Atorvastatin Git

Package leaflet: Information for the user

ATORVASTATINA GIT

80 mg film-coated tablets.
Calcium atorvastatin
Generic medicine
Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. This medicine may be harmful to others, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Contents of this leaflet: 1 What ATORVASTATINA GIT is and what it is used for 2 What you need to know before taking ATORVASTATINA GIT 3 How to take ATORVASTATINA GIT 4 Possible side effects 5 How to store ATORVASTATINA GIT 6 Contents of the pack and other information

1. WHAT ATORVASTATIN GIT IS AND WHAT IT IS USED FOR

ATORVASTATIN GIT belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN GIT 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, ATORVASTATIN GIT 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 SHOULD KNOW BEFORE TAKING ATORVASTATIN GIT

Do not take ATORVASTATIN GIT:

• if you are hypersensitive (allergic) to atorvastatin, or to medicines similar to those used to lower lipid levels in the blood, or to any of the excipients of this medicine – see Section 6 for details.
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding

Take special care with ATORVASTATIN GIT
The following are reasons why ATORVASTATIN GIT may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate classes)
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old

Check with your doctor or pharmacist before taking ATORVASTATIN GIT

• if you suffer from severe respiratory insufficiency

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN GIT to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see Section 2 "Taking ATORVASTATIN GIT with other medicines"). Furthermore, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition. During treatment with this medicine, your doctor will 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, and have high blood pressure.

Taking ATORVASTATIN GIT with other medicines
Some medicines may alter the effect of ATORVASTATIN GIT or the effect of these medicines may be altered by ATORVASTATIN GIT. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a 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 medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Other medicines known to interact with ATORVASTATIN GIT include ezetimibe (which lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach discomfort and peptic ulcer), phenazone (a painkiller), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St. John’s Wort. Always inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription, as they may interact with ATORVASTATIN GIT.

Taking ATORVASTATIN GIT with food and drinks
See Section 3 for instructions on how to take ATORVASTATIN GIT. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as larger quantities may alter the effects of ATORVASTATIN GIT.
Alcohol
Avoid drinking excessive amounts of alcohol when taking this medicine. For further details, refer to Section 2. "Take special care with ATORVASTATIN GIT".

Pregnancy and breastfeeding
Do not take ATORVASTATIN GIT if you are pregnant or planning a pregnancy.
Do not take ATORVASTATIN GIT if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN GIT if you are breastfeeding.
The safety of ATORVASTATIN GIT during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines
This medicine usually does not affect your ability to drive or use 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.

3. HOW TO TAKE ATORVASTATIN GIT

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet throughout your treatment with ATORVASTATIN GIT.
The usual dose of ATORVASTATIN GIT is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks.
The maximum dose of ATORVASTATIN GIT is 80 mg once daily for adults and 20 mg once daily for children.
ATOVASTATIN GIT tablets must 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.
Always take ATORVASTATIN GIT exactly as instructed by your doctor. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN GIT is determined by your doctor.
If you feel that the effect of ATORVASTATIN GIT is too strong or too weak, consult your doctor.
If you take more ATORVASTATIN GIT than you should
If you accidentally take too many ATORVASTATIN GIT tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN GIT
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking ATORVASTATIN GIT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ATORVASTATIN GIT may cause adverse reactions, although not everyone experiences them.
If you experience any of the following serious adverse reactions, stop taking your tablets immediately
and contact your doctor right away or go to the nearest hospital emergency department.

Rare adverse reactions: affecting 1–10 patients in 10,000:

• Severe allergic reaction causing swelling of the face, tongue, and trachea, which may cause significant breathing difficulties.
• A serious condition associated with severe skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience muscle weakness, tenderness, or pain—especially if you also feel unwell and have a high fever—this could be due to abnormal and potentially fatal muscle breakdown, which may lead to kidney problems.

