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LIVAZO 4MG FILM-COATED TABLETS

Active substance(s): PITAVASTATIN CALCIUM / PITAVASTATIN CALCIUM / PITAVASTATIN CALCIUM

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Kowa Pharmaceutical Europe Co Ltd

Livazo 1mg, 2mg & 4mg film-coated tablets
UK/H/1555/01-3/DC

Package Leaflet: Information for the user
Livazo
1mg, 2mg and 4mg film-coated tablets
pitavastatin
Read all of this leaflet carefully before you start taking Livazo 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. See section 4.
What is in this leaflet:
1.
What Livazo is and what it is used for
2.
What you need to know before you take Livazo
3.
How to take Livazo
4.
Possible side effects
5.
How to store Livazo
6.
Contents of the pack and other information
1.
What Livazo is and what it is used for
Livazo contains a medicine called pitavastatin. This belongs to a group of medicines called ‘statins’.
Livazo 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 Livazo 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 Livazo.
2.
What you need to know before you take Livazo
Do not take Livazo:
 if you are allergic (hypersensitive) to pitavastatin, any other statin or the other ingredients of
Livazo (listed in ‘6. Contents of the pack and other information’).
 if you are pregnant or breast-feeding.
 if you are a woman able to have children and you are not using a reliable contraceptive method
(see ‘Pregnancy, breast-feeding and fertility’).
 if you currently have liver problems.
 if you take ciclosporin – used after an organ transplant.
 if you have repeated or unexplained muscle aches or pains.
If you are not sure, talk to your doctor or pharmacist before taking Livazo

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Kowa Pharmaceutical Europe Co Ltd

Livazo 1mg, 2mg & 4mg film-coated tablets
UK/H/1555/01-3/DC

Warnings and precautions
Talk to your doctor or pharmacist before taking Livazo 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 Livazo.
 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.
 you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for
bacterial infection) orally or by injection. The combination of fusidic acid and Livazo can lead to
serious muscle problems (rhabdomyolysis).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Livazo. Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional
tests and medicines may be needed to diagnose and treat this.
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 Livazo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 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 you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop
using this medicine. Your doctor will tell you when it is safe to restart Livazo use. Taking Livazo
with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See
more information regarding rhabdomyolysis in section 4.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Livazo.
Taking Livazo with food and drink
Livazo can be taken with or without food.
Pregnancy, breast-feeding and fertility,
Do not take Livazo if you are pregnant or breast-feeding. If you are trying to become pregnant, talk to
your doctor before taking Livazo. If you are a woman who is able to have children, you must use a
reliable contraceptive method, while taking Livazo. Stop taking Livazo and see a doctor straight away
if you become pregnant while taking Livazo. Ask your doctor or pharmacist for advice before taking
any medicine, if you are pregnant or breast-feeding.
Driving and using machines
Livazo is not expected to interfere with your ability to drive or operate machinery. However, if you
feel dizzy or sleepy whilst taking Livazo do not drive, use any machinery or tools.
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Kowa Pharmaceutical Europe Co Ltd

Livazo 1mg, 2mg & 4mg film-coated tablets
UK/H/1555/01-3/DC

Livazo contains Lactose.
Livazo 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 Livazo
Always take this medicine exactly as your doctor has told you. 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.
Use in children and adolescents
Livazo is not recommended for use in children aged below 18 years.
Other things you need to know whilst taking Livazo
 If you go into hospital or receive treatment for another problem, tell the medical staff that you are
taking Livazo.
 Your doctor may do regular cholesterol checks.
 Do not stop taking Livazo without talking to your doctor first. Your cholesterol levels might
increase.
If you take more Livazo than you should
If you take more Livazo than you should, talk to a doctor or go to hospital straight away. Take the
medicine pack with you.
If you forget to take Livazo
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.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The
following side effects may happen with this medicine:
Stop taking Livazo 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. Livazo 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)

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Kowa Pharmaceutical Europe Co Ltd

Livazo 1mg, 2mg & 4mg film-coated tablets
UK/H/1555/01-3/DC

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
Side effects of unknown frequency
 Muscle weakness that is constant.
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.
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 directly via the national reporting system :
United Kingdom 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 Livazo
Do not store above 25°C. To protect from light keep the blisters in the carton.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. Do not throw
away any medicines via waste water or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.

UK/H/xxxx/WS/213
QRD template alignment Fusidic Acid
June 2016 Clean Version

Kowa Pharmaceutical Europe Co Ltd

Livazo 1mg, 2mg & 4mg film-coated tablets
UK/H/1555/01-3/DC

6.
Contents of the pack and other information
What Livazo contains
Livazo 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 Livazo looks like and contents of the pack
Livazo 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 Médicament Production
Rue du Lycée, 45502 Gien Cedex, France
Or
Recodati Industria Chimica E Farmaceutica SpA
Via M Civitali 1, 20148, Milan, ITALY
This leaflet was last revised {month YYYY}

Other sources of information
Detailed information on this medicine is available on the website of the MHRA.
www.mhra.gov.uk
Note:

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

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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