Xarator

Package leaflet: Information for the user

XARATOR 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What XARATOR is and what it is used for

XARATOR belongs to a class of medicines called statins, which regulate lipid (fat) levels.
XARATOR 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, XARATOR 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 XARATOR

Do not take XARATOR

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

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

• 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 infection) orally or by injection. The combination of fusidic acid and XARATOR can 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 XARATOR 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 XARATOR”).
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
While being treated 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.

Other medicines and XARATOR
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of XARATOR or the effect of these medicines may be altered by XARATOR. 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, itraconazolo, 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

• Medicines 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 XARATOR 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), 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 advise you when it is safe to restart XARATOR. Taking XARATOR with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

XARATOR with food and drink
See section 3 for instructions on how to take XARATOR. Please note the following:
Grapefruit juice
Do 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 XARATOR.
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 XARATOR if you are pregnant or planning to become pregnant.
Do not take XARATOR if you are of childbearing age unless you are using an effective method of contraception.
Do not take XARATOR if you are breastfeeding.
The safety of XARATOR during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking any 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 operate tools or machinery if your ability to use them is impaired by this medicine.

XARATOR 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 causing accumulation of phenylalanine because the body cannot properly eliminate it.

XARATOR 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 XARATOR

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet during treatment with XARATOR.
The usual starting dose of XARATOR 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 XARATOR is 80 mg once daily.
XARATOR 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 take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with XARATOR is determined by your doctor.
If you feel that the effect of XARATOR is too strong or too weak, consult your doctor.
If you take more XARATOR than you should
If you accidentally take too many XARATOR tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take XARATOR
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 XARATOR
If you have any doubts about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following serious adverse reactions 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 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, pain, or muscle damage, or notice a change in the colour of your urine to red-brown, 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 after stopping atorvastatin; it may be life-threatening and can 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 illness syndrome (including skin rash, joint problems, and effects on blood cells).

Other adverse reactions that may occur with XARATOR

Common: (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 must 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 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 closely)
• 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)
• 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, 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)

Not known: frequency cannot be determined from available data

• Persistent muscle weakness

Possible adverse reactions 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at the following website:
. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store XARATOR

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 does not require any special storage conditions.
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 XARATOR contains
The active substance in XARATOR is atorvastatin.
Each tablet contains 5 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each tablet contains 40 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 XARATOR and the pack contents
XARATOR 5 mg chewable tablets are round-shaped and white to off-white, with pink-purple specks. They are engraved with the code "5" on one side and "LCT" on the other.
XARATOR 10 mg chewable tablets are round-shaped and white to off-white, with pink-purple specks. They are engraved with the code "10" on one side and "LCT" on the other.
XARATOR 20 mg chewable tablets are round-shaped and white to off-white, with pink-purple specks. They are engraved with the code "20" on one side and "LCT" on the other.
XARATOR 40 mg chewable tablets are round-shaped and white to off-white, with pink-purple specks. They are engraved with the code "40" on one side and "LCT" on the other.
XARATOR tablets are available in blister packs containing 30 chewable 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
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090, Freiburg, Germany

Package leaflet: information for the user

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

Contents of this leaflet

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

1. What XARATOR is and what it is used for

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

2. What you should know before taking XARATOR

Do not take XARATOR

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and you 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 XARATOR:

• 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) by mouth or injection. The combination of fusidic acid and XARATOR can 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 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 of age

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with XARATOR 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 XARATOR”).
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. 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 XARATOR
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 XARATOR, or the effect of these medicines may be altered by XARATOR. 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
• Letermovir, a medicine used to help prevent cytomegalovirus disease
• Medicines 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 XARATOR include ezetimibe (a cholesterol-lowering agent), warfarin (a blood clotting reducer), 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 to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart XARATOR. Taking XARATOR with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

XARATOR with food and drink
See section 3 for instructions on how to take XARATOR. 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 may alter the effects of XARATOR.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take XARATOR if you are pregnant or planning to become pregnant.
Do not take XARATOR if you are of childbearing age unless you are using an effective method of contraception.
Do not take XARATOR if you are breastfeeding.
The safety of XARATOR during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking any 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 do so. Do not use tools or machinery if your ability to operate them is impaired by this medicine.
XARATOR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
XARATOR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
XARATOR 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 XARATOR

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet during treatment with XARATOR.
The usual starting dose of XARATOR 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 XARATOR is 80 mg once daily.
XARATOR 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 this medicine exactly as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with XARATOR is determined by your doctor.
If you feel that the effect of XARATOR is too strong or too weak, consult your doctor.
If you take more XARATOR than you should
If you accidentally take too many XARATOR tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take XARATOR
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 XARATOR
If you have any questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, or genital area, 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 notice a change in the colour of your urine to 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 illness syndrome (including skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with XARATOR

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

• Inflammation of the nasal airways, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased 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 should continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, reduced sensation 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)
• Skin 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

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 XARATOR

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 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 XARATOR Contains
The active substance in XARATOR is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

The coating of XARATOR tablets contains hypromellose, macrogol 8000, titanium
dioxide (E171), talc, and a 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 XARATOR and Contents of the Package
The 10 mg film-coated tablets of XARATOR are white, round, 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 XARATOR are white, round, 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 XARATOR are white, round, 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 XARATOR are white, round, 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 of polyamide/aluminum and polyvinyl chloride, and a sealing foil made of aluminum with a vinyl thermal adhesive coating.

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

XARATOR film-coated tablets are available in blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, and 100 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
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090 Freiburg (Germany)