Atorvastatin ABC: detailed information

Package leaflet: Information for the user

ATORVASTATIN ABC

80 mg film-coated tablets.
Atorvastatin calcium
Generic medicine
Please read this leaflet carefully before 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, contact your doctor or pharmacist. See section 4.

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

1. What ATORVASTATINA ABC is and what it is used for

ATORVASTATINA ABC belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA ABC 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 ABC 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 need to know before taking ATORVASTATIN ABC

Do not take ATORVASTATIN ABC:

if you are allergic to atorvastatin or to similar medicines used to reduce lipid levels in the blood, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
if you have or have had a liver disease
if liver function tests have shown unexplained abnormal results
if you are a woman of childbearing potential 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 ATORVASTATIN ABC:

If you suffer from severe respiratory insufficiency.
If you are taking or have taken within the last seven days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and ATORVASTATIN ABC may cause serious muscle problems (rhabdomyolysis).
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 old.

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN ABC 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 “Other medicines and ATORVASTATIN ABC”).
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.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Other medicines and ATORVASTATIN ABC
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 ATORVASTATIN ABC, or the effect of these medicines may be altered by ATORVASTATIN ABC. 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 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.
Letermovir, a medicine used to help prevent diseases caused by cytomegalovirus.
Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with ATORVASTATIN ABC include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach pain and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
Over-the-counter medicines: St John's Wort.
If you need to take oral fusidic acid for the treatment of bacterial infections, you will need to temporarily discontinue it during treatment with this medicine. Your doctor will advise you when it is safe to restart ATORVASTATIN ABC. Taking ATORVASTATIN ABC with fusidic acid may rarely lead to muscle weakness, tenderness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

ATORVASTATIN ABC with food and drink
See section 3 for instructions on how to take ATORVASTATIN ABC. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as larger quantities may alter the effects of ATORVASTATIN ABC.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take ATORVASTATIN ABC if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN ABC if you think you may become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN ABC if you are breastfeeding.
The safety of ATORVASTATIN ABC during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine usually does not affect your ability to drive or operate machinery. 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.
ATORVASTATIN ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ATORVASTATIN ABC

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout the course of treatment with ATORVASTATIN ABC.
The recommended starting dose of ATORVASTATIN ABC 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 dose at intervals of 4 or more weeks. The maximum dose of ATORVASTATIN ABC is 80 mg once daily.
ATOVASTATIN ABC 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 ATORVASTATIN ABC will be determined by your doctor.
If you think that the effect of ATORVASTATIN ABC is too strong or too weak, talk to your doctor.

If you take more ATORVASTATIN ABC than you should
If you accidentally take too many ATORVASTATIN ABC tablets (more than your usual daily dose), contact your doctor or the nearest hospital for advice.

If you forget to take ATORVASTATIN ABC
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 ABC
If you have any doubts 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 everybody gets them.
If you notice any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

Rare side effects (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, mouth, eyes, genitals and fever. Skin rash with red spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
Muscle weakness, tenderness, pain or tearing, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever. This may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it may be life-threatening and can lead to kidney problems.

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

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

Other side effects that may occur with ATORVASTATIN ABC
Common side effects (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 creatine kinase in the blood.
Headache.
Nausea, constipation, flatulence, indigestion, diarrhoea.
Joint pain, muscle pain and back pain.
Changes in liver function laboratory tests.

Uncommon side effects (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).
Rash, skin eruptions 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 (may affect up to 1 in 1,000 people):

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

Very rare side effects (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.
Loss of hearing.
Gynaecomastia (enlargement of the breasts in men).

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

Persistent muscle weakness.

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

Sexual difficulties.
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 your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you get any side effects, 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 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 ATORVASTATIN ABC

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 label or the carton 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ATORVASTATIN ABC contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATIN ABC contains 80 mg of
atorvastatin (as atorvastatin calcium).
The other components 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 ABC and pack contents
The 80 mg film-coated tablets of ATORVASTATIN ABC are elliptical, biconvex, off-white in colour.
ATORVASTATIN ABC tablets are available in packs of 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:
Pharmacare Srl
Via Marghera 29
20149 Milan
Italy
Exclusive distributor for sale:
ABC Farmaceutici SPA
Corso Vittorio Emanuele II, 72
10121 Turin
Italy
Manufacturer and batch release responsible:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain

Package leaflet: Information for the user

ATORVASTATIN ABC

40 mg film-coated tablets
Atorvastatin calcium
Generic Medicine
Please read this leaflet carefully before 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, consult 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

