Prospect: information for the user

Ezetimiba/Atorvastatina Stadafarma 10 mg/10 mg film-coated tablets

Ezetimiba/Atorvastatina Stadafarma 10 mg/20 mg film-coated tablets

Ezetimiba/Atorvastatina Stadafarma 10 mg/40 mg film-coated tablets

Ezetimiba/Atorvastatina Stadafarma 10 mg/80 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because 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 to 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 are not listed in this prospect. See section 4.

Content of the prospect

1. What is Ezetimiba/Atorvastatina Stadafarma and for what it is used
2. What you need to know before starting to take Ezetimiba/Atorvastatina Stadafarma
3. How to take Ezetimiba/Atorvastatina Stadafarma
4. Possible adverse effects

5.Storage of Ezetimiba/Atorvastatina Stadafarma

6.Contents of the package and additional information

Ezetimiba/Atorvastatina Stadafarma is a medication that lowers high levels of cholesterol. This medication contains ezetimiba and atorvastatina.

Ezetimiba/atorvastatina is used in adults to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, ezetimiba/atorvastatina increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimiba/atorvastatina 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 against heart disease.

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

Your doctor may prescribe ezetimiba/atorvastatina if you are already taking the same doses of atorvastatina and ezetimiba separately, in addition to your cholesterol-reducing diet if you have:

• high levels of cholesterol in the blood (primary heterozygous and homozygous familial and non-familial hypercholesterolemia) or high levels of fat in the blood (mixed hyperlipidemia)

• heart disease

Ezetimiba/atorvastatina does not help you lose weight.

Do not take Ezetimiba/Atorvastatina Stadafarma if:

• You are allergic to atorvastatin, ezetimiba, or any of the other components of this medication (listed in section 6).
• You have or have had a liver disease.
• You have had any unexplained abnormal results 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 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 have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing), or myasthenic eye disease (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• 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 medications may cause severe muscle problems (rhabdomyolysis).
• If you regularly consume large amounts of alcohol.
• If you have a history of liver disease.
• If you are over 70 years old.

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 atorvastatin causes muscle problems, and cases of muscle problems with ezetimiba have also been reported.

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

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

• If you have severe respiratory failure.

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 muscle adverse effects. It is known that the risk of experiencing muscle adverse effects, e.g., rhabdomyolysis (destruction of skeletal muscle), increases when certain medications are taken simultaneously (see section 2 “Taking Ezetimiba/Atorvastatina Stadafarma with other medications”).

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 about all your medical conditions, including allergies.

Children and adolescents

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Taking Ezetimiba/Atorvastatina Stadafarma with other medications

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

Fibrates (medications to lower cholesterol) should be avoided while taking ezetimiba/atorvastatina.

There are some medications that may 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 severe condition in which muscle destruction occurs, known as “rhabdomyolysis”, which is described in section 4:

• Ciclosporin (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)
• Letermovir (a medication that helps prevent citomegalovirus infection)
• 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, ledipasvir/sofosbuvir
• Daptomycin (a medication used to treat complicated skin and soft tissue infections and bacteremia)
• If you need to take oral fusidic acid 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. Taking this medication with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• 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 (an analgesic)
  • 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 Stadafarma 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 may 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, breastfeeding, and fertility

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

Do not take ezetimiba/atorvastatina if you are of childbearing potential, unless you are using 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.

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

Driving and operating machinery

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

Ezetimiba/Atorvastatina Stadafarma 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 him before taking this medication.

Ezetimiba/Atorvastatina Stadafarma contains sodium

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

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

Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation.

• 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 to take

The recommended dose is one tablet of ezetimiba/atorvastatina once a day, preferably at the same time every day. The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

When to take it

You can 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 cholestyramine or any other bile acid sequestrant (medications 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 Stadafarma than you should

Consult with 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 Stadafarma

Do not take a double dose to make up for the missed dose. Take the usual 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 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, muscle rupture or pain, change in urine color to brown-red, and especially if it occurs simultaneously, feeling unwell or high temperature that may be caused by abnormal muscle destruction that can 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)

• nasal congestion, sore throat, nasal bleeding
• Allergic reactions
• Increased blood glucose levels, diabetic patients should control their blood glucose levels
• Headache
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain
• Sore throat and/or larynx
• Joint pain and/or hands or feet, back pain, muscle pain (myalgia), muscle spasms, joint swelling
• Elevations in some blood tests of muscle function (CK)
• Abnormal liver function test results, elevations in some blood tests of liver function (transaminases)
• Fatigue

Rare(may affect up to 1 in 100 people):

• Swelling due to an allergic reaction
• Reduced blood glucose levels, diabetic patients should control their blood glucose levels
• Loss of appetite, weight gain
• Cough
• Weakness, neck pain, chest pain
• Seizures, high blood pressure
• Vomiting
• Belching
• Pancreatitis and liver inflammation
• Heartburn
• Stomach membrane inflammation
• Dry mouth
• Skin redness, urticaria, skin rash, itching
• Hair loss
• Nightmares, difficulty sleeping
• Dizziness
• Numbness
• Alteration of taste
• Amnesia
• Abnormal local sensations
• Blurred vision
• Tinnitus
• General feeling of discomfort, restlessness, or pain
• Weakness
• Increased gamma-glutamyl transferase liver enzyme
• Positive urine test for white blood cells

Very rare(may affect up to 1 in 10,000 people)

• Anaphylactic shock due to allergic reaction
• Loss of hearing
• Liver insufficiency
• Male breast enlargement

Frequency unknown(cannot be estimated from available data)

• Allergic reaction, including rash and swelling of the lower skin layers
• Lack of breath, inflammation of the bile duct, gallstones
• Physical weakness and loss of strength, muscle tissue loss due to autoimmune antibodies
• Depression
• 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 your 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 during post-marketing surveillance of some statins (medicines used to reduce cholesterol):

• Difficulty breathing, 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
• Sexual dysfunction

Reporting of 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 prospectus. 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 medicine.

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 blister, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

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

Composition of Ezetimiba/Atorvastatina Stadafarma

• 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-dose and multi-dose) of OPA/AL/PVC//Al packaged in cardboard boxes.

Packaging with 30, 30x1 film-coated tablets.

For 10 mg/20 mg and 10 mg/40 mg also 100, 100x1 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048

Keratea 19001

Greece

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

Last review date of this leaflet: August 2023

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