Pioglitