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Package Leaflet: Information for the user

Lipitor® 80 mg Film-Coated Tablets

(atorvastatin calcium)

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, pharmacist or nurse.

•    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 of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called as Lipitor 80 mg Film-coated Tablets but will be referred as Lipitor throughout this leaflet.

What is 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

Talk to your doctor, pharmacist or nurse before taking Lipitor.

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) and boceprevir (used to treat liver disease such as hepatitis C)

•    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 breastfeeding 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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. The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it 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 via Yellow Card Scheme www.mhra.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lipitor

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not use Lipitor after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.

•    Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Manufacturer

This product is manufactured by:

Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg,

Mooswaldallee 1,

79090 Freiburg,

Germany.

PL No. 39352/0166

Leaflet date: 09.03.2015

Lipitor® is a registered trade mark of Pfizer Ireland Pharmaceuticals, Ireland.

Atorvastatin 80 mg Film-Coated Tablets

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, pharmacist or nurse.

•    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 of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Se section 4.

Your medicine is called as Atorvastatin 80 mg Film-coated Tablets but will be referred as Atorvastatin throughout this leaflet.

What is 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

Talk to your doctor, pharmacist or nurse before taking Atorvastatin.

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 anticonvulsant 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) and boceprevir (used to treat liver disease such as hepatitis C)

•    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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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. The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it 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.