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Format: 200 x 340 mm

Colour: Pantone Reflex Blue U

PIL Atorvastatin film-coated tablets

Schrift: Corporate S/9 pt

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatin 10 tablets

Atorvastatin 20 tablets

Atorvastatin 40 tablets

Atorvastatin 80 tablets

Atorvastatin

In this leaflet:

1.    What Atorvastatin is and what it is used for

2.    Before you take Atorvastatin

3.    How to take Atorvastatin

4.    Possible side effects

5.    How to store Atorvastatin

6.    Further information

1. WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR

Atorvastatin belongs to a group of medicines known as statins. Statins lower blood cholesterol (and triglycerides).

Atorvastatin is advised when a low-fat diet and lifestyle changes have not been adequate to lower blood cholesterol as recommended.

If you are at an increased risk of heart disease, Atorvastatin may also be used to reduce such risk even if your blood cholesterol is “normal”. You should maintain a standard cholesterol-lowering diet during treatment.

2. BEFORE YOU TAKE ATORVASTATIN

Do not take Atorvastatin if you

-    are hypersensitive (allergic) to Atorvastatin or to any similar medicines used to lower blood cholesterol or to any of the other ingredients of the medicine - see Section 6 for details.

-    have or have ever had a disease that 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 or trying to become pregnant

-    are breast-feeding.

Take special care with Atorvastatin if you have:

-    had a previous stroke caused by bleeding

-    kidney problems

-    an under-active thyroid gland (hypothyroidism)

-    (or have had) repeated or unexplained muscle aches or pains or a family history of muscle problems

-    had previous muscle problems during treatment with other cholesterol-lowering medicines (i.e. other ‘statin’ or ‘fibrate’ medicines)

-    had liver disease

-    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.

also take special care with Atorvastatin and if you:

-    regularly drink a large amount of alcohol

-    are older than 70 years.

Check with your doctor or pharmacist before taking Atorvastatin

-    if you have severe respiratory failure.

The above are reasons why Atorvastatin may not be suitable for you: if any of the above reasons apply to you, your doctor will need to carry out a blood test before and possibly during your treatment with Atorvastatin especially to predict your risk of muscle related side effects. The risk of muscle related side effects is known to increase when certain medicines are taken at the same time (see Section 2 “Taking other medicines”).

Taking 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 lower cholesterol e.g. gemfibrozil, other fibrates, colestipol

-    Medicines used for angina or high blood pressure known as “calcium channel blockers” 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

-    Other medicines known to interact with Atorvastatin include ezetimibe (lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (for epilepsy), cimetidine (for heartburn and peptic ulcers), phenazone (a painkiller) 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.

Taking 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 “Take special care with Atorvastatin” 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.

Before starting treatment, your doctor will advise a low-cholesterol diet: you should continue this diet whilst taking 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.

Schrift: Corporate S/9 pt

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, Atorvastatin 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.

Uncommon: affects 1 to 10 users in 1000:

-    Inflammation of the pancreas causing abdominal pain and vomiting

Rare: affects 1 to 10 users in 10,000:

-    swelling of the face, tongue and windpipe that can cause great difficulty in breathing

-    severe, extensive, blistering skin rash

-    severe muscle disease: symptoms include muscle weakness, tenderness or pain and if you also feel unwell or have a high temperature then the symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems.

-    unexpected or unusual bleeding or bruising Very rare: affect less than 1 user in 10,000:

-    a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure

-    severe liver problems

The following side-effects have also been reported:

Common: affects 1 to 10 users in 100:

-    inflammation and pain in the upper airways, nose bleed

-    allergic reactions

-    change in blood sugar (if you have diabetes continue careful monitoring of your blood sugar levels),

-    headache

-    nausea, constipation, wind, indigestion, diarrhoea

-    joint pain, muscle pain and back pain

-    changes in blood test results that report on your muscles and liver

Uncommon: affects 1 to 10 users in 1000:

