Package Leaflet: Information for the User

atorvastatina cinfa 20 mg film-coated tablets

Read this leaflet carefully before you start to take 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 others even if their symptoms are the same as yours, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

atorvastatina cinfa belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).

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

Do not take atorvastatin cinfa

• If you are allergic to atorvastatin or any of the other ingredients in this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal results in liver function blood tests.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take atorvastatin cinfa.

• If you have severe respiratory failure,
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis),
• If you have had a previous stroke with bleeding in the brain, or have small fluid collections in the brain due to previous strokes,
• If you have kidney problems,
• If you have a thyroid gland with low activity (hypothyroidism),
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems,
• If you have had muscle problems during previous treatment with other medicines to reduce lipids (for example, 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 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 may sometimes worsen the disease or cause myasthenia (see section 4).

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medicine, your doctor will monitor 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 your blood, overweight, and high blood pressure.

Other medicines and atorvastatin cinfa

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

There are some medicines that may affect the proper functioning of atorvastatin or the effects of these medicines may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:

• Medicines used to modify the functioning of your immune system, for example, ciclosporin.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used in the treatment of 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 diseases caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout), and antacids (products for indigestion that contain aluminum or magnesium).

• Over-the-counter medicines: St. John's Wort.
• Daptomycin (a medicine used to treat skin and soft tissue infections and bacteria present in the blood).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will instruct you when it is safe to restart the treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking atorvastatin cinfa with food, drinks, and alcohol

See section 3 for instructions on how to take atorvastatin cinfa. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day because large amounts of orange 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures. Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been demonstrated.

Driving and operating machinery

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

atorvastatin cinfa contains lactose and sucrose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

atorvastatin cinfa contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during atorvastatin treatment.

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

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

Your doctor will decide the duration of treatment with atorvastatin cinfa.

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

If you take more atorvastatin cinfa than you should

In case of overdose or accidental ingestion, consult immediately your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.Do not forget to bring the medication packaging.

If you forgot to take atorvastatin cinfa

If you forgot to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with atorvastatin cinfa

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following side effects or severe symptoms, stop taking these tablets and inform your doctor immediately, or go to the nearest hospital emergency service.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that can make breathing very difficult.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that can form blisters.
• Muscle weakness, pain on palpation, pain, urine discoloration, or brownish-red color, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear, even after stopping atorvastatin, and can be fatal and cause kidney problems.

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

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

Other possible side effects with atorvastatin cinfa:

Frequent (may affect up to 1 in 10 patients)

• Swelling of the nasal passages, sore throat, nasal bleeding.
• Allergic reactions.
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.
• Joint pain, muscle pain, and back pain.
• Abnormal blood test results that may show abnormal liver function.

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

• Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to carefully monitor your blood sugar levels).
• Nightmares, insomnia.
• Dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss.
• Blurred vision.
• Tinnitus in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes 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, inflammation, especially in the ankles (edema), increased temperature.
• Positive urine tests for white blood cells.

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

• Visual disturbances.
• Unexpected or unusual bleeding or bruising.
• Cholestasis (yellowing of the skin and white of the eyes).
• • Tendon injury.
  • Skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
  • Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Loss of hearing.
• Gynecomastia (breast enlargement in men).

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

• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing or difficulty breathing.

The possible side effectsof some statins (medicines of the same type):

• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Do not usethis medicationif you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of atorvastatina cinfa

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

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

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

Appearance of the product and contents of the package

They are white, cylindrical, biconvex, scored, and marked with the code “AT2”.

The tablets are packaged in aluminum/aluminum blisters.

atorvastatina cinfa 20 mg is packaged in containers that contain 28 or 500 (clinical package) coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Galenicum Health, S.L.

Cornellá Avenue, 144 7th floor

Edificio EKLA

08950 Esplugues de Llobregat (Barcelona)

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:October 2024

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

You can access detailed and updated information on this medication 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/69536/P_69536.html

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