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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their 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 packaging 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 reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective on their own.
Atorvagen can also be used to reduce the risk of heart disease, even if the cholesterol level is normal.
During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvagen

When not to take Atorvagen:

• if the patient is 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 the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C
• if the patient has or has had liver disease
• if the patient has unexplained, abnormal liver function test results
• in women of childbearing age who are not using effective methods of contraception
• in pregnant or breastfeeding women

Warnings and precautions

Before starting to take Atorvagen, the patient should discuss the following with their doctor or pharmacist:

• if the patient has or has had muscle weakness (a disease that causes general muscle weakness, including in some cases muscles involved in breathing), as statins can sometimes worsen the symptoms of the disease or lead to the development of muscle weakness (see section 4)
• if the patient has severe respiratory failure
• if the patient has had a stroke or "mini-stroke" (also known as a transient ischemic attack) or a stroke with bleeding in the brain or if there is a small amount of fluid in the brain from a previous stroke
• if the patient has kidney problems
• if the patient has reduced thyroid function (hypothyroidism)
• if the patient has had recurring muscle pain of unknown cause or muscle problems in the past or similar problems in relatives
• if the patient has had muscle problems while taking other lipid-lowering medicines in the past (e.g., other statins or fibrates)
• if the patient regularly consumes excessive amounts of alcohol
• if the patient has had liver disease in the past
• in patients over 70 years of age
• if the patient is taking or has taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid and Atorvagen at the same time can lead to serious muscle problems (rhabdomyolysis).

If any of the above situations apply to the patient, the 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 the patient has diabetes or is at risk of developing diabetes, the patient will be closely monitored by the doctor while taking Atorvagen. The risk of developing diabetes is higher in patients with high blood sugar and lipid levels, those who are overweight, and those with high blood pressure.
The doctor or pharmacist should also be informed if the patient experiences persistent muscle weakness. To diagnose and treat this condition, additional tests and medications may be necessary.

Atorvagen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines can change the effect of atorvastatin or the effect of these medicines on the body may be changed by atorvastatin. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can 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 cyclosporine
• 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, cholestyramine, niacin
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone
• letermovir, a medicine used to prevent cytomegalovirus disease
• 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, such as telaprevir, boceprevir, and a combination of elbasvir with grazoprevir, ledipasvir with sofosbuvir
• other medicines known to interact with atorvastatin, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (used to treat indigestion, containing aluminum or magnesium)
• over-the-counter medicines: St. John's Wort
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia)

If the patient needs to take fusidic acid orally for the treatment of bacterial infections, they should temporarily stop taking Atorvagen. The doctor will decide when it is safe to resume taking Atorvagen. Taking Atorvagen with fusidic acid can rarely lead to 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, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atorvagen.
Alcohol
Avoid excessive alcohol consumption while taking Atorvagen. More information on this can be found in section 2: "Warnings and precautions".

Pregnancy and breastfeeding

Do not take Atorvagen if you are pregnant or planning to become pregnant. Taking Atorvagen is contraindicated in women of childbearing age who do not use effective methods of contraception.
Do not take Atorvagen while breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Atorvagen usually does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to drive. Do not use any tools or machines if taking the medicine affects their ability to use them.

Atorvagen contains lactose and sodium.

Patients who have been informed by their doctor about intolerance to certain sugars should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Atorvagen

Take this medicine always as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Before starting treatment, the 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 daily in adults and children aged 10 years and older. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvagen at intervals of 4 weeks or more. The maximum dose of Atorvagen is 80 mg once daily.
Atorvagen tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day. The 20 mg and 40 mg tablets can be divided into equal doses.
The duration of treatment with Atorvagen is determined by the doctor.
If the patient feels that the effect of Atorvagen is too strong or too weak, they should consult their doctor.

Taking more than the recommended dose of Atorvagen

In case of accidental ingestion of more than the recommended dose of Atorvagen (more than the usual daily dose), consult a doctor or the nearest hospital for advice.

Missing a dose of Atorvagen

If a dose is missed, 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

In case of any further doubts about taking this medicine and if the patient plans to stop treatment, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects or symptoms, they should stop taking Atorvagen and contact their doctor immediately or go to the emergency department of the 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, chest pain or tightness, 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 in the mouth, eyes, genitals, and fever. 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 the patient also experiences malaise or high fever, it may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and may 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 less than 1 in 10,000 people:

• if the patient experiences upper right abdominal pain, abdominal swelling, and yellowing of the skin or eyes, it may indicate liver problems. The patient should consult their 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).

The patient should talk to their doctor if they experience weakness in their 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 (in diabetic patients, blood glucose levels should continue to be closely monitored), 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 (in diabetic patients, blood glucose levels should continue to be closely monitored);
• nightmares, insomnia;
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain and 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, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature;
• presence of white blood cells in the urine.

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

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

Very rare(may affect less than 1 in 10,000 people):

• hearing loss;
• gynecomastia (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 the patient has high blood sugar and lipid levels, is overweight, and has high blood pressure. During treatment with this medicine, the doctor will closely monitor the patient.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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 authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Atorvagen

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture. There are no special storage temperature recommendations for this medicine.
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 the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, hydroxypropyl cellulose, 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 and PP caps, 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 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 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 authorized 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 about this medicine, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

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