Atorvasterol

Package leaflet: Information for the patient

Atorvasterol, 10 mg, film-coated tablets
Atorvasterol, 20 mg, film-coated tablets
Atorvasterol, 40 mg, film-coated tablets
Atorvastatinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Atorvasterol is and what it is used for

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

2. Important information before using Atorvasterol

When not to use Atorvasterol:

• if the patient is allergic to atorvastatin or to any other similar medicine used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6);
• 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 women who are pregnant or planning to become pregnant;
• in women who are breastfeeding;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atorvasterol, discuss this with your doctor or pharmacist.
Below are reasons why Atorvasterol may not be suitable for the patient:

• if the patient currently 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);
• in case of haemorrhagic stroke, or if there is a small amount of fluid in the brain from a previous stroke;
• in case of kidney problems;
• in case of hypothyroidism;
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems 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 liver disease;
• in patients over 70 years of age;
• in case of severe respiratory insufficiency;
• if the patient is currently taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Concomitant administration of atorvastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atorvasterol and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 "Atorvasterol and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Atorvasterol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may alter the effect of Atorvasterol, or the effect of these medicines on the body may be altered by Atorvasterol. This type of interaction may reduce the 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, fusidic acid;
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir, etc.;
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir with grazoprevir;
• other medicines known to interact with Atorvasterol 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 (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium);
• over-the-counter medicines: St John's wort (Hypericum perforatum).

If treatment with fusidic acid (either oral or injectable) is required for a bacterial infection, treatment with Atorvasterol should be temporarily discontinued. Your doctor will inform you when it is safe to resume treatment with Atorvasterol.
Concomitant use of Atorvasterol with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Atorvasterol, food, drink and alcohol
Information on how to take Atorvasterol can be found 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 quantities may alter the effect of Atorvasterol.

Alcohol
While taking this medicine, avoid consuming excessive amounts of alcohol.
Further details on this are provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Use of Atorvasterol in women who are pregnant or planning to become pregnant is contraindicated.
Use of Atorvasterol in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
Use of Atorvasterol during breastfeeding is contraindicated.
The safety of Atorvasterol during pregnancy and breastfeeding has not been established.

Driving and using machines
Normally, this medicine 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.

Atorvasterol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Atorvasterol

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvasterol.
The usual dose of Atorvasterol is 10 mg once daily for adults and children aged 10 years or older. If necessary, your doctor may increase this dose up to the level required for the individual patient. Your doctor will adjust the dose at intervals of at least 4 weeks.
The maximum dose of Atorvasterol is 80 mg once daily for adults and 20 mg once daily for children.
Atorvasterol 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 the same time each day.
The duration of treatment with Atorvasterol is determined by your doctor.
Taking more Atorvasterol than prescribed
If you accidentally take too many Atorvasterol tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvasterol
If you forget to take a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Atorvasterol
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department
of the nearest hospital.

Rare (occurs in 1 out of 10,000 patients):

• severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties
• severe illness characterized by peeling and swelling of the skin, skin blisters, and blisters in the mouth, eyes, genitals, accompanied by fever; skin rash with pink-red spots especially on the palms or soles, possibly with blisters
• muscle weakness, tenderness, muscle pain or muscle rupture, red-brown discoloration of urine. If these symptoms occur together with malaise or high fever, this may indicate a life-threatening condition affecting the kidneys – rhabdomyolysis, which may persist even after discontinuation of atorvastatin treatment.

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

• if the patient experiences:
• lupus-like syndrome (including skin rash, joint problems and effects on blood cells)
• unexpected or unusual bleeding or bruising, which may indicate liver problems. Medical advice should be sought as soon as possible.

Other possible adverse reactions of Atorvasterol:
Common (occurs in 1 to 10 out of 100 patients):

• inflammation of nasal passages, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored), increased blood creatine kinase levels
• headache
• nausea, constipation, bloating, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• blood test results indicating abnormal liver function.

Uncommon (occurs in 1 to 10 out of 1,000 patients):

• anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• blurred vision
• ringing in the ears or head
• vomiting, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• hepatitis
• rash, skin rash and itching, urticaria, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling especially in the ankles, elevated temperature
• presence of white blood cells in urine.

Rare (occurs in 1 to 10 out of 10,000 patients):

• visual disturbances
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture.

Very rare (occurs in 1 out of 10,000 patients):

• allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• hearing loss
• gynecomastia (excessive growth of glandular breast tissue in men and women).

Unknown frequency (cannot be estimated from 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 eye muscles). If the patient experiences weakness in hands or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, they should speak to their doctor.

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 risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvasterol

Do not store above 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Atorvasterol contains

• The active substance is atorvastatin (in the form of atorvastatin calcium). Each coated tablet contains 10 mg, 20 mg or 40 mg of atorvastatin (in the form of atorvastatin calcium).
• Other ingredients are: mannitol (E 421), microcrystalline cellulose, calcium carbonate (E 170), povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 6000.

What Atorvasterol looks like and contents of the pack
Atorvasterol 10 mg: white, round, biconvex coated tablets, 7 mm in diameter.
Atorvasterol 20 mg: white, round, biconvex coated tablets, 9 mm in diameter.
Atorvasterol 40 mg: white, oval, biconvex coated tablets, 8.2 mm x 17 mm.
Blister packs containing 10, 30 or 100 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. + 48 22 364 61 01