PACKAGE LEAFLET: INFORMATION FOR THE USER

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Pioglitazone 15 mg Tablets Pioglitazone 30 mg Tablets Pioglitazone 45 mg Tablets

Pioglitazone

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 your 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 Pioglitazone is and what it is used for

2.    What you need to know before you take Pioglitazone

3.    How to take Pioglitazone

4.    Possible side effects

5.    How to store Pioglitazone

6.    Contents of the pack and other information

SANDOZ

1 What Pioglitazone is and what it is used for

Pioglitazone tablets contain pioglitazone. It 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 tablets may be used on their 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 in combination with insulin) which have failed to provide sufficient control in blood sugar.

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).

•    have heart failure or have had heart failure in the past.

•    have liver disease.

•    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 or pharmacist before taking Pioglitazone if you:

•    retain water (fluid retention) or have heart failure problems, in particular if you are over 75 years old.

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

•    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.

•    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 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 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 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 were seen in women (but not in men) taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children

Use in children 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:

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 stop taking 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

If you have been told that you have intolerance to some sugars, tell your doctor before taking Pioglitazone.

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How to take Pioglitazone

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

Dose

Take one tablet of 15 mg, 30 mg or 45 mg of pioglitazone once daily. If necessary your doctor may tell you to take a different dose. If you feel that the effect of these tablets is too weak, talk to your doctor.

Taking with other medicines for diabetes

When these tablets are taken together with other medicines used to treat diabetes (such as insulin) your doctor will tell you if you need to take a smaller dose of any of your medicines.

Blood tests

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

Diet

If you are following a diabetic diet, you should continue with this while you are taking these tablets.

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

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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 with you some sugar lumps, sweets, biscuits or sugary fruit juice.

If you forget to take Pioglitazone

Take these 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

Pioglitazone should be used every day to work properly. If you stop using these 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, ask your doctor or pharmacist.

•    spinning sensation (vertigo)

•    sweating

•    tiredness

•    increased appetite.

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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

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How to store Pioglitazone

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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.

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 commonly (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 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, talk to 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 are:

common (may affect up to 1 in 10 people)

•    respiratory infection

•    abnormal vision

•    weight gain

•    numbness.

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 liver enzymes

•    allergic reactions.

The other side effects that have been experienced by some patients when pioglitazone is taken with other anti-diabetic 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

•    joint pain

•    impotence

•    back pain

•    shortness of breath

•    small reduction in red blood cell count

•    flatulence.

uncommon (may affect up to 1 in 100 people)

•    sugar in urine, proteins in urine

•    increase in enzymes

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.

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

This medicinal product does not require any special storage conditions.

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.

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Contents of the pack and other information

What Pioglitazone contains

•    The active substance(s) is pioglitazone.

Pioglitazone 15 mg tablets:

Each tablet contains 15 mg pioglitazone (as pioglitazone hydrochloride).

Pioglitazone 30 mg tablets:

Each tablet contains 30 mg pioglitazone (as pioglitazone hydrochloride).

Pioglitazone 45 mg tablets:

Each tablet contains 45 mg pioglitazone (as pioglitazone hydrochloride).

•    The other ingredients are Lactose monohydrate,

Hydroxypropylcellulose,

Carmellose calcium,

Magnesium stearate.

See the end of Section 2 for further information on lactose.

What Pioglitazone looks like and contents of the pack

Pioglitazone 15 mg tablets:

White, round tablet, with imprint “PGT 15” on one side and with score line on both sides.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pioglitazone 30 mg tablets:

White, round tablet, with imprint “PGT 30” on one side and with score line on both sides.

The tablet can be divided into equal halves.

Pioglitazone 45 mg tablets:

White, round tablet, with imprint “PGT 45” on one side and with three-part score line on the other side.

The tablet can be divided into three equal parts.

Al/Al blister: 10, 14, 28, 30, 50, 56, 84, 90, 98, 100, 182, 196 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany orS.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania.

This leaflet was last revised in 09/2013.

Detailed information on this medicine is available on the web site of: The Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk).

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