ATORVASTATIN/EZETIMIBE CINFA 10 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Atorvastatin/Ezetimibe Cinfa 10 mg/10 mg Hard Capsules

Atorvastatin/Ezetimibe Cinfa 20 mg/10 mg Hard Capsules

Atorvastatin/Ezetimibe Cinfa 40 mg/10 mg Hard Capsules

Atorvastatin Calcium/Ezetimibe

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What Atorvastatin/Ezetimibe Cinfa is and what it is used for
2. What you need to know before you take Atorvastatin/Ezetimibe Cinfa
3. How to take Atorvastatin/Ezetimibe Cinfa
4. Possible side effects

1. Storage of Atorvastatin/Ezetimibe Cinfa
2. Contents of the Pack and Further Information

1. What Atorvastatin/Ezetimibe Cinfa is and what it is used for

Atorvastatin/Ezetimibe Cinfa contains two different active substances in one capsule. One of the active substances is atorvastatin, which belongs to a group of medicines called statins, the other active substance is ezetimibe.

Atorvastatin/Ezetimibe Cinfa is a medicine used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that are circulating in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the gut and the cholesterol produced by the body itself.

For most people, high cholesterol does not affect how they feel. However, if left untreated, fatty deposits can build up in the walls of the blood vessels, narrowing them.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other health problems can be reduced.

This medicine is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Your doctor may prescribe this medicine if you are already taking both medicines, atorvastatin and ezetimibe, at the same dose level, in addition to your cholesterol-lowering diet, if you have:

• A high level of cholesterol in the blood (primary heterozygous and homozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) or high levels of fatty substances in the blood (mixed hyperlipidaemia).

This medicine does not help you lose weight.

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

Do not take Atorvastatin/Ezetimibe Cinfa

• if you are allergic to atorvastatin, ezetimibe, 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 blood test results indicating liver problems,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,
• if you are pregnant or trying to become pregnant,
• if you are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and Precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have severe respiratory failure,
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and this medicine can cause muscle problems (rhabdomyolysis). (See section "Other medicines and Atorvastatin/Ezetimibe Cinfa"),
• if you have had a previous stroke with bleeding in the brain, or have small fluid collections 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 repeats or is unexplained or a personal or family history of muscle problems,
• if you have had muscle problems while taking other cholesterol-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• if you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or myasthenic syndrome (a condition that causes weakness of the eye muscles), as statins can sometimes make these conditions worse or trigger myasthenia (see section 4),
• if you regularly drink large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old.

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking atorvastatin/ezetimibe.This is because, on rare occasions, muscle problems can be serious, including muscle breakdown causing 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 experience persistent muscle weakness. You may need to have tests and additional medicines to diagnose and treat this problem.

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 Atorvastatin/Ezetimibe Cinfa and fibrates (certain cholesterol-lowering medicines) should be avoided, as the combined use of this medicine and fibrates has not been studied.

Children and Adolescents

Atorvastatin/Ezetimibe Cinfa is not recommended for children and adolescents under 18 years of age.

Other Medicines and Atorvastatin/Ezetimibe Cinfa

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

There are some medicines that can affect the way atorvastatin/ezetimibe works, or their effects can be altered by atorvastatin/ezetimibe. 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:

• Medicines used to alter the way the immune system works, e.g. ciclosporin
• Certain antibiotics, e.g. erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• Certain antifungals, e.g. ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid and derivatives, colestipol, colestyramine
• Certain calcium channel blockers used for the treatment of angina or high blood pressure, e.g. amlodipine, diltiazem
• Medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent you from getting ill with cytomegalovirus
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C (inflammation of the liver), e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Fusidic acid. If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop using this medicine temporarily. Your doctor will tell you when it is safe to restart the treatment with atorvastatin/ezetimibe. Taking this medicine with fusidic acid can rarely cause weakness, tenderness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteria in the blood).
• Other medicines that are known to interact with this medicine:
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clotting)
• oral contraceptives (medicines to prevent pregnancy)
• stiripentol (an anticonvulsant medicine used to treat epilepsy)
• cimetidine (a medicine used for stomach acidity and peptic ulcers)
• phenazone (a pain reliever)
• colchicine (used to treat gout)
• antacids (products for the treatment of indigestion that contain aluminium or magnesium)
• St. John's Wort (a medicine for depression).

