EZETIMIBE/ATORVASTATIN STADA 10 mg/40 mg FILM-COATED TABLETS

2. What you need to know before you take Ezetimibe/Atorvastatin Stada

Do not take Ezetimibe/Atorvastatin Stada if:

• you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6).
• you have or have ever had a liver disease
• you have had any unexplained abnormal blood test results indicating liver disease
• you are a woman who can become pregnant and are not using reliable contraceptive methods
• you are pregnant, trying to become pregnant, or are breast-feeding
• you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before taking ezetimibe/atorvastatin

• if you have had a previous stroke with bleeding in the brain, or have small amounts of fluid in the brain from 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 has not been explained or a personal or family history of muscle problems
• if you have had muscle problems while taking other lipid-lowering medicines (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 you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause muscle problems (rhabdomyolysis)
• if you have or have had myasthenia (a disease that causes general 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 trigger myasthenia (see section 4).

Muscle problems

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin.This is because muscle problems can be serious, including muscle breakdown, which can cause kidney damage. Atorvastatin is known to cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.

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

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment 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 (breakdown of damaged skeletal muscle), increases when certain medicines are taken at the same time (see section 2 "Other medicines and Ezetimibe/Atorvastatin Stada").

While you are taking this medicine, 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 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.

Children and adolescents

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fusidic acid

If you need to take fusidic acid by mouth to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart the treatment with ezetimibe/atorvastatin. Taking this medicine with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

There are some medicines that can affect the way ezetimibe/atorvastatin works or their effects can be altered 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 breaks down, known as "rhabdomyolysis," which is described in section 4:

• cyclosporin(a medicine often used in transplant patients)
• fibrates(medicines to lower cholesterol) should be avoided as the combined use of ezetimibe/atorvastatin with fibrates has not been studied
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin(medicines used to treat bacterial infections)
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole(medicines used to treat fungal infections)
• gemfibrozil, 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 in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS)
• certain medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• daptomycin(a medicine used to treat complicated skin and skin structure infections and bacteremia).

• Other medicines that are known to interact with the combination of ezetimibe/atorvastatin
• • 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 pain reliever)
  • antacids(medicines for the treatment of indigestion that contain aluminum or magnesium)
  • warfarin, phenprocoumon, acenocoumarol, or flindione(medicines that prevent blood clot formation)
  • colchicine(used to treat gout)
  • St. John's Wort(a medicine used to treat depression)

Taking Ezetimibe/Atorvastatin Stada with food, drinks, and alcohol

See section 3 for instructions on how to take ezetimibe/atorvastatin. 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.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Do not take ezetimibe/atorvastatin if you are pregnant, think you may be pregnant, or are planning to have a baby.

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

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

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. If you feel dizzy after taking this medicine, do not drive or use machinery.

Ezetimibe/Atorvastatin Stada 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Ezetimibe/Atorvastatin Stada 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 Stada

Follow exactly the instructions of administration of this medicine given by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and your personal risk situation.

In case of 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 ezetimibe/atorvastatin tablet 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.

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

If your doctor has prescribed ezetimibe/atorvastatin 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 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimibe/Atorvastatin Stada

Do not take a double dose to make up for forgotten doses. Take the normal dose at the usual time the next day.

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 adverse effects or severe symptoms, stop taking your tablets and inform your doctor immediately, or go to the emergency department of the nearest hospital and take the tablets with you.

• 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, rupture, or muscle pain, change in urine color to reddish-brown, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction (rhabdomyolysis) that can be potentially fatal and trigger kidney problems
• lupus-like 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 fact may be indicative of liver disease.

Other Possible Adverse Effects with Ezetimibe/Atorvastatin:

Frequent(may affect up to 1 in 10 people)

• diarrhea
• muscle pain

Uncommon(may affect up to 1 in 100 people)

• flu
• depression, sleep problems, sleep disorder
• dizziness, headache, tingling sensation
• slow heartbeat
• hot flashes
• breathing difficulties
• 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 muscle weakness
• pain in the arms and legs
• unusual weakness, feeling of tiredness or discomfort
• swelling, especially in the ankles (edema)
• increase in some liver or muscle function tests (CK) in laboratory blood tests
• weight gain

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

• 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 breathing difficulties.

