Atorvasterol

Leaflet accompanying the packaging: patient information

Atorvastatin, 80 mg, film-coated tablets

Atorvastatinum

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 tell 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. Package contents 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 known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes are not effective.
In people with an increased risk of heart disease and stroke, Atorvastatin may also be used to reduce this risk, even if the cholesterol level is normal. During treatment, a standard cholesterol-lowering 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 blood lipid levels 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

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

• in case of a 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 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 old;
• 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. Concomitant administration of atorvastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis).

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Atorvastatin and probably 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 fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Atorvastatin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Certain medicines may change the effect of Atorvastatin or the effect of these medicines on the body may be changed by Atorvastatin. This type of interaction may cause reduced efficacy of one or both medicines. Alternatively, it may increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• medicines that affect the immune system, such as cyclosporine;
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine;
• 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 of elbasvir and grazoprevir;
• other medicines known to interact with Atorvastatin include 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), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (medicines 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 may 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 patient should pay attention to the following information:
Grapefruit juice
The patient should 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
The patient should avoid drinking excessive amounts of alcohol while taking Atorvastatin.
More 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 taking 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 taking 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 the medicine is considered "sodium-free".

3. How to take Atorvastatin

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be maintained during treatment with Atorvastatin.
The recommended initial dose of Atorvastatin is 10 mg per day for adults and children over 10 years old. 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 per day for adults and 20 mg per 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 typical daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin

If the patient forgets to take a dose, they 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 any further doubts about taking this medicine or if the patient wants to stop treatment, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

If the patient experiences any of the 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 (affect 1 to 10 in 10,000 patients):

• severe allergic reaction causing swelling of the face, tongue, and throat, which can cause 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
• weakness, tenderness, or muscle pain, or muscle rupture, reddish-brown urine, especially if accompanied by malaise or high fever. This may be caused by abnormal muscle breakdown, which can persist even after stopping atorvastatin treatment and can be life-threatening and cause kidney problems.

Very rare (affect 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, this may indicate liver problems. The patient should consult their doctor as soon as possible.

Other possible side effects of Atorvastatin:

Common (affect 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 activity in the blood
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function.

Uncommon (affect 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 of the hands and feet, decreased sensitivity to pain and touch, change 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 (affect 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 (affect 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 fat 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 the medicine.

5. How to store Atorvastatin

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
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. Package contents and other information

What Atorvastatin contains

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

What Atorvastatin looks like and what the package contains

White, oval, biconvex, 10 mm x 19 mm, film-coated tablets.
OPA/Aluminum/PVC/Aluminum blisters in a cardboard box containing 30 film-coated tablets.

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: