ATORVASTATIN CINFA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin Cinfa 40 mg film-coated tablets EFG

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 experience 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 Cinfa is and what it is used for
2. What you need to know before you take Atorvastatin Cinfa
3. How to take Atorvastatin Cinfa
4. Possible side effects
5. Storing Atorvastatin Cinfa
6. Contents of the pack and other information

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

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

Atorvastatin 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 not worked. If you are at high risk of heart disease, Atorvastatin Cinfa can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

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

Do not take Atorvastatin 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 a disease that affects the liver.
• If you have or have had unexplained abnormal results in blood tests for liver function.
• If you are a woman of childbearing age and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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) orally or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis),
• if you have had a previous 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, personal or family history of muscle problems,
• if you have had muscle problems before while taking other medicines to lower lipid levels (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 that causes general muscle weakness that can affect 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).

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

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

While 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 sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin 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 proper functioning of atorvastatin or the effects of these medicines may be altered by atorvastatin. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• Medicines used to modify the functioning of your immune system, e.g. cyclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain 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, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for gout), and antacids (indigestion products containing aluminum or magnesium).

• Medicines obtained without a prescription: St. John's Wort.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, 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:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of atorvastatin.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

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.

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

Do not take atorvastatin if you are of childbearing age unless you use adequate contraceptive measures. Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin during pregnancy and breast-feeding has not been established.

Driving and using machines

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

Atorvastatin Cinfa contains lactose and sucrose.

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

Atorvastatin Cinfa contains sodium.

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

3. How to take Atorvastatin 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.

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

The initial dose of atorvastatin is usually 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you 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.

The tablets of atorvastatin 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 at the same time every day. 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 your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Do not forget to take the medicine packaging with you.

If you forget to take Atorvastatin Cinfa

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

If you stop taking Atorvastatin Cinfa

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.
• Severe disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.
• Muscle weakness, pain on palpation, pain, rupture, or brownish-red color of the urine, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does 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 people):

• If you experience bleeding or bruising problems or unexpected or unusual bleeding, this may suggest 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 side effects with Atorvastatin Cinfa:

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

• Inflammation of the nasal passages, sore throat, nosebleeds.
• Allergic reactions.
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.
• Pain in the joints, pain in the muscles, and back pain.
• Blood test results that may show abnormal liver function.

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

• Anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you are diabetic, you should 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.
• Ringing 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 people):

• Changes in vision.
• Unexpected bleeding or bruising.
• Jaundice (yellowing of the skin and whites of the eyes).
• • Tendon injury.
  • Skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
  • Purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• 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.
• Gynecomastia (breast enlargement in men).

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

• Constant muscle weakness.
• Severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects of 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 fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atorvastatin Cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorvastatin Cinfa

• The active ingredient is atorvastatin calcium. Each tablet contains 40 mg of atorvastatin (as atorvastatin 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 (sucrose, sorbitan triester, macrogol 40 stearate, dimethicone, silica, 2-bromo-2-nitropropane-1,3-diol).

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

Appearance of the Product and Package Contents

They are white, film-coated, cylindrical, biconvex, scored tablets, marked with the code "AT4".

The tablets are packaged in aluminum/aluminum blisters.

Atorvastatin Cinfa 40 mg is packaged in containers containing 28 or 500 (clinical package) film-coated tablets.

Only some package 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 Last Revision of this Leaflet:October 2024

Detailed and updated information on this medication 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 medication 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/69537/P_69537.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69537/P_69537.html