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 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, 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 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)

Possible adverse 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 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 muscle weakness that is constant 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 (unknown frequency – the frequency cannot be estimated from the available data)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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/Atorvastatin Stada

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. 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 wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. 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/Atorvastatin Stada

• The active ingredients are ezetimibe and atorvastatin.

10 mg/10 mg: Each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

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

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

• The other ingredients are:

Core of the tablet

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

Coating of the tablet

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 Package Contents

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

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

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

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

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

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

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

10 mg/80 mg:

Multiples packages contain 90 (2 packages of 45) and 100 (2 packages of 50) film-coated tablets.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14,

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

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

Iceland: Ezetimibe/Atorvastatin STADA 10 mg/10 mg filmuhúðuð tafla

Ezetimibe/Atorvastatin STADA 10 mg/20 mg filmuhúðuð tafla

Ezetimibe/Atorvastatin STADA 10 mg/40 mg filmuhúðuð tafla

Ezetimibe/Atorvastatin STADA 10 mg/80 mg filmuhúðuð tafla

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

Belgium: 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

Czech Republic: Ezetimib/Atorvastatin STADA

Germany: 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

Greece: 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

Spain: Ezetimiba/Atorvastatina STADA 10 mg/10 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina STADA 10 mg/20 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina STADA 10 mg/40 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina STADA 10 mg/80 mg comprimidos recubiertos con película EFG

France: EZETIMIBE/ATORVASTATINE EG 10 mg/10 mg comprimé pelliculé EZETIMIBE/ATORVASTATINE EG 10 mg/20 mg comprimé pelliculé

EZETIMIBE/ATORVASTATINE EG 10 mg/40 mg comprimé pelliculé EZETIMIBE/ATORVASTATINE EG 10 mg/80 mg comprimé pelliculé

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

Ezetimibe/Atorvastatina EG STADA 10 mg/20 mg

Ezetimibe/Atorvastatina EG STADA 10 mg/40 mg

Ezetimibe/Atorvastatina EG STADA 10 mg/80 mg

Lithuania: Ezetimibe/Atorvastatin STADA 10 mg/10 mg plevele dengtos tabletes

Ezetimibe/Atorvastatin STADA 10 mg/20 mg plevele dengtos tabletes

Ezetimibe/Atorvastatin STADA 10 mg/40 mg plevele dengtos tabletes

Ezetimibe/Atorvastatin STADA 10 mg/80 mg plevele dengtos tabletes

Luxembourg: Ezetimibe/Atorvastatine EG 10 mg/10 mg comprimés pelliculés

Ezetimibe/Atorvastatine EG 10 mg/20 mg, comprimés pelliculés

Ezetimibe/Atorvastatine EG 10 mg/40 mg comprimés pelliculés

Ezetimibe/Atorvastatine EG 10 mg/80 mg comprimés pelliculés

Latvia: Ezetimibe/Atorvastatin STADA 10 mg/10 mg apvalkotas tabletes

Ezetimibe/Atorvastatin STADA 10 mg/20 mg apvalkotas tabletes

Ezetimibe/Atorvastatin STADA 10 mg/40 mg apvalkotas tabletes

Ezetimibe/Atorvastatin STADA 10 mg/80 mg apvalkotas tabletes

Slovakia: Ezetimibe/Atorvastatin STADA 10 mg/10 mg filmom obalené tablety

Ezetimibe/Atorvastatin STADA 10 mg/20 mg filmom obalené tablety

Ezetimibe/Atorvastatin STADA 10 mg/40 mg filmom obalené tablety

Ezetimibe/Atorvastatin STADA 10 mg/80 mg filmom obalené tablety

Date of the Last Revision of this Leaflet:December 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/