had a liver disease,
• if you have had unexplained abnormal results in liver function blood tests,
• if you are a woman who could become pregnant and are not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant, or breastfeeding,
• if you are taking the combination of glecaprevir/pibrentasvir, ledipasvir/sofosbuvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before starting ezetimiba/atorvastatina

• if you have previously had a stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain due to prior strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or have personal or family history of muscle disorders,
• if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old,
• if your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine,
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis),
• if you have or have had myasthenia (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking Ezetimiba/Atorvastatina. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. It is known that atorvastatin can cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting this medicine:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before starting ezetimiba/atorvastatina, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimiba/atorvastatina to assess your risk of experiencing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Ezetimiba/Atorvastatina”).

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Inform your doctor about all your medical conditions, including allergies.

The combined use of ezetimiba/atorvastatina and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of ezetimiba/atorvastatina and fibrates has not been studied.

Children

Ezetimiba/Atorvastatina is not recommended in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Some medicines may alter the effect of ezetimiba/atorvastatina or their effects may be affected by ezetimiba/atorvastatina (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious disorder involving muscle breakdown known as "rhabdomyolysis", described in section 4:

• cyclosporine (a medicine often used in transplant patients),
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• letermovir, a medicine that helps prevent cytomegalovirus infection,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

** If you need to take oral fusidic acid to treat a bacterial infection temporarily, you will need to stop using this medicine. Your doctor will advise you when you can restart treatment with ezetimiba/atorvastatina. The use of ezetimiba/atorvastatina with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Other medicines known to interact with ezetimiba/atorvastatina

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used for stomach acidity and peptic ulcers),
• phenazone (a painkiller),
• antacids (products for indigestion containing aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),
• colchicine (used to treat gout),
• St. John’s wort (a medicine used to treat depression).

Taking Ezetimiba/Atorvastatina pensa with food and alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of ezetimiba/atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take ezetimiba/atorvastatina if you are pregnant, trying to become pregnant, or think you might be pregnant. Do not take ezetimiba/atorvastatina if you could become pregnant unless you are using reliable contraceptive methods.

If you become pregnant while taking ezetimiba/atorvastatina, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are breastfeeding.

The safety of ezetimiba/atorvastatina during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimiba/Atorvastatina 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/atorvastatina.

Ezetimiba/Atorvastatina pensa contains lactose

Ezetimiba/Atorvastatina pensa tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Ezetimiba/Atorvastatina pensa contains sodium

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

3. How to take Ezetimiba/Atorvastatina pensa

Follow exactly the administration instructions for this medicine as indicated by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your personal risk situation. If in doubt, consult your doctor or pharmacist again.

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

What dose to take

The recommended dose is one ezetimiba/atorvastatina tablet once daily by oral administration.

Method of administration

Take ezetimiba/atorvastatina at any time of day. You may take it with or without food.

If your doctor has prescribed ezetimiba/atorvastatina together with colestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ezetimiba/atorvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Atorvastatina pensa than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimiba/Atorvastatina pensa

Do not take a double dose; on the following day, take your usual dose of ezetimiba/atorvastatina at the usual time. 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.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties
• a serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may progress to blistering
• muscle weakness, tenderness, pain, or muscle breakdown, or change in urine color to red-brown, particularly if accompanied by a feeling of malaise or high temperature, which may be due to abnormal muscle destruction that can be potentially life-threatening and lead to kidney problems
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver disease.

The following frequent adverse effects have been reported (may affect up to 1 in 10 patients):

• diarrhea,
• muscle pain.

The following uncommon adverse effects have been reported (may affect up to 1 in 100 patients):

• flu,
• depression; sleep disturbances; sleep disorders,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• shortness of breath,
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increased levels in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin, ezetimibe, or atorvastatin tablets:

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash, sometimes target-shaped,
• liver problems,
• cough,
• acid reflux,
• loss of appetite; lack of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rash and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
• inflammation of the pancreas, often accompanied by severe abdominal pain,
• decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; chest pain; sore throat,
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in fingers and toes,
• reduced sensitivity to pain or touch,
• altered sense of taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• belching,
• hair loss,
• high temperature,
• presence of white blood cells in urine tests,
• blurred vision; visual disturbances,
• gynecomastia (breast enlargement in men),
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects muscles used for breathing),
• ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible adverse effects reported with some statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath or fever,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, which may not resolve after stopping ezetimibe/atorvastatin (frequency not known).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 Ezetimibe/Atorvastatin Pensa

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 "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Package contents and other information

Composition of Ezetimiba/Atorvastatina pensa

The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; polysorbate 80; sodium lauryl sulfate (E487).

The tablet coating contains: hypromellose, lactose monohydrate, titanium dioxide, macrogol, talc.

Appearance of the medicine and contents of the pack

Film-coated, capsule-shaped, biconvex tablets, white to off-white, marked with "2T" on one side.

Pack sizes:

Aluminum/aluminum blister packs containing 30 film-coated tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible:

Delorbis Pharmaceuticals Ltd.

17 Athinon Street

Ergates Industrial Area

2643 Ergates Lefkosia

Cyprus

Or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Ezetimiba/Atorvastatina pensa 10 mg/20 mg film-coated tablets EFG

Date of latest revision of this leaflet: 12/2023

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