XARATOR 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. XARATOR 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 mg chewable tablets
   1. What is XARATOR and what is it 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. Package Contents and Other Information
2. XARATOR 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is XARATOR and what is it 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. Package Contents and Other Information

XARATOR 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 mg chewable tablets

atorvastatin

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is XARATOR and what is it 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 can also be used to reduce
this risk, even if cholesterol levels are normal. You should continue a standard cholesterol-lowering diet during treatment.

2. What you need to know before taking XARATOR

Do not take XARATOR

• 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 a disease that affects the liver.
• if the results of liver function tests have shown inexplicably altered values.
• if you are a woman of childbearing potential and not using a reliable method of contraception.
• if you are pregnant or planning a pregnancy.
• if you are breastfeeding.
• if you are using the combination of glecaprevir/pibrentasvir in 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 in 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 had a previous stroke with cerebral haemorrhage or if you have limited 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 had recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume significant 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 will need to perform a blood test before and possibly during treatment with XARATOR to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see Section 2 “Other medicines and XARATOR”).
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further examinations and medicines may be necessary for the diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully monitor that you do not have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you 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 can alter the effect of XARATOR or the effect of these medicines can be altered by XARATOR. This type of interaction can reduce the effect of one or both medicines. Alternatively, it can increase the risk or severity of side effects including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to change the way 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 antagonists 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 to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.

Other medicines that are known to interact with XARATOR 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 (pain reliever), colchicine (used to treat gout), antacids (products against indigestion containing aluminum or magnesium)

• Non-prescription medicines: St. John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking XARATOR. Taking XARATOR with fusidic acid can rarely cause muscle weakness, soreness 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. Keep the following in mind:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice a day, as high amounts of grapefruit juice can 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 a pregnancy.
Do not take XARATOR if you are of childbearing potential unless you are using effective contraception.
Do not take XARATOR if you are breastfeeding.
The safety of XARATOR during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine alters your ability to drive. Do not use tools or machinery if your ability to use them is altered by this medicine.

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

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 you a low-cholesterol diet and you should
continue to follow the diet during therapy with XARATOR.
The usual initial dose of XARATOR is 10 mg once a day in adults and in children aged
10 years or older. If necessary, this dose may be increased by your doctor until the
achievement of the dose you need. Your doctor will adjust the dosage at intervals of 4 or more
weeks. The maximum dose of XARATOR is 80 mg once a day.
XARATOR tablets can be chewed or swallowed whole with water and can
be taken at any time of the day, with or without food. However, try to take the
tablets every day at the same time.
Always take this medicine exactly as your doctor or pharmacist has instructed. If
you have any doubts, consult your doctor or pharmacist.

The duration of treatment with XARATORis established by the doctor.
If you feel that the effect of XARATOR is too strong or too weak, contact your doctor.

If you take more XARATORthan 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 right 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 stop 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 and immediately inform your doctor or go to the nearest hospital emergency room.
Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue and throat which can cause significant difficulty in breathing.
• Serious condition associated with severe peeling and swelling of the skin, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may become blisters
• If you experience muscle weakness, soreness, pain or breakage or a change in the color of your urine, which becomes red-brown, and especially if you do not feel well and have a high fever at the same time, this may be caused by abnormal muscle deterioration

(rhabdomyolysis). Abnormal muscle deterioration does not always disappear, even after stopping atorvastatin; it can 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 suggest a liver disorder. You should see a doctor as soon as possible.
• Syndrome resembling lupus erythematosus (including skin rash, joint disorders 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 passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function

Not common: (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Tinnitus (ringing in the ears) and/or in the 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 (edema), increased body temperature
• Urinalysis positive for white blood cells

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

• vision disturbances
• 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 a feeling of tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (enlargement of the breasts in men).

Not known: frequency cannot be estimated based on available data

• persistent muscle weakness

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

• sexual dysfunction
• depression
• difficulty breathing including persistent cough and/or shortness of breath or fever
• diabetes. This is more likely if you have high sugar and fat levels in your blood, if you 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 effects, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
. By reporting side effects you
can contribute to providing 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 reported on the blister and on the package after
 Exp.  . The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient of 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 ingredients are: calcium carbonate, microcrystalline cellulose, sodium croscarmellose, polysorbate 80,
hydroxypropylcellulose, pregelatinized starch (corn), mannitol, aspartame (E951), sucralose, grape flavor
(maltodextrin, grape juice concentrate, gum arabic, pineapple juice concentrate, citric acid,
natural flavors) and magnesium stearate.

Description of the appearance of XARATORand package contents
The chewable tablets of XARATOR 5 mg are round in shape and are off-white in color,
with pink-purple dots. They are engraved with the inscription “5” on one side and “LCT” on the other.
The chewable tablets of XARATOR 10 mg are round in shape and are off-white in color,
with pink-purple dots. They are engraved with the inscription “10” on one side and “LCT” on the other.
The chewable tablets of XARATOR 20 mg are round in shape and are off-white in color,
with pink-purple dots. They are engraved with the inscription “20” on one side and “LCT” on the other.
The chewable tablets of XARATOR 40 mg are round in shape and are off-white in color,
with pink-purple dots. They are engraved with the inscription “40” on one side and “LCT” on the other.
XARATOR tablets are available in blister packs of 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
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090, Freiburg (Germany)

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

atorvastatin

Read this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is XARATOR and what is it 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. You should continue a standard cholesterol-lowering diet during treatment.

