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Atorvastatin 20mg Tablets

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ATORVASTATIN 20mg TABLETS ATORVASTATIN 40mg TABLETS (atorvastatin calcium)

Patient Information Leaflet

This product is available in all of the above names and strengths, but will be referred to throughout this leaflet as Atorvastatin. Other strengths (10mg and 80mg), are also available.

Read all of 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 further questions, ask your doctor or pharmacist.

   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Atorvastatin is and what it is used for

2.    What you need to know before you take Atorvastatin

3.    How to take Atorvastatin

4.    Possible side effects

5.    How to store Atorvastatin

6.    Contents of the pack and other information

1. What Atorvastatin is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2. What you need to know before you take Atorvastatin

Do not take Atorvastatin

•    if you are hypersensitive (allergic) to Atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine - listed in section 6

•    if you    have    or have ever had a disease which affects the liver

•    if you    have    had any unexplained abnormal blood tests for liver function

•    if you    are a    woman able to have children and not using reliable contraception

•    if you are pregnant or trying to become pregnant

•    if you are breast-feeding.

Warnings and precautions

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

•    if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes

•    if you    have    kidney problems

•    if you    have    an under-active thyroid gland (hypothyroidism)

•    if you    have    had repeated or unexplained muscle aches or pains, a personal history or    family    history    of muscle problems

•    if you    have    had previous muscular problems during treatment with other lipid-lowering    medicines    (e.g. other    ‘-statin'    or

‘-fibrate' medicines)

•    if you regularly drink a large amount of alcohol

•    if you have a history of liver disease

•    if you are older than 70 years.

Check with your doctor or pharmacist before taking Atorvastatin

•    if you have severe respiratory failure.

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atorvastatin treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g. rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 "Other medicines and Atorvastatin”).

While you are on this medicine your doctor will monitor you closely if you have Diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Atorvastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are some medicines that may change the effect of Atorvastatin, or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4:

•    Medicines used to alter the way your immune system works, e.g. ciclosporin

•    Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid

•    Other medicines 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 your heart rhythm e.g. digoxin, verapamil, amiodarone

•    Medicines used in 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

•    Other medicines known to interact with Atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (indigestion products containing aluminium or magnesium)

•    Medicines obtained without a prescription: St John's Wort

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Atorvastatin with food and drink

See Section 3 for instructions on how to take Atorvastatin. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin.

Alcohol

Avoid drinking too much alcohol while taking this medicine.

See Section 2 "Warnings and precautions” for details

Pregnancy and breast-feeding

Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant.

Do not take Atorvastatin if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take Atorvastatin if you are breast-feeding.

The safety of Atorvastatin during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Important information about some of the ingredients of Atorvastatin

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Atorvastatin

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin.

The usual starting dose of Atorvastatin is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

The duration of treatment with Atorvastatin is determined by your doctor.

Please ask your doctor if you think that the effect of Atorvastatin is too strong or too weak.

If you take more Atorvastatin than you should

If you accidently take too many Atorvastatin tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Atorvastatin

If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atorvastatin

If you have any further questions on the use of this medicine or wish to stop your treatment, ask 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, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

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

•    Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.

•    Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.

•    Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems.

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

If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatin:

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

•    inflammation of the nasal passages, pain in the throat, nose bleed

•    allergic reactions

•    increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase

•    headache

•    nausea, constipation, wind, indigestion, diarrhoea

•    joint pain, muscle pain and back pain

•    blood test results that show your liver function can become abnormal

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

•    anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)

•    having nightmares, insomnia

•    dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory

•    blurred vision

•    ringing in the ears and/or head

•    vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)

•    hepatitis (liver inflammation)

•    rash, skin rash and itching, hives, hair loss

•    neck pain, muscle fatigue

•    fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature

•    urine tests that are positive for white blood cells

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

•    visual disturbance

•    unexpected bleeding or bruising

•    cholestasis (yellowing of the skin and whites of the eyes)

•    tendon injury

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

•    an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse

•    hearing loss

•    gynecomastia (breast enlargement in men and women).

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

•    Sexual difficulties

•    Depression

•    Breathing problems including persistent cough and/or shortness of breath or fever

•    Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

5. How to store Atorvastatin

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal.

•    Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.

•    Do not use after the last day of the month shown in the expiry date on the carton and blister.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Atorvastatin contains

Your medicine is called Atorvastatin tablets. Each tablet contains the active ingredient, atorvastatin (as the calcium trihydrate) in two strengths 20mg and 40mg.

The 20mg tablets are white, round, film-coated and marked 'ATV' on one side and '20' on the other side.

The 40mg tablets are white, round, film-coated and marked 'ATV' on one side and '40' on the other side.

Atorvastatin tablets also contain the following:

Lactose monohydrate, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, calcium carbonate, polysorbate 80, hydroxypropylmethylcellulose, polyethylene glycol, talc, simethicone, sorbic acid, benzoic acid, stearate emulsifiers, thickeners and titanium dioxide (E171).

Atorvastatin tablets, each strength, are available as calendar blister packs of 28 tablets.

i M i    PL No: 6464/1322 Atorvastatin 20mg tablets

POM    PL No: 6464/1323 Atorvastatin 40mg tablets

These products are manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee, Freiburg, Germany and are procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR

Leaflet revision and issue date (Ref.) 07.04.2014

LIPITOR® 20mg TABLETS/ATORVASTATIN 20mg TABLETS LIPITOR® 40mg TABLETS/ATORVASTATIN 40mg TABLETS (atorvastatin calcium)

Patient Information Leaflet

This product is available in all of the above names and strengths, but will be referred to throughout this leaflet as Lipitor. Other strengths (10mg and 80mg), are also available.