1. What ATORVASTATIN ABC is and what it is used for

ATORVASTATIN ABC belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN ABC 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 successful. If you are at high risk of cardiovascular disease, ATORVASTATIN ABC 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 need to know before taking ATORVASTATINA ABC

Do not take ATORVASTATINA ABC:

if you are allergic to atorvastatin or to medicines similar to those used to reduce lipid levels in the blood, or to any of the other ingredients of this medicine (listed in section 6)
if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
if you have or have had a liver disease
if liver function tests have shown unexplained abnormal results
if you are a woman of childbearing age and do not use 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 ABC:

If you suffer from severe respiratory failure.
If you are taking or have taken in the last seven days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and ATORVASTATINA ABC can cause serious muscle problems (rhabdomyolysis).
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 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 ABC 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 “Other medicines and ATORVASTATINA ABC”).
Furthermore, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be necessary for diagnosis and management of 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.
Other medicines and ATORVASTATINA ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Some medicines can alter the effect of ATORVASTATINA ABC or the effect of these
medicines can be altered by ATORVASTATINA ABC. 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 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.
Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
Protease inhibitors used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with ATORVASTATINA ABC include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
Over-the-counter medicines: St. John’s wort.
If you need to take oral fusidic acid for the treatment of bacterial infections, you will need to temporarily stop it during treatment with this medicine. Your doctor will advise you when it is safe to restart ATORVASTATINA ABC. Taking ATORVASTATINA ABC with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

ATORVASTATINA ABC with food and drinks
See section 3 for instructions on how to take ATORVASTATINA ABC. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of ATORVASTATINA ABC.
Alcohol
Avoid drinking excessive amounts of alcohol when taking this medicine. For further details, consult section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take ATORVASTATINA ABC if you are pregnant or planning to become pregnant.
Do not take ATORVASTATINA ABC if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATINA ABC if you are breastfeeding.
The safety of ATORVASTATINA ABC during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine usually does not affect the 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.
ATORVASTATINA ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ATORVASTATIN ABC

Take this medicine exactly as indicated in this leaflet or according to your doctor's or pharmacist's instructions.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with ATORVASTATIN ABC.
The recommended starting dose of ATORVASTATIN ABC 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 ABC is 80 mg once daily. The ATORVASTATIN ABC 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.
The duration of treatment with ATORVASTATIN ABC is determined by your doctor.
If you think that the effect of ATORVASTATIN ABC is too strong or too weak, consult your doctor.

If you take more ATORVASTATIN ABC than you should
If you accidentally take too many ATORVASTATIN ABC tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

If you forget to take ATORVASTATIN ABC
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 ABC
If you have any doubts about using 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 notice any of the serious side effects or symptoms listed below,
stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department.

Rare side effects (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.
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.
Muscle weakness, tenderness, pain or muscle tearing, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever. This may be caused by abnormal breakdown of muscles (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin. It may be life-threatening and lead to kidney problems.

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

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

Other side effects that may occur with ATORVASTATINA ABC
Common side effects (may affect up to 1 in 10 people):

Nasal airway inflammation, sore throat, nosebleeds.
Allergic reactions.
Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood.
Headache.
Nausea, constipation, flatulence, indigestion, diarrhoea.
Joint pain, muscle pain, and back pain.
Changes in laboratory tests assessing liver function.

Uncommon side effects (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 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, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain).
Hepatitis (inflammation of the liver).
Rash, skin eruptions 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 (leukocytes).

Rare side effects (may affect up to 1 in 1,000 people):
vision disorders.

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

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

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 (enlargement of the breasts 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 difficulties.
Depression.
Breathing difficulties including persistent cough and/or breathlessness or fever.
Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

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 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 ATORVASTATIN ABC

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 label or the packaging, following Exp..
The expiry date refers to the last day of that 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 ATORVASTATIN ABC contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATIN ABC contains 40 mg of
atorvastatin (as atorvastatin calcium).
The other components 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 ABC and pack sizes Film-coated tablets of ATORVASTATIN ABC 40 mg are elliptical, biconvex, off-white in colour. ATORVASTATIN ABC tablets are available in packs containing 10 and 30 tablets. This medicine 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: Pharmacare Srl
Via Marghera 29
20149 Milan
Italy
Exclusive distributor for sales:
ABC Farmaceutici SPA
Corso Vittorio Emanuele II, 72
10121 Turin – Italy
Manufacturer and batch release responsible:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain

Patient Information Leaflet: Information for the User

ATORVASTATIN ABC

20 mg film-coated tablets.
Atorvastatin calcium
Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:
13 What ATORVASTATIN ABC is and what it is used for
14 What you need to know before taking ATORVASTATIN ABC
15 How to take ATORVASTATIN ABC
16 Possible side effects
17 How to store ATORVASTATIN ABC
18 Contents of the pack and other information.

