Torvast: detailed information

Package leaflet: Information for the user

TORVAST 10 mg chewable tablets, 20 mg chewable tablets

atorvastatin
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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What TORVAST is and what it is used for
What you need to know before taking TORVAST
How to take TORVAST
Possible side effects
How to store TORVAST
Contents of the pack and other information

1. What TORVAST is and what it is used for

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

2. What you should know before taking TORVAST

Do not take TORVAST

if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
if you have or have had liver disease
if liver function tests have shown unexplained abnormal results
if you are 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
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TORVAST:

if you suffer from severe respiratory insufficiency
if you are taking or have taken within the last 7 days fusidic acid (a medicine used for bacterial infections) orally or by injection. The combination of fusidic acid and TORVAST 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 had repeated or unexplained muscle pain, or a personal or family history of muscle disorders
if you have previously experienced muscle problems while being treated 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 TORVAST 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 TORVAST”).
Furthermore, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional 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. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.

Other medicines and TORVAST
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can alter the effect of TORVAST, or the effect of these medicines can be altered by TORVAST. 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 cytomegalovirus-related diseases
Medicines 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 TORVAST include ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium)
Over-the-counter medicines: St. John’s wort (Hypericum perforatum)
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart TORVAST. Taking TORVAST with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

TORVAST with food and drink
See section 3 for instructions on how to take TORVAST. 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 TORVAST.
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 TORVAST if you are pregnant or planning to become pregnant.
Do not take TORVAST if you are of childbearing age unless you are using an effective method of contraception.
Do not take TORVAST if you are breastfeeding.
The safety of TORVAST 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 operate them is impaired by this medicine.

TORVAST contains aspartame
5 mg chewable tablet
This medicine contains 0.625 mg of aspartame per chewable tablet.
10 mg chewable tablet
This medicine contains 1.25 mg of aspartame per chewable tablet.
20 mg chewable tablet
This medicine contains 2.5 mg of aspartame per chewable tablet.
40 mg chewable tablet
This medicine contains 5 mg of aspartame per chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.

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

3. How to take TORVAST

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with TORVAST.
The usual starting dose of TORVAST 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 TORVAST is 80 mg once daily.
TORVAST tablets may be chewed or 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 follow your doctor’s or pharmacist’s instructions exactly when taking this medicine. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with TORVAST is determined by your doctor.
If you think that the effect of TORVAST is too strong or too weak, consult your doctor.
If you take more TORVAST than you should
If you accidentally take too many TORVAST tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take TORVAST
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 missed tablet.
If you stop taking TORVAST
If you have any questions about using this medicine, or if you wish to stop treatment, 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 experience any of the following serious side effects or symptoms, stop taking your tablets immediately and inform your doctor straight away or go to the nearest hospital emergency department.

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

Severe allergic reaction causing swelling of the face, tongue and throat, which may cause significant difficulty in breathing.
A 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.
If you experience muscle weakness, tenderness, pain or muscle breakdown or changes in the colour of your urine, which become red-brown, especially if you also feel unwell and have a high fever, this may be due to abnormal muscle breakdown (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: 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 disease syndrome (including skin rash, joint disorders and effects on blood cells).

Other side effects that may occur with TORVAST

Common: may affect up to 1 in 10 people

Inflammation of the nasal airways, sore throat, nosebleeds
Allergic reactions
Increased blood sugar levels (if you have diabetes, you must 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: may affect up to 1 in 100 people

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, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
Hepatitis (inflammation of the liver)
Rash, skin eruption and itching, urticaria, hair loss
Neck pain, muscle fatigue
Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
Positive urine test for white blood cells

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

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

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

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

Not known: 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, pharmacist or nurse. 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 TORVAST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
 Exp.  . The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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 TORVAST contains
The active substance in TORVAST is atorvastatin.
Each tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other components are: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80,
hydroxypropylcellulose, pregelatinized starch (maize), mannitol, aspartame (E951), sucralose, grape flavour
(maltodextrin, grape juice concentrate, gum arabic, pineapple juice concentrate, citric acid, natural flavours), and magnesium stearate.

Description of the appearance of TORVAST and pack contents
TORVAST 10 mg chewable tablets are round-shaped and white to off-white in colour, with pink-violet specks. They are engraved with the code "10" on one side and "LCT" on the other.
TORVAST 20 mg chewable tablets are round-shaped and white to off-white in colour, with pink-violet specks. They are engraved with the code "20" on one side and "LCT" on the other.
TORVAST tablets are available in blister packs containing 30 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano, Italy

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090 Freiburg, Germany

Package leaflet: information for the user

TORVAST 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

atorvastatin
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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What TORVAST is and what it is used for
What you need to know before taking TORVAST
How to take TORVAST
Possible side effects
How to store TORVAST
Contents of the pack and other information

