EZETIMIBE/ATORVASTATIN CINFA 10 mg/10 mg FILM-COATED TABLETS

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

Do not take Ezetimibe/Atorvastatin Cinfa

• 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 results in blood tests 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 breastfeeding,
• if 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 ezetimibe/atorvastatin

• if you have had a previous stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain derived from previous strokes
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have had recurring or unexplained muscle pain or a history of muscle problems,
• if you have experienced muscle problems while taking other lipid-lowering medications (e.g., other medications containing "statins" or "fibrates"),
• if you habitually 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 your doctor before taking this medicine,
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, 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 to appear (see section 4),
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and ezetimibe/atorvastatin can cause serious muscle problems (rhabdomyolysis).

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking ezetimibe/atorvastatin.This is because, in rare cases, muscle problems can be serious, including muscle breakdown that causes 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. Additional tests and medications may be necessary to diagnose and treat this problem.

Consult your doctor or pharmacist before starting to take ezetimibe/atorvastatin

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before starting to take ezetimibe/atorvastatin, 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 you present of experiencing muscle side effects. It is known that the risk of experiencing muscle side effects, e.g., rhabdomyolysis, increases when certain medications are taken simultaneously (see section 2 "Taking Ezetimibe/Atorvastatin Cinfa with other medicines").

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 sugars and fats 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 medications 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 Cinfa

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 change the effect of ezetimibe/atorvastatin, and whose effects can be altered by ezetimibe/atorvastatin (see section 3). This type of interaction could decrease 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 breakdown occurs, known as "rhabdomyolysis", which is described in section 4:

• cyclosporine (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, cholestyramine (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,
• 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 temporarily have to stop using this medicine. Your doctor will tell you when you can restart treatment with ezetimibe/atorvastatin. The use of this medicine with fusidic acid can rarely cause muscle weakness, sensitivity, 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 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 fluindione (medicines that prevent blood clot formation),
• colchicine (used to treat gout),
• St. John's Wort (a medicine used to treat depression).

Taking Ezetimibe/Atorvastatin Cinfa with food and drink

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 alter 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 breastfeeding

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

Do not take ezetimibe/atorvastatin if you can become pregnant, unless you are using 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 breastfeeding.

The safety of ezetimibe/atorvastatin during pregnancy and breastfeeding has not yet been proven. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Ezetimibe/Atorvastatin Cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

Ezetimibe/Atorvastatin Cinfa 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 certain sugars, consult your doctor before taking this medicine.

3. How to take Ezetimibe/Atorvastatin Cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor. 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 ezetimibe/atorvastatin, you should be following a cholesterol-lowering diet.

? You will need to 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 orally.

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 Cinfa than you should

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 Cinfa

Do not take a double dose to make up for forgotten doses; the next day, take your normal amount of ezetimibe/atorvastatin at the usual time.

If you have any other questions about 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 inform your doctor immediately, 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 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 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 a liver condition.

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

• diarrhea,
• muscle pain.

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

• flu,
• depression; sleep disorders; sleep disturbance,
• dizziness; headache; tingling sensation,
• slow heartbeat,
• 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 weakness; pain in the arms and legs,
• unusual weakness; feeling of fatigue or discomfort; inflammation, especially in the ankles (edema),
• 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).

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 difficulty breathing.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin tablets, or ezetimibe or atorvastatin tablets alone:

• allergic reactions, including inflammation of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which require immediate medical treatment),
• red, sometimes target-shaped, skin rash,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions, including the appearance of skin rash and hives,
• tendon trauma,
• 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).

Possible adverse effects observed 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 sugar and fat 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).

Reporting of 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 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 cinfa

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

Do not use this medicine after the expiration date stated on the packaging and blister 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 disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin cinfa

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 ingredients (excipients) are:

Tablet core:

mannitol, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, calcium carbonate, hydroxypropylcellulose, polysorbate 80, and yellow iron oxide (E-172).

Tablet coating:

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg

Opadry white (hypromellose, macrogol, titanium dioxide (E-171), and lactose monohydrate)

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg

DrCoat FCU (hypromellose, titanium dioxide (E-171), talc, macrogol, yellow iron oxide (E-172))

Appearance of the Product and Package Contents

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg: white, round, biconvex, film-coated tablets, approximately 8.1 mm in diameter.

Ezetimibe/Atorvastatin cinfa 10 mg/20 mg: white, oval, biconvex, film-coated tablets, approximately 11.6 x 7.1 mm in size.

Ezetimibe/Atorvastatin cinfa 10 mg/40 mg: white, capsule-shaped, biconvex, film-coated tablets, approximately 16.1 x 6.1 mm in size.

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg: yellow, oblong, biconvex, film-coated tablets, approximately 19.1 x 7.6 mm in size.

Package sizes:

Blisters of OPA/Al/PVC//Al containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95, Pikermi, Attiki,

190 09, Greece

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea,

190 01, Greece

Date of the Last Revision of this Leaflet: October 2024

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

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

Ezetimibe/Atorvastatin cinfa 10 mg/20 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

Ezetimibe/Atorvastatin cinfa 10 mg/40 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html