-    loss of appetite, vomiting, belching, abdominal pain

-    weight gain

-    nightmares, insomnia

-    dizziness, ringing in the ears (tinnitus)

-    numbness or tingling in the fingers and toes, reductions of sensation to pain or touch

-    change in sense of taste

-    loss of memory

-    visual disturbance

-    liver problems

-    skin rash, itching, hives, hair loss

-    neck pain, chest pain

-    fatigue, feeling unwell, weakness

-    fluid retention causing swelling of the extremities

-    fever

-    a urine test that gives a positive result for the presence of white blood cells

Rare: affects 1 to 10 users in 10,000:

-    jaundice (yellowing of skin)

-    sore muscle tendons that may rupture

Very rare: affects less than 1 user in 10,000:

-    hearing loss

-    increase in breast tissue in men

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE ATORVASTATIN

Keep out of the reach and sight of children.

HDPE-bottles:

This medicinal product does not require any special storage conditions.

OPA/Al/PVC-Al blister:

Atorvastatin 10 mg, 40 mg, 80 mg

This medicinal product does not require any special storage conditions.

Do not use Atorvastatin 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.

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. FURTHER INFORMATION_

What Atorvastatin contains

-    The active substance is atorvastatin.

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

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

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

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

-    The other ingredients of Atorvastatin are:

Tablet core: lactose monohydrate, crospovidone (type A), macrogol 6000, meglumine, microcrystalline cellulose, sodium hydrogen carbonate, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), talc.

What Atorvastatin looks like and contents of the pack

Atorvastatin 10 mg film-coated tablets

White to off white coloured, biconvex, oval shaped, film coated tablets debossed with ‘1’ on both sides of break line on one side and break line on other side.

Atorvastatin 20 mg film-coated tablets

White to off white coloured, biconvex, oval shaped, film coated tablets debossed with ‘2’ on both sides of break line on one side and break line on other side.

Atorvastatin 40 mg film-coated tablets

White to off white coloured, biconvex, oval shaped, film coated tablets debossed with ‘4’ on both sides of break line on one side and break line on other side.

Atorvastatin 80 mg film-coated tablets

White to off white coloured, biconvex, oval shaped, film coated tablets debossed with ‘8’ on both sides of break line on one side and break line on other side.

The tablets can be divided in equal halves.

For 10/20/40 mg film-coated tablets:

HPDE-bottles containing 10, 14, 28, 30, 50 or 100 film-coated tablets OPA/Al/PVC-Al blister packs with 10, 14, 28, 30, 50 and 100 film-coated tablets For 80 mg film-coated tablets:

HPDE-bottles containing 10, 14, 28, 30 or 100 film-coated tablets OPA/Al/PVC-Al blister packs with 10, 14, 28, 30, 49, 50, 98 and 100 film-coated tablets

Not all pack sizes may be marketed.

The HDPE-bottle contains besides the film-coated tablets two separate plastic containers, one with desiccant and one with oxygen absorber. Do not remove, open or eat these plastic containers.

The OPA/Al/PVC-Al blister contains besides the film-coated tablets a red plastic capsule with oxygen absorber. Do not remove, open or eat this plastic capsule.

Marketing authorisation holder

Torrent Pharma (UK) Ltd.

Unit 4, Charlwood Court,

County Oak Way Crawley

West Sussex. RH11 7XA United Kingdom

Manufacturer

Torrent Pharma GmbH Suedwestpark 50 90449 Nuremberg Germany

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

Germany:    Atorvastatin Heumann 10 mg/20 mg/40 mg/

80 mg Filmtabletten

Italy:    Atorvastatin Torrent 10 mg/20 mg/40 mg/80 mg

Lithuania    Atorvastatin Torrent 10 mg/20 mg/40 mg/80 mg

Romania:    Modlip 10 mg/20 mg/40 mg/80 mg

United Kingdom Atorvastatin Torrent 10 mg/20 mg/40 mg/80 mg film-coated tablets

This leaflet was last approved in 10/2012.

Atorvastatin 20 mg Do not store above 30 °C.