Package Insert: Information for the Patient

Ezetimiba/Atorvastatina Tecnigen 10 mg/10 mg Film-Coated Tablets

Ezetimiba/Atorvastatina Tecnigen 10 mg/20 mg Film-Coated Tablets

Ezetimiba/Atorvastatina Tecnigen 10 mg/40 mg Film-Coated Tablets

Ezetimiba/Atorvastatina Tecnigen 10 mg/80 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

Ezetimibe/Atorvastatin Tecnigen is a medication that decreases high levels of cholesterol. This medication contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to decrease total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, this medication increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract, as well as the cholesterol that your body produces on its own.

Cholesterol is one of the fatty substances that are found in the circulatory system. Your total cholesterol is composed mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a heart attack or stroke.

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

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

Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should follow a cholesterol-reducing diet.

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

• elevated blood levels of cholesterol (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated blood levels of fatty substances (mixed hyperlipidemia):
• • that are not well controlled with a single statin;
  • for which a statin and ezetimibe have been used in separate tablets.

• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.

• cardiovascular disease, ezetimibe/atorvastatin reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

Do not takeEzetimiba/Atorvastatina Tecnigen

• if you are allergic to ezetimiba, atorvastatina, or any of the other ingredients of this medication (listed in section 6),
• if you have or have had a liver disease,
• if you have had any unexplained abnormal results in liver function blood tests,
• if you are a woman of childbearing age 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 in the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have had a previous stroke with intracranial hemorrhage, or have small fluid accumulations in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle problems,
• if you have experienced muscle problems during previous treatment with other lipid-lowering medications (e.g., other medications 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 some sugars, contact them before taking this medication,
• if you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and ezetimiba/atorvastatina can cause severe muscle problems (rhabdomyolysis),
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking ezetimiba/atorvastatina.This is because, in rare cases, muscle problems can be severe, including muscle rupture causing kidney damage. It is known that atorvastatina can cause muscle problems, and muscle problems have also been reported with ezetimiba.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

Consult your doctor or pharmacist before starting to take this medication:

• if you have severe respiratory failure.

If you are in any of the above circumstances (or are unsure), consult your doctor before starting to take this medication, as your doctor will need to perform a blood test before starting your treatment with ezetimiba/atorvastatina, and possibly during it, to predict the risk of experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g., rhabdomyolysis, increases when certain medications are taken simultaneously (see section 2 “Other medications and Ezetimiba/Atorvastatina Tecnigen”).

While you are taking this medication, your doctor will monitor 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 your blood, overweight, and high blood pressure.

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

You should avoid the combined use of ezetimiba/atorvastatina and fibrates (certain medications to reduce cholesterol), as the combined use of ezetimiba/atorvastatina and fibrates has not been studied.

Children

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Other medications and Ezetimiba/Atorvastatina Tecnigen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

There are some medications that can modify the effect of ezetimiba/atorvastatina or whose effects may be affected by ezetimiba/atorvastatina (see section 3). This type of interaction could reduce the effectiveness of one or both medications. On the other hand, it could also increase the risk or severity of adverse effects, including a serious condition in which muscle is destroyed, known as “rhabdomyolysis”, which is described in section 4:

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

** If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medication. Your doctor will tell you when you can restart the treatment with ezetimiba/atorvastatina. The use of ezetimiba/atorvastatina with fusidic acid rarely can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medications that are known to interact with ezetimiba/atorvastatina
• • oral contraceptives (medications that prevent pregnancy),
  • estiripentol (an anticonvulsant medication used to treat epilepsy),
  • cimetidine (a medication used to treat stomach acid and ulcers),
  • phenazone (an analgesic),
  • antacids (products used to treat indigestion that contain aluminum or magnesium),
  • warfarin, phenprocoumon, acenocoumarol, or fluindione (medications that prevent blood clotting),
  • colchicine (used to treat gout),
  • St. John's Wort (a medication 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:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice can alter the effects of ezetimiba/atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medication. For more 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 may be pregnant. Do not take ezetimiba/atorvastatina if you can 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 proven.

