Atorvasterol

Leaflet accompanying the packaging: patient information

Atorvastatin, 10 mg, film-coated tablets

Atorvastatin, 20 mg, film-coated tablets

Atorvastatin, 40 mg, film-coated tablets

Atorvastatin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective.
Atorvastatin may also be used to reduce the risk of heart disease and stroke, 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 the patient is 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 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 contraception methods;
• in pregnant or breastfeeding women;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin, the patient should discuss it with their doctor or pharmacist.
The following are reasons why Atorvastatin may not be suitable for the patient:

• 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 the patient is currently taking or has taken fusidic acid orally or by injection in the last 7 days. Concurrent 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 concurrently (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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines may change the effect of Atorvastatin or be affected by Atorvastatin. This type of interaction may reduce the effectiveness of one or both medicines or increase the risk of severe side effects, including serious 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; as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone;
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc.;
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir;
• other medicines that are known to interact with Atorvastatin, such as ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (used to treat 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, the patient should temporarily stop taking Atorvastatin. The doctor will inform the patient when it is safe to resume taking Atorvastatin.
Taking Atorvastatin with fusidic acid can rarely 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, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts 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, the patient should not drive if the medicine affects their ability to drive. The patient should not use any tools or machines if the medicine affects their ability to use them.

Atorvastatin contains sodium

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

3. How to take Atorvastatin

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Before starting treatment, the 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 by the doctor if necessary, up 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, the patient should try to take the tablet at the same time every day.
The duration of treatment with Atorvastatin is determined by the doctor.

Taking a higher dose of Atorvastatin than recommended

In case of accidental ingestion of too many Atorvastatin tablets (more than the usual daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin

If a dose is missed, the patient should simply take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin 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 or go to the emergency department of the nearest hospital immediately.

Rare (affecting 1 in 10,000 patients):

• severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties
• severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Rash with reddish-purple spots, especially on the palms or soles, with possible blisters
• muscle weakness, tenderness, or pain, or muscle rupture, with brownish-red urine. If this is accompanied by malaise or high fever, it may be caused by a life-threatening condition that can cause kidney problems - rhabdomyolysis, which can persist even after stopping atorvastatin treatment.

Very rare (affecting less 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 problems. The patient should consult their doctor as soon as possible.

Other possible side effects of Atorvastatin:

Common (affecting 1 in 10 patients):

• nasal congestion, 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 in 100 patients):

• 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
• 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 in 10,000 patients):

• 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 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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
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 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 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 inscription 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. 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 pack and other information

What Atorvastatin contains

• The active substance of Atorvastatin 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: