Prospect: information for the user

Ezetimiba/Atorvastatina Stada 10 mg/10 mg film-coated tabletsEFG

Ezetimiba/Atorvastatina Stada 10 mg/20 mg film-coated tabletsEFG

Ezetimiba/Atorvastatina Stada 10 mg/40 mg film-coated tabletsEFG

Ezetimiba/Atorvastatina Stada 10 mg/80 mg film-coated tabletsEFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people 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 do not appear in this prospect. See section 4.

5.Storage of Ezetimiba/Atorvastatina Stada

6.Contents of the pack and additional information

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

Ezetimibe/atorvastatin is used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol) and certain types of fat called triglycerides that circulate in the blood. Additionally, ezetimibe/atorvastatin raises the 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.

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

What is cholesterol?

Cholesterol is one of the fatty substances 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 against heart disease.

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

Diseases for which it is used

Ezetimibe/atorvastatin is used in conjunction with a cholesterol-lowering diet if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia [familial and non-familial heterozygote] or mixed hyperlipidemia) that are not well controlled with a statin alone
• • for whom 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.

• heart 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 take Ezetimiba/Atorvastatina Stada if:

• You are allergic to ezetimiba, atorvastatina, or any of the other components of this medication (listed in section 6).
• You have or have had a liver disease that affects the liver.
• You have had an unexplained abnormal result in liver function blood tests.
• You are a woman of childbearing potential and are not using reliable contraceptive methods.
• You are pregnant, trying to become pregnant, or breastfeeding.
• You are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina.

• 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 "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 you have severe respiratory failure.
• If you are taking or have taken within the last 7 days a medication called 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).

Muscle Problems

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

Also, speak with your doctor or pharmacist if you have persistent muscle weakness. You may need further tests and additional medications to diagnose and treat it.

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina, as your doctor will need to perform a blood test before starting your treatment, 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 (destruction of damaged skeletal muscle), increases when certain medications are taken simultaneously (see section 2 “Other Medications and Ezetimiba/Atorvastatina Stada”).

While you are taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

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

Children and Adolescents

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Other Medications and Ezetimiba/Atorvastatina Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Fusidic Acid

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

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 decrease 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:

• Ciclosporin(a medication often used in transplant patients)
• Fibrates(lipid-lowering medications) should be avoided as they have not been studied in combination with ezetimiba/atorvastatina
• Erythromycin,clarithromycin,telithromycin,azithromycin,fusidic acid,rifampicin(medications used to treat bacterial infections)
• Ketoconazole,itraconazole,voriconazole,fluconazole,posaconazole(medications used to treat fungal infections)
• Gemfibrozil,nicotinic acid,derivatives,colestipol,colestiramine(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,Boceprevirand the combination ofElbasvir/Grazoprevir,ledipasvir/sofosbuvir
• Daptomycin(a medication used to treat complicated skin and soft tissue infections and bacteremia).

• Other medications that are known to interact with the combination 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)
  • Fenazone(a pain reliever)
  • Antacids(medications 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 Stada with Food, Drinks, and Alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. 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.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Ezetimiba/atorvastatina has not been proven to be safe during pregnancy and breastfeeding.

Do not take ezetimiba/atorvastatina if you are pregnant, intend to become pregnant, or think you may be pregnant.

Do not take ezetimiba/atorvastatina if you can become pregnant, unless you use reliable contraceptive methods. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are breastfeeding.

Consult your doctor or pharmacist before taking this medication.

Driving and Using Machines

Ezetimiba/atorvastatina is not expected to interfere with your ability to drive or use machines. However, some people experience dizziness after taking ezetimiba/atorvastatina. If you feel dizzy after taking this medication, do not drive or use machinery.

Ezetimiba/Atorvastatina Stada 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg contains Lactose

If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medication.

Ezetimiba/Atorvastatina Stada contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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.

