Pioglitazon Lek 45 mg, tabletten

Pioglitazon Lek contains 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.

Pioglitazon Lek 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 Pioglitazon Lek is working 3 to 6 months after you start taking it.

Pioglitazon Lek 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 metformin, sulphonylurea or insulin) which have failed to provide sufficient control in blood sugar.

Pioglitazon Lek

Do NOT take Pioglitazon Lek if you:

• are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Pioglitazon Lek (see Section 6 and end of Section 2).
• 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.

Take special care with Pioglitazon Lek

Tell your doctor before you start to take this medicine if you:

• retain water (fluid retention) or have heart failures 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 Pioglitazon Lek. 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 Pioglitazon Lek 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 Pioglitazon Lek 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 Pioglitazon Lek 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 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.

You can usually continue to take other medicines whilst you are being treated with Pioglitazon Lek. 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 Pioglitazon Lek may need to be changed.

Taking Pioglitazon Lek 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..

Important information about some of the ingredients of Pioglitazon Lek

This medicinal product contains:

• lactose. If you have been told that you have intolerance to some sugars, tell your doctor before taking Pioglitazon Lek.

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

Dose

Take one tablet of 15 mg of pioglitazone once daily.

Take one tablet of 30 mg of pioglitazone once daily.

Take one tablet of 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, chlorpropamide, glibenclamide, gliclazide, tolbutamide) 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.

If you take more Pioglitazon Lek 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 Pioglitazon Lek

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 Pioglitazon Lek

Pioglitazon Lek 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.

Like all medicines, Pioglitazon Lek 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 (1 to 10 users in 100) 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 (1 to 10 users in 1000) 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 (1 to 10 users in 100) 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.

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

common (affects 1 to 10 users in 100)

• respiratory infection
• abnormal vision
• weight gain
• numbness

uncommon (affects 1 to 10 users in 1,000)

• inflammation of the sinuses (sinusitis)
• difficulty sleeping (insomnia)

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

• increase in liver enzymes

The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are:

very common (affects more than 1 user in 10)

• decreased blood sugar (hypoglycaemia)

common (affects 1 to 10 users in 100)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• small reduction in red blood cell count
• flatulence

uncommon (affects 1 to 10 users in 1,000)

• sugar in urine, proteins in urine
• increase in enzymes
• spinning sensation (vertigo)
• sweating
• tiredness
• increased appetite

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

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.

What Pioglitazon Lek contains

- The active substance(s) is Pioglitazon Lek 15 mg

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

Pioglitazon Lek 30 mg

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

Pioglitazon Lek 45 mg

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

- The other ingredient(s) are Lactose monohydrate, Hydroxypropylcellulose, Carmellose calcium, Magnesium stearate.

See end of Section 2 for further information on lactose.

What Pioglitazon Lek looks like and contents of the pack

Tablet

Pioglitazon Lek 15 mg

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.

Pioglitazon Lek 30 mg

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.

Pioglitazon Lek 45 mg

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.

NL/H/2222/001-002-003

Al/Al blister: 28 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

Manufacturers

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-540472 Targu-Mures

Romania

Marketing Authorisation Numbers

RVG 108649

RVG 108650

RVG 108651

This medicinal product is authorised in the Member States of the EEA under the following names:

Slovenia	Pioglitazon Lek 15 mg tablete
	Pioglitazon Lek 30 mg tablete
	Pioglitazon Lek 45 mg tablete
The	Pioglitazon Lek 15 mg, tabletten
Netherlands	Pioglitazon Lek 30 mg, tabletten
	Pioglitazon Lek 45 mg, tabletten

This leaflet was last approved in mei 2012

Detailed information on this medicine is available on the web site of CBG-MEB