Atorvastatin Teva Pharmaceuticals Polska

PATIENT INFORMATION LEAFLET: USER INFORMATION

Atorvastatin Teva Pharmaceuticals Polska, 10 mg, film-coated tablets

Atorvastatin Teva Pharmaceuticals Polska, 20 mg, film-coated tablets

Atorvastatin Teva Pharmaceuticals Polska, 40 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, pharmacist or nurse.
• 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 not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS ATORVASTATIN TEVA PHARMACEUTICALS POLSKA AND WHAT IS IT USED FOR

Atorvastatin Teva Pharmaceuticals Polska belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Atorvastatin Teva Pharmaceuticals Polska 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 Teva Pharmaceuticals Polska 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 TEVA PHARMACEUTICALS POLSKA

When not to take Atorvastatin Teva Pharmaceuticals Polska

• if the patient is allergic to atorvastatin or any other ingredient 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,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing age who do not use effective contraception methods,
• in pregnant or breastfeeding women,
• in women who are breastfeeding.

Warnings and precautions

Before starting treatment with Atorvastatin Teva Pharmaceuticals Polska, the patient should discuss the following with their doctor, pharmacist or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Teva Pharmaceuticals Polska can cause serious muscle problems (rhabdomyolysis),
• if the patient has had a stroke with bleeding in the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• if the patient has kidney problems,
• if the patient has hypothyroidism (underactive thyroid),
• if the patient has had repeated or unexplained muscle pain, or muscle problems in the past, or similar problems in family members,
• if the patient has had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient regularly drinks large amounts of alcohol,
• if the patient has had liver disease in the past,
• in patients over 70 years of age.
• if the patient has persistent muscle weakness and elevated creatine kinase levels in the blood, which persist despite stopping statin treatment.

If any of these conditions apply to the patient, their doctor will order a blood test before starting treatment with Atorvastatin Teva Pharmaceuticals Polska and may do so during treatment to monitor the risk of side effects related to the muscles. It is known that the risk of muscle side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atorvastatin Teva Pharmaceuticals Polska and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
The patient should talk to their doctor or pharmacist before taking Atorvastatin Teva Pharmaceuticals Polska if they have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen symptoms or cause myasthenia (see section 4).
During treatment with Atorvastatin Teva Pharmaceuticals Polska, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Teva Pharmaceuticals Polska and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take. Some medicines can change the effect of Atorvastatin Teva Pharmaceuticals Polska, or the effect of these medicines on the body may be changed by Atorvastatin Teva Pharmaceuticals Polska. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or 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; and certain medicines used to regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent disease caused by cytomegalovirus,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines that are known to interact with Atorvastatin Teva Pharmaceuticals Polska include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (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 the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Teva Pharmaceuticals Polska. The doctor will tell the patient when it is safe to restart treatment with Atorvastatin Teva Pharmaceuticals Polska. Taking Atorvastatin Teva Pharmaceuticals Polska with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Atorvastatin Teva Pharmaceuticals Polska with food, drink, and alcohol

Information on taking Atorvastatin Teva Pharmaceuticals Polska 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 of grapefruit juice can change the effect of Atorvastatin Teva Pharmaceuticals Polska.
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 Teva Pharmaceuticals Polska during pregnancy or breastfeeding is contraindicated.
Taking Atorvastatin Teva Pharmaceuticals Polska in women of childbearing age is contraindicated if they do not use effective contraception methods.
The safety of Atorvastatin Teva Pharmaceuticals Polska during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult a doctor or pharmacist.

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 do so. The patient should not use any tools or machines if taking the medicine affects their ability to use them.

Important information about some ingredients of Atorvastatin Teva Pharmaceuticals Polska

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Atorvastatin Teva Pharmaceuticals Polska contains sodium

This 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 TEVA PHARMACEUTICALS POLSKA

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Teva Pharmaceuticals Polska.
Usually, the initial dose of Atorvastatin Teva Pharmaceuticals Polska for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvastatin Teva Pharmaceuticals Polska at intervals of at least 4 weeks. The maximum dose of Atorvastatin Teva Pharmaceuticals Polska is 80 mg once daily.
Atorvastatin Teva Pharmaceuticals Polska 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.
This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Duration of treatment with Atorvastatin Teva Pharmaceuticals Polska is determined by the doctor

If the patient feels that the effect of Atorvastatin Teva Pharmaceuticals Polska is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atorvastatin Teva Pharmaceuticals Polska than recommended

If the patient has accidentally taken more than the recommended dose of Atorvastatin Teva Pharmaceuticals Polska (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Teva Pharmaceuticals Polska

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

Stopping treatment with Atorvastatin Teva Pharmaceuticals Polska

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Atorvastatin Teva Pharmaceuticals Polska 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: may occur in up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or brownish-red urine color. If the patient also feels unwell or has a high fever, it may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops taking atorvastatin, and it can be life-threatening and cause kidney problems.

Very rare: may occur in up to 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult their doctor as soon as possible.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Teva Pharmaceuticals Polska:

Common: may occur in up to 1 in 10 people

• 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: may occur in up to 1 in 100 people

• 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 of fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated body temperature
• presence of white blood cells in the urine

Rare: may occur in up to 1 in 1,000 people

• vision disturbances
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (signs of vasculitis)

Very rare: may occur in up to 1 in 10,000 people

• 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 breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes muscle weakness in the eyes)

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
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 this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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
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 or its representative.
Reporting side effects can help gather more information on the safety of the medicine.

5. HOW TO STORE ATORVASTATIN TEVA PHARMACEUTICALS POLSKA

Keep out of the reach and sight of children.
Store in a temperature below 30°C.
Do not use Atorvastatin Teva Pharmaceuticals Polska after the expiry date stated on the packaging.
Do not use Atorvastatin Teva Pharmaceuticals Polska after the expiry date stated on the blister and carton after the "EXP:" or "Expiry date (EXP):" label. The expiry date refers to the last day of the given month.
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 Teva Pharmaceuticals Polska contains

• The active substance of the medicine is atorvastatin (in the form of atorvastatin calcium) in a quantity of 10 mg, 20 mg, or 40 mg. The medicine also contains: core: microcrystalline cellulose, sodium carbonate, maltose, sodium carmellose, magnesium stearate; coating: hypromellose 6cP, low-substituted hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E171).

What Atorvastatin Teva Pharmaceuticals Polska looks like and what the pack contains

ATORVASTATIN TEVA PHARMACEUTICALS POLSKA, 10 mg, film-coated tablets: white or almost white, elliptical, biconvex, and smooth film-coated tablets. The dimensions of each tablet are approximately 9.7 mm x 5.2 mm.
ATORVASTATIN TEVA PHARMACEUTICALS POLSKA, 20 mg, film-coated tablets: white or almost white, elliptical, biconvex, and smooth film-coated tablets. The dimensions of each tablet are approximately 12.5 mm x 6.6 mm.
ATORVASTATIN TEVA PHARMACEUTICALS POLSKA, 40 mg, film-coated tablets: white or almost white, elliptical, biconvex, and smooth film-coated tablets. The dimensions of each tablet are approximately 15.6 mm x 8.3 mm.
The pack contains 30 and 90 film-coated tablets.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Teva Pharma, S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza
Spain
Date of last revision of the leaflet:February 2025