Label: information for the user

PREVENCOR 40 mg film-coated tablets

atorvastatina

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Prevencor is and for what it is used

2.What you need to know before starting to take Prevencor

3.How to take Prevencor

4.Possible adverse effects

5.Storage of Prevencor

6.Contents of the pack and additional information

Prevencorbelongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Prevencoris 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,Prevencormay 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 Prevencor

• 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 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Prevencor.

• if you have severe respiratory insufficiency.
• 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 Prevencor may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small fluid accumulations 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 (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 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 Prevencor to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of Prevencor with other medicines”).

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

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

Other medicines and Prevencor

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 Prevencor or the effects of these medicines may be modified by Prevencor.

• 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 hypertension, 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.
• Some 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 Prevencor include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum or magnesium).

• Over-the-counter medicines: St. John's Wort.
• 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 Prevencor. Taking Prevencor in combination 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 skin and soft tissue infections and bacteria present in the blood).

Taking Prevencor with food, drinks and alcohol

See section 3 for instructions on how to take Prevencor. 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 Prevencor.

Alcohol

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

Pregnancy, breastfeeding and fertility

Do not take Prevencor if you are pregnant, think you may be pregnant or intend to become pregnant.

Do not take Prevencor if you are fertile and do not use adequate contraceptive measures.

Do not take Prevencor if you are breastfeeding your child.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

This medicine usually 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.

Prevencor contains lactose

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

Prevencor contains sodium

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

Prevencor contains benzoic acid

This medicine contains 0.00016 mg of benzoic acid in each tablet.

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

The usual initial dose of Prevencor is 10 mg once a day in adults and children over 10 years old. 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 Prevencor is 80 mg once a day.

Prevencor tablets should be swallowed whole 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.

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

Your doctor will decide the duration of Prevencor treatment.

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

If you take more Prevencor than you should

If you accidentally take too many Prevencor tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication you took.

If you forget to take Prevencor

If you forget 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 Prevencor treatment

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

Like all medicines, this medicine may 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 visit the nearest hospital emergency service.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that may cause severe difficulty breathing.

• 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 may 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 may be fatal and cause kidney problems.

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

• 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 problems, and effects on blood cells).

Other possible side effects withPrevencor

Frequent: may affect up to 1 in 10 people

• nasal inflammation, sore throat, nasal bleeding
• Allergic reactions
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in 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 people

• Anorexia (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)
• Heptatitis (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 bleeding or bruising
• Bile duct obstruction (yellow discoloration of the skin and white of the eyes)
• Tendon damage
• Skin rash or ulcers in the mouth (drug reaction)
• Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, 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 that, 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, eyelid drooping, 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. 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 medicine

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does 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 usethis medicationafter the expiration date that appears on the blister pack and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofPrevencor

• The active ingredient is atorvastatina.

Each film-coated tablet contains 40 mg of atorvastatina (as atorvastatina calcium trihydrate).

• The other components (excipients) are:

calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polisorbate 80, hydroxypropylcellulose and magnesium stearate.

The coating of Prevencor contains hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (polisorbate 65, magnesium stearate, glyceryl monostearate 40-55), thickeners (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid and sulfuric acid.

Appearance of the product and contents of the package

Prevencor 40 mg film-coated tablets are white, round and 9.5 mm in diameter. They are marked with 40 on one side and with “ATV” on the other side.

Blister packs consisting of a polyamide/aluminum laminate/polyvinyl chloride front and an aluminum/laminate back.

The bottle is made of HDPE, contains a desiccant, and has a child-resistant “push and turn” closure.

Prevencor 40 mg is available in packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets and in clinical packs containing 50, 84, 100, 200 (10 x 20) or 500 film-coated tablets and bottles containing 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

MEDIS INTERNATIONAL a.s., production plant Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

or

Pfizer Manufacturing Deutschland GmbH –

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

A. Menarini Manufacturing Logistics and Services, s.r.l.

Via Campo di Pile

67100 L'Aquila

Italy

or

Menarini-Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet: October 2024

The detailed information about thismedicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/