1. What ATORVASTATINA ABC is and what it is used for

ATORVASTATINA ABC belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA ABC 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 successful. If you are at high risk of cardiovascular disease, ATORVASTATINA ABC may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. What you should know before taking ATORVASTATIN ABC

Do not take ATORVASTATIN ABC:

if you are allergic to atorvastatin, or to medicines similar to those used to reduce blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6)
if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
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.

Warnings and precautions
Talk to your doctor or pharmacist before taking ATORVASTATIN ABC:

If you suffer from severe respiratory failure.
If you are taking or have taken within the last seven days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and ATORVASTATIN ABC may cause serious muscle problems (rhabdomyolysis).
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 had repeated or unexplained muscle pain, or 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.

If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with ATORVASTATIN ABC 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 “Other medicines and ATORVASTATIN ABC”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be necessary for diagnosis and management of this condition.
During treatment with this medicine, your doctor will closely 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.

Other medicines and ATORVASTATIN ABC
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 ATORVASTATIN ABC, or the effect of these medicines may be altered by ATORVASTATIN ABC. This type of interaction may reduce the effectiveness 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.
Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
Protease inhibitors used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with ATORVASTATIN ABC include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
Over-the-counter medicines: St. John’s wort.
If you need to take oral fusidic acid for the treatment of bacterial infections, you will need to temporarily stop taking it during treatment with this medicine. Your doctor will advise you when it is safe to restart ATORVASTATIN ABC. Taking ATORVASTATIN ABC with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

ATORVASTATIN ABC with food and drinks
Refer to section 3 for instructions on how to take ATORVASTATIN ABC. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of ATORVASTATIN ABC.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.

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

ATORVASTATIN ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ATORVASTATIN ABC

Take this medicine exactly as stated in this leaflet or as directed 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 therapy with ATORVASTATIN ABC.
The recommended starting dose of ATORVASTATIN ABC 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 ABC is 80 mg once daily. The tablets of ATORVASTATIN ABC 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.
The duration of treatment with ATORVASTATIN ABC is determined by your doctor.
If you feel that the effect of ATORVASTATIN ABC is too strong or too weak, consult your doctor.

If you forget to take ATORVASTATIN ABC
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 ABC
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Severe allergic reaction causing swelling of the face, tongue and throat, which can lead to significant breathing difficulties.
Serious condition associated with severe peeling and swelling of the skin, skin blisters, 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.
Muscle weakness, tenderness, pain or muscle tearing, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever. This may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

Unexpected or unusual bleeding or bruising, which may indicate a liver disorder. You should contact your doctor as soon as possible.
Lupus-like illness syndrome (including skin rash, joint problems and effects on blood cells).

Other side effects that may occur with ATORVASTATIN ABC

Common side effects (may affect up to 1 in 10 people):

Nasal airway inflammation, sore throat, nosebleeds.
Allergic reactions.
Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood.
Headache.
Nausea, constipation, flatulence, indigestion, diarrhoea.
Joint pain, muscle pain and back pain.
Changes in liver function laboratory tests.

Uncommon side effects (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 sensitivity 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).
Rash, skin eruptions 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 (may affect 1 in 1,000 people):

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

Very rare side effects (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 (enlargement of the breasts in men).

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

Persistent muscle weakness.

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

Sexual difficulties.
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 your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

5. How to store ATORVASTATIN ABC

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 label or the packaging, following 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ATORVASTATINA ABC contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATINA ABC contains 20 mg of atorvastatin (as atorvastatin calcium).
The other components 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 ABC and contents of the pack
The 20 mg film-coated tablets of ATORVASTATINA ABC are elliptical, biconvex, off-white in colour.
ATORVASTATINA ABC 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:
Pharmacare Srl
Via Marghera 29
20149 Milan
Italy
Exclusive distributor for sale:
ABC Farmaceutici SPA
Corso Vittorio Emanuele II, 72
10121 Turin
Italy
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain
This patient information leaflet was last revised on

