Pioglitazon Orion 45 mg, tabletten

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

Pioglitazon Orion 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 in blood sugar.

Do not take Pioglitazon Orion tablets:

• If you are hypersensitive (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

Talk to your doctor or pharmacist or nurse before taking Pioglitazon Orion:

NL Pioglitazon Orion tabl PIL

Page 1 of 6

• If you retain water (fluid retention) or have heart failures problems in particular if you are over 75 years old.
• 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 Pioglitazon Orion. 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 Pioglitazon Orion 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 Orion 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 localized swelling (oedema).

If you take Pioglitazon Orion 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 and adolescents

Use in children under 18 years is not recommended.

Other medicines and Pioglitazon Orion

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 Pioglitazon Orion. 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 Orion may need to be changed.

Pioglitazon Orion tablets with food and drink and alcohol

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

Pregnancy and breastfeeding and fertility

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

NL Pioglitazon Orion tabl PIL

Page 2 of 6

Pioglitazon Orion contains lactose

This medicinal product contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazon Orion tablets.

One tablet of 15 mg 30 mg 45 mg pioglitazone 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 Pioglitazon Orion tablets is too weak, talk to your doctor.

When Pioglitazon Orion 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 Pioglitazon Orion. 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 Pioglitazon Orion tablets.

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

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

If you take more Pioglitazon Orion tablets 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 sugar fruit juice.

If you forget to take Pioglitazon Orion tablets

Take Pioglitazon Orion 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 Orion tablets

Pioglitazon Oriontablets should be used every day to work properly. If you stop taking Pioglitazon Orion your blood sugar may go up. Talk to your doctor before stopping the treatment.

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

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 (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.

NL Pioglitazon Orion tabl PIL

Page 3 of 6

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 Pioglitazon Orion 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 Pioglitazon Orion 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

NL Pioglitazon Orion tabl PIL

Page 4 of 6

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any side effects not listed in this leaflet.

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 and the blister pack after the word “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage precautions.

Do not throw away any medicines of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Pioglitazon Orion contains

The active substance is pioglitazone. Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).

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

What Pioglitazon Orion looks like and contents of the pack

Pioglitazon Orion15 mg: white to off-white, round, flat faced beveled edge uncoated tablets debossed with ‘15’ on one side and plain on the other side.

Pioglitazon Orion30 mg: white to off-white, round, flat faced beveled edge uncoated tablets with breakline on both sides. The tablet can be divided into equal halves.

Pioglitazon Orion45 mg: white to off-white, round, flat faced beveled edge uncoated tablets debossed with ‘T’ shape breakline on both sides. The tablet can be divided into equal thirds.

Triplex (PVC/PE/PVdC)/Al blisters or OPA/Al/PVC/Al blisters

Packs of 28, 50 and 98 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturers

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Dit geneesmiddel is geristreerd onder:

Pioglitazon Orion 15 mg: RVG 108661

Pioglitazon Orion 30 mg: RVG 108663

Pioglitazon Orion 45 mg: RVG 108665

NL Pioglitazon Orion tabl PIL

Page 5 of 6

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

NL : Pioglitazon Orion 15/30/45 mg, tabletten FI: Pioglitazon Orion 15/30/45 mg tablettia SE: Pioglitazon Orion 15/30/45 mg tabletter DK: Pioglitazon Orion 15/30/45 mg tabletter NO: Pioglitazon Orion 15/30/45 mg tabletter EE: Pioglitazone Orion 15/30/45 mg tabletid LT: Pioglitazon Orion 15/30/45 mg tablets

This leaflet was last revised in mei 2012

NL Pioglitazon Orion tabl PIL

Page 6 of 6