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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 possible side effects not listed in this leaflet.

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 allergic (hypersensitive) to Atorvastatin or to any similar medicines used to lower blood lipids (fats) or to any of the other ingredients of this medicine (listed in section 6);

-    if you have 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 (you are fertile) 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 or pharmacist before taking Atorvastatin

-    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;

-    if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

It is especially important to 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 treatment with this medicine to predict your risk of muscle related side effects. The risk of muscle related side effects e.g. rhabdomyolysis (abnormal muscle breakdown) 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 this medicine. 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 medical condition where abnormal muscle breakdown occurs (rhabdomyolysis) described in section 4. It is especially important that you tell your doctor if you are taking:

-    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 (fats), e.g. gemfibrozil, other fibrates, colestipol;

-    some calcium channel blockers used for angina (chest pain) 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, etc.;

-    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) and antacids (indigestion products containing aluminium or magnesium);

-    St John's Wort, a herbal remedy.

Atorvastatin with food, drink and alcohol 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 this medicine.

Alcohol

Avoid drinking too much alcohol while taking this medicine. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 (you are fertile) unless you use reliable contraceptive measures.

Do not take Atorvastatin if you are breast-feeding.

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 contains lactose monohydrate

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

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

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

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 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

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

If you stop taking Atorvastatin

If you have any further questions on the use of this medicine, 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 (uneven patch of colour) 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 (rhabdomyolysis) 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 of this medicine:

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

-    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 (may affect up to 1 in 100 people):

-    anorexia (loss of appetite and loss of weight), 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 (may affect up to 1 in 1,000 people):

-    visual disturbance;

-    unexpected bleeding or bruising;

-    cholestasis (manifested as yellowing of the skin and whites of the eyes);

-    tendon injury.

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

-    an allergic reaction - symptoms may include sudden wheezing (breathing hard with a whistling sound) 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).

Not known (frequency cannot be estimated from the available data):

-    muscle weakness that is constant.

5. How to store Atorvastatin

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the container and outer packaging 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. Contents of the pack and other information

What Atorvastatin contains

-    The active substance is atorvastatin.

Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).

-    The other ingredients of Atorvastatin are lactose monohydrate/ cellulose, microcrystalline, calcium carbonate, copovidone VA 64, crospovidone type B, croscarmellose sodium, sodium laurilsulfate, silica, colloidal anhydrous, talc and magnesium stearate.

The coating contains: hypromellose, titanium dioxide E 171 and macrogol 400.

What Atorvastatin looks like and contents of the pack

10 mg: Atorvastatin film-coated tablets are white, round, biconvex tablets with bisection line on one side and debossing 10 on other side. The dimensions of each tablet are approximately 7 mm.

20 mg: Atorvastatin film-coated tablets are white, round, biconvex tablets with bisection line on one side and debossing 20 on other side. The dimensions of each tablet are approximately 9 mm.

40 mg: Atorvastatin film-coated tablets are white, round, biconvex tablets with bisection line on one side and debossing 40 on other side. The dimensions of each tablet are approximately 11 mm.

80 mg: Atorvastatin film-coated tablets are white, oblong, biconvex tablets with bisection line on one side and debossing 80 on other side. The dimensions of each tablet are approximately 20 mm x 8 mm.

The tablet can be divided into equal halves.

Each strength of Atorvastatin film-coated tablets is supplied in blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer

ALKALOID-INT d.o.o., Slandrova ulica 4,

1231 Ljubljana - Crnuce, Slovenia Tel.: 386 1 300 42 90 Fax: 386 1 300 42 91 email: info@alkaloid.si

This medicinal product is authorised in the Member States of the EEA under the following names:

Calipra

10 mg; 20 mg; 40 mg; 80 mg film-coated tablets Stavra 10 mg; 20 mg; 40 mg; 80 mg Toreza

10 mg; 20 mg; 40 mg; 80 mg filmtabletta Calipra

Slovak Republic Calipra 10 mg; 20 mg; 40 mg; 80 mg

Stavra

10 mg; 20 mg; 40 mg; 80 mg filmsko oblozene tablete

Stavra

10 mg; 20 mg; 40 mg; 80 mg comprimate filmate Atorvastatin

10 mg; 20 mg; 40 mg; 80 mg film-coated tablets

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.

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet.

Atorvastatin 10 mg film-coated Atorvastatin 20 mg film-coated Atorvastatin 40 mg film-coated Atorvastatin 80 mg film-coated Leaflet last revised 03/2015.

Atorvastatin_01c_UK_mock_up.indd 2 3/19/2015 2:42:32 PM