Atorvastatin Viatris 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatina Viatris 80 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Atorvastatina Viatris is and what it is used for

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

Atorvastatina is used to reduce lipids such as cholesterol and other fats (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 Viatris may 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 taking Atorvastatin Viatris

Do not take Atorvastatin Viatris:

• If you are allergic to atorvastatin or to any other similar medicine used to lower blood lipids, or to any of the other ingredients of this medicine (listed in section 6).
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• 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 potential and are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatin Viatris:

• If you have or have had myasthenia (a disease causing generalized muscle weakness, which 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).

• If you have severe respiratory insufficiency.
• If you have previously had a stroke or mini-stroke (also known as transient ischemic attack, 'TIA'), a hemorrhagic stroke, or have small accumulations of fluid in the brain from 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 had muscle problems during treatment with other lipid-lowering medicines (e.g., other statins or fibrates).
• If you regularly drink large amounts of alcohol.
• If you have a history of liver problems.
• If you are over 70 years of age.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).

In any of these cases, your doctor may decide whether you need a blood test before and possibly during treatment with atorvastatin 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, “Other medicines and Atorvastatin Viatris”).

While taking this medicine, your doctor will monitor you if you have diabetes or are at risk of developing it. You may be at increased risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

Other medicines and Atorvastatin Viatris

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 atorvastatin, or the effects of these medicines may be altered by atorvastatin. 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 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.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol, niacin.
• Certain 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 infection.
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
• Some medicines used to treat hepatitis C, for example, telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• 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 you can restart treatment with atorvastatin. Taking atorvastatin together with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Taking Atorvastatin Viatris with food, drinks and alcohol

Grapefruit juice

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

Alcohol

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

Pregnancy, breastfeeding and fertility

Do not take atorvastatin if you are pregnant or trying to become pregnant. Do not take atorvastatin if you could become pregnant unless you are using adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using this medicine.

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 safely. Do not operate tools or machines if this medicine impairs your ability to handle them.

Atorvastatin Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Atorvastatin Viatris

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 cholesterol-lowering diet, which you must continue during treatment with atorvastatin.

The recommended starting 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 whole 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 atorvastatin:

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

If you take more Atorvastatin Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Viatris

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 forgotten doses.

If you stop taking Atorvastatin Viatris

If you have any further questions about the use of this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause 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 right away or go to the nearest hospital emergency department:

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis (inflammation of the pancreas causing severe stomach pain that may extend to the back).
• Hepatitis (inflammation of the liver).

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

• Severe allergic reaction, symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, or collapse.
• Serious illness with severe skin peeling and inflammation; blisters on the skin, mouth, eyes, genitals, 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, muscle breakdown, or brownish-red discoloration of the urine, especially if accompanied by feeling unwell or high fever—this may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve and may continue even after stopping atorvastatin, and can be fatal and cause kidney problems.
• Blockage of the bile duct (cholestasis), which may include signs such as yellowing of the skin or eyes, pain in the upper right part of the abdomen, or loss of appetite.

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

• If you experience pain in the upper right abdomen, abdominal swelling, and yellowing of the skin and eyes, this may indicate a liver problem. You should consult your doctor as soon as possible.
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).

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 weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects with atorvastatin:

Common adverse effects (may affect up to 1 in 10 people)

• Nasal inflammation, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, gas, indigestion, diarrhea.
• Joint pain, muscle pain, back pain, muscle spasms.
• Blood test results that may indicate abnormal liver function.

Uncommon adverse effects (may affect up to 10 in 100 people)

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, 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.
• 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 adverse effects (may affect up to 1 in 1,000 people)

• Vision disturbances.
• Unexpected bleeding or bruising.
• Tendon injury.
• Skin rash or mouth ulcers (drug-induced lichenoid reaction).
• Purple-colored skin lesions (signs of inflammation of blood vessels, vasculitis).

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

• Hearing loss.
• Gynecomastia (enlargement of breasts in men).

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:

More likely if you have high levels of sugar and fats in the blood, are overweight, and 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 Viatris

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from moisture. This medicine does not require any special storage temperature.

Do not use this medicine after the expiry date stated on the cardboard box, label of the bottle and blister after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Viatris

• The active substance is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin as atorvastatin calcium trihydrate.

• The other components of the tablet core are colloidal anhydrous silica, sodium carbonate, microcrystalline cellulose (E-460), L-arginine, lactose, sodium croscarmellose, hydroxypropylcellulose (E-463) and magnesium stearate (E-470B). The coating contains polyvinyl alcohol, titanium dioxide (E-171), talc (E-553B) and macrogol.

Nature of the product and pack sizes

The film-coated tablets are round and white to off-white in colour. The tablets are marked with '80' on one side and have a score line on the other side.

Atorvastatin Viatris is available in opaque plastic bottles containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 200, 250 and 500 tablets.

Atorvastatin Viatris is also available in blister packs of 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets, calendar blister packs of 28 tablets, and in a multiple pack of 98 tablets consisting of 2 cartons (each containing 49 tablets).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Hungary Kft
H-2900 Komárom, Mylan út. 1
Hungary

or

Logiters, Logistica, Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal

or

Viatris UK Healthcare Limited
Building 20, Station Close, Potters Bar
EN6 1TL
United Kingdom

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Atorvastatine Viatris 80 mg filmomhulde tabletten
Bulgaria: Atorgen 80 mg Film-coated tablets
Cyprus: Atorvastatin Mylan 80 mg film-coated tablets
Denmark: Atorvastatin Viatris 80 mg
Spain: Atorvastatina Viatris 80 mg comprimidos recubiertos con película EFG
Greece: Atorvastatin/Mylan 80 mg film-coated tablets
Ireland: Atorvastatin Viatris 80 mg
Netherlands: Atorvastatine Mylan 80 mg filmomhulde tabletten
Poland: ATORVAGEN
Portugal: Atorvastatina Mylan 80 mg
United Kingdom (Northern Ireland): Atorvastatin 80 mg Film-coated Tablets
Czech Republic: Atorvastatin Viatris 80 mg
Slovakia: Atorvastatin Viatris 80 mg Filmom obalené tableta
Sweden: Atorvastatin Viatris 80 mg

Date of the latest revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/