2. What you need to know before taking XARATOR

Do not take XARATOR

• 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 a disease that affects the liver
• if the results of liver function tests have shown inexplicably altered values
• if you are a woman of childbearing potential and not using a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding
• if you are using the combination of glecaprevir/pibrentasvir in 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 in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and XARATOR can cause serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with cerebral haemorrhage or if you have limited 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 had recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin class or fibrates)
• if you regularly consume significant 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 will need to perform a blood test before and possibly during treatment with XARATOR to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see Section 2 “Other medicines and XARATOR”).
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will carefully monitor that you do not have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you 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 can alter the effect of XARATOR or the effect of these medicines can be changed by XARATOR. This type of interaction can reduce the effect of one or both medicines. Alternatively, it can increase the risk or severity of side effects including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to change the way the immune system works, e.g. ciclosporin
• 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 antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Leteremovir, 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 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 that are known to interact with XARATOR 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 (painkiller), colchicine (used to treat gout), and antacids (products against indigestion containing aluminium or magnesium)
• Non-prescription medicines: St John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely restart taking XARATOR. Taking XARATOR with fusidic acid can rarely cause muscle weakness, soreness 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. Keep the following in mind:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice a day because high amounts of grapefruit juice can alter the effects of XARATOR.

Alcohol
Avoid drinking excessive amounts of alcohol when 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 a pregnancy.
Do not take XARATOR if you are of childbearing potential unless you are using effective contraception.
Do not take XARATOR if you are breastfeeding.
The safety of XARATOR during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine alters your ability to drive. Do not use tools or machinery if your ability to use them is altered by this medicine.

XARATOR contains lactose
If your doctor has diagnosed you with an intolerance to certain types of sugar, contact him or her 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 should
continue to follow this diet during therapy with XARATOR.
The usual initial dose of XARATOR is 10 mg once a day in adults and children aged
10 years or older. If necessary, this dose may be increased by your doctor until
reaching the dose you need. Your doctor will adjust the dosage at intervals of 4 or more
weeks. The maximum dose of XARATOR is 80 mg once a day.
XARATOR tablets should be swallowed whole with water and can be taken at
any time of day, with or without food. However, try to take the tablets every
day at the same time.
Always take this medicine exactly as your doctor or pharmacist has instructed. If
you have any doubts, consult your doctor or pharmacist.

The duration of treatment with XARATORis established by the doctor.
If you feel that the effect of XARATOR is too strong or too weak, consult your doctor.

If you take more XARATORthan 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 correct 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 stop 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 and immediately inform your doctor or go to the nearest hospital emergency room.
Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue and throat which can cause significant difficulty in breathing.
• Serious condition associated with severe skin peeling and blistering, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may become blisters.
• If you experience muscle weakness, soreness, pain or breakage or changes in the color of urine,

which becomes reddish-brown and especially if at the same time you do not feel well and have a high fever, this may be caused by abnormal muscle deterioration (rhabdomyolysis). Abnormal muscle deterioration does not always disappear, even after stopping atorvastatin: it can 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 suggest liver disorder. You should see a doctor as soon as possible.
• Lupus-like illness syndrome (including rash, joint disorders 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 passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function

Not common: (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Tinnitus (ringing in the ears) and/or in the 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 (edema), increased body temperature
• Urine test positive for white blood cells

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

• vision disturbances
• 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 a feeling of tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men) Not known: the frequency cannot be estimated on the basis of available data
• persistent muscle weakness

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

• sexual dysfunction
• depression
• difficulty breathing including persistent cough and/or shortness of breath or fever
• diabetes. This is more likely if you have high blood sugar and fat levels, if you 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 effects, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the pack 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 in waste water 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 ingredient of 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 ingredients are:
calcium carbonate, microcrystalline cellulose, lactose monohydrate,
sodium croscarmellose, polysorbate 80, hydroxypropyl cellulose and magnesium stearate.
The coating of XARATOR tablets contains hypromellose, macrogol 8000, titanium
dioxide (E171), talc, simeticone emulsion containing: simeticone, stearate emulsifiers
(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 package contents
The 10 mg film-coated tablets of XARATOR are white and have a round shape 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 and have a round shape 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 and have a round shape 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 and have a round shape with
a diameter of 11.9 mm. They are marked “80” on one side and “ATV” on the other.
Blisters consisting of a polyamide/aluminum foil and polyvinyl chloride and an aluminum sealing foil
with vinyl heat-sealing lacquer.
The HDPE bottle contains a desiccant and has a child-resistant closure with a press-and
turn cap.
XARATOR tablets are available in blister packs of 4, 7, 10, 14, 20, 28, 30, 50, 56,
84, 90, 98 and 100 film-coated tablets and in hospital packs of 50, 84, 100, 200 (10x20) or
500 film-coated tablets and bottles of 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
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090, Freiburg (Germany)