Very rare adverse reactions: affecting fewer than 1 in 10,000 patients:

• 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 adverse reactions that may occur with ATORVASTATIN GIT

Common adverse reactions (1–10 patients in 100) include:

• Nasal airway inflammation, sore throat, nosebleeds,
• Allergic reactions,
• Diabetes. This is more likely if you have increased blood sugar (glucose) and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine (if you have diabetes, you must continue to monitor your blood sugar levels carefully), increased blood creatine kinase,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhea,
• Joint pain, muscle pain, and back pain,
• Abnormal liver function laboratory tests.

Uncommon adverse reactions (1–10 patients in 1,000) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully),
• Nightmares, insomnia,
• Dizziness, reduced sensitivity 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, abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain),
• Hepatitis (liver inflammation),
• Rash, skin rash and itching, hives, hair loss,
• Neck pain, muscle fatigue,
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature,
• Positive urine test for white blood cells (leukocytes).

Rare adverse reactions (1–10 patients in 10,000) include:

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

Very rare adverse reactions (affecting fewer than 1 in 10,000 patients) include:

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

Possible adverse reactions reported with some statins (medicines of the same type):

• Sexual dysfunction,
• Depression,
• Breathing difficulties including persistent cough and/or shortness of breath or fever.

Adverse reactions with unknown frequency:

• Persistent muscle weakness.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN GIT

Keep ATORVASTATIN GIT out of the reach and sight of children.
Store ATORVASTATIN GIT at a temperature not exceeding 30°C.
Do not use ATORVASTATIN GIT after the expiry date stated on the label or carton (Exp.). The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What ATORVASTATINA GIT contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATINA GIT contains 80 mg of
atorvastatin (as atorvastatin calcium).
The excipients are:

• Tablet core: Microcrystalline cellulose, Anhydrous sodium carbonate, Maltose, Sodium croscarmellose, Magnesium stearate.
• Tablet coating: Hypromellose, Hydroxypropylcellulose, Triethyl citrate, Polysorbate 80, Titanium dioxide.

Description of the appearance of ATORVASTATINA GIT and pack contents
The 80 mg film-coated tablets of ATORVASTATINA GIT are elliptical-shaped, biconvex, off-white in colour.
ATORVASTATINA GIT tablets are available in packs of 30 tablets. This medicinal product is available in film-coated tablets of 10 mg, 20 mg, 40 mg and 80 mg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
SF GROUP Srl – Via Tiburtina 1143, 00156 Rome (Italy)
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain
the

Package leaflet: information for the user

ATORVASTATIN GIT

40 mg film-coated tablets.
Atorvastatin calcium
Generic Medicine
Please read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:
1 What ATORVASTATIN GIT is and what it is used for
2 What you need to know before taking ATORVASTATIN GIT
3 How to take ATORVASTATIN GIT
4 Possible side effects
5 How to store ATORVASTATIN GIT
6 Package contents and other information

1. WHAT IS ATORVASTATIN GIT AND WHAT IS IT USED FOR

ATORVASTATIN GIT belongs to a class of medicines known as statins, which regulate lipid (fat) levels.
ATORVASTATIN GIT 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, ATORVASTATIN GIT may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you should continue to follow a standard cholesterol-lowering diet.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ATORVASTATIN GIT

Do not take ATORVASTATIN GIT:

• if you are hypersensitive (allergic) to atorvastatin, or to medicines similar to those used to reduce lipid levels in the blood, or to any of the excipients of this medicine – see Section 6 for details.
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• 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

Take special care with ATORVASTATIN GIT

Listed below are reasons why ATORVASTATIN GIT may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid reserves 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 during treatment with other lipid-lowering medicines (e.g. other medicines in 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 of age

Check with your doctor or pharmacist before taking ATORVASTATIN GIT

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN GIT to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see Section 2 “Taking ATORVASTATIN GIT with other medicines”). Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition. During treatment with this medicine, your doctor will 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 the blood, if you are overweight, or if you have high blood pressure.

Taking ATORVASTATIN GIT with other medicines
Some medicines may alter the effect of ATORVASTATIN GIT or the effect of these medicines may be altered by ATORVASTATIN GIT. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a 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 for controlling heart rhythm, e.g. digoxin, verapamil, amiodarone
• Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Other medicines known to interact with ATORVASTATIN GIT include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St John’s Wort. Always inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription, as they may interact with ATORVASTATIN GIT.

