Atorvastatin Cinfa 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

atorvastatine cinfa 20 mg film-coated tablets EFG

Read the 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, and you should not give it 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What atorvastatine cinfa is and what it is used for
2. What you need to know before taking atorvastatine cinfa
3. How to take atorvastatine cinfa
4. Possible side effects
5. How to store atorvastatine cinfa
6. Contents of the pack and other information

1. What atorvastatina cinfa is and what it is used for

atorvastatina cinfa belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

atorvastatina cinfa is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, atorvastatina cinfa may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before starting to take atorvastatina cinfa

Do not take atorvastatina cinfa

• If you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had unexplained abnormal results in liver function blood tests.
• If you are a woman of childbearing age and are not using adequate contraceptive measures.
• 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

Talk to your doctor or pharmacist before starting to take atorvastatina cinfa

• if you have severe respiratory failure,
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis),
• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes,
• if you have kidney problems,
• if you have an underactive thyroid gland (hypothyroidism),
• if you have repeated or unexplained muscle pain, or personal or family history of muscle disorders,
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates),
• if you regularly drink large amounts of alcohol,
• if you have a history of liver problems,
• if you are over 70 years old,
• if you have or have had myasthenia (a disease causing generalized muscle weakness that, 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).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with atorvastatina cinfa to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2).

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 you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and atorvastatina cinfa

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

Some medicines may interfere with the proper functioning of atorvastatina cinfa, or their effects may be altered by atorvastatina cinfa. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.

• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.

• Other lipid-regulating medicines, for example, gemfibrozil, other fibrates, colestipol.

• Some calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.

• Letermovir, a medicine that helps prevent cytomegalovirus-related diseases.

• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.

• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.

• Other medicines known to interact with atorvastatin include ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).

• Over-the-counter medicines: St. John’s wort.

• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

• 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 atorvastatina cinfa. Taking atorvastatina cinfa together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking atorvastatina cinfa with food, drinks and alcohol

See section 3 for instructions on how to take atorvastatina cinfa. 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 may alter the effects of atorvastatin.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility

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.

Do not take atorvastatina cinfa if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take atorvastatina cinfa if you are of childbearing age unless you are using adequate contraceptive measures. Do not take atorvastatina cinfa if you are breastfeeding.

The safety of atorvastatina cinfa during pregnancy and breastfeeding has not been established.

Driving and using machines

Normally, this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machinery if this medicine impairs your ability to handle them.

atorvastatina cinfa contains lactose and sucrose.

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

atorvastatina cinfa contains sodium.

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

3. How to take atorvastatine cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with atorvastatin.

The usual initial dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin tablets should be swallowed with a glass of water and may be taken at any time of day, with or without food. However, try to take your tablet at the same time every day. The tablet may be divided into equal doses.

Your doctor will decide the duration of treatment with atorvastatine cinfa

Ask your doctor if you think that the effect of atorvastatin is too strong or too weak.

If you take more atorvastatine cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested. Do not forget to bring the medicine packaging.

If you forget to take atorvastatine cinfa

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

If you stop taking atorvastatine cinfa

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 produce adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects or symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.
• Serious illness with severe skin peeling and inflammation; skin blisters, blisters in the mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle rupture, or brownish-red discoloration of the urine, especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and may be fatal and cause kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects with atorvastatina cinfa:

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

• Inflammation of the nasal passages, sore throat, nosebleeds.
• Allergic reactions.
• Increases in blood sugar levels (if you have diabetes, monitor your blood sugar levels closely), increased blood creatine kinase.
• Headache.
• Nausea, constipation, flatulence, indigestion, diarrhea.
• Joint pain, muscle pain, and back pain.
• Blood test results that may indicate abnormal liver function.

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully).
• Nightmares, insomnia.
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss.
• Blurred vision.
• Ringing in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain).
• Hepatitis (inflammation of the liver).
• Rash, skin rash and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature.
• Urine tests positive for white blood cells.

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

• Vision disturbances.
• Unexplained bleeding or bruising.
• Cholestasis (yellowing of the skin and whites of the eyes).
  • Tendon injury.
  • Skin rash or mouth ulcers (drug-induced lichenoid reaction).
  • Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Hearing loss.
• Gynaecomastia (enlargement of the breasts in men).

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

• Persistent muscle weakness.
• 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 experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of atorvastatin cinfa

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

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

Do not store above 30°C.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of atorvastatin cinfa

• The active substance is atorvastatin calcium. Each tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
• The other components are:

Core: monohydrate lactose, magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E-460), colloidal anhydrous silica, butylhydroxyanisole (E-320), crospovidone, sodium hydrogen carbonate, Sinespum C (sucrose, sorbitan triesterate, macrogol stearate 40, dimethicone, silica, 2-bromo-2-nitropropane-1,3-diol).

Coating: monohydrate lactose, hypromellose (E-464), titanium dioxide (E-171), and macrogol 4000.

Appearance of the product and contents of the pack

The tablets are white, film-coated, cylindrical, biconvex, scored tablets marked with the code “AT2”.

The tablets are packaged in aluminum/aluminum blisters.

Atorvastatin cinfa 20 mg is available in packs containing 28 or 500 tablets (hospital pack) of film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Galenicum Health, S.L.

Avda. Cornellá, 144 7º1º

Edificio EKLA

08950 Esplugues de Llobregat (Barcelona)

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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 outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69536/P_69536.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69536/P_69536.html