Consult your doctor or pharmacist before taking this medication.

Driving and operating machines

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

Ezetimiba/Atorvastatina Tecnigen contains lactose

The tablets of Ezetimiba/Atorvastatina Tecnigen 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 medication.

Ezetimiba/Atorvastatina Tecnigen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication 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. In case of doubt, consult your doctor or pharmacist again.

What quantity to take

The recommended dose is one tablet of ezetimiba/atorvastatina once a day taken orally.

Form of administration

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

If your doctor has prescribed ezetimiba/atorvastatina along with colestiramine or any other bile acid sequestrant (medications 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 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ezetimiba/Atorvastatina Tecnigen

Do not take an extra dose; the next day, take your normal amount of ezetimiba/atorvastatina at the usual time.

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

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

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

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing.
• Severe disease whose symptoms are intense peeling 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 soles of the feet, which may lead to blistering.
• Weakness, sensitivity, pain, or muscle rupture or change in urine color to brown-red and especially, if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction that may 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 may be indicative of liver disease.

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

• Diarrhea,
• Muscle pain.

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

• Flu,
• Depression; sleep disorders; sleep disturbances,
• Dizziness; headache; tingling sensation,
• Slow heart rate,
• Angina,
• 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 weakness; pain in the arms and legs,
• Unusual weakness; feeling tired or unwell; inflammation, especially in the ankles (edema),
• Increased levels of some liver or muscle function tests (CK) in laboratory blood tests,
• Weight gain.

In addition, the following side effects have been reported in people taking ezetimibe/atorvastatin tablets, ezetimibe, or atorvastatin:

• Allergic reactions that include facial inflammation, lip, tongue, and/or throat inflammation that may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• Red skin rash and, occasionally, in the shape of a target,
• Liver problems,
• Cough,
• Heartburn,
• Loss of appetite; lack of appetite,
• High blood pressure,
• Itchy skin rash and hives; allergic reactions that include the appearance of skin rash and hives,
• Tendon injury,
• Bile stones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
• Pancreatitis, often accompanied by severe abdominal pain,
• Decreased blood cell count, which may cause bruising or bleeding (thrombocytopenia),
• Nasal congestion; nasal bleeding,
• Neck pain; chest pain; throat pain,
• Increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• Nightmares,
• Numbness or tingling in the fingers of the hands and feet,
• Decreased sensitivity to pain or touch,
• Alteration of taste; dry mouth,
• Memory loss,
• Tinnitus and/or headache; 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 disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing),
• Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Possible side effects reported 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 blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication,
• Constant muscle pain, sensitivity, or weakness, and especially if it occurs at the same time, feeling unwell or high temperature that may not disappear after stopping ezetimibe/atorvastatin treatment (unknown frequency).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box or on the blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ezetimibe/Atorvastatin Tecnigen Composition

The active principles 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; polisorbate 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 package

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

Ezetimibe/Atorvastatin Tecnigen 10 mg/10 mg tablets: with the code “1T” on one face.

Ezetimibe/Atorvastatin Tecnigen 10 mg/20 mg tablets: with the code “2T” on one face.

Ezetimibe/Atorvastatin Tecnigen 10 mg/40 mg tablets: with the code “4T” on one face.

Ezetimibe/Atorvastatin Tecnigen 10 mg/80 mg tablets: with the code “8T” on one face.

Package sizes:

Blister packs of 30 film-coated tablets in aluminum/aluminum.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, nº 13.3ºD

28108 - Alcobendas (Madrid)

Spain

Responsible manufacturer:

Delorbis Pharmaceuticals Limited

17 Athinon Street. Ergates Industrial Area

2643 Ergates.

Cyprus

This medicinal product is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:November 2023.

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