ATORVASTATIN VIATRIS 40 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

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

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

Atorvastatin Viatris belongs to a group of medicines known as statins, which are lipid-modifying medicines.

Atorvastatin is used to lower lipid levels such as cholesterol and other fats (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 Viatris can be used to reduce this risk even if your cholesterol levels are normal.

During treatment, you should follow a standard cholesterol-lowering diet.

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

Do not take Atorvastatin Viatris:

• If you are allergic to atorvastatin or to any other medicine used to lower blood lipid levels or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• If you have or have had liver disease.
• If you have had unexplained abnormal blood test results for liver function.
• If you are a woman able to become pregnant and are not using reliable contraception.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Atorvastatin Viatris:

- If you have had muscle problems (myopathy) or muscle disease (myasthenia gravis) or eye muscle disease (ocular myasthenia), as statins can sometimes worsen the condition or trigger myasthenia (see section 4).

• If you have severe respiratory failure.
• If you have had a previous stroke or transient ischaemic attack (TIA) or cerebral haemorrhage, or have small fluid-filled areas 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 pains, personal or family history of muscle problems.
• If you have had muscle problems while taking 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 old.
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis).

In any of these cases, your doctor may decide to perform 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 Atorvastatin Viatris”).

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

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and medicines may be needed to diagnose and treat this problem.

Other medicines and Atorvastatin Viatris

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 correct 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.
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol, niacin.
• 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 you from getting ill with cytomegalovirus.
• Medicines used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
• Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), 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.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine temporarily. Your doctor will tell you when you can restart atorvastatin treatment. 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.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria in the blood).

Taking Atorvastatin Viatris with food, drinks, and alcohol

Grapefruit juice

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

Alcohol

Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and precautions”.

Pregnancy, breast-feeding, and fertility

Do not take atorvastatin if you are pregnant or if you are trying to become pregnant. Do not take atorvastatin if you can become pregnant, unless you use reliable contraception.

Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin during pregnancy and breast-feeding 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 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 Viatris contains lactose and sodium

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

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

3. How to take Atorvastatin Viatris

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 atorvastatin tablets 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. The tablet can 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatin Viatris

If you forget to take a dose, take the next scheduled dose at the correct time. Do nottake a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Viatris

If you have any other questions about the use of this medicine or want 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:

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

• Pancreatitis (inflammation of the pancreas that causes severe stomach pain, which can radiate to the back).
• Hepatitis (inflammation of the liver).

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

• Severe allergic reaction, symptoms can include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, eyes, genitals, 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, rupture, or brown discoloration of the urine, and especially if you also have discomfort or have a high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after you stop taking atorvastatin, and can be fatal and cause kidney problems.
• Bile duct obstruction (cholestasis) that can include signs such as yellowing of the skin or eyes, pain in the upper right abdomen, loss of appetite.

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

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

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

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult 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.

Other possible side effects with atorvastatin:

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

• Nasal passage inflammation, sore throat, nosebleeds.
• 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, muscle spasms.
• Blood test results that may show abnormal liver function.

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

• Anorexia (loss of appetite), weight gain, decreased 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.
• 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 temperature.
• Positive urine tests for white blood cells.

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

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

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

• Hearing loss.
• Gynaecomastia (breast enlargement in men).

Other 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:

It is more likely if you have high levels of sugar and fats in your 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 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. Storage of Atorvastatin Viatris

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

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

Do not use this medicine after the expiry date which is stated on the carton, label, and blister after CAD or 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 containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Viatris

• The active ingredient is atorvastatin.

Each film-coated tablet contains 40 mg of atorvastatin as atorvastatin calcium trihydrate.

• The other components of the tablet core are anhydrous colloidal 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.

Appearance of the Product and Container Content

The film-coated tablets are round and white to off-white in color. The tablets are marked with '40' on one side and have a score line on the other side.

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 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

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

Belgium: Atorvastatine Viatris 40 mg filmomhulde tabletten

Bulgaria: Atorgen 40 mg Film-coated tablets

Cyprus: Atorvastatin Mylan 40 mg film-coated tablets

Denmark: Atorvastatin Viatris 40 mg

Spain: Atorvastatina Viatris 40 mg film-coated tablets EFG

Greece: Atorvastatin/Mylan 40 mg film-coated tablets

Ireland: Atorvastatin Viatris 40 mg

Netherlands: Atorvastatine Mylan 40 mg filmomhulde tabletten

Poland: ATORVAGEN

Portugal: Atorvastatina Mylan 40 mg

United Kingdom (Northern Ireland): Atorvastatin 40 mg Film-coated Tablets

Czech Republic: Atorvastatin Viatris 40 mg

Slovakia: Atorvastatin Viatris 40 mg Filmom obalené tableta

Sweden: Atorvastatin Viatris 40 mg

Date of the last revision of this leaflet:September 2024

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