Read all of 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 further questions, ask your doctor or pharmacist.

   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Lipitor is and what it is used for

2.    What you need to know before you take Lipitor

3.    How to take Lipitor

4.    Possible side effects

5.    How to store Lipitor

6.    Contents of the pack and other information

1. What Lipitor is and what it is used for

Lipitor belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Lipitor is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Lipitor can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2. What you need to know before you take Lipitor

Do not take Lipitor

•    if you are hypersensitive (allergic) to Lipitor or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine - listed in section 6

•    if you    have or have ever had a disease which affects the liver

•    if you    have had any unexplained abnormal blood tests for liver function

•    if you    are a woman able to have children and not using reliable contraception

•    if you are pregnant or trying to become pregnant

•    if you are breast-feeding.

Warnings and precautions

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

•    if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes

•    if you    have kidney problems

•    if you    have an under-active thyroid gland (hypothyroidism)

•    if you    have had repeated or unexplained muscle aches or pains, a personal history or    family    history of    muscle    problems

•    if you    have had previous muscular problems during treatment with other lipid-lowering    medicines (e.g.    other ‘-statin'    or

‘-fibrate' medicines)

•    if you regularly drink a large amount of alcohol

•    if you have a history of liver disease

•    if you are older than 70 years.

Check with your doctor or pharmacist before taking Lipitor

•    if you have severe respiratory failure.

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Lipitor treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g. rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 "Other medicines and Lipitor”).

While you are on this medicine your doctor will monitor you closely if you have Diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Lipitor

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are some medicines that may change the effect of Lipitor, or their effect may be changed by Lipitor. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4:

•    Medicines used to alter the way your immune system works, e.g. ciclosporin

•    Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid

•    Other medicines 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 your heart rhythm e.g. digoxin, verapamil, amiodarone

•    Medicines used in 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

•    Other medicines known to interact with Lipitor include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (indigestion products containing aluminium or magnesium)

•    Medicines obtained without a prescription: St John's Wort

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Lipitor with food and drink

See Section 3 for instructions on how to take Lipitor. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Lipitor.

Alcohol

Avoid drinking too much alcohol while taking this medicine.

See Section 2 "Warnings and precautions” for details

Pregnancy and breast-feeding

Do not take Lipitor if you are pregnant, or if you are trying to become pregnant.

Do not take Lipitor if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take Lipitor if you are breast-feeding.

The safety of Lipitor during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Important information about some of the ingredients of Lipitor

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Lipitor

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Lipitor.

The usual starting dose of Lipitor is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Lipitor is 80 mg once daily for adults and 20 mg once daily for children.

Lipitor tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

The duration of treatment with Lipitor is determined by your doctor.

Please ask your doctor if you think that the effect of Lipitor is too strong or too weak.

If you take more Lipitor than you should

If you accidently take too many Lipitor tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Lipitor

If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lipitor

If you have any further questions on the use of this medicine or wish to stop your treatment, ask 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, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

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

•    Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.

•    Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.

•    Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems.

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

If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Lipitor:

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

•    inflammation of the nasal passages, pain in the throat, nose bleed

•    allergic reactions

•    increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase

•    headache

•    nausea, constipation, wind, indigestion, diarrhoea

•    joint pain, muscle pain and back pain

•    blood test results that show your liver function can become abnormal

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

•    anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)

•    having nightmares, insomnia

•    dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory

•    blurred vision

•    ringing in the ears and/or head

•    vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)

•    hepatitis (liver inflammation)

•    rash, skin rash and itching, hives, hair loss

•    neck pain, muscle fatigue

•    fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature

•    urine tests that are positive for white blood cells

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

•    visual disturbance

•    unexpected bleeding or bruising

•    cholestasis (yellowing of the skin and whites of the eyes)

•    tendon injury

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

•    an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse

•    hearing loss

•    gynecomastia (breast enlargement in men and women).

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

•    Sexual difficulties

•    Depression

•    Breathing problems including persistent cough and/or shortness of breath or fever

•    Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

5.    How to store Lipitor

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal.

•    Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.

•    Do not use after the last day of the month shown in the expiry date on the carton and blister.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Lipitor contains

Your medicine is called Lipitor tablets/Atorvastatin tablets. Each tablet contains the active ingredient, atorvastatin (as the calcium trihydrate) in two strengths 20mg and 40mg.

The 20mg tablets are white, round, film-coated and marked 'ATV' on one side and '20' on the other side.

The 40mg tablets are white, round, film-coated and marked 'ATV' on one side and '40' on the other side.

Lipitor tablets/Atorvastatin tablets also contain the following:

Lactose monohydrate, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, calcium carbonate, polysorbate 80, hydroxypropylmethylcellulose, polyethylene glycol, talc, simethicone, sorbic acid, benzoic acid, stearate emulsifiers, thickeners and titanium dioxide (E171).

Lipitor tablets/Atorvastatin tablets, each strength, are available as calendar blister packs of 28 tablets.

PL No: 6464/1322 Lipitor 20mg tablets/Atorvastatin 20mg tablets POM    PL No: 6464/1323 Lipitor 40mg tablets/Atorvastatin 40mg tablets

These products are manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee, Freiburg, Germany and are procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR

Leaflet revision and issue date (Ref.) 07.04.2014

Lipitor is a registered trademark of PFIZER IRELAND PHARMACEUTICALS

V