Atorvastatin Teva Pharmaceuticals Polska

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

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 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Atorvastatin Teva Pharmaceuticals Polska is and what it is 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 ATORVASTATIN TEVA PHARMACEUTICALS POLSKA IS AND WHAT IT IS 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 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 Teva Pharmaceuticals Polska may also be used to reduce the risk of heart disease, even if your cholesterol levels are normal.
During treatment, you should continue to follow a standard low-cholesterol diet.

2. IMPORTANT INFORMATION BEFORE TAKING ATORVASTATIN TEVA PHARMACEUTICALS POLSKA

When not to take Atorvastatin Teva Pharmaceuticals Polska

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have had unexplained, abnormal liver function tests,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant or breast-feeding women,
• in nursing mothers.

Warnings and precautions

Before taking Atorvastatin Teva Pharmaceuticals Polska, you should discuss with your doctor, pharmacist, or nurse:

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

If any of the above apply to you, your doctor will order a blood test before starting treatment with Atorvastatin Teva Pharmaceuticals Polska and as needed 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 at the same time (see section 2 "Atorvastatin Teva Pharmaceuticals Polska and other medicines").
Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
You should discuss with your doctor or pharmacist before taking Atorvastatin Teva Pharmaceuticals Polska if you 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, your doctor will closely monitor you for signs of diabetes or an increased risk of diabetes. Patients with high blood sugar and lipid 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Some medicines may affect the way Atorvastatin Teva Pharmaceuticals Polska works, or the way other medicines work, which can lead to reduced efficacy or increased risk of serious side effects, including muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or 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,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• 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, such as ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used for heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used for gout), and antacids (used for heartburn, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atorvastatin Teva Pharmaceuticals Polska. Your doctor will tell you when you can safely restart treatment with Atorvastatin Teva Pharmaceuticals Polska. Taking Atorvastatin Teva Pharmaceuticals Polska 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,
• 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 the use of Atorvastatin Teva Pharmaceuticals Polska can be found in section 3. However, please note the following:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the action of Atorvastatin Teva Pharmaceuticals Polska.
Alcohol
You should avoid excessive alcohol consumption while taking this medicine.
More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Atorvastatin Teva Pharmaceuticals Polska should not be taken by women who are pregnant or plan to become pregnant.
Atorvastatin Teva Pharmaceuticals Polska should not be taken by women of childbearing age who do not use effective methods of contraception.
Atorvastatin Teva Pharmaceuticals Polska should not be taken during breast-feeding.
The safety of Atorvastatin Teva Pharmaceuticals Polska during pregnancy and breast-feeding has not been established.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

Atorvastatin Teva Pharmaceuticals Polska is unlikely to affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive.
Do not use any tools or machines if your ability to use them is affected by your medicine.

Important information about some of the ingredients of Atorvastatin Teva Pharmaceuticals Polska

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Atorvastatin Teva Pharmaceuticals Polska contains sodium

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

3. HOW TO TAKE ATORVASTATIN TEVA PHARMACEUTICALS POLSKA

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Teva Pharmaceuticals Polska.
The usual starting dose of Atorvastatin Teva Pharmaceuticals Polska for adults and children over 10 years old is 10 mg once daily. This dose may be increased if necessary by your doctor to the dose that is suitable for you. Your doctor will adjust your dose 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, try to take your tablet at the same time each day.
This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

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

If you feel that the effect of Atorvastatin Teva Pharmaceuticals Polska is too strong or too weak, talk to your doctor.

Taking more than the recommended dose of Atorvastatin Teva Pharmaceuticals Polska

If you accidentally take too many Atorvastatin Teva Pharmaceuticals Polska tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Teva Pharmaceuticals Polska

If you forget to take a dose, just take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Atorvastatin Teva Pharmaceuticals Polska

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 Teva Pharmaceuticals Polska can cause side effects, although not everybody gets them.

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

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Severe skin disease characterized by blistering and peeling of the skin, blisters on the mouth, eyes, genitals, and fever. Rash with reddish-purple spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, pain, or muscle rupture, or brownish discoloration of the urine. If you also feel unwell or have a high fever, this could be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always go away, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Teva Pharmaceuticals Polska:

Common: may affect up to 1 in 10 people

• nose and throat infections, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully 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 affect 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 carefully 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 and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin 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 affect up to 1 in 1,000 people

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

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

• allergic reactions - symptoms may include sudden wheezing, 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)

Talk to your doctor if you experience weakness in your 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 coughing and/or shortness of breath or fever
• diabetes; the risk of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN TEVA PHARMACEUTICALS POLSKA

Keep out of the sight and reach 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 "EXP:" or "Expiry date (EXP):". The expiry date refers to the last day of that month.
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 Teva Pharmaceuticals Polska contains

• The active substance is atorvastatin (as atorvastatin calcium) in a dose of 10 mg, 20 mg, or 40 mg. The other ingredients are: core: microcrystalline cellulose, sodium carbonate, maltose, sodium carboxymethylcellulose, magnesium stearate; coating: hypromellose 6cP, hydroxypropylcellulose low-substituted, triethyl citrate, polysorbate 80, titanium dioxide (E171).

What Atorvastatin Teva Pharmaceuticals Polska looks like and contents of the pack

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