Package leaflet: information for the user

ATORVASTATIN ABC

10 mg film-coated tablets
Atorvastatin calcium
Generic Medicine
Please read this leaflet carefully before taking 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 could be harmful. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

1. What ATORVASTATINA ABC is and what it is used for

2. What you should know before taking ATORVASTATINA ABC

Do not take ATORVASTATINA ABC:

if you are allergic to atorvastatin or to similar medicines used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
if you have or have had liver disease
if your 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking ATORVASTATINA ABC:

If you suffer from severe respiratory failure
If you are taking or have taken within the last seven days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and ATORVASTATINA ABC may cause serious muscle problems (rhabdomyolysis).
If you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid volume 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 while being treated with other lipid-lowering medicines (for

example, 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.

If any of these conditions apply to you, your doctor should perform a blood test
before and possibly during treatment with ATORVASTATINA ABC 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 “Other medicines and ATORVASTATINA ABC”).
Additionally, inform your doctor or pharmacist if you experience 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 your blood, if you are overweight, and if you have high blood pressure.
Other medicines and ATORVASTATINA ABC
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 ABC or the effect of these medicines may be altered by ATORVASTATINA ABC. 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.
Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
Protease inhibitors used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with ATORVASTATINA ABC include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
Over-the-counter medicines: St. John’s wort.
If you need to take oral fusidic acid for the treatment of bacterial infections, you will need to temporarily stop taking it during treatment with this medicine. Your doctor will advise you when it is safe to restart taking ATORVASTATINA ABC. Taking ATORVASTATINA ABC with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

ATORVASTATINA ABC with food and drinks
See section 3 for instructions on how to take ATORVASTATINA ABC. 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 ATORVASTATINA ABC.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take ATORVASTATINA ABC if you are pregnant or planning to become pregnant.
Do not take ATORVASTATINA ABC if you think you could become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATINA ABC if you are breastfeeding.
The safety of ATORVASTATINA ABC during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine usually does not affect the ability to drive or use machines. 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 ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ATORVASTATIN ABC

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue to follow this diet during treatment with ATORVASTATIN ABC.
The recommended starting dose of ATORVASTATIN ABC 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 dose at intervals of 4 or more weeks. The maximum dose of ATORVASTATIN ABC is 80 mg once daily. The tablets of ATORVASTATIN ABC 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.
The duration of treatment with ATORVASTATIN ABC will be determined by your doctor.
If you feel that the effect of ATORVASTATIN ABC is too strong or too weak, talk to your doctor.

If you forget to take ATORVASTATIN ABC
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 ABC
If you have any doubts about using this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Rare side effects (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, mouth, eyes, genitals, and fever. Skin rash with red spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
Muscle weakness, tenderness, pain or muscle tearing, or red-brown discoloration of urine, especially if accompanied by feeling unwell and high fever. This may be due to abnormal breakdown of muscles (rhabdomyolysis). Abnormal muscle breakdown does not always resolve after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

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

Other side effects that may occur with ATORVASTATIN ABC
Common side effects (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 creatine kinase in the blood.
Headache.
Nausea, constipation, flatulence, indigestion, diarrhoea.
Joint pain, muscle pain, and back pain.
Changes in liver function laboratory tests.

Uncommon side effects (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 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, upper and lower 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 (may affect up to 1 in 1,000 people):

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

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

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 (enlargement of the breast in men).

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

Persistent muscle weakness.

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

Sexual difficulties.
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 your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

5. How to store ATORVASTATIN ABC

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 label or the packaging following "Exp.".
The expiry date refers to the last day of the month.
Do not dispose of medicines 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 ATORVASTATIN ABC contains
The active substance is atorvastatin calcium. Each tablet of ATORVASTATIN ABC contains 10 mg of
atorvastatin (as atorvastatin calcium).
The other components 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 ABC and pack contents
The 10 mg film-coated tablets of ATORVASTATIN ABC are elliptical, biconvex, and white to off-white in colour.
ATORVASTATIN ABC 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 Authorisation Holder and manufacturer
Marketing Authorisation Holder:
Pharmacare Srl
Via Marghera 29
20149 Milan
Italy
Exclusive distributor for sale:
ABC Farmaceutici SPA
Corso Vittorio Emanuele II, 72
10121 Turin
Italy
Manufacturer and responsible for batch release:
Teva Pharma S.L.U.
Polígono Industrial Malpica, c/ C, 4
50016 Zaragoza - Spain