Taking Atorvastatin/Ezetimibe Cinfa with Food and Alcohol

See section 3 for instructions on how to take this medicine. 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 way this medicine works.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 "Warnings and Precautions".

Pregnancy and Breast-feeding

Do not take atorvastatin/ezetimibe if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. Do not take this medicine 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 atorvastatin/ezetimibe if you are breast-feeding.

The safety of this medicine during pregnancy and breast-feeding has not yet been proven.

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

Driving and Using Machines

Atorvastatin/ezetimibe is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking this medicine. If you feel dizzy, consult your doctor before driving or using machines.

Atorvastatin/Ezetimibe Cinfa Contains Sucrose and Sodium

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

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

3. How to Take Atorvastatin/Ezetimibe Cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should continue with a cholesterol-lowering diet while taking this medicine.

The recommended daily dose for adults is one capsule of the indicated dose.

Take Atorvastatin/Ezetimibe Cinfa once a day.

You can take the capsules at any time of the day, with or without food. However, try to take the capsule at the same time each day.

Swallow each capsule whole with water.

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the active substances separately, and once the appropriate doses have been adjusted, it is possible to switch to atorvastatin/ezetimibe of the corresponding dose.

If your doctor has prescribed atorvastatin/ezetimibe along with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you should take this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Atorvastatin/Ezetimibe Cinfa than you should

If you accidentally take too many capsules (more than your recommended daily dose), contact your doctor or the nearest hospital for medical assistance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatin/Ezetimibe Cinfa

If you forget to take a dose, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin/Ezetimibe Cinfa

Consult your doctor if you want to stop taking atorvastatin/ezetimibe. Your cholesterol levels may increase again if you stop taking this medicine.

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 serious adverse effects or symptoms, stop taking this medicine and immediately inform your doctor, or go to the emergency department of the nearest hospital.

Rare (may affect up to 1 in 1,000 people):

• 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 brownish-red urine color, 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). This abnormal muscle destruction does not always disappear, even after stopping this medicine, and can be potentially fatal and lead to kidney problems.

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

• If you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this fact may be indicative of liver disease, consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).

Other Possible Adverse Effects

Frequent (may affect up to 1 in 10 people):

• Common cold (nasopharyngitis)
• Allergic reactions
• Increased blood sugar levels
• Headache
• Sore throat
• Nasal bleeding
• Constipation
• Flatulence (excess gas in the intestinal tract)
• Dyspepsia
• Feeling nauseous (nausea)
• Diarrhea
• Abdominal pain
• Muscle pain
• Joint pain
• Pain in arms and legs
• Muscle spasms
• Joint inflammation
• Back pain
• Feeling tired (fatigue)
• Increased levels in some blood tests of muscle function (CK)
• Abnormal liver function test results, increased levels in some blood tests of liver function (transaminases)

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

• Low blood sugar levels
• Weight gain
• Decreased or lost appetite
• Nightmares
• Sleeping problems
• Dizziness
• Numbness or tingling in the fingers of hands and feet
• Decreased sensation to pain or touch
• Altered sense of taste
• Memory loss
• Blurred vision
• Ringing/buzzing in the ears
• Hot flashes
• High blood pressure
• Cough
• Vomiting
• Belching
• Pancreatitis, which causes intense stomach pain that can extend to the back
• Acid reflux
• Dry mouth
• Gastritis (stomach inflammation)
• Hepatitis (liver inflammation)
• Hives
• Itching
• Skin rash
• Hair loss
• Neck pain
• Muscle weakness
• Malaise (general feeling of weakness)
• Fatigue (lack of energy and strength)
• Chest pain
• Pain
• Swelling, especially in the hands and feet
• Fever
• Positive urine test for white blood cells
• Increased level of liver enzyme in the blood

