Pitavastatin 1mg, 2mg & 4mg film-coated tablets

UK/H/1555-8/01-3/DC

Kowa Pharmaceutical Europe Co Ltd

Package Leaflet: Information for the user Vezepra

1mg, 2mg and 4mg film-coated tablets pitavastatin

Read all of this information carefully before you start taking Vezepra.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Vezepra is and what it is used for

2.    What you need to know before you take Vezepra

3.    How to take Vezepra

4.    Possible side effects

5.    How to store Vezepra

6.    Contents of the pack and other information

What Vezepra is and what it is used for

Vezepra contains a medicine called pitavastatin. This belongs to a group of medicines called ‘statins’. Vezepra is used to correct the levels of fat (lipid) in your blood. An imbalance of fats particularly cholesterol can sometimes lead to a heart attack or stroke.

You have been given Vezepra because you have an imbalance of fats and changing your diet and making lifestyle changes have not been enough to correct this. You should continue with your cholesterol-lowering diet and lifestyle changes while you are taking Vezepra.

2_What you need to know before you take Vezepra

Do not take Vezepra if:

•    you are allergic (hypersensitive) to pitavastatin, any other statin or the other ingredients of Vezepra (listed in ‘6. Contents of the pack and other information’).

•    you are pregnant or breast-feeding.

•    you are a woman able to have children and you are not using a reliable contraceptive method (see ‘Pregnancy and breast-feeding’).

•    you currently have liver problems.

•    you take ciclosporin - used after an organ transplant.

•    you have repeated or unexplained muscle aches or pains.

If you are not sure, talk to your doctor or pharmacist before taking Vezepra.

Take special care with Vezepra

Check with your doctor or pharmacist before taking your medicine if:

•    you have severe respiratory failure (severe breathing problems).

•    you have ever had problems with your kidneys.

•    you have previously had liver problems. ‘Statins’ can affect the liver in a small number of people. Your doctor will usually carry out a blood test (liver function test) before and during treatment with Vezepra.

•    you have ever had problems with your thyroid gland.

•    you or any member of your family have a history of muscle problems.

•    you have had a previous history of muscle problems when taking other cholesterol-lowering medicines (e.g. statins or fibrates).

•    you drink excessive amounts of alcohol.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vezepra.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes any medicines obtained without a prescription and herbal remedies. Some medicines can stop each other from working properly. In particular tell your doctor or pharmacist if you are taking any of the following:

•    other medicines called ‘fibrates’ - such as gemfibrozil and fenofibrate.

•    erythromycin, fusidic acid or rifampicin - types of antibiotics used for infections.

•    warfarin or any other medicine used to thin the blood.

•    medicines for HIV called ‘protease inhibitors’.

•    niacin (Vitamin B3).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vezepra.

Pregnancy and breast-feeding

Do not take Vezepra if you are pregnant or breast-feeding. If you are trying to become pregnant, talk to your doctor before taking Vezepra. If you are a woman who is able to have children, you must use a reliable contraceptive method, while taking Vezepra. Stop taking Vezepra and see a doctor straight away if you become pregnant while taking Vezepra. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Taking Vezepra with food and drink

Vezepra can be taken with or without food.

Driving and using machines

Vezepra is not expected to interfere with your ability to drive or operate machinery. However, if you feel dizzy or sleepy whilst taking Vezepra do not drive, use any machinery or tools.

Important information about some of the ingredients of Vezepra

Vezepra contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

3. How to take Vezepra

Always take Vezepra exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

Swallow the tablet whole with a drink of water, with or without food. You can take it at any time of day. However, try to take your tablet at the same time every day.

How much to take

•    The usual starting dose is 1mg once a day. After a few weeks your doctor may decide to increase your dose. The maximum dose is 4mg each day.

•    If you have problems with your liver you should not take more than 2mg a day.

Children

Vezepra is not recommended for use in children aged below 18 years.

Other things you need to know whilst taking Vezepra

•    If you go into hospital or receive treatment for another problem, tell the medical staff that you are taking Vezepra.

•    Your doctor may do regular cholesterol checks.

•    Do not stop taking Vezepra without talking to your doctor first. Your cholesterol levels might increase.

If you take more Vezepra than you should

If you take more Vezepra than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you.

If you forget to take a dose

Do not worry, just take your next dose at the correct time. Do not take a double dose to make up for the one you have missed.

Possible side effects

Like all medicines, Vezepra can cause side effects, although not everybody will have them. The following side effects may happen with this medicine:

Stop taking Vezepra and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

•    allergic reaction - the signs may include: difficulty breathing, swelling of the face, lips, tongue or throat, problems swallowing, severe itching of the skin (with raised lumps).

•    unexplained muscle pain or weakness, especially if you feel unwell, have a fever or have reddish brown urine. Vezepra can rarely (less than 1 in 1,000 people) cause unpleasant muscle effects. If not investigated they can lead to serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can lead to kidney problems.

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

•    liver problems which may cause yellowing of the skin and eyes (jaundice)

•    pancreatitis (severe pain in the abdomen and back)

Other side effects include:

Common (affects less than 1 in 10 people)

•    joint pain, muscle ache

•    constipation, diarrhoea, indigestion, feeling sick

•    headache.

Uncommon (affects less than 1 in 100 people)

•    muscle spasms

•    feeling weak, weary or unwell

•    swelling of the ankles, feet or fingers

•    stomach pain, dry mouth, being sick, loss of appetite, altered taste

•    pale skin and feeling weak or breathless (anaemia)

•    itching or rash

•    ringing in the ears

•    feeling dizzy or sleepy, insomnia (other sleep disturbances including nightmares)

•    increased need to go to the toilet (urinary frequency)

•    feeling of numbness and reduced sensation in the fingers, toes, legs and face

Rare (affects less than 1 in 1,000 people)

• redness of the skin, raised red itchy skin

•    deteriorating eye sight

•    pain in the tongue

•    unpleasant sensation or discomfort in the stomach

Other possible side effects

•    Memory loss

•    Sexual difficulties

•    Depression

•    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 may 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.

5. How to store Vezepra

Do not store above 25°C. To protect from light keep the blisters in the carton.

The blisters and carton have an expiry date printed on them, do not take these tablets if this date has passed. Keep your tablets in a safe place out of the reach and sight of children. Medicines should not be disposed of via waste water 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

Vezepra tablets contain pitavastatin calcium equal to 1mg, 2mg or 4mg of pitavastatin. Your tablets also contain lactose monohydrate, LS-hydroxyproylcellulose, hypromellose (E464), titanium dioxide (E171), triethyl citrate (E1505) magnesium aluminometasilicate, magnesium stearate, colloidal anhydrous silica.

What Vezepra looks like and contents of the pack

Vezepra film-coated tablets are supplied in packs of 7, 28, 30, 90 or 100. Not every pack is available in the market for each strength. The tablets are round, white and marked on one side with the letters ‘KC’. To help identify the different strengths, they are each a different size and marked with either ‘1’, ‘2’ or ‘4’ on the other side.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:    Kowa Pharmaceutical Europe Co Ltd

Winnersh Triangle, Wokingham RG41 5RB UK Manufacturer:    Pierre Fabre Medicament Production

Rue du Lycee, 45502 Gien Cedex, France Or

Recodati Industria Chimica E Farmaceutica SpA Via M Civitali 1, 20148, Milan, ITALY This leaflet was approved in August 2012.

Note: Only the manufacture site responsible for product release into an individual market will be named on the leaflet circulated in that particular market.