ATORVASTATIN CINFA 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina Cinfa 30 mg film-coated tablets

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 Atorvastatina Cinfa is and what it is used for
2. What you need to know before you take Atorvastatina Cinfa
3. How to take Atorvastatina Cinfa
4. Possible side effects
5. Storing Atorvastatina 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 medicines.

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 not worked. If you are at high risk of heart disease, atorvastatin may 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 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 a liver disease.
• if you have or have had unexplained abnormal results in blood tests for liver function.
• 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 breast-feeding.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Atorvastatina 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 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 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 that causes generalised muscle weakness which, in some cases, affects 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 trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may indicate that you should have a blood test 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 "Other medicines and Atorvastatina Cinfa").

Also, tell your doctor or pharmacist if you have constant muscle weakness. Tests and additional medication may be needed 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 sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatina Cinfa

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

There are some medicines that may affect the proper functioning of atorvastatin or the effects of these medicines may be altered by atorvastatin. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use may 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. ciclosporin.
• 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 ulcer), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminium 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 Atorvastatina Cinfa with food, drinks, and alcohol

See section 3 for instructions on how to take atorvastatin. 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 large amounts of alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

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 and are not using 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.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

Atorvastatina Cinfa contains lactose and sucrose.

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

Atorvastatina Cinfa contains sodium.

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

3. How to take Atorvastatina Cinfa

Follow exactly the instructions of administration of this medicine 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 should also follow during treatment with atorvastatin.

The initial recommended dose of atorvastatin is 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 whole with a glass of water and can be taken at any time of day with or without food. However, try to take your tablet at the same time every day.

Your doctor will decide the duration of treatment with Atorvastatina Cinfa

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

If you take more Atorvastatina 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 taken.

Take the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Cinfa

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

If you stop taking Atorvastatina Cinfa

If you have any further questions on the use of this medicine or wish to stop treatment, 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 in 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 change in urine color to reddish-brown, and especially if you 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 Atorvastatina 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
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite (anorexia), 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

• vision changes
• unexpected or unusual 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 and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, 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 generalised muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell your doctor if you have 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, even if it is possible side effects that are not listed in this leaflet. You can also report them 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 Atorvastatina Cinfa

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist. By doing so, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Atorvastatina Cinfa

• The active ingredient is atorvastatin. Each tablet contains 30 mg of atorvastatin as atorvastatin calcium trihydrate.
• The other components (excipients) are:

Tablet core:Lactose monohydrate, Sodium lauryl sulfate, Butylhydroxyanisole (E-320), Crospovidone, Magnesium stearate, Microcrystalline cellulose (E-460), Anhydrous colloidal silica, Sucrose, Sorbitan triesterate, Macrogol 40 stearate (E-431), Dimethicone, Silica, 2-Bromo-2-nitropropane-1,3-diol, Sodium bicarbonate.

Coating: Lactose monohydrate, Hypromellose (E-464), Titanium dioxide (E-171), Macrogol 4000.

Product Appearance and Packaging Content

The tablets are film-coated, white, cylindrical, biconvex, and marked with the code "AT3".

The packs contain 28 tablets.

Marketing Authorization Holder and Manufacturer

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 medicinal product 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 medicinal product 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/85715/P_85715.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85715/P_85715.html