Atorvagen

Leaflet accompanying the packaging: patient information

Atorvagen, 20 mg, film-coated tablets

Atorvagen, 40 mg, film-coated tablets

(Atorvastatin)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvagen and what is it used for
• 2. Important information before taking Atorvagen
• 3. How to take Atorvagen
• 4. Possible side effects
• 5. How to store Atorvagen
• 6. Contents of the pack and other information

1. What is Atorvagen and what is it used for

Atorvagen belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Atorvagen is used to lower the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes on their own have not been effective.
Atorvagen may also be used to reduce the risk of heart disease, even if your cholesterol levels are normal.
During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before taking Atorvagen

When not to take Atorvagen:

• if you are allergic to atorvastatin or any other similar medicines used to lower blood lipid levels or any of the other ingredients of this medicine (listed in section 6)
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection
• if you have or have had liver disease
• if you have had unexplained, abnormal liver function tests
• in women of childbearing age who are not using effective methods of contraception
• in pregnant or breast-feeding women
• in women who are breast-feeding

Warnings and precautions

Before taking Atorvagen, discuss with your doctor or pharmacist:

• if you have or have had muscle weakness (myasthenia) or eye muscle weakness (ocular myasthenia), as statins can sometimes worsen the symptoms of the disease or lead to myasthenia (see section 4)
• if you have severe respiratory failure
• if you have had a stroke or "mini-stroke" (transient ischaemic attack) or a haemorrhagic stroke or if there is a small amount of fluid in the brain from a previous stroke
• if you have kidney problems
• if you have decreased thyroid function (hypothyroidism)
• if you have had recurring muscle pain of unknown cause or muscle problems in the past or similar problems in relatives
• if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates)
• if you regularly drink excessive amounts of alcohol
• if you have had liver disease in the past
• if you are over 70 years old
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used for bacterial infections) - orally or by injection. Taking Atorvagen with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis).

If any of the above applies to you, your doctor will order a blood test before and (if possible) during treatment with atorvastatin to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when other medicines with similar effects are taken at the same time (see section 2: "Atorvagen and other medicines").
If you have diabetes or are at risk of developing diabetes, you will be closely monitored by your doctor while taking Atorvagen. The risk of developing diabetes is higher in patients with high blood sugar and lipid levels, patients who are overweight and have high blood pressure.
Your doctor or pharmacist should also be informed if you experience persistent muscle weakness. To diagnose and treat this condition, additional tests and medications may be necessary.

Atorvagen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take.
Some medicines may affect the way atorvastatin works or increase the risk of side effects. This type of interaction can reduce the effectiveness of one or both medicines or increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, such as cyclosporin
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine, niacin
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; and medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone
• letermovir, a medicine used to prevent disease caused by cytomegalovirus
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination medicine containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
• other medicines that are known to interact with atorvastatin, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminium or magnesium)
• over-the-counter medicines: St. John's Wort
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria)

If you need to take fusidic acid orally for the treatment of bacterial infections, you should temporarily stop taking Atorvagen. Your doctor will decide when it is safe to resume taking Atorvagen. Taking Atorvagen with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Atorvagen with food, drink, and alcohol

Information on taking Atorvagen can be found in section 3. However, please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the way Atorvagen works.
Alcohol
Avoid excessive alcohol consumption while taking Atorvagen. More information on this can be found in section 2: "Warnings and precautions".

Pregnancy and breast-feeding

Do not take Atorvagen if you are pregnant or breast-feeding. Atorvagen is contraindicated in women of childbearing age who are not using effective methods of contraception.
Do not take Atorvagen during breast-feeding.
The safety of atorvastatin during pregnancy and breast-feeding has not been established. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Atorvagen is unlikely to affect your ability to drive or use machines. However, do not drive if you experience any effects that may impair your ability to drive. Do not use any tools or machines if taking Atorvagen affects your ability to use them.

Atorvagen contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Atorvagen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvagen.
The recommended initial dose of Atorvagen is 10 mg once a day for adults and children aged 10 years and older. This dose may be increased if necessary by your doctor to the dose that is suitable for you. Your doctor will adjust your dose at intervals of 4 weeks or more. The maximum dose of Atorvagen is 80 mg once a day.
Swallow the tablets whole with water; they can be taken at any time of day, with or without food. However, try to take your tablet at the same time each day. The 20 mg and 40 mg tablets can be divided into equal doses.
The duration of treatment with Atorvagen is determined by your doctor.
If you feel that the effect of Atorvagen is too strong or too weak, talk to your doctor.