Taking ATORVASTATIN GIT with food and drink
See Section 3 for instructions on how to take ATORVASTATIN GIT. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as larger quantities may alter the effects of ATORVASTATIN GIT.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to Section 2. “Take special care with ATORVASTATIN GIT”.

Pregnancy and breastfeeding
Do not take ATORVASTATIN GIT if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN GIT if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN GIT if you are breastfeeding.
The safety of ATORVASTATIN GIT during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

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

3. HOW TO TAKE ATORVASTATIN GIT

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with ATORVASTATIN GIT.
The usual dose of ATORVASTATIN GIT is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks.
The maximum dose of ATORVASTATIN GIT is 80 mg once daily for adults and 20 mg once daily for children.
ATOVASTATIN GIT tablets must 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.
Always take ATORVASTATIN GIT exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN GIT is determined by your doctor.
If you feel that the effect of ATORVASTATIN GIT is too strong or too weak, consult your doctor.
If you take more ATORVASTATIN GIT than you should
If you accidentally take too many ATORVASTATIN GIT tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN GIT
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking ATORVASTATIN GIT
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ATORVASTATIN GIT may cause adverse reactions, although not everybody experiences them.
If you experience any of the following serious adverse reactions, stop taking your tablets immediately
and contact your doctor right away or go to the nearest hospital emergency department.

Rare adverse reactions: affecting 1–10 patients in 10,000:

• Severe allergic reaction causing swelling of the face, tongue, and trachea, which may lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell and high fever, this could be due to abnormal, potentially fatal muscle breakdown, which may lead to kidney problems.

Very rare adverse reactions: affecting fewer than 1 patient in 10,000:

• 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 adverse reactions that may occur with ATORVASTATIN GIT

Common adverse reactions (1–10 patients in 100) include:

• Nasal airway inflammation, sore throat, nosebleeds,
• Allergic reactions,
• Diabetes. This is more likely if you have elevated blood sugar (glucose) and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine (if you have diabetes, you must continue to monitor your blood sugar levels carefully), increased blood creatine kinase levels,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhea,
• Joint pain, muscle pain, and back pain,
• Abnormal liver function laboratory tests.

Uncommon adverse reactions (1–10 patients in 1,000) include:

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

Rare adverse reactions (1–10 patients in 10,000) include:

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

Very rare adverse reactions (affecting fewer than 1 patient in 10,000) include:

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

Possible adverse reactions reported with some statins (medicines of the same type):

• Sexual dysfunction,
• Depression,
• Breathing difficulties including persistent cough and/or shortness of breath or fever.

Adverse reactions of unknown frequency:

• Persistent muscle weakness.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN GIT

Keep ATORVASTATIN GIT out of the reach and sight of children.
Store ATORVASTATIN GIT below 30°C.
Do not use ATORVASTATIN GIT after the expiry date stated on the label or carton (Exp.). The expiry date refers to the last day of the month.
Medicines must 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 PACKAGE AND OTHER INFORMATION

What ATORVASTATIN GIT contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATIN GIT contains 40 mg of
atorvastatin (as atorvastatin calcium).
The other components (excipients) are:

• Tablet core: Microcrystalline cellulose, Anhydrous sodium carbonate, Maltose, Sodium croscarmellose, Magnesium stearate.
• Tablet coating: Hypromellose, Hydroxypropylcellulose, Triethyl citrate, Polysorbate 80, Titanium dioxide. Description of the appearance of ATORVASTATIN GIT and contents of the pack Film-coated tablets of ATORVASTATIN GIT 40 mg are elliptical, biconcave, off-white in colour. ATORVASTATIN GIT tablets are available in packs of 10 and 30 tablets. This medicine is available as film-coated tablets containing 10 mg, 20 mg, 40 mg and 80 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
SF GROUP SrL – Via Tiburtina 1143, 00156 Rome (Italy)
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain
the

