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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ezetimibe/Atorvastatin Tecnigen 10 mg/10 mg film-coated tablets EFG

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

Ezetimibe/Atorvastatin Tecnigen 10 mg/40 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Tecnigen 10 mg/80 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways. It reduces cholesterol absorbed in the gastrointestinal tract, as well as cholesterol produced by your body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly composed 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. Disruption of blood flow may trigger 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 present in your blood that may increase the risk of heart disease.

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

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

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated 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.

• a hereditary condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

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

Do not take Ezetimiba/Atorvastatina Tecnigen

• 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 ever 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 or ledipasvir/sofosbuvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have previously had a stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (hypothyroidism),
• if you have experienced recurrent or unexplained muscle pain or discomfort, or have a 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, contact 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 ezetimiba/atorvastatina 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 weakness while taking ezetimiba/atorvastatina. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to 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 taking this medicine:

• if you have severe respiratory insufficiency.

If you are in any of the above situations (or are unsure), consult your doctor before starting this medicine, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimiba/atorvastatina to assess your risk of developing 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 Tecnigen”).

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

Tell 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 has not been studied.

Children

Ezetimiba/atorvastatina is not recommended for use in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Tecnigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription.

Some medicines may alter the effect of ezetimiba/atorvastatina or their effects may be altered by ezetimiba/atorvastatina (see section 3). These interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition 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 and 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),
• some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir or 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, you will need to temporarily stop taking 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 about 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 aluminum or magnesium),
  • warfarin, phenprocoumon, acenocoumarol, or phenindione (medicines that prevent blood clots),
  • colchicine (used to treat gout),
  • St. John’s wort (a herbal medicine used to treat depression).

Taking Ezetimiba/Atorvastatina Tecnigen with food and alcohol

See section 3 for instructions on how to take Ezetimiba/Atorvastatina Tecnigen. 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 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 Tecnigen contains lactose

Ezetimiba/Atorvastatina Tecnigen 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 Tecnigen contains sodium

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

3. How to take Ezetimibe/Atorvastatin Tecnigen

Follow exactly the instructions given by your doctor for taking this medicine. Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting ezetimibe/atorvastatin, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

What dose to take

The recommended dose is one tablet of ezetimibe/atorvastatin taken once daily by mouth.

Method of administration

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

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

If you take more Ezetimibe/Atorvastatin Tecnigen than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact 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.

If you forget to take Ezetimibe/Atorvastatin Tecnigen

Do not take a double dose; on the following day, take your usual dose of ezetimibe/atorvastatin at the regular 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 lead to severe difficulty breathing.
• 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, particularly on the palms of the hands or soles of the feet, which may progress to blistering.
• Muscle weakness, tenderness, pain, or rupture, or change in urine color to red-brown, especially if accompanied simultaneously by a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown 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 problems associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.

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

• Diarrhea,
• Muscle pain.

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

• Influenza-like illness,
• Depression; sleep disturbances; sleep disorders,
• Dizziness; headache; tingling sensation,
• Slow heart rate,
• Hot flushes,
• Choking sensations,
• Abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; malaise,
• Acne; hives,
• Joint pain; back pain; leg muscle cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• Unusual weakness; feeling of tiredness or malaise; 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,
• Heartburn,
• Decreased appetite; loss 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,
• Taste disturbances; 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 (enlargement of the breast in men),
• Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects muscles used for breathing),
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens 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 choking sensations or fever,
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Persistent muscle pain, tenderness, or weakness, especially if accompanied simultaneously by malaise or high temperature that does not resolve after stopping ezetimibe/atorvastatin treatment (frequency not known).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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 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 carton or blister pack after "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. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of the medicines or containers, please ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Atorvastatina Tecnigen

The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

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

Appearance of the product and contents of the pack

Film-coated tablets, capsule-shaped, biconvex, white to off-white in colour.

Ezetimiba/Atorvastatina Tecnigen 10 mg/10 mg tablets: with the code “1T” on one side.

Ezetimiba/Atorvastatina Tecnigen 10 mg/20 mg tablets: with the code “2T” on one side.

Ezetimiba/Atorvastatina Tecnigen 10 mg/40 mg tablets: with the code “4T” on one side.

Ezetimiba/Atorvastatina Tecnigen 10 mg/80 mg tablets: with the code “8T” on one side.

Pack sizes:

Packs of 30 film-coated tablets in aluminium/aluminium blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Spain

Manufacturer:

Delorbis Pharmaceuticals Limited

17 Athinon Street. Ergates Industrial Area

2643 Ergates.

Cyprus

Or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

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

Netherlands:

Ezetimibe/Atorvastatine Tecnigen 10 mg/10 mg filmomhulde tabletten

Ezetimibe/Atorvastatine Tecnigen 10 mg/20 mg filmomhulde tabletten

Ezetimibe/Atorvastatine Tecnigen 10 mg/40 mg filmomhulde tabletten

Ezetimibe/Atorvastatine Tecnigen 10 mg/80 mg filmomhulde tabletten

Date of the most recent review of this leaflet: November 2023.

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