EZETIMIBE/ATORVASTATIN TECNIGEN 10 mg/80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ezetimibe/Atorvastatin Tecnigen and what is it used for

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

Ezetimibe/atorvastatin is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that circulate in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by the body.

Cholesterol is one of the fatty substances that can be found in the blood. 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 can lead to a narrowing of the arteries, which can reduce or block the flow of blood to vital organs such as the heart and brain. This blocking of the flow of blood can cause a heart attack or a 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 found in the blood that can increase the risk of heart disease.

Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe/atorvastatin is used, along with a low-cholesterol diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of triglycerides in the blood (mixed hyperlipidaemia):
• • that are not well controlled with a statin alone;
  • for which a statin and ezetimibe have been used in separate tablets.

• a hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You may also receive other treatments.

• heart disease, ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to increase 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 you take Ezetimibe/Atorvastatin Tecnigen

Do not takeEzetimibe/Atorvastatin 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 disease that affects the liver,
• if you have had any unexplained abnormal blood test results for liver function,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant or are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir or ledipasvir/sofosbuvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have had a previous stroke with bleeding in the brain, or have small amounts of fluid in the brain caused by previous strokes,
• if you have kidney problems,
• if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have had muscle pain or weakness that repeats or is unexplained, or a personal or family history of muscle problems,
• if you have had muscle problems while taking other medicines to lower cholesterol (e.g. other medicines containing "statins" or "fibrates"),
• if you regularly drink 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 some sugars, contact them before taking this medicine,
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause serious muscle problems (rhabdomyolysis),
• if you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or myasthenic syndrome (a condition that causes weakness of the eye muscles), as statins can sometimes make these conditions worse or trigger myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness or weakness while taking ezetimibe/atorvastatin.This is because, on rare occasions, muscle problems can be serious, including muscle breakdown that can cause 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 have persistent muscle weakness. You may need to have tests and additional medicines to diagnose and treat this condition.

Consult your doctor or pharmacist before taking this medicine:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before taking this medicine, as your doctor will need to perform a blood test before starting your treatment with ezetimibe/atorvastatin, and possibly during treatment, to predict the risk of muscle side effects. It is known that the risk of muscle side effects, e.g. rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Other medicines and Ezetimibe/Atorvastatin Tecnigen").

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

Tell your doctor about all your medical problems, including allergies.

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

Children

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Tecnigen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

There are some medicines that can affect the way ezetimibe/atorvastatin works, or their effects can be influenced by ezetimibe/atorvastatin (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of side effects, including a serious disorder in which muscle tissue is broken down, known as "rhabdomyolysis", which is described in section 4:

• cyclosporin (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, colestyramine (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 to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used to treat 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 have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart treatment with ezetimibe/atorvastatin. The use of ezetimibe/atorvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with ezetimibe/atorvastatin
• • oral contraceptives (medicines that prevent pregnancy),
  • stiripentol (an anticonvulsant medicine used to treat epilepsy),
  • cimetidine (a medicine used to treat stomach acid and peptic ulcers),
  • phenazone (a pain reliever),
  • antacids (products for the treatment of indigestion that contain aluminium or magnesium),
  • warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
  • colchicine (used to treat gout),
  • St. John's Wort (a medicine used to treat depression).

Taking Ezetimibe/Atorvastatin Tecnigen with food and drink

See section 3 for instructions on how to take Ezetimibe/Atorvastatin Tecnigen. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect the effects of ezetimibe/atorvastatin.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Do not take ezetimibe/atorvastatin if you are pregnant, trying to become pregnant or think you may be pregnant. Do not take ezetimibe/atorvastatin if you can become pregnant, unless you use reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.

Do not take ezetimibe/atorvastatin if you are breast-feeding.

The safety of ezetimibe/atorvastatin during pregnancy and breast-feeding has not yet been proven.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimibe/atorvastatin is not expected to affect your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Tecnigen contains lactose

The tablets of Ezetimibe/Atorvastatin Tecnigen contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

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

How much to take

The recommended dose is one tablet of ezetimibe/atorvastatin once a day by mouth.

Method of administration

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

If your doctor has prescribed ezetimibe/atorvastatin along with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol levels), you should 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ezetimibe/Atorvastatin Tecnigen

Do not take an extra dose; the next day, take your normal dose of ezetimibe/atorvastatin at the usual time.

If you have any further questions on 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 all people suffer from them.

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

• severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing.
• severe disease whose symptoms are intense exfoliation and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or the soles of the feet, which can lead to blisters.
• weakness, sensitivity, pain, or muscle rupture or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that can be caused by abnormal muscle destruction that can be potentially fatal and trigger 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 the unexpected or unusual appearance of bleeding or bruising, as this fact may be indicative of liver disease.

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

• diarrhea,
• muscle pain.

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

• flu,
• depression; sleep problems; sleep disorder,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flashes,
• shortness of breath,
• abdominal pain; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
• acne; hives,
• joint pain; back pain; muscle cramps in the legs; muscle fatigue, spasms, or muscle weakness; pain in the arms and legs,
• unusual weakness; feeling of tiredness or discomfort; inflammation especially in the ankles (edema),
• increase in some 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 that include inflammation of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which require immediate medical treatment),
• red skin rash, and sometimes in a target-like shape,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions that include the appearance of skin rash and hives,
• tendon injury,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting),
• pancreatitis, often accompanied by severe abdominal pain,
• decrease in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nosebleeds,
• neck pain; chest pain; throat pain,
• increase or decrease in blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in the fingers and toes,
• decreased sensitivity to pain or touch,
• alteration of the 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),
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• ocular myasthenia (a disease that causes 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 Noted with Some Statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath or fever,
• diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• pain, sensitivity, or constant muscle weakness, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may not disappear after stopping treatment with ezetimibe/atorvastatin (frequency not known).

Reporting Adverse Effects

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

5. Storage of Ezetimibe/Atorvastatina Tecnigen

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

Do not use this medicine after the expiration date that appears on the box or on the blister pack after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatina Tecnigen

The active ingredients 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 Package Contents

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

Ezetimibe/Atorvastatina Tecnigen 10 mg/10 mg tablets: with the code "1T" on one side.

Ezetimibe/Atorvastatina Tecnigen 10 mg/20 mg tablets: with the code "2T" on one side.

Ezetimibe/Atorvastatina Tecnigen 10 mg/40 mg tablets: with the code "4T" on one side.

Ezetimibe/Atorvastatina Tecnigen 10 mg/80 mg tablets: with the code "8T" on one side.

Package sizes:

Packages of 30 film-coated tablets in aluminum/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Ezetimibe/Atorvastatine Tecnigen 10 mg/10 mg film-coated tablets

Ezetimibe/Atorvastatine Tecnigen 10 mg/20 mg film-coated tablets

Ezetimibe/Atorvastatine Tecnigen 10 mg/40 mg film-coated tablets

Ezetimibe/Atorvastatine Tecnigen 10 mg/80 mg film-coated tablets

Date of the last revision of this prospectus:November 2023.

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