Atorvastatin/ezetimibe CINFA 40 mg/10 mg hard capsules

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Atorvastatina/Ezetimiba cinfa 10 mg/10 mg hard capsules

Atorvastatina/Ezetimiba cinfa 20 mg/10 mg hard capsules

Atorvastatina/Ezetimiba cinfa 40 mg/10 mg hard capsules

Atorvastatin calcium/Ezetimibe

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Atorvastatina/Ezetimiba cinfa is and what it is used for

2. What you need to know before taking Atorvastatina/Ezetimiba cinfa

3. How to take Atorvastatina/Ezetimiba cinfa

4. Possible side effects

5. How to store Atorvastatina/Ezetimiba cinfa

6. Contents of the pack and other information

1. What Atorvastatine/Ezetimibe cinfa is and what it is used for

Atorvastatine/Ezetimibe cinfa contains two different active substances in one capsule. One of the active substances is atorvastatine, which belongs to the group of medicines known as statins; the other active substance is ezetimibe.

Atorvastatine/Ezetimibe cinfa is a medicine used in adults that lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, it increases levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed in the gastrointestinal tract, as well as cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off 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 related health problems can be reduced.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Your doctor may prescribe this medicine if you are already taking both atorvastatine and ezetimibe at the same dose levels, along with a cholesterol-lowering diet, and you have:

• High cholesterol levels in the blood (heterozygous and homozygous familial and non-familial primary hypercholesterolemia), or elevated levels of fatty substances in the blood (mixed hyperlipidemia).

This medicine does not help you lose weight.

2. What you need to know before taking 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 liver disease,
• if you have ever had unexplained abnormal blood test results for liver function,
• if you are a woman of childbearing potential and are not using reliable contraceptive methods,
• if you are pregnant or trying to become pregnant,
• if you 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 this medicine:

• if you have severe respiratory insufficiency,
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (an antibacterial medicine). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis). (See section “Other medicines and Atorvastatin/Ezetimibe cinfa”),
• if you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or personal or family history of muscle disorders,
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• if you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years of age.

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking atorvastatin/ezetimibe. This is because, rarely, muscle problems can be serious, including muscle breakdown leading to 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. Additional tests and treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

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

The combined use of Atorvastatin/Ezetimibe cinfa and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of this medicine with 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

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

Some medicines may alter the effect of atorvastatin/ezetimibe or their effects may be affected by atorvastatin/ezetimibe. Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis”, described in section 4:

• Medicines used to modify the immune system, e.g., cyclosporine
• Certain antibiotics, e.g., erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• Certain antifungals, e.g., ketoconazole, itraconazol, voriconazole, fluconazole, posaconazole
• Other lipid-regulating medicines, e.g., gemfibrozil, other fibrates, nicotinic acid and derivatives, colestipol, cholestyramine
• Some calcium channel blockers used for angina or high blood pressure, e.g., amlodipine, diltiazem
• Medicines to regulate heart rhythm, e.g., digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent cytomegalovirus infection
• Medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir, etc.
• Some medicines used in the treatment of hepatitis C (liver inflammation), e.g., telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with atorvastatin/ezetimibe. Taking this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections due to bacteria)
• Other medicines known to interact with this medicine:
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots)
• 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 (an analgesic)
• colchicine (used to treat gout)
• antacids (products for indigestion containing aluminium or magnesium)
• St. John’s wort (a herbal medicine used to treat 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 quantities of grapefruit juice may alter the effects of this medicine.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take atorvastatin/ezetimibe if you are pregnant, trying to become pregnant, or think you might be pregnant. Do not take this medicine if you could become pregnant unless you are using 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 breastfeeding.

The safety of this medicine during pregnancy and breastfeeding has not been established.

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

Driving and using machines

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

Atorvastatin/Ezetimibe cinfa contains sucrose and sodium

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., it is essentially “sodium-free”.

3. How to take Atorvastatin/Ezetimibe cinfa

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Take Atorvastatin/Ezetimibe cinfa once daily.

You may take the capsules at any time of 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. Treatment initiation or dose adjustments, if necessary, should only be done by taking the active substances separately. Once the appropriate doses have been established, switching to atorvastatin/ezetimibe at the corresponding dose may be considered.

If your doctor has prescribed atorvastatin/ezetimibe together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atorvastatin/Ezetimibe cinfa

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

If you stop taking Atorvastatin/Ezetimibe cinfa

Consult your doctor if you wish to discontinue treatment with atorvastatin/ezetimibe. Your cholesterol levels may rise again if you stop taking this medicine.

If you have any further 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 everyone experiences them.

If you experience any of the following serious adverse effects or symptoms, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

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

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• A serious illness characterized by extensive skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or brownish-red discoloration of the urine, especially if accompanied by malaise or high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis). This abnormal muscle breakdown does not always resolve, even after discontinuation of this medicine, and may 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 unexpected or unusual bleeding or bruising, as this may indicate liver disease, consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects

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

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

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

• Low blood sugar levels
• Weight gain
• Decreased or loss of appetite
• Nightmares
• Sleep disturbances
• Dizziness
• Numbness or tingling in fingers and toes
• Reduced sensation to pain or touch
• Taste disturbance
• Memory loss
• Blurred vision
• Ringing or buzzing in the ears
• Hot flushes
• High blood pressure
• Cough
• Vomiting
• Belching
• Pancreatitis, causing severe stomach pain that may spread to the back
• Stomach acid reflux
• Dry mouth
• Stomach inflammation (gastritis)
• Liver inflammation (hepatitis)
• Hives
• Itching
• Skin rash
• Hair loss
• Neck pain
• Muscle weakness
• Malaise (general feeling of weakness)
• Tiredness (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):

• Reduction in blood platelet levels, increasing the risk of bruising/bleeding (thrombocytopenia)
• Nerve damage in arms and legs (such as numbness)
• Visual disturbances
• Cholestasis (yellowing of the skin and whites of the eyes)
• Raised, red skin 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 injury

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

• Hearing loss
• Liver failure
• Breast enlargement in men (gynaecomastia)

Frequency not known (cannot be estimated from available data):

• Depression
• Shortness of breath
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• Persistent muscle weakness (immune-mediated necrotizing myopathy)
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you develop worsening weakness in the arms or legs 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. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide 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 the sight and reach of children.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin/Ezetimibe cinfa

• The active substances 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 components are:

Core:

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

Capsule coating:

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 contents of the pack

Appearance:

Atorvastatin/Ezetimibe cinfa 10 mg/10 mg hard capsules

Hard gelatin capsule with non-marked snap-fit closure, size 0, with a caramel-colored cap and yellow body, filled with pellets and a tablet. The capsule length is approximately 21.7 mm.

Atorvastatin/Ezetimibe cinfa 20 mg/10 mg hard capsules

Hard gelatin capsule with non-marked snap-fit closure, size 0, with a reddish-brown cap and yellow body, filled with pellets and a tablet. The capsule length is approximately 21.7 mm.

Atorvastatin/Ezetimibe cinfa 40 mg/10 mg hard capsules

Hard gelatin capsule with non-marked snap-fit closure, size 0, with a dark brown cap and yellow body, filled with pellets and a tablet. The capsule length is approximately 21.7 mm.

Capsule contents:

Atorvastatin IR pellets: Spherical-shaped pellets.

Ezetimibe 10 mg tablet:

A cylindrical, flat tablet with beveled edges, with a stylized "E" engraved on one side and "612" engraved on the other.

Pack contents:

OPA/Al/PVC/Al blisters containing 30 hard capsules, packed in a cardboard box.

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 latest review of this leaflet: April 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. 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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