PIOGLITAZONE ACCORD 15 mg TABLETS

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

Do not take Pioglitazone Accord

• 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 any liver disease.
• if you have had diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• if you have or have had bladder cancer.
• if you have blood in your urine that has not been checked by your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting Pioglitazone Accord (see also section 4).

• if you have fluid retention or heart problems, especially if you are over 75 years old. If you are taking anti-inflammatory medicines which can also cause fluid retention and swelling, you should also consult your doctor.
• 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 the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant, as Pioglitazone Accord may cause you to ovulate again. If this applies to you, use appropriate contraceptive methods to avoid the possibility of unplanned pregnancy.
• if you have liver or heart problems. Before starting treatment with Pioglitazone Accord, you will have a blood test to check your liver function. These tests should be done regularly.
• Some patients with type 2 diabetes who have had a long history of the condition and have heart disease or have had a stroke, and who have taken Pioglitazone Accord and insulin, have developed heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localised swelling (oedema).

If you take Pioglitazone Accord with other diabetes medicines, you are more likely to get low blood sugar (hypoglycaemia).

You may also show a reduction in blood cell count (anaemia)

Bone fractures

A higher number of bone fractures has been seen in patients, especially women, taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

It is not recommended for children and adolescents under 18 years.

Taking Pioglitazone Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

You can usually continue to take other medicines while taking Pioglitazone Accord tablets. However, certain medicines have a higher chance of affecting your blood sugar levels:

• 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 medicines. They will check your blood sugar levels and may need to change your dose of Pioglitazone Accord.

Taking Pioglitazone Accord with food and drink

You can take the tablets with or without food. Take them with a glass of water.

Pregnancy and breast-feeding

Tell your doctor if:

• you are or think you may be pregnant or are planning to have a baby
• you are breast-feeding or plan to breast-feed your child

Your doctor will advise you to stop taking this medicine.

Driving and using machines

This medicine does not affect your ability to drive or use machines, but you should be careful if you experience vision problems.

Pioglitazone Accord contains lactose monohydrate

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.

3. How to take Pioglitazone Accord

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual recommended dose is one 15 mg or 30 mg pioglitazone tablet per day. Your doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will tell you which dose to take.

If you think that Pioglitazone Accord is not working as well as expected, consult your doctor.

When taking Pioglitazone Accord 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 lower dose of these medicines.

Your doctor will ask you to have regular blood tests while you are taking Pioglitazone Accord. These tests are necessary to check that your liver is working normally.

If you follow a special diet for diabetics, keep to it while you are taking Pioglitazone Accord.

You should check your weight regularly. If you gain weight, tell your doctor.

If you take more Pioglitazone Accord than you should

If you accidentally take too many tablets, or if someone else (e.g. a child) takes your medicine, tell your doctor or pharmacist immediately. Your blood sugar levels may become too low, but this can be treated by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or some sugary fruit juice with you.

If you forget to take Pioglitazone Accord

Take Pioglitazone Accord every day as prescribed by your doctor. If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pioglitazone Accord

Pioglitazone Accord should be taken every day to have the right effect. If you stop taking Pioglitazone Accord, your blood sugar levels may increase. Consult your doctor before stopping 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, this medicine can cause side effects, although not everybody gets them.

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

Heart failure, common (may affect up to 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin. The symptoms are unusual shortness of breath or rapid weight gain or localised swelling (oedema). If you experience any of these symptoms, especially if you are over 65 years old, consult your doctor immediately.

Uncommon (may affect up to 1 in 100 people), bladder cancer has been reported in patients taking Pioglitazone Accord. The signs and symptoms include blood in the urine, pain when urinating or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Patient taking Pioglitazone Accord in combination with insulin also reported very common (may affect more than 1 in 10 people) localised swelling (oedema). Consult your doctor as soon as possible if you experience this side effect.

Bone fractures: frequently (may affect up to 1 in 10 people) reported in both women and men taking pioglitazone (frequency cannot be estimated from the available data) taking Pioglitazone Accord. Consult your doctor as soon as possible if you experience this side effect.

Blurred vision due to swelling (or fluid) in the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord. If you experience this symptom for the first time or if you already have it and it gets worse, consult your doctor as soon as possible.

Allergic reactions (frequency not known, cannot be estimated from the available data) have been reported in patients treated with Pioglitazone Accord. If you have a severe 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 consult your doctor immediately.

Other side effects that some patients have experienced while taking Pioglitazone Accord are:

common (may affect up to 1 in 10 people)

• respiratory infection,
• vision disorders,
• weight gain,
• numbness

uncommon (may affect up to 1 in 100 people)

• inflammation of the nasal passages (sinusitis)
• difficulty sleeping (insomnia)

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

• increase in liver enzymes
• allergic reactions

Other side effects that some patients have experienced while taking Pioglitazone Accord with other anti-diabetic medicines are:

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

• low blood sugar (hypoglycaemia)

common (may affect up to 1 in 10 people)

• headache
• dizziness

• joint pain
• impotence
• back pain
• shortness of breath
• mild reduction in red blood cell count
• gas (flatulence)

uncommon (may affect up to 1 in 100 people)

• sugar in the urine, protein in the urine

• increase in enzymes
• vertigo
• sweating
• fatigue
• increased appetite

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pioglitazone Accord

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

This medicine does not require any special storage precautions.

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.

6. Contents of the pack and other information

Composition of Pioglitazone Accord

• The active substance in Pioglitazone Accord is pioglitazone.
• Each 15 mg Pioglitazone Accord tablet contains 15 mg pioglitazone (as hydrochloride).
• Each 30 mg Pioglitazone Accord tablet contains 30 mg pioglitazone (as hydrochloride).
• Each 45 mg Pioglitazone Accord tablet contains 45 mg pioglitazone (as hydrochloride).

• The other ingredients are: lactose monohydrate, calcium carmellose, hydroxypropyl cellulose (E465) and magnesium stearate (E 572).

Appearance of Pioglitazone Accord and contents of the pack

• The 15 mg Pioglitazone Accord tablets are white or almost white, round, biconvex, uncoated tablets with "P" engraved on one side and "15" on the other.
• The 30 mg Pioglitazone Accord tablets are white or almost white, flat, round, uncoated tablets with bevelled edges with "PIO" engraved on one side and "30" on the other side.
• The 45 mg Pioglitazone Accord tablets are white or almost white, flat, round, uncoated tablets with bevelled edges with "PIO" engraved on one side and "45" on the other side.

Pioglitazone Accord is available in aluminium/aluminium blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

This leaflet was last revised in {Month/year}

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.

The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.