Rare (may affect up to 1 in 1,000 people):

• Reduced blood platelet levels, which increases the risk of bruising/bleeding (thrombocytopenia)
• Nerve damage in the legs and arms (such as numbness)
• Visual disturbances
• Jaundice (yellowing of the skin and whites of the eyes)
• Bulging and reddened rashes, sometimes with target-like lesions (erythema multiforme)
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)
• Muscle disease with muscle weakness (myopathy)
• Muscle inflammation
• Tendon damage

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

• Hearing loss
• Liver failure
• Male breast enlargement (gynecomastia).

Frequency Not Known (cannot be estimated from available data):

• Depression
• Shortness of breath
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting)
• Muscle weakness that is constant (immunomediated necrotizing myopathy)
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenic syndrome (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.

Possible Adverse Effects Reported with Some Statins:

• Sexual dysfunction
• Respiratory problems, including persistent cough and/or difficulty breathing 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Atorvastatin/Ezetimibe cinfa

This medicine does not require any special storage temperature. Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

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 the pharmacy. In case of 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 Atorvastatin/Ezetimibe cinfa

• The active ingredients are atorvastatin (as atorvastatin calcium trihydrate) and ezetimibe. Each capsule contains 10 mg, 20 mg, or 40 mg of atorvastatin and 10 mg of ezetimibe.
• The other ingredients are:

Core:

Calcium carbonate, hydroxypropylcellulose, polysorbate 80, sodium croscarmellose, sugar spheres (containing sucrose and cornstarch), talc, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, povidone, sodium lauryl sulfate, and magnesium stearate.

Capsule shell:

Atorvastatin/Ezetimibe cinfa 10 mg/10 mg hard capsules:

Cap: titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172), and gelatin.

Body: titanium dioxide (E-171), yellow iron oxide (E-172), and gelatin.

Atorvastatin/Ezetimibe cinfa 20 mg/10 mg hard capsules:

Cap: titanium dioxide (E-171), red iron oxide (E-172), and gelatin.

Body: titanium dioxide (E-171), yellow iron oxide (E-172), and gelatin.

Atorvastatin/Ezetimibe cinfa 40 mg/10 mg hard capsules:

Cap: titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172), and gelatin.

Body: titanium dioxide (E-171), yellow iron oxide (E-172), and gelatin.

Appearance of Atorvastatin/Ezetimibe cinfa and Package Contents

Appearance:

Atorvastatin/Ezetimibe cinfa 10 mg/10 mg hard capsules

Hard gelatin capsule with no markings, size 0, with a caramel-colored cap and yellow body, filled with pellets and a tablet. The length of the capsule is approximately 21.7 mm.

Atorvastatin/Ezetimibe cinfa 20 mg/10 mg hard capsules

Hard gelatin capsule with no markings, size 0, with a reddish-brown cap and yellow body, filled with pellets and a tablet. The length of the capsule is approximately 21.7 mm.

Atorvastatin/Ezetimibe cinfa 40 mg/10 mg hard capsules

Hard gelatin capsule with no markings, size 0, with a dark brown cap and yellow body, filled with pellets and a tablet. The length of the capsule is approximately 21.7 mm.

Capsule filling:

IR Atorvastatin pellets: Spherical pellets.

Ezetimibe 10 mg tablet:

A cylindrical, flat tablet with a beveled edge, with a stylized E engraved on one face of the tablet and 612 engraved on the other face.

Package Contents:

OPA/Al/PVC/Al blisters in cartons of 30 hard capsules.

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

or

Egis Pharmaceuticals PLC, Site 2.

1165 Budapest, Bökényföldi út 118-120.

Hungary

or

Egis Pharmaceuticals PLC, Site 3

9900 Körmend, Mátyás király utca 65.

Hungary

Date of Last Revision of this Leaflet: April 2025

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

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

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