Patient Information Leaflet: Product Information

Atorvastatina Viatris 80 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 side effects

5. Storage of Atorvastatina Viatris

6. Contents of the pack and additional information

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

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 have a high risk of heart disease,Atorvastatina Viatris may 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 Atorvastatina Viatris:

• If you are allergic to atorvastatin or to any other medication used to reduce blood lipids or to any of the other components of this medication (listed in section 6).
• If you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.
• If you have or have had any liver disease.
• If you have or have had unjustified abnormal results in blood tests for liver function.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnantor trying to become pregnant.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina Viatris:

-If you have or have had myasthenia (a disease that courses with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

• If you have severe respiratory insufficiency.
• If you have had a previous stroke or mini-stroke (also known as transient ischemic attack ('TIA')), or a hemorrhagic stroke, or have small embolisms of fluid in the brain from 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 previously during treatment with other medications to reduce lipids (for example, with 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 medication that contains fusidic acid, (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).

In any of these cases, your doctor may instruct you to have a blood test before and, possibly, during treatment with atorvastatin to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medications are taken at the same time (see section 2, “Other medications and Atorvastatina Viatris”).

While taking this medication, 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 blood sugar and lipid levels, overweight, and high blood pressure.

Also inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Other medications and Atorvastatina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

There are some medications that can affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medications. Alternatively, this concomitant use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine, niacin.
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps you avoid getting sick from cytomegalovirus.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
• Other medications used to treat hepatitis C, for example, telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medications 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 (products for indigestion that contain aluminum or magnesium).
• Over-the-counter medications: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication temporarily. Your doctor will instruct you when you can restart the treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may cause, rarely, muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections and bacteria present in the blood).

Atorvastatina Viatris with food, drinks, and alcohol

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of atorvastatin.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. 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 may become pregnant, unless you use adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding.

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

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to operate them.

Atorvastatina Viatris contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 atorvastatina treatment.

The recommended initial dose of atorvastatina is 10 mg once a dayin adults and children 10 years of age and older. 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 atorvastatina is 80 mg once a day.

Atorvastatina 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. The tablet can be divided into equal doses.

Your doctor will decide the duration of atorvastatina treatment:

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

If you take more Atorvastatina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Atorvastatina Viatris

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

If you interrupt treatment with Atorvastatina Viatris

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency service:

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

• Pancreatitis (pancreas inflammation that produces intense stomach pain, which can reach the back).
• Hepatitis (liver inflammation).

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

• Severe allergic reaction, symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, and throat, difficulty breathing, collapse.
• Severe skin disease with severe 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 that may form blisters.
• Muscle weakness, pain on palpation, urine discoloration brown-red, and especially, if at the same time you have discomfort or have high fever, it may be due to abnormal muscle breakdown(rhabdomyolysis). Abnormal muscle breakdown may not always disappear, even after you have stopped taking atorvastatin, andmay be fatal and cause kidney problems.
• Bile duct obstruction (cholestasis) that may 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 right 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 disease syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Unknown frequency(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 your arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing or difficulty breathing.

Other possible side effects with atorvastatin:

Common side effects(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, back pain, muscle spasms.
• Abnormal blood test results that may show abnormal liver function.

Less common side effects(may affect up to 10 in 100 people)

• Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to closely 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.
• 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 side effects(may affect up to 1 in 1,000 people)

• Vision changes.
• Unexpected bleeding or bruising.
• Tendon injury.
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction).
• Skin lesions of purple color (signs of blood vessel inflammation, vasculitis).

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

• Loss of hearing.
• Gynecomastia (breast enlargement 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:

It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting 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 leaflet. 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.

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

Do not usethis medication after the expiration date that appears on the carton box, bottle label, and blister pack after CADor EXP. The expiration date is the last day of the month indicated.

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

Composition of Atorvastatina Viatris

• The active ingredient is atorvastatina.

Each film-coated tablet contains 80 mg of atorvastatina as atorvastatina 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 contents of the package

The film-coated tablets are round and white to off-white in color.The tablets are marked with ‘80’ on one side andwith a notch 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 blister of 28 tablets, and a multiple pack of 98 tablets that includes 2 cartons (each containing 49 tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer:

McDermott Laboratories Limited Trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

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

Mylan UK Healthcare Limited

Building 20, Station Close, Potters Bar

EN6 1TL

United Kingdom

Further information on this medicinal product can be obtained by contacting 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) with 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

Last review date of this leaflet:September 2024

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/