Package leaflet: Information for the user

ATORVASTATIN GIT

20 mg film-coated tablets.
Atorvastatin calcium
Generic Medicine
Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Contents of this leaflet: 1 What ATORVASTATIN GIT is and what it is used for 2 What you need to know before taking ATORVASTATIN GIT 3 How to take ATORVASTATIN GIT 4 Possible side effects 5 How to store ATORVASTATIN GIT 6 Package contents and other information

1. WHAT ATORVASTATIN GIT IS AND WHAT IT IS USED FOR

ATORVASTATIN GIT belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN GIT is used to lower 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, ATORVASTATIN GIT may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ATORVASTATIN GIT

Do not take ATORVASTATIN GIT:

• if you are hypersensitive (allergic) to atorvastatin, or to medicines similar to those used to lower blood lipid levels, or to any of the excipients of this medicine – see Section 6 for details.
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• 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

Take special care with ATORVASTATIN GIT

The following are reasons why ATORVASTATIN GIT may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves 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 during treatment with other lipid-lowering medicines (e.g. other medicines in 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 of age

Consult your doctor or pharmacist before taking ATORVASTATIN GIT

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN GIT to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see Section 2 "Taking ATORVASTATIN GIT with other medicines"). Also, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition. During treatment with this medicine, your doctor will 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 the blood, are overweight, and have high blood pressure.

Taking ATORVASTATIN GIT with other medicines
Some medicines may alter the effect of ATORVASTATIN GIT or their own effect may be altered by ATORVASTATIN GIT. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a condition of 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 medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Other medicines known to interact with ATORVASTATIN GIT include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St. John’s wort. Always inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription, as they may interact with ATORVASTATIN GIT.

Taking ATORVASTATIN GIT with food and drink
See Section 3 for instructions on how to take ATORVASTATIN GIT. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as larger quantities may alter the effects of ATORVASTATIN GIT.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to Section 2 "Take special care with ATORVASTATIN GIT".

Pregnancy and breastfeeding
Do not take ATORVASTATIN GIT if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN GIT if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN GIT if you are breastfeeding.
The safety of ATORVASTATIN GIT during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

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

3. HOW TO TAKE ATORVASTATIN GIT

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet during treatment with ATORVASTATIN GIT.
The usual dose of ATORVASTATIN GIT 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 ATORVASTATIN GIT is 80 mg once daily for adults and 20 mg once daily for children.
ATORVASTATIN GIT tablets must be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Always take ATORVASTATIN GIT exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN GIT is determined by your doctor.
If you think that the effect of ATORVASTATIN GIT is too strong or too weak, talk to your doctor.
If you take more ATORVASTATIN GIT than you should
If you accidentally take too many ATORVASTATIN GIT tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN GIT
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking ATORVASTATIN GIT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ATORVASTATIN GIT may cause adverse reactions, although not everybody experiences them.
If you experience any of the following serious adverse reactions, stop taking your tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.
Rare adverse reactions: affecting 1–10 patients in 10,000:

• Severe allergic reaction causing swelling of the face, tongue, and trachea, which may lead to significant breathing difficulties.
• A serious condition associated with severe skin peeling and swelling, skin blisters, lesions in the mouth, eyes, and genitals, and fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell and high fever, this may be due to abnormal and potentially fatal muscle breakdown, which can lead to kidney problems. Very rare adverse reactions: affecting fewer than 1 patient in 10,000:
• 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 adverse reactions that may occur with ATORVASTATIN GIT Common adverse reactions (1–10 patients in 100) include:
• Nasal airway inflammation, sore throat, nosebleeds,
• Allergic reactions,
• Diabetes. This is more likely if you have elevated blood sugar (glucose) and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine (if you have diabetes, you must continue to monitor your blood sugar levels carefully), increased blood creatine kinase,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhea,
• Joint pain, muscle pain, and back pain,
• Abnormal liver function laboratory tests. Uncommon adverse reactions (1–10 patients in 1,000) include:
• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully),
• Nightmares, insomnia,
• Dizziness, reduced sensitivity 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, abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain),
• Hepatitis (liver inflammation),
• Rash, skin rash and itching, hives, hair loss,
• Neck pain, muscle fatigue,
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature,
• Positive urine test for white blood cells (leukocytes). Rare adverse reactions (1–10 patients in 10,000) include:
• Vision disorders,
• Unexpected bleeding or bruising,
• Jaundice (yellowing of the skin and whites of the eyes),
• Tendon damage. Very rare adverse reactions (affecting fewer than 1 patient in 10,000) include:
• Allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• Hearing loss,
• Gynecomastia (breast enlargement in men and women). Possible adverse reactions reported with some statins (medicines of the same type):
• Sexual dysfunction,
• Depression,
• Breathing difficulties including persistent cough and/or shortness of breath or fever. Adverse reactions with unknown frequency:
• Persistent muscle weakness. Reporting of adverse reactions If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN GIT

