Atorvasterol

Package Leaflet: Information for the Patient

Atorvastatin, 10 mg, Film-Coated Tablets

Atorvastatin, 20 mg, Film-Coated Tablets

Atorvastatin, 40 mg, Film-Coated Tablets

Atorvastatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Atorvastatin and what is it used for

Atorvastatin belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin is used to lower the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes on their own have not been effective.
Atorvastatin may also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvastatin

When not to take Atorvastatin:

• if you are allergic to atorvastatin or any other similar medicine used to lower lipid levels in the blood or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had liver disease;
• if you have unexplained, abnormal liver function test results;
• in women of childbearing age who do not use effective contraception methods;
• in pregnant or breastfeeding women;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin, discuss it with your doctor or pharmacist.
The following are reasons why Atorvastatin may not be suitable for you:

• in case of a hemorrhagic 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 recurring or unexplained muscle pain 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 large amounts of alcohol;
• in case of liver disease;
• in patients over 70 years of age;
• in case of severe respiratory failure;
• if you are currently taking or have taken oral or injectable fusidic acid (used to treat bacterial infections) within the last 7 days. Concomitant administration of atorvastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis).

In patients who experience any of the above situations, the doctor will order a blood test before starting treatment with Atorvastatin and, if possible, during treatment to monitor the risk of muscle-related side effects.
It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken concomitantly (see section 2 "Atorvastatin and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications 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 risk of developing diabetes.

Atorvastatin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines may change the effect of Atorvastatin or be affected by Atorvastatin. This type of interaction can lead to reduced efficacy of one or both medicines or increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine;
• certain antibiotics and antifungals, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine;
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; and certain heart rhythm regulators, such as digoxin, verapamil, amiodarone;
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir, etc.;
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir;
• other medicines known to interact with Atorvastatin, such as 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 (used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium);
• over-the-counter medicines: St. John's Wort.

If it is necessary to treat a bacterial infection with fusidic acid orally or by injection, Atorvastatin should be temporarily discontinued. The doctor will inform the patient when it is safe to resume taking Atorvastatin.
Taking Atorvastatin with fusidic acid can, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Atorvastatin with food, drink, and alcohol

Information on taking Atorvastatin can be found in section 3. However, pay attention to the following:

Grapefruit juice
Do 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 Atorvastatin.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Atorvastatin during pregnancy or breastfeeding is contraindicated.
Taking Atorvastatin in women of childbearing age is contraindicated if they do not use effective contraception methods.
Taking Atorvastatin during breastfeeding is contraindicated.
The safety of Atorvastatin during pregnancy and breastfeeding has not been established.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, do not drive if the medicine affects your ability to drive. Do not use any tools or machines if taking the medicine affects your ability to use them.

Atorvastatin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Atorvastatin

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin.
The usual dose of Atorvastatin is 10 mg once a day for adults and children over 10 years of age. This dose may be increased if necessary by your doctor to the dose required for the individual patient. The doctor will adjust the dose of Atorvastatin at intervals of at least 4 weeks.
The maximum dose of Atorvastatin is 80 mg once a day for adults and 20 mg once a day for children.
Atorvastatin 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 duration of treatment with Atorvastatin is determined by your doctor.

Taking a higher dose of Atorvastatin than recommended

If you have taken too many Atorvastatin tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin

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 the missed dose.

Stopping treatment with Atorvastatin

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, stop taking Atorvastatin and contact your doctor immediately or go to the emergency department at your nearest hospital.

Rare (affecting 1 to 10 in 10,000 patients):

• severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties
• severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the hands or feet, with possible blisters
• weakness, tenderness, or pain in the muscles, reddish-brown urine. If accompanied by malaise or high fever, it may be caused by a life-threatening disease that can cause kidney problems - muscle breakdown, which can persist even after stopping atorvastatin treatment.

Very rare (affecting less than 1 in 10,000 patients):

• If you experience:
• lupus-like syndrome (including rash, joint pain, and effects on blood cells)
• unexpected or unusual bleeding or bruising, which may indicate liver problems. Consult your doctor as soon as possible.

Other possible side effects of Atorvastatin:

Common (affecting 1 to 10 patients in 100):

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function.

Uncommon (affecting 1 to 10 patients in 1,000):

• 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 and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin 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 (affecting 1 to 10 patients in 10,000):

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

Very rare (affecting less 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
• gynecomastia (excessive growth of breast tissue in men and women).

Unknown (frequency cannot be estimated from the available data):

• persistent muscle weakness.

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 risk of developing diabetes is higher in patients with high blood sugar and lipid levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 this medicine.

5. How to store Atorvastatin

Do not store above 25°C.
Keep the medicine out of the sight and 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 month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin contains

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

What Atorvastatin looks like and contents of the pack

Atorvastatin, 10 mg: white, round, biconvex, 7 mm, film-coated tablets.
Atorvastatin, 20 mg: white, round, biconvex, 9 mm, film-coated tablets.
Atorvastatin, 40 mg: white, oval, biconvex, 8.2 mm x 17 mm, film-coated tablets.
10, 30, or 100 film-coated tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Phone: +48 22 364 61 01

Date of last revision of the leaflet: