Atorvastatin Teva Italia

Package leaflet: Information for the user

Atorvastatin Teva 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 taking this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Atorvastatina Teva Italia belongs to a group of medicines known as statins, which are drugs that regulate lipids (fats).
Atorvastatina Teva Italia is used to lower levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes alone are not sufficient. If you are at increased risk of developing heart disease, Atorvastatina Teva Italia may also be used to reduce this risk even if your cholesterol levels are normal. You must continue to follow a cholesterol-lowering diet during treatment.

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

Do not take Atorvastatina Teva Italia:

• If you are allergic to atorvastatin, to any similar medicine used to lower blood lipids, or to any of the other ingredients of this medicine (listed in section 6)
• If you have or have ever had a liver disease
• If you have had unexplained abnormal results in blood tests assessing liver function
• If you are a woman of childbearing potential and are not using a reliable method of contraception
• If you are pregnant or trying to become pregnant
• If you are breastfeeding
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatina Teva Italia.

• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and Atorvastatina Teva Italia can lead to serious muscle problems (rhabdomyolysis).
• If you have previously had a stroke with bleeding in the brain, or if you have small fluid-filled pockets in the brain as a consequence of previous strokes;
• If you have kidney problems;
• If your thyroid gland is underactive (hypothyroidism);
• If you have experienced repeated or unexplained muscle pain, or if you or a family member have a history of muscle disorders;
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other 'statins' or 'fibrates');
• If you regularly drink large amounts of alcohol;
• If you have a history of liver disease;
• If you are over 70 years old.

While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.
Talk to your doctor or pharmacist before taking Atorvastatina Teva Italia

• If you suffer from severe respiratory insufficiency.

If any of the conditions described above apply to you, your doctor will need to perform a blood test before and possibly during your treatment with Atorvastatina Teva Italia to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken together with atorvastatin (see section 2 'Other medicines and Atorvastatina Teva Italia').
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
Other medicines and Atorvastatina Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may alter the effect of Atorvastatina Teva Italia, or their effects may be altered by Atorvastatina Teva Italia. These interactions could make one or both medicines less effective. Alternatively, they could increase the risk or severity of side effects, including the serious condition of muscle breakdown known as rhabdomyolysis described in section 4:

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatina Teva Italia. Taking Atorvastatina Teva Italia with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information regarding rhabdomyolysis in section 4.
• Medicines used to alter the way the immune system works, e.g. cyclosporine;
• Other antibiotics (medicines for bacterial infections) or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin;
• Other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol;
• Some calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.;
• Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir;
• Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenytoin (an anticonvulsant), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium);
• Over-the-counter medicines: St. John’s wort.

Atorvastatina Teva Italia with food and drink
See section 3 for instructions on how to take Atorvastatina Teva Italia. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effects of Atorvastatina Teva Italia.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. See section 2 “Warnings and precautions” for details.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Atorvastatina Teva Italia if you are pregnant or trying to become pregnant.
Do not take Atorvastatina Teva Italia if you are of childbearing age unless you are using reliable contraceptive measures.
Do not take Atorvastatina Teva Italia if you are breastfeeding.
The safety of Atorvastatina Teva Italia during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Normally, this medicine does not affect your ability to drive or operate machinery.
However, do not drive if you notice that this medicine impairs your ability to drive. Do not use tools or machinery if your ability to use them is impaired by this medicine.
This medicine contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Atorvastatin Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will advise you to follow a low-cholesterol diet, which you should
continue throughout your therapy with Atorvastatin Teva Italia.
The recommended starting dose of Atorvastatin Teva Italia is 10 mg once daily in adults and in children aged 10 years and older. If necessary, your doctor may increase this dose
gradually until the required amount is reached. Your doctor will adjust the dose at intervals of 4 weeks or more.
The maximum dose of Atorvastatin Teva Italia is 80 mg once daily.
Swallow the Atorvastatin Teva Italia tablets whole with a glass of water. They can 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 Atorvastatin Teva Italia will be determined by your doctor.
Consult your doctor if you feel the effect of Atorvastatin Teva Italia is too strong or too weak.
If you take more Atorvastatin Teva Italia than you should
If you accidentally take too many Atorvastatin Teva Italia tablets (more than your usual daily dose),
contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatin Teva Italia
If you forget to take a dose, simply take the next scheduled dose at the correct time. Do not take a double
dose to make up for the missed dose.
If you stop taking Atorvastatin Teva Italia
If you have any doubts about using this medicine or wish to discontinue treatment, speak to your
doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience 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 cause severe breathing difficulties
• Severe illness with extensive skin peeling and swelling, blistering of the skin, inside the mouth, eyes, genitals, and fever. Skin rash with red-pink patches, especially on the palms of the hands or soles of the feet, where blisters may develop
• Weakness, tenderness, muscle pain, muscle breakdown or red-brown discoloration of urine, especially if you also feel unwell or have a fever, symptoms which could be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always resolve even after stopping atorvastatin, and this can 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 liver problems. You should consult your doctor as soon as possible.

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

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results showing possible liver dysfunction

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 closely)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, itchy rash, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially of the ankles (oedema), increased body temperature
• Urine tests positive for white blood cells

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

• Visual disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injuries

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

• An allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Loss of hearing
• Gynaecomastia (enlargement of the breasts in men)

Side effects of unknown frequency:

• Persistent muscle weakness

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Respiratory problems, including persistent cough and/or shortness of breath or fever
• Diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. While taking this medicine, your doctor will monitor you closely.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatina Teva Italia

Keep this medicine out of the sight and reach of children.
Store below 30 C.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atorvastatina Teva Italia contains

• The active substance is atorvastatin. Each 10 mg tablet contains 10 mg of atorvastatin as atorvastatin calcium. Each 20 mg tablet contains 20 mg of atorvastatin as atorvastatin calcium. Each 40 mg tablet contains 40 mg of atorvastatin as atorvastatin calcium. Each 80 mg tablet contains 80 mg of atorvastatin as atorvastatin calcium.
• The other excipients of the tablet core are microcrystalline cellulose, sodium carbonate, maltose, sodium croscarmellose, and magnesium stearate. The film-coating excipients are hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80, and titanium dioxide (E171).

Description of the appearance of Atorvastatina Teva Italia and package contents

• 10 mg: Atorvastatina Teva Italia film-coated tablets are white to off-white, elliptical, biconvex, film-coated tablets with a smooth surface. The size of each tablet is approximately 9.7 mm x 5.2 mm.

• Atorvastatina Teva Italia is available in aluminium-aluminium blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 200 tablets, in high-density polyethylene bottles containing 50 or 100 tablets, and as a multipack containing 100 tablets (2 bottles of 50 tablets each).
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Teva Pharma, S.L.U.
C/C, n.4, Poligono Industrial Malpica, 50016 Zaragoza (Spain)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Teva Operations Poland Sp. Z.o.o.
Ul. Mogilska 80, 31-546 Kraków (Poland)
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren (Germany)

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Atorvastatin ratiopharm 10 mg Film Tablets
Atorvastatin ratiopharm 20 mg Film Tablets
Atorvastatin ratiopharm 40 mg Film Tablets
Atorvastatin ratiopharm 80 mg Film Tablets
Belgium Atorvastatine Teva 10 mg Film-coated Tablets
Atorvastatine Teva 20 mg Film-coated Tablets
Atorvastatine Teva 40 mg Film-coated Tablets
Atorvastatine Teva 80 mg Film-coated Tablets
Bulgaria Avanor 10 mg Film-coated Tablets
Avanor 20 mg Film-coated Tablets
Avanor 40 mg Film-coated Tablets
Avanor 80 mg Film-coated Tablets
Czech Republic Atorvastatin ratiopharm GmbH 10 mg, coated tablets
Atorvastatin ratiopharm GmbH 20 mg, coated tablets
Atorvastatin ratiopharm GmbH 40 mg, coated tablets
Denmark Atorvastatin Teva
Estonia Atorvastatin Teva
Finland Atorvastatin ratiopharm 10 mg Film-coated Tablets
Atorvastatin ratiopharm 20 mg Film-coated Tablets
Atorvastatin ratiopharm 40 mg Film-coated Tablets
Atorvastatin ratiopharm 80 mg Film-coated Tablets
France ATORVASTATINE TEVA Santé 10 mg, film-coated tablet
ATORVASTATINE TEVA Santé 20 mg, film-coated tablet
ATORVASTATINE TEVA Santé 40 mg, film-coated tablet
ATORVASTATINE TEVA Santé 80 mg, film-coated tablet
Greece TEVASTATIN 10 mg Film-coated Tablets
TEVASTATIN 20 mg Film-coated Tablets
TEVASTATIN 40 mg Film-coated Tablets
TEVASTATIN 80 mg Film-coated Tablets
Ireland Atorvastatin Teva 10 mg Film-coated Tablets
Atorvastatin Teva 20 mg Film-coated Tablets
Atorvastatin Teva 40 mg Film-coated Tablets
Atorvastatin Teva 80 mg Film-coated Tablets
Italy Atorvastatina Teva Italia 10 mg Film-coated Tablets
Atorvastatina Teva Italia 20 mg Film-coated Tablets
Atorvastatina Teva Italia 40 mg Film-coated Tablets
Atorvastatina Teva Italia 80 mg Film-coated Tablets
Lithuania Atorvastatin Teva 10 mg Film-coated Tablets
Atorvastatin Teva 20 mg Film-coated Tablets
Atorvastatin Teva 40 mg Film-coated Tablets
Atorvastatin Teva 80 mg Film-coated Tablets
Netherlands Atorvastatine 10 mg Teva, Film-coated Tablets
Atorvastatine 20 mg Teva, Film-coated Tablets
Atorvastatine 40 mg Teva, Film-coated Tablets
Atorvastatine 80 mg Teva, Film-coated Tablets
Norway Atorvastatin Teva 10 mg Film-coated Tablets
Atorvastatin Teva 20 mg Film-coated Tablets
Atorvastatin Teva 40 mg Film-coated Tablets
Atorvastatin Teva 80 mg Film-coated Tablets
Poland 10 mg, 20 mg & 40 mg: Atorvastatinum 123ratio
80 mg: Atorvox
Portugal Atorvastatina Teva
Sweden Atorvastatin Teva 10 mg Film-coated Tablets
Atorvastatin Teva 20 mg Film-coated Tablets
Atorvastatin Teva 40 mg Film-coated Tablets
Atorvastatin Teva 80 mg Film-coated Tablets
Slovenia Bisatum 10 mg Film-coated Tablets
Bisatum 20 mg Film-coated Tablets
Bisatum 40 mg Film-coated Tablets
Bisatum 80 mg Film-coated Tablets
Slovakia Atorvastatin Teva Pharma 10 mg
Atorvastatin Teva Pharma 20 mg
Atorvastatin Teva Pharma 40 mg
Atorvastatin Teva Pharma 80 mg
United Kingdom Atorvastatin 10 mg Film-coated Tablets
Atorvastatin 20 mg Film-coated Tablets
Atorvastatin 40 mg Film-coated Tablets
Atorvastatin 80 mg Film-coated Tablets