Keep ATORVASTATIN GIT out of the reach and sight of children.
Store ATORVASTATIN GIT at a temperature not exceeding 30°C.
Do not use ATORVASTATIN GIT after the expiry date stated on the label or carton (Exp.). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ATORVASTATINA GIT contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATINA GIT contains 20 mg of
atorvastatin (as atorvastatin calcium).
The excipients are:

• Tablet core: Microcrystalline cellulose, Anhydrous sodium carbonate, Maltose, Sodium croscarmellose, Magnesium stearate.
• Tablet coating: Hypromellose, Hydroxypropylcellulose, Triethyl citrate, Polysorbate 80, Titanium dioxide. Description of the appearance of ATORVASTATINA GIT and contents of the package The 20 mg film-coated tablets of ATORVASTATINA GIT are elliptical, biconcave, off-white in colour. ATORVASTATINA GIT tablets are available in packs containing 10 and 30 tablets. This medicinal product is available as film-coated tablets in strengths of 10 mg, 20 mg, 40 mg and 80 mg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
SF GROUP SrL – Via Tiburtina 1143, 00156 Rome (Italy)
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain
the

Package leaflet: information for the user

ATORVASTATIN GIT

10 mg film-coated tablets.
Atorvastatin calcium
Generic Medicine
Please read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:
1 What ATORVASTATIN GIT is and what it is used for
2 What you need to know before taking ATORVASTATIN GIT
3 How to take ATORVASTATIN GIT
4 Possible side effects
5 How to store ATORVASTATIN GIT
6 Package contents and other information

1. WHAT IS ATORVASTATIN GIT AND WHAT IS IT USED FOR

ATORVASTATIN GIT belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN GIT 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, ATORVASTATIN GIT may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you should continue following a standard cholesterol-lowering diet.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ATORVASTATIN GIT

Do not take ATORVASTATIN GIT:

• if you are hypersensitive (allergic) to atorvastatin, or to medicines similar to those used to reduce lipid levels in the blood, or to any of the excipients of this medicine – see Section 6 for details.
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding

Take special care with ATORVASTATIN GIT
The following are reasons why ATORVASTATIN GIT may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid reserves 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 experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in 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 Check with your doctor or pharmacist before taking ATORVASTATIN GIT
• If you suffer from severe respiratory failure If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN GIT to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see Section 2 "Taking ATORVASTATIN GIT with other medicines"). In addition, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition. During treatment with this medicine, your doctor will 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 the blood, if you are overweight, and if you have high blood pressure.

Taking ATORVASTATIN GIT with other medicines
Some medicines may alter the effect of ATORVASTATIN GIT or their effects may be altered by ATORVASTATIN GIT. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a 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 medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Other medicines known to interact with ATORVASTATIN GIT include ezetimibe (which lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St John's Wort.

Always inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription, as they may interact with ATORVASTATIN GIT.
Taking ATORVASTATIN GIT with food and drink
See Section 3 for instructions on how to take ATORVASTATIN GIT. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as larger quantities may alter the effects of ATORVASTATIN GIT.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to Section 2. "Take special care with ATORVASTATIN GIT".
Pregnancy and breastfeeding
Do not take ATORVASTATIN GIT if you are pregnant or planning a pregnancy.
Do not take ATORVASTATIN GIT if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN GIT if you are breastfeeding.
The safety of ATORVASTATIN GIT during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine usually does not affect your ability to drive or use machines. However, do not drive if this medicine impairs your ability to drive. Do not use tools or machinery if your ability to use them is impaired by this medicine.

