Atorvagen

Package leaflet: Information for the patient

Atorvagen, 20 mg, film-coated tablets
Atorvagen, 40 mg, film-coated tablets
(Atorvastatinum)
Read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Atorvagen is and what it is 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 Atorvagen is and what it is used for

Atorvagen belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvagen is used to reduce blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are not effective.
Atorvagen may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range.
Standard cholesterol-lowering diet should be continued during treatment.

2. Important information before using Atorvagen

When not to use Atorvagen:

• if the patient is allergic to atorvastatin or to any other similar medicines used to lower blood lipid levels, or to 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 currently has or has previously 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 women or women planning to become pregnant
• in breastfeeding women

Warnings and precautions
Before starting treatment with Atorvagen, discuss the following with your doctor or pharmacist:

• if the patient has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4)
• if the patient has severe respiratory insufficiency
• in case of previous stroke or "mini-stroke" (also called transient ischaemic attack), 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 reduced thyroid gland function (hypothyroidism)
• in case of previous episodes of unexplained muscle pain or muscle problems, or if such problems occurred in family members
• 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 large amounts of alcohol
• in case of previous liver diseases
• in patients over 70 years of age
• if the patient is taking or has taken within the last 7 days fusidic acid (a medicine used for bacterial infections) – orally or by injection. Concomitant use of fusidic acid and Atorvagen 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 adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when other medicines with similar effects are used concomitantly (see section 2: "Atorvagen with other medicines").
If the patient has diabetes or is at risk of developing diabetes, the patient will be under close medical supervision during treatment with Atorvagen. The risk of developing diabetes is higher in patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure.
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medications may be necessary to diagnose and treat this condition.
Atorvagen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may alter the effect of atorvastatin or their effect may be altered by atorvastatin. This type of interaction may result in reduced effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine
• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine, niacin
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• letermovir, a medicine used to prevent cytomegalovirus disease
• medicines used in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
• certain medicines used in the treatment of hepatitis C virus infection, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
• other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (a medicine used in the treatment of gout), and acid-neutralizing medicines (medicines used for indigestion containing aluminium or magnesium)
• over-the-counter medicines: St John's wort
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria)

If the patient needs to take oral fusidic acid for the treatment of bacterial infections, they should temporarily stop taking this medicine. The doctor will decide when it is safe to resume treatment with Atorvagen. Concomitant use of Atorvagen with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information about rhabdomyolysis can be found in section 4.
Atorvagen, food, drink, and alcohol
Information on how to take Atorvagen is provided in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Atorvagen.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. Further details are provided in section 2: "Warnings and precautions".
Pregnancy and breastfeeding
Do not use Atorvagen in women who are pregnant or planning to become pregnant. The use of Atorvagen in women of childbearing potential is contraindicated unless they are using effective methods of contraception.
Do not use Atorvagen during breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Atorvagen usually does not affect the ability to drive or operate machinery. However, patients should not drive if the medicine affects their ability to do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.
Atorvagen contains lactose and sodium.
Patients who have been advised by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free."

3. How to take Atorvagen

This medicine should always be taken exactly as your doctor or pharmacist has advised. If in doubt,
you should consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be
continued throughout treatment with Atorvagen.
The recommended starting dose of Atorvagen is 10 mg once daily in adults and children aged 10 years and older. This dose may be adjusted by the doctor as needed, up to the dose appropriate for the individual patient. Your doctor will adjust the dose at intervals of 4 weeks or longer. The maximum dose of Atorvagen is 80 mg once daily.
Atorvagen tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is advisable to take the tablet at approximately the same time each day. The 20 mg and 40 mg tablets may 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, you should consult your doctor.
Taking more Atorvagen than you should
If you accidentally take too many Atorvagen tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvagen
If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Atorvagen
If you have any further questions about using this medicine, or if you are planning to stop treatment, you should consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions or symptoms, the medicine must be discontinued immediately and the patient should contact a doctor or go to the emergency department of the nearest hospital without delay:
Uncommon: may occur in 1 out of 100 patients:

• pancreatitis (inflammation of the pancreas causing acute abdominal pain radiating to the back);
• hepatitis.

Rare: may occur in 1 out of 1,000 patients:

• 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 illness characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters;
• weakness, tenderness, muscle pain, muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of striated muscle). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems;
• biliary obstruction (cholestasis), which may cause symptoms such as yellowing of the skin or eyes, pain in the upper right part of the abdomen, loss of appetite.

Very rare: may occur in less than 1 out of 10,000 patients:

• If the patient experiences pain in the upper right part of the abdomen, abdominal swelling, and yellowing of the skin or eyes, this may indicate liver abnormalities. Medical advice should be sought immediately;
• 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 causing general muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease causing weakness of the eye muscles).

Patients should speak to their doctor if they experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions of Atorvagen:
Common (may occur in less than 1 out of 10 patients):

• inflammation of the nasal passages, 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, flatulence, indigestion, diarrhoea;
• joint pain, muscle pain, and back pain, muscle cramps;
• blood test results indicating potential liver function abnormalities.

Uncommon (may occur in 1 out of 100 patients):

• anorexia (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 fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss;
• blurred vision;
• tinnitus and/or in the head;
• vomiting, regurgitation, pain in the upper and lower abdomen;
• rash, skin rash and itching, urticaria, hair loss;
• neck pain, muscle fatigue;
• fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature;
• presence of white blood cells in urine analysis.

Rare (may occur in 1 out of 1,000 patients):

• visual disturbances;
• unexpected bleeding or bruising (bruises);
• tendon rupture;
• rash which may appear on the skin, or oral ulcers (lichenoid drug reaction);
• purple skin lesions (symptoms of vasculitis).

Very rare (may occur in less than 1 out of 10,000 patients):

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

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

• sexual dysfunction;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diabetes: the likelihood of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight, and high blood pressure. The doctor will carefully monitor the patient during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvagen

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

6. Contents of the pack and other information

What Atorvagen contains
The active substance is atorvastatin. Each film-coated tablet contains 20 mg or 40 mg of
atorvastatin as 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 break line on the other side.
Atorvagen is available in opaque HDPE plastic bottles with PP caps, packed in cardboard boxes 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, and in 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 medicinal product is authorised in 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400