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PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatin 10 mg, 20 mg, 40 mg, 80 mg film-coated Tablets Atorvastatin

In this leaflet:

What Atorvastatin Tablets are and what they are used for

What you need to know before you take

Atorvastatin Tablets

How to take Atorvastatin Tablets

Possible side effects

How to store Atorvastatin Tablets

Contents of the pack and other information

1. What Atorvastatin Tablets are and what they are used for

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

Atorvastatin Tablets are 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 Tablets 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 Tablets

Do not take Atorvastatin Tablets 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 - see Section 6 for details

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

•    have had any unexplained abnormal blood tests for liver function

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

•    are pregnant, trying to become pregnant

•    breast-feeding.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Atorvastatin Tablets.

The following are reasons why Atorvastatin Tablets 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 Tablets

•    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 Tablets").

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 Tablets

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 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 Tablets with food and drink

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

Grapefruitjuice

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 Tablets if you are pregnant, or if you are trying to become pregnant.

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

Do not take Atorvastatin Tablets if you are breast-feeding.

The safety of Atorvastatin Tablets 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.

Atorvastatin Tablets contain lactose and sucrose

This product contains sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Atorvastatin Tablets

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

The usual starting dose 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 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 Atorvastatin exactly as your doctor has told you. You should 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 Tablets than you should

If you accidentally 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 Tablets

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 Tablets

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, Atorvastatin Tablets 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atorvastatin Tablets

Keep out of the sight and reach of children. Store below 25°C.

Do not use Atorvastatin Tablets after the expiry date which is stated on the blister, carton or label after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Further information

What Atorvastatin Tablets contain

The active substance in your tablets is atorvastatin.

Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin known as atorvastatin calcium.

The other ingredients of Atorvastatin Tablets are:

Tablet core: Butyl hydroxyanisole, cellulose microcrystalline, silica colloidal anhydrous, lactose monohydrate, sodium laurilsulfate, sodium hydrogen carbonate crospovidone (Type A), magnesium stearate, dimethicone 400, sucrose, sorbitan tristearate, macrogol 40 stearate, 2-bromo-2-nitropropane-1,3-diol Tablet coating: Opadry OyL-28900 White -contains lactose monohydrate, hydroxypropyl methylcellulose (hypromellose 15 CP), titanium dioxide (E171) and macrogol/PEG 4000.

What Atorvastatin Tablets look like and contents of the pack

Atorvastatin Tablets are white with a capsule shape.

Atorvastatin 10 mg tablets are marked with RDY on one side and '571' on the other side. Atorvastatin 20 mg tablets are marked with RDY on one side and '570' on the other side Atorvastatin 40 mg tablets are marked with R569 on one side and plain on the other side. Atorvastatin 80 mg tablets are marked with R568 on one side and plain on the other side.

Atorvastatin Tablets are supplied in blister packs of:

10 mg: 10, 14, 28, 30, 50, 56 and 100 20 mg: 10, 28, 30, 50, 56 and 100 40 mg: 28, 30, 50, 56 and 100 80 mg: 28, 30, 50, 56 and 100

Marketing Authorisation Holder and Manufacturer

Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK

This leaflet was last updated in 03/2015

PL numbers: 08553/0336 - 0339