Package leaflet: Information for the user

Pioglitazone

15mg, 30mg, 45mg Tablets

Pioglitazone

Read all of this leaflet carefully before you start taking this medicine because It contains Important Information foryou.

•    Keep this leaflet. You may need to read it again.

•    If you haveanyfjrtherquestions,askyourdoctor or pharmacist.

•    This medicine has been prescribed foryou 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.

3.

4.

5.

6.

What Pioglitazone Tablets are and what are theyusedfor

What you need to know before you take

Pioglitazone Tablets

How to take Pioglitazone Tablets

Possible side effects

How to store Pioglitazone Tablets

Contents of the packand other information.

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

Pioglitazone is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.

Pioglitazone Tablets help control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. Your doctor will check whether Pioglitazone tablet is working 3 to 6 monthsafteryou start taking it.

Pioglitazone tablets may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.

2.    What you need to know before you take Pioglitazone Tablets

Do not take Pioglitazone tablets

•    If you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).

•    If you have heart failure or have had heart failure in the past

•    Ifyouhaveliverdisease.

•    If you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).

•    If you have or have ever had bladder cancer

•    If you have blood in your urine that your doctor has not checked.

Warnings and precautions

Talk to your doctor before taking Pioglitazone

tablets.

•    If you retain water (fluid retention) or have heart failures problems in particular if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.

•    If you have a special type of diabetic eye disease called macular oedema (swelling of the backoftheeye).

•    If you have a problem with your liver or heart. Before you start taking Pioglitazone Tablets you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Tablets and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

•    If you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Tablets. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

If you take Pioglitazone Tablets with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).

You may also experience a reduction in blood count (anaemia).

Broken bones

A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating yourdiabetes.

Children

Use in children under 18 years is not recommended.

Other medicines and Pioglitazone tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You can usually continue to take other medicines whilst you are being treated with Pioglitazone Tablets. However, certain medicines are especially likely to affect the amountof sugar in your blood:

•    Gemfibrozil (used to lower cholesterol)

•    Rifampicin (used to treat tuberculosis and other infections).

Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Pioglitazone may need to be changed.

Pioglitazone Tablets with food and drink

•    You maytakeyourtabletswith orwithoutfood.

•    You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding

Tell your doctor if

-    you are, you think you might be or are planning to become pregnant.

-    you are breast-feeding or if you are planning to breast-feed your baby

Your doctor will advise you to discontinue this medicine.

Driving and using machines

Pioglitazone tablets will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Pioglitazone Tablets contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Tablets

3. Howtotake Pioglitazone Tablets

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

One tablet of 15 mg, 30 mg or 45 mg should be taken once daily. If necessary your doctor may tell you to take a different dose. If you have the impression that the effect of Pioglitazone Tablets is too weak, talkto your doctor.

When Pioglitazone Tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.

Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Tablets. This is to check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Tablets.

Your weight should be checked at regular intervals; if yourweight increases, inform your doctor.

If you take more Pioglitazone Tablets than you should

If you accidentally take too many tablets, or if someone else ora child takes your medicine, talkto a doctor or pharmacist immediately. Your blood sugar could fall below the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugaryfruit juice.

If you forgetto take Pioglitazone Tablets:

Take Pioglitazone Tablets daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pioglitazone Tablets

Pioglitazone Tablets should be used every day to work properly. If you stop taking Pioglitazone Tablets, your blood sugar may go up. Talk to your doctor before stopping this treatment.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. Possible side effects

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide more information on the safety of this medicine.

5. Howto store Pioglitazone Tablets

Like all medicines, this medicine can cause side effects, although not everyone gets them.

In particular, patients have experienced the following serious side effects:

Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.

Bladdercancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.

Localised swelling (oedema) has also been experienced very commonly in patients taking Pioglitazone in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.

Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Pioglitazone. If you experience this side effect, talk toyourdoctorassoon as possible.

Blurred vision due to swelling (orfluid) at the back of the eye (frequency not known) has also been reported in patients taking Pioglitazone. If you experience this symptom for the first time, talk to your doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talkto your doctor as soon as possible.

Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor as soon as possible.

The other side effects that have been experienced by some patients taking Pioglitazone Tablets are:

Common (may affect up to 1 in 10 people)

-    weightgain

-    respiratory infection

-    numbness

-    abnormal vision.

Uncommon (may affect up to 1 in 100 people)

-    inflammation of the sinuses (sinusitis)

-    difficulty sleeping (insomnia).

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

-    increase in liverenzymes

-    allergic reactions.

The other side effects that have been experienced by some patients when Pioglitazone tablet is taken with otherantidiabetic medicines are:

Very common (may affect more than 1 in 10 people)

-    decreased blood sugar (hypoglycaemia).

Common (may affect up to 1 in 10 people)

-    headache

-    dizziness

-    flatulence

-    joint pain

-    impotence

-    small reduction in red blood cell count

-    back pain

-    shortnessofbreath.

Uncommon (may affect up to 1 in 100 people)

-    spinning sensation (vertigo)

-    sweating

-    tiredness

-    sugar in urine, proteins in urine

-    increased appetite

-    increase in enzymes.

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 the carton after {ExpJ.The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Pioglitazone Tablets contains

The active substance is Pioglitazone.

Pioglitazone 15mg

Each    tablet    contains    16.53    mg    Pioglitazone

Hydrochloride, equivalent to 15 mg Pioglitazone.

Pioglitazone 30mg

Each    tablet    contains    33.06    mg    Pioglitazone

Hydrochloride, equivalent to 30 mg Pioglitazone.

Pioglitazone 45mg

Each    tablet    contains    49.59    mg    Pioglitazone

Hydrochloride, equivalent to 45 mg Pioglitazone.

The other ingredients are lactose monohydrate, hydroxypropyl cellulose, carmellose calcium, purified water, magnesium stearate.

What Pioglitazone Tablets look like and contents of the pack

Pioglitazone 15mg:The tablets are white to off white, round of about 0.5mm diameter, flat beveled edge tablet, debossed with 'RB' on one side and '94'ontheotherside.

Pioglitazone 30mg:The tablets are white to off white, round of about 0.7mm diameter, flat beveled edge tablet, debossed with 'RB' on one side and '95'on the other side.

Pioglitazone 45mg:The tablets are white to off white, round of about 0.8mm diameter, flat beveled edge tablet, debossed with 'RB' on one side and '96'on the other side.

Product is available in following pack sizes.

(For 15mg, 30mg and45mg strength)

Cold from blister with 14,28,30,50,56,84,90 and 98 tablets

Desiccant Embedded Cold form blister with 14, 28,30,50,56,84,90 and 98 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:

Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE, United Kingdom

Manufacturer:

Ranbaxy Ireland Ltd, Spafield, Cork Road,

Cashel, Co. Tipperary, Ireland

Basics GmbH, HemmelratherWeg 201, D-51377

Leverkusen, Germany

Terapia SA, 124 Fabricii Street, 400 632 Cluj

Napoca, Romania

This leaflet was last revised in March 2014.

O

LO

RANBAXY