Atorvasterol

Package leaflet: Information for the patient

Atorvasterol, 80 mg, film-coated tablets
Atorvastatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 a low-fat diet and lifestyle changes alone are not effective.
In individuals at increased risk of heart disease and its recurrence, Atorvasterol may also be used to reduce this risk, even when cholesterol levels are within the normal range. During treatment, the standard cholesterol-lowering 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 potential 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 currently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Below is a list of conditions that may make Atorvasterol unsuitable for the patient. Before starting treatment with Atorvasterol, discuss these with your doctor or pharmacist:

• 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 a history of recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in close 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 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 possibly 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 required 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
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Some medicines may alter the effect of Atorvasterol or their effect on the body may be altered by Atorvasterol. This type of interaction may reduce the effectiveness of one or both medicines. Alternatively, it may increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, 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 of 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 of a bacterial infection with oral or injectable fusidic acid is necessary, treatment with Atorvasterol should be temporarily discontinued. Your doctor will inform you when it is safe to resume taking Atorvasterol.
Concomitant use of Atorvasterol with fusidic acid may rarely lead to muscle weakness, tenderness or muscle pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

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

Alcohol
Avoid excessive alcohol consumption while taking this medicine. More detailed information is 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 operating machinery
Atorvasterol usually does not affect the ability to drive or operate machinery. However, the patient should not drive if the medicine affects their ability to do so.
Do not use any tools or machinery 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, meaning the medicine is considered "sodium-free".

3. How to use Atorvasterol

This medicine should always be taken exactly as your doctor has advised. If in doubt, consult your
doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be
maintained throughout treatment with Atorvasterol.
The recommended starting dose of Atorvasterol is 10 mg once daily in adults and children aged 10 years
or older. This dose may be adjusted by your doctor as needed to achieve the appropriate dose 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 nearest hospital for advice.
Missing a dose of Atorvasterol
If you forget to take your 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 using this medicine or if you wish to stop treatment, consult
your doctor, pharmacist, or nurse.

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 a doctor or go to the emergency department of the
nearest hospital without delay.
Rare (occurring in 1 to 10 out of 10,000 patients):

• severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties
• severe illness characterized by peeling and swelling of the skin, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters
• muscle weakness, tenderness, muscle pain, or muscle rupture, red-brown discoloration of urine, especially if accompanied by malaise or high fever. This may be due to abnormal muscle breakdown, which may persist even after discontinuation of atorvastatin treatment, may be life-threatening, and may lead to kidney problems.

Very rare (occurring in fewer than 1 in 10,000 patients):

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

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

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

Uncommon (occurring 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 of the ankles, elevated temperature
• presence of white blood cells in urine.

Rare (occurring 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 (occurring in fewer than 1 in 10,000 patients):

• allergic reactions – symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynaecomastia (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 that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, they should consult a doctor. Other possible adverse reactions reported during treatment with certain 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 individuals with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your 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 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 provide more information on the safety of the medicine.

5. How to store Atorvasterol

Keep this medicine out of the sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month indicated.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the marking following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via the sewage system 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 Atorvasterol contains

• The active substance is atorvastatin. Each coated tablet contains 80 mg of atorvastatin (as calcium salt).
• Other ingredients are: mannitol (E 421), microcrystalline cellulose, calcium carbonate, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol 6000.

What Atorvasterol looks like and contents of the pack
White, oval, biconvex coated tablets, 10 mm x 19 mm.
Aluminum/OPA/PVC/Aluminum blisters in cardboard packaging containing 30 coated tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01