Package leaflet: Information for the user

PIOGLITAZONE 15MG, 30MG AND 45MG TABLETS

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

See section 4.

1. WHAT PIOGLITAZONE IS AND WHAT IT IS USED FOR

The name of your medicine is Pioglitazone 15mg, 30mg or 45mg Tablets (referred to as pioglitazone throughout this leaflet). 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 helps 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 is working 3 to 6 months after you start taking it.

Pioglitazone 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

metformin,

sulphonylurea or insulin) which have failed to provide sufficient control in blood sugar.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE

Do not take Pioglitazone

-    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.

-    If you have liver disease.

-    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

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke, who were treated with pioglitazone and insulin, experienced 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).

Talk to your doctor before you start to take this medicine:

-    If you retain water (fluid retention) or have heart failure problems, particularly if you are over 75 years old.

-    If you take anti-inflammatory medicines which can cause fluid retention and swelling.

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

-    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. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

-    If you have a problem with your liver or heart. Before you start taking pioglitazone you will have a blood sample taken to check your liver function. This check-up may be repeated at intervals.

If you take pioglitazone 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 patients, particularly women pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Use in children and adolescents under 18 years is not recommended.

Other medicines and pioglitazone

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. However, certain medicines are especially likely to affect the amount of 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 with food and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding

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.

Your doctor will advise you to discontinue this medicine.

Driving and using machines

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

Pioglitazone contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking pioglitazone.

3. HOW TO TAKE PIOGLITAZONE

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

Take 1 tablet, once a day. If necessary your doctor may tell you to take a different dose. If you have the impression that the effect of pioglitazone is too weak, talk to your doctor.

Pioglitazone can be taken with or without food.

When pioglitazone is 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. This is to check that your liver is working normally.

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If you are following a diabetic diet, you should continue with it while you are taking pioglitazone.

Your weight should be checked at regular intervals. If your weight increases, inform your doctor.

If you take more pioglitazone than you should

If you accidentally take too many tablets, or if someone else, or a child takes your medicine, talk to 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 sweetened fruit juice.

If you forget to take pioglitazone

Try to take pioglitazone 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 To work properly, pioglitazone should be taken every day. If you stop using pioglitazone, 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, pioglitazone can cause side effects, although not everybody gets them.

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

-    Heart failure has been experienced

(may affect up to 1 in 10 people) in patients taking pioglitazone in combination with insulin. Symptoms are unusual shortness of breath, 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.

-    Bladder cancer 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

(may affect up to 1 in 10 people) in women patients taking pioglitazone. If you experience this side effect, talk to your doctor as soon as possible.

-    Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) 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 symptoms get worse, talk to your doctor as soon as possible.

-    Allergic reactions have been reported (frequency cannot be estimated from the available data) 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 following side effects have been experienced by some patients taking pioglitazone:

Common side-effects (may affect up to 1 in 10 people)

-    respiratory infection

-    abnormal vision

-    weight gain

-    numbness

__ Uncommon side-effects (may affect up to 1 in 100 people)

^m - inflammation of the sinuses (sinusitis)

-    difficulty sleeping (insomnia)

frequency not known j (frequency cannot be estimated from the available data)

-    increase in liver enzymes

-    allergic reactions

The following additional side-effects have been experienced by some patients when    m

pioglitazone was taken with other antidiabetic    _u

medicines:    m

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

-    decreased blood sugar (hypoglycaemia)

Common side-effects (may affect up to

1 in 10 people)

-    headache

-    dizziness

-    joint pain

-    impotence

-    back pain

-    shortness of breath

-    small reduction in red blood cell count

-    flatulence

Uncommon side-effects (may affect up to 1 in 100 people)

-    sugar in urine, proteins in urine

-    spinning sensation (vertigo)

-    sweating

-    tiredness

-    increased appetite

-    increase in enzymes

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. HOW TO STORE PIOGLITAZONE

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

Store below 25°C in its original package in order to protect from moisture.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pioglitazone contains

The active substance is pioglitazone. Pioglitazone 15mg tablets: each tablet contains 15 mg of pioglitazone (as hydrochloride).

Pioglitazone 30mg tablets: each tablet contains 30 mg of pioglitazone (as hydrochloride).

Pioglitazone 45mg tablets: each tablet contains 45 mg of pioglitazone (as hydrochloride).

The other ingredients are: lactose monohydrate, crosscarmellose sodium, hydroxypropylcellulose, low substituted hydroxypropyl cellulose, magnesium stearate.

What Pioglitazone looks like and contents of the pack

Pioglitazone 15mg tablets are round, biconvex, white tablets.

Pioglitazone 30mg tablets are round, flat, white tablets with impression “30” on one side. Pioglitazone 45mg tablets are round, flat, white tablets with impression “45” on one side.

The tablets are supplied in OPA/AI/PVC//AI blisters, packs of 14, 28, 30, 50, 56, 60, 84, 90, 98,100,112,120 or 196 tablets. Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer:

Zentiva, k.s., U kabelovny 130, Prague 10, Dolnf Mecholupy, 102 37, Czech Republic

This leaflet was last revised in September 2014.