1. What TORVAST is and what it is used for

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

2. What you should know before taking TORVAST

Do not take TORVAST

if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
if you have or have had liver disease
if liver function tests have shown unexplained abnormal results
if you are 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
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TORVAST

if you suffer from severe respiratory failure
if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TORVAST can cause serious muscle problems (rhabdomyolysis)
if you have previously had a stroke with cerebral haemorrhage or if you have low fluid reserves in the brain due to previous strokes
if you have kidney problems
if you have an underactive thyroid gland (hypothyroidism)
if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
if you have previously 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 should perform a blood test before and possibly during treatment with TORVAST to assess the risk of muscle-related side 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 TORVAST”).
Furthermore, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat 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.
Other medicines and TORVAST
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines can alter the effect of TORVAST or the effect of these medicines can be altered by TORVAST. 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 how the immune system works, e.g. cyclosporine
Some 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
Some 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 cytomegalovirus-related diseases
Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with TORVAST 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), colchicine (used to treat gout), antacids (indigestion remedies containing aluminium or magnesium)
Over-the-counter medicines: St. John’s Wort
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart TORVAST. Taking TORVAST with fusidic acid may rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

TORVAST with food and drink
See section 3 for instructions on how to take TORVAST. Please note the following:
Grapefruit juice
You should 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 TORVAST.
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 TORVAST if you are pregnant or planning to become pregnant.
Do not take TORVAST if you are of childbearing age unless you are using an effective method of contraception.
Do not take TORVAST if you are breastfeeding.
The safety of TORVAST 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 machines if your ability to use them is impaired by this medicine.
TORVAST contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
TORVAST contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
TORVAST contains benzoic acid
10 mg tablet
This medicine contains 0.00004 mg of benzoic acid in each tablet.
20 mg tablet
This medicine contains 0.00008 mg of benzoic acid in each tablet.
40 mg tablet
This medicine contains 0.00016 mg of benzoic acid in each tablet.
80 mg tablet
This medicine contains 0.00032 mg of benzoic acid in each tablet.

3. How to take TORVAST

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during your treatment with TORVAST.
The usual starting dose of TORVAST 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 dose at intervals of 4 weeks or more. The maximum dose of TORVAST is 80 mg once daily.
TORVAST 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.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with TORVAST is determined by your doctor.
If you feel that the effect of TORVAST is too strong or too weak, consult your doctor.
If you take more TORVAST than you should
If you accidentally take too many TORVAST tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take TORVAST
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 TORVAST
If you have any questions about using this medicine, or if you wish to stop treatment, 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 experience 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: may affect up to 1 in 1,000 people

Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause 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, pain, or injury, or notice changes in the colour of your urine (turning red-brown), especially if you also feel unwell and have a high fever, this may be due to abnormal muscle breakdown (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: 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 disease syndrome (including skin rash, joint disorders, and effects on blood cells).

Other side effects that may occur with TORVAST

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

Inflammation of the nasal passages, sore throat, nosebleeds
Allergic reactions
Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased creatine kinase in the blood
Headache
Nausea, constipation, flatulence, indigestion, diarrhoea
Joint pain, muscle pain, and back pain
Changes in laboratory tests for liver function

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

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

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

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

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

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

Not known: 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 TORVAST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label after
 Exp.  . The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 TORVAST Contains
The active substance in TORVAST is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatine calcium trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatine calcium trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatine calcium trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatine calcium trihydrate).

The other components are:
calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropylcellulose and magnesium stearate.

The coating of TORVAST tablets contains hypromellose, macrogol 8000, titanium dioxide (E171), talc,
simeticone emulsion containing: simeticone, emulsifying stearates (polysorbate 65, macrogol stearate 400,
glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E210),
sorbic acid and sulfuric acid.

Description of the Appearance of TORVAST and Contents of the Package
The 10 mg film-coated tablets of TORVAST are white, round-shaped tablets with a diameter of 5.6 mm.
They are marked "10" on one side and "ATV" on the other.
The 20 mg film-coated tablets of TORVAST are white, round-shaped tablets with a diameter of 7.1 mm.
They are marked "20" on one side and "ATV" on the other.
The 40 mg film-coated tablets of TORVAST are white, round-shaped tablets with a diameter of 9.5 mm.
They are marked "40" on one side and "ATV" on the other.
The 80 mg film-coated tablets of TORVAST are white, round-shaped tablets with a diameter of 11.9 mm.
They are marked "80" on one side and "ATV" on the other.

Blister packs consist of a sheet made of polyamide/aluminum and polyvinyl chloride, and a sealing foil made of aluminum with a vinyl heat-seal lacquer.

The HDPE bottle contains a desiccant and has a child-resistant closure with a push-and-turn cap.

TORVAST tablets are available in blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets, in hospital packs containing 50, 84, 100, 200 (10x20) or 500 film-coated tablets, and in bottles containing 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Production site Freiburg - Mooswaldallee 1 - 79090 Freiburg (Germany)