Atorvastatin teva pharmaceuticals polska

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 entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others.
• It may harm other people, even if their symptoms are similar.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

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 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 (fat) metabolism in the body.
Atorvastatin Teva Pharmaceuticals Polska is used to lower blood levels of lipids known as cholesterol and triglycerides when diet low in fat and lifestyle changes alone are not effective. Atorvastatin Teva Pharmaceuticals Polska may also be used to reduce the risk of heart disease, even when cholesterol levels are normal.
A standard low-cholesterol diet should be continued during treatment.

2. IMPORTANT INFORMATION BEFORE USING ATORVASTATIN TEVA PHARMACEUTICALS POLSKA

Do not use Atorvastatin Teva Pharmaceuticals Polska if:

• the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• the patient has current or past liver disease,
• the patient has unexplained abnormal liver function test results,
• the patient is 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 women or women planning to become pregnant,
• in breastfeeding women.

Warnings and precautions
Before starting treatment with Atorvastatin Teva Pharmaceuticals Polska, discuss the following with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Atorvastatin Teva Pharmaceuticals Polska may lead to serious muscle problems (rhabdomyolysis),
• in case of haemorrhagic stroke, 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),
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• if the patient previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has a history of liver disease,
• in patients over 70 years of age,
• in case of persistent muscle weakness and elevated serum creatine kinase activity, which persists even after discontinuation of statin therapy.

For patients with any of the above conditions, the doctor may order a blood test before starting treatment with Atorvastatin Teva Pharmaceuticals Polska and, where possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are used concomitantly (see section 2 “Atorvastatin Teva Pharmaceuticals Polska and other medicines”).

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting Atorvastatin Teva Pharmaceuticals Polska if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms or trigger the onset of myasthenia (see section 4).

While on treatment, your doctor will closely monitor you for the development of diabetes or risk factors for diabetes. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Atorvastatin Teva Pharmaceuticals Polska and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines may alter the effect of Atorvastatin Teva Pharmaceuticals Polska, or the effect of those medicines on the body may be altered by Atorvastatin Teva Pharmaceuticals Polska. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol,
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination products containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atorvastatin Teva Pharmaceuticals Polska include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St John’s wort (Hypericum perforatum),
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily suspended. The doctor will inform the patient when it is safe to restart Atorvastatin Teva Pharmaceuticals Polska. Taking Atorvastatin Teva Pharmaceuticals Polska together with fusidic acid may 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 tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Teva Pharmaceuticals Polska, food, drink, and alcohol
Information on how to take Atorvastatin Teva Pharmaceuticals Polska is provided in section 3. However, please note the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Atorvastatin Teva Pharmaceuticals Polska.

Alcohol
Avoid excessive alcohol consumption while taking this medicine. Further details are provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Use of Atorvastatin Teva Pharmaceuticals Polska in women who are pregnant or planning to become pregnant is contraindicated.

Use of Atorvastatin Teva Pharmaceuticals Polska in women of childbearing potential is contraindicated unless effective contraception methods are used.

Use of Atorvastatin Teva Pharmaceuticals Polska during breastfeeding is contraindicated.

The safety of Atorvastatin Teva Pharmaceuticals Polska during pregnancy and breastfeeding has not been established.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
This medicine usually does not affect the ability to drive or operate machinery. However, patients should not drive if the medicine affects their ability to do so. Do not use any tools or machinery if taking this medicine impairs your ability to operate them safely.

Important information about certain ingredients of Atorvastatin Teva Pharmaceuticals Polska
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Atorvastatin Teva Pharmaceuticals Polska contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.

3. HOW TO USE 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 in adults and children aged 10 years or older is 10 mg once daily. This dose may be adjusted by your doctor as needed to achieve the appropriate dose for the patient. Your doctor will adjust the 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, it is recommended to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The 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, consult your doctor.
Taking more Atorvastatin Teva Pharmaceuticals Polska than prescribed
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 your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Atorvastatin Teva Pharmaceuticals Polska
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions or symptoms listed below,
they should stop taking the medicine immediately and contact their doctor or
go to the emergency department of the nearest hospital.

Rare: may occur in not more than 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, muscle pain or muscle rupture, or red-brown discoloration of urine. If these symptoms occur together with feeling unwell or high fever, this may be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after the patient stops taking atorvastatin; it may be life-threatening and may cause kidney problems.

Very rare: may occur in not more than 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. Medical advice should be sought as soon as possible.
• Drug-induced lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse reactions of Atorvastatin Teva Pharmaceuticals Polska:

Common: may occur in not more than 1 in 10 people

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored), increased blood creatine kinase levels
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in not more than 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially of the ankles, elevated temperature
• Presence of white blood cells in urine

Rare: may occur in not more than 1 in 1,000 people

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare: may occur in not more than 1 in 10,000 people

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in men)

Frequency not known: cannot be estimated from available data

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Patients should speak to their doctor if they experience weakness in arms or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes; the likelihood of developing diabetes is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. HOW TO STORE ATORVASTATIN TEVA PHARMACEUTICALS

POLAND
Keep out of the sight and reach of children.
Store 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 following the abbreviation "EXP:" or "Expiry date (EXP):". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps 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 strengths of 10 mg, 20 mg, or 40 mg.
  Other ingredients are:
  Core: microcrystalline cellulose, sodium carbonate, maltose, sodium croscarmellose, magnesium stearate;
  Coating: hypromellose 6 cP, low-substituted hydroxypropylcellulose, 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, smooth film-coated tablets. Each tablet measures approximately 9.7 mm x 5.2 mm.
ATORVASTATIN TEVA PHARMACEUTICALS POLSKA, 20 mg, film-coated tablets: white or almost white, elliptical, biconvex, smooth film-coated tablets. Each tablet measures approximately 12.5 mm x 6.6 mm.
ATORVASTATIN TEVA PHARMACEUTICALS POLSKA, 40 mg, film-coated tablets: white or almost white, elliptical, biconvex, smooth film-coated tablets. Each tablet measures approximately 15.6 mm x 8.3 mm.
Pack sizes contain 30 and 90 film-coated tablets.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80 Street
31-546 Kraków
Teva Pharma, S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza
Spain