Atorvagen

Leaflet attached to the packaging: patient information

Atorvagen, 10 mg, film-coated tablets

Atorvagen, 20 mg, film-coated tablets

Atorvagen, 40 mg, film-coated tablets

(Atorvastatin)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 on their own are not effective.
Atorvagen can also be used to reduce the risk of heart disease, even if the cholesterol level is 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 the patient is allergic to atorvastatin or any other similar medicines used to lower lipid levels in the blood 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 virus infection
• 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 do not use effective methods of contraception
• in pregnant or breast-feeding women
• in women who are breast-feeding

Warnings and precautions

Before starting to take Atorvagen, you should discuss this with your doctor or pharmacist:

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

If any of the above situations apply to the patient, the doctor will order a blood test before starting 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 levels of sugars and fats in the blood, patients who are overweight, and patients with high blood pressure.
The doctor or pharmacist should also be informed if muscle weakness persists. 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 currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may 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, colestyramine, 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 virus infection, such as telaprevir, boceprevir, and a combination product containing 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 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 aluminum or magnesium)
• over-the-counter medicines: St. John's Wort
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria)

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 the use of Atorvagen can be found in section 3. However, please note the following:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atorvagen.
Alcohol
While taking Atorvagen, you should avoid consuming excessive amounts of alcohol. More information on this can be found in section 2: "Warnings and precautions".

Pregnancy and breast-feeding

Atorvagen should not be taken by women who are pregnant or plan to become pregnant. The use of Atorvagen in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Atorvagen should not be taken during breast-feeding.
The safety of atorvastatin during pregnancy and breast-feeding has not been established. Before taking this medicine, you should consult a doctor or pharmacist.

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. The patient should not use any tools or machines if the use of 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 the medicine is considered "sodium-free".

3. How to take Atorvagen

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts, you should consult a 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 in adults and children aged 10 years and older. This dose may be increased by your doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvagen at intervals of at least 4 weeks. The maximum dose of Atorvagen is 80 mg once a day.
Atorvagen tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, you should 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 you feel that the effect of Atorvagen is too strong or too weak, you should consult a doctor.

Taking a higher dose of Atorvagen than recommended

If you have accidentally taken more than the recommended dose of Atorvagen (more than the usual daily dose), you should contact a doctor or the nearest hospital for advice.

Missing a dose of Atorvagen

If you miss a dose, you should 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 doubts about taking this medicine and plan to stop treatment, you should consult a 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 the medicine 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;
• a severe skin condition characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. A 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 this is accompanied by a feeling of general malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops 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 less than 1 in 10,000 people:

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

The patient should talk to their doctor if they experience weakness in their hands or feet, 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 patients with diabetes, 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 patients with diabetes, blood glucose levels should continue to be closely monitored);
• nightmares, insomnia;
• dizziness, numbness or tingling in the fingers of the hands and feet, decreased 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;
• skin rash, skin rash and itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, general 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;
• a skin rash that may occur on the skin or ulcers in the mouth (lichenoid drug reaction);
• purple skin discoloration (symptoms of vasculitis).

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

• hearing loss;
• gynecomastia (excessive breast tissue growth 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 levels of sugars and fats in the blood, is overweight, and has high blood pressure. During treatment with this medicine, the doctor will closely monitor the patient.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Atorvagen

The medicine should be stored out of 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 that month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 10 mg, 20 mg, or 40 mg of atorvastatin in the form of atorvastatin calcium trihydrate.
The other ingredients in the tablet core are: anhydrous colloidal 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 10 mg tablets are marked with "10" on one side, 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 authorization holder and manufacturer

Marketing authorization holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary
Logiters, Logistica, Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal
Mylan UK Healthcare Limited
Building 20, Station Close, Potters Bar
EN6 1TL
United Kingdom
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet:September 2024