Taking too much Atorvagen

If you accidentally take too many Atorvagen tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Forgetting to take Atorvagen

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atorvagen

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvagen can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking Atorvagen and contact your doctor immediately or go to the casualty department at your nearest hospital:

Uncommon:may affect up to 1 in 100 people:

• pancreatitis (inflammation of the pancreas causing severe abdominal pain that may radiate to the back);
• liver inflammation.

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

• severe allergic reaction - symptoms may include sudden wheezing, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse;
• severe skin disease characterized by blistering and peeling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the hands or feet with possible blisters;
• muscle weakness, tenderness, or pain, muscle rupture, or brownish discoloration of the urine. If you also experience malaise or a high fever, this could be a sign of muscle breakdown (rhabdomyolysis). Muscle breakdown does not always go away, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems
• bile duct obstruction (cholestasis), which may cause symptoms such as yellowing of the skin or eyes, pain in the upper right abdomen, loss of appetite.

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

• if you experience abdominal pain, abdominal swelling, and yellowing of the skin or eyes, this may indicate liver problems. You should see a doctor as soon as possible;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Frequency not known:frequency cannot be estimated from the available data:

• persistent muscle weakness;
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease that causes muscle weakness in the eyes).

Talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of Atorvagen:

Common(may affect up to 1 in 10 people):

• nasal inflammation, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (if you have diabetes, you should continue to monitor your blood glucose levels carefully), increased blood creatine kinase levels;
• headache;
• nausea, constipation, bloating, indigestion, diarrhea;
• joint pain, muscle pain, and back pain, muscle spasms;
• blood test results indicating potential liver problems.

Uncommon(may affect up to 1 in 100 people)

• loss of appetite, weight gain, decreased blood glucose levels (if you have diabetes, you should continue to monitor your blood glucose levels carefully);
• nightmares, insomnia;
• dizziness, numbness or tingling in fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, abdominal pain;
• skin rash, skin rash and itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), increased body temperature;
• presence of white blood cells in the urine.

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

• vision disturbances;
• unexpected bleeding or bruising (bruises);
• tendon rupture;
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction);
• purple skin discoloration (symptoms of vasculitis).

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

• hearing loss;
• gynaecomastia (excessive growth of breast tissue in men).

Other possible side effects reported during treatment with some statins (medicines of the same type):

• sexual disorders;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diabetes: the likelihood is higher if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvagen

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from moisture. There are no special storage temperature requirements.
Do not use this medicine after the expiry date stated on the carton, label on the bottle, or blister after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atorvagen contains

The active substance of Atorvagen is atorvastatin. Each film-coated tablet contains 20 mg or 40 mg of atorvastatin in the form of atorvastatin calcium trihydrate.
The other ingredients in the tablet core are: colloidal anhydrous silica, sodium carbonate, microcrystalline cellulose, L-arginine, lactose, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. The coating contains: polyvinyl alcohol, titanium dioxide (E 171), talc, and macrogol.

What Atorvagen looks like and contents of the pack

White to off-white, round, film-coated tablets. The 20 mg tablets are marked with "20" on one side, and the 40 mg tablets are marked with "40" on one side. The 20 mg and 40 mg tablets have a score line on the other side.
Atorvagen is available in non-transparent plastic bottles with HDPE with a PP cap, in a cardboard box, containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 200, 250, or 500 tablets.
Atorvagen is also available in blisters containing 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets, calendar packs containing 28 tablets.
Not all 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 utca 1
Hungary
Logiters, Logistica, Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal
Viatris UK Healthcare Limited
Building 20, Station Close, Potters Bar
EN6 1TL
United Kingdom

This medicine 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
Netherlands: Atorvastatine Mylan
Czech Republic, Denmark, Ireland, Slovakia, Sweden: Atorvastatin Viatris
Bulgaria: Atorgen
Cyprus: Atorvastatin/Mylan
Greece: Atorvastatin/Mylan
Portugal: Atorvastatina Mylan
Spain: Atorvastatina Viatris
Poland: Atorvagen
United Kingdom (Northern Ireland): Atorvastatin [10/20/40/80] mg Film-coated Tablets
For more information on this medicine, contact your local representative of the marketing authorisation holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet:June 2025