• Before starting to take ezetimiba/atorvastatina, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking ezetimiba/atorvastatina.

How much you should take

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

Administration form

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

The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

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

If you take more Ezetimiba/Atorvastatina Stada 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 Stada

Do not take a double dose to compensate for the missed dose. Take the regular dose at the usual time the next day.

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 side effects or severe symptoms, stop taking your tablets and immediately inform your doctor, or go to the nearest hospital emergency service and bring your tablets with you.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause 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 blisters
• Weakness, sensitivity, muscle rupture or pain, 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 (rhabdomyolysis) which may be potentially fatal and trigger kidney problems
• Lupus-like disease syndrome (which includes skin 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.

Other possible side effects with ezetimiba/atorvastatina:

Frequent(may affect up to 1 in 10 people)

• Diarrea
• Muscle pain

Less frequent(may affect up to 1 in 100 people)

• Flu
• Depression, difficulty sleeping, sleep disorder
• Dizziness, headache, tingling sensation
• Slow heart rate
• Angina
• Difficulty breathing
• 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, muscle spasms or weakness
• Pain in the arms and legs
• Unusual weakness, feeling tired or unwell
• Swelling, especially in the ankles (edema)
• Increased levels of liver or muscle function tests (CK) in blood laboratory tests
• Weight gain

The following side effects have been reported with unknown frequency (frequency cannot be estimated from available data):

• Myasthenia gravis (a disease that causes generalized muscle weakness that, 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.

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

• Allergic reactions that include facial inflammation, lip, tongue, and/or throat inflammation that may cause difficulty breathing or swallowing (which require immediate medical treatment)
• Red, inflamed skin rash, and sometimes in the shape of a target
• Liver problems
• Cough
• Acid reflux
• Loss of appetite, lack of appetite
• High blood pressure
• Itchy skin rash and 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, 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
• Altered sense of taste, dry mouth
• Memory loss
• Tinnitus and/or headache, hearing loss
• Vomiting
• Belching
• Hair loss
• Fever
• Presence of white blood cells in urine tests
• Blurred vision, visual disturbances
• Gynecomastia (breast enlargement in men)

Side effects reported with some statins:

• Sexual dysfunction
• 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 go away after stopping ezetimiba/atorvastatina treatment (unknown frequency – frequency cannot be estimated from available data)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.Mediante the reporting of side effects, you can contribute to providing more information on 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 packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ezetimiba/Atorvastatina Stada

• The active principles are ezetimiba and atorvastatina.

10 mg/10 mg: Each tablet contains 10 mg of ezetimiba and 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

10 mg/20 mg: Each tablet contains 10 mg of ezetimiba and 20 mg of atorvastatina (as atorvastatina calcium trihydrate).

10 mg/40 mg: Each tablet contains 10 mg of ezetimiba and 40 mg of atorvastatina (as atorvastatina calcium trihydrate).

10 mg/80 mg: Each tablet contains 10 mg of ezetimiba and 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

• The other components are:

Tablet core

Microcrystalline cellulose 101, mannitol, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polisorbate 80, yellow iron oxide (E172), magnesium stearate, povidone K-29/32, sodium lauryl sulfate.

Tablet coating

10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg - Opadry white OY-L-28900 containing: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521)

10 mg/80 mg – DrCoat FCU containing: hypromellose 2910, titanium dioxide (E171), talc (E553b), macrogol 400, yellow iron oxide (E172)

Appearance of the product and contents of the package

10 mg/10 mg tablet: White, round, biconvex, coated with a film, with a diameter of approximately 8.1 mm

10 mg/20 mg tablet: White, oval, biconvex, coated with a film, with a size of approximately 11.6 x 7.1 mm

10 mg/40 mg tablet: White, capsule-shaped, biconvex, coated with a film, with a size of approximately 16.1 x 6.1 mm

10 mg/80 mg tablet: Yellow, oblong, biconvex, coated with a film, with a size of approximately 19.1 x 7.6 mm

Blister packs (single and multi-dose) of OPA/AL/PVC//Al packaged in cardboard boxes.

Packages with 10, 20, 30, 50, 60, 90, 100 coated tablets.

Single-dose packages with 10, 20, 30, 50, 60, 90, 100 coated tablets.

10 mg/80 mg:

Multi-dose packages contain 90 (2 packages of 45) and 100 (2 packages of 50) coated tablets.

Single-dose packages contain 90 (2 packages of 45) and 100 (2 packages of 50) coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048,

Keratea, 190 01

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Islandia:Ezetimibe/Atorvastatin STADA 10 mg/10 mg film-coated tablet

Ezetimibe/Atorvastatin STADA 10 mg/20 mg film-coated tablet

Ezetimibe/Atorvastatin STADA 10 mg/40 mg film-coated tablet

Ezetimibe/Atorvastatin STADA 10 mg/80 mg film-coated tablet

Austria:Ezetimib/Atorvastatin STADA 10 mg/10 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/20 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/40 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/80 mg Filmtabletten

Bélgica:Ezetimibe/Atorvastatine EG 10 mg/10 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Ezetimibe/Atorvastatine EG 10 mg/20 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Ezetimibe/Atorvastatine EG 10 mg/40 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Ezetimibe/Atorvastatine EG 10 mg/80 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

República Checa:Ezetimib/Atorvastatin STADA

Alemania:

Ezetimib/Atorvastatin STADA 10 mg/10 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/20 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/40 mg Filmtabletten

Ezetimib/Atorvastatin STADA 10 mg/80 mg Filmtabletten

Estonia:Ezetimibe/Atorvastatin STADA

Grecia:Ezetimib/Atorvastatin STADA 10 mg/10 mg

Ezetimib/Atorvastatin STADA 10 mg/20 mg

Ezetimib/Atorvastatin STADA 10 mg/40 mg

Ezetimib/Atorvastatin STADA 10 mg/80 mg

España:Ezetimiba/Atorvastatina STADA 10 mg/10 mg coated tablets

Ezetimiba/Atorvastatina STADA 10 mg/20 mg coated tablets

Ezetimiba/Atorvastatina STADA 10 mg/40 mg coated tablets

Ezetimiba/Atorvastatina STADA 10 mg/80 mg coated tablets

Francia:EZETIMIBE/ATORVASTATINE EG 10 mg/10 mg coated tablet EZETIMIBE/ATORVASTATINE EG 10 mg/20 mg coated tablet

EZETIMIBE/ATORVASTATINE EG 10 mg/40 mg coated tablet EZETIMIBE/ATORVASTATINE EG 10 mg/80 mg coated tablet

Italia:Ezetimibe/Atorvastatina EG STADA 10 mg/10 mg

Ezetimibe/Atorvastatina EG STADA 10 mg/20 mg

Ezetimibe/Atorvastatina EG STADA10 mg/40 mg

Ezetimibe/Atorvastatina EG STADA 10 mg/80 mg

Lituania:Ezetimibe/Atorvastatin STADA 10 mg/10 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/20 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/40 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/80 mg coated tablets

Luxemburgo:Ezetimibe/Atorvastatine EG 10 mg/10 mg coated tablets

Ezetimibe/Atorvastatine EG 10 mg/20 mg coated tablets

Ezetimibe/Atorvastatine EG 10 mg/40 mg coated tablets

Ezetimibe/Atorvastatine EG 10 mg/80 mg coated tablets

Letonia:Ezetimibe/Atorvastatin STADA 10 mg/10 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/20 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/40 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/80 mg coated tablets

Eslovaquia:Ezetimibe/Atorvastatin STADA 10 mg/10 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/20 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/40 mg coated tablets

Ezetimibe/Atorvastatin STADA 10 mg/80 mg coated tablets

Last review date of this leaflet:December 2023

For more detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/