Atorvastatin Zentiva Italia

PATIENT INFORMATION LEAFLET

Atorvastatina Zentiva Italia 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Atorvastatina Zentiva Italia is and what it is used for
2. What you need to know before taking Atorvastatina Zentiva Italia
3. How to take Atorvastatina Zentiva Italia
4. Possible side effects
5. How to store Atorvastatina Zentiva Italia
6. Contents of the pack and other information

1. What Atorvastatina Zentiva Italia is and what it is used for

Atorvastatina Zentiva Italia belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Atorvastatina Zentiva Italia is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been effective. If you are at high risk of cardiovascular disease, Atorvastatina Zentiva Italia may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue a standard cholesterol-lowering diet.

2. What you need to know before taking Atorvastatina Zentiva Italia

Do not take Atorvastatina Zentiva Italia

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had liver disease;
• if liver function tests have shown unexplained abnormal results;
• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C;
• if you are a woman of childbearing age and are not using a reliable method of contraception;
• if you are pregnant or planning to become pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatina Zentiva Italia. Listed below are reasons why Atorvastatina Zentiva Italia may not be suitable for you:

• if you have severe respiratory insufficiency;
• if you are taking or have taken within the last 7 days oral or injectable fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Atorvastatina Zentiva Italia can lead to serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with cerebral haemorrhage or if you have low fluid reserves in the brain due to previous strokes;
• if you have kidney problems;
• if you have an underactive thyroid gland (hypothyroidism);
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders;
• if you have previously had muscle problems while being treated with other lipid-lowering medicines (e.g. other medicines of the “statin” or “fibrate” class);
• if you regularly consume large amounts of alcohol;
• if you have a history of liver disease;
• if you are over 70 years old.

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with Atorvastatina Zentiva Italia to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatina Zentiva Italia”).
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be necessary to diagnose and manage this condition.
While taking this medicine, your doctor should carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatina Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Atorvastatina Zentiva Italia, or their effects may be altered by Atorvastatina Zentiva Italia. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine;
• Certain antibiotics or antifungals, 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; medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone;
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.;
• Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir;
• Over-the-counter medicines: St. John’s wort;
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will inform you when it is safe to resume taking Atorvastatina Zentiva Italia. Taking Atorvastatina Zentiva Italia with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Atorvastatina Zentiva Italia with food, drinks and alcohol
See section 3 for instructions on how to take Atorvastatina Zentiva Italia. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effects of Atorvastatina Zentiva Italia.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further information, refer to section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Atorvastatina Zentiva Italia if you are pregnant or planning to become pregnant.
Do not take Atorvastatina Zentiva Italia if you think you could become pregnant unless you are using an effective method of contraception.
Do not take Atorvastatina Zentiva Italia if you are breastfeeding.
The safety of Atorvastatina Zentiva Italia during pregnancy and breastfeeding has not yet been established.

Driving and using machines
Generally, this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to operate them is impaired by this medicine.

Atorvastatina Zentiva Italia contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Atorvastatina Zentiva Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatina Zentiva Italia.
The usual starting dose of Atorvastatina Zentiva Italia is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of Atorvastatina Zentiva Italia is 80 mg once daily.
Atorvastatina Zentiva Italia tablets should be swallowed whole with water and may be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
The duration of treatment with Atorvastatina Zentiva Italia is determined by your doctor.
If you feel that the effect of Atorvastatina Zentiva Italia is too strong or too weak, consult your doctor.
If you take more Atorvastatina Zentiva Italia than you should
If you accidentally take too many Atorvastatina Zentiva Italia tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatina Zentiva Italia
If you forget to take a dose, take the next dose at the correct time.
Do not take a double dose to make up for the missed dose.
If you stop taking Atorvastatina Zentiva Italia
If you have any doubts about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects or symptoms, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department.
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 significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, and genital area, accompanied by fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
• Weakness, tenderness, muscle pain, or muscle breakdown, especially if you simultaneously feel unwell or have a high fever. This may be due to abnormal muscle deterioration (rhabdomyolysis). Abnormal muscle deterioration does not always resolve after stopping atorvastatin and may be life-threatening and lead to kidney problems.

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

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

Other possible side effects with Atorvastatina Zentiva Italia:
Common (may affect up to 1 in 10 people):

• Inflammation of the nasal airways, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, joint swelling, muscle pain, muscle spasms, pain in arms and legs, and back pain
• Blood test results showing possible changes in liver function.

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, reduced sensation or tingling in the fingers of hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin eruption, and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells.

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

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage.

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

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (breast enlargement in men).

Side effects with unknown frequency (frequency cannot be determined from available data):

• Persistent muscle weakness. Possible side effects reported with some statins (medicines of the same type):
• Sexual dysfunction
• Depression
• Breathing difficulties including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store Atorvastatina Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atorvastatina Zentiva Italia contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other components are:
Core: calcium carbonate, microcrystalline cellulose (E 460), lactose monohydrate, low-substituted hydroxypropylcellulose, povidone K12, anhydrous colloidal silica, magnesium stearate (E 572).
Coating: hypromellose (E 464), macrogol 6000, titanium dioxide (E 171), talc, yellow iron oxide (E 172), lactose monohydrate.

Description of the appearance of Atorvastatina Zentiva Italia and pack contents
Atorvastatina Zentiva Italia 10 mg film-coated tablets are white or almost white, film-coated, round, biconvex tablets. The tablet diameter is approximately 6 mm.
Atorvastatina Zentiva Italia 20 mg film-coated tablets are yellowish, film-coated, round, biconvex tablets. The tablet diameter is approximately 8 mm.
Atorvastatina Zentiva Italia 40 mg film-coated tablets are yellow-orange to orange-yellow, film-coated, round, biconvex tablets. The tablet diameter is approximately 10 mm.
Atorvastatina Zentiva Italia 80 mg film-coated tablets are orange-yellow, film-coated, round, biconvex tablets. The tablet diameter is approximately 12 mm.

Pack sizes:
10 mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets.
20 mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets.
40 mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets.
80 mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder:
Zentiva Italia S.r.l. - Viale L. Bodio, 37/b - 20158 Milano, Italy

Manufacturers:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10, Czech Republic

Uždaroji Akcine Bendrove “Oriola Vilnius”
Laisves pr. 75
06144 Vilnius, Lithuania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This leaflet was last updated on