3. HOW TO TAKE ATORVASTATIN GIT

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with ATORVASTATIN GIT.
The usual dose of ATORVASTATIN GIT is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks.
The maximum dose of ATORVASTATIN GIT is 80 mg once daily for adults and 20 mg once daily for children.
ATOVASTATIN GIT tablets must 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.
Always take ATORVASTATIN GIT exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN GIT is determined by your doctor.
If you feel that the effect of ATORVASTATIN GIT is too strong or too weak, consult your doctor.
If you take more ATORVASTATIN GIT than you should
If you accidentally take too many ATORVASTATIN GIT tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN GIT
If you forget to take a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed tablet.
If you stop taking ATORVASTATIN GIT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ATORVASTATIN GIT may cause side effects, although not everyone experiences them.
If you experience any of the following serious side effects, stop taking your tablets immediately
and contact your doctor right away or go to the nearest hospital emergency department.
Rare side effects: occurring in 1–10 patients out of 10,000:

• Severe allergic reaction causing swelling of the face, tongue, and trachea, which may lead to significant breathing difficulties,
• A serious condition associated with severe skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters,
• If you experience muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell and high fever, this may be due to abnormal and potentially fatal muscle breakdown, which can lead to kidney problems. Very rare side effects: occurring in fewer than 1 patient out of 10,000:
• 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 side effects that may occur with ATORVASTATIN GIT Common side effects (1–10 patients out of 100) include:
• Inflammation of the nasal passages, sore throat, nosebleeds,
• Allergic reactions,
• 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 (if you have diabetes, you must continue to carefully monitor your blood sugar levels), increased blood creatine kinase,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhoea,
• Joint pain, muscle pain, and back pain,
• Abnormal liver function tests. Uncommon side effects (1–10 patients out of 1,000) include:
• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you must continue to carefully monitor your blood sugar levels),
• Nightmares, insomnia,
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, taste disturbances, memory loss,
• Blurred vision,
• Ringing in the ears and/or head,
• Vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain),
• Hepatitis (inflammation of the liver),
• Rash, skin rash 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 (leucocytes). Rare side effects (1–10 patients out of 10,000) include:
• Vision disorders,
• Unexpected bleeding or bruising,
• Jaundice (yellowing of the skin and whites of the eyes),
• Tendon damage. Very rare side effects (occurring in fewer than 1 patient out of 10,000) include:
• Allergic reaction – symptoms may include sudden shortness of breath 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 and women). Possible side effects reported with some statins (medicines of the same type):
• Sexual difficulties,
• Depression,
• Breathing difficulties including persistent cough and/or breathlessness or fever. Side effects of unknown frequency:
• Persistent muscle weakness. 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATINA GIT

Keep ATORVASTATINA GIT out of the reach and sight of children.
Store ATORVASTATINA GIT below 30°C.
Do not use ATORVASTATINA GIT after the expiry date stated on the label or carton (Exp.).
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ATORVASTATINA GIT contains
The active substance is atorvastatin-calcium. Each tablet of ATORVASTATINA GIT contains 10 mg of
atorvastatin (as atorvastatin-calcium).
The excipients are:

• Tablet core: Microcrystalline cellulose, Anhydrous sodium carbonate, Maltose, Sodium croscarmellose, Magnesium stearate.
• Film coating: Hypromellose, Hydroxypropylcellulose, Triethyl citrate, Polysorbate 80, Titanium dioxide. Description of the appearance of ATORVASTATINA GIT and package contents The 10 mg film-coated tablets of ATORVASTATINA GIT are elliptical, biconvex, off-white in colour. ATORVASTATINA GIT tablets are available in packages containing 10 and 30 tablets. This medicine is available in 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
SF GROUP SrL – Via Tiburtina 1143, 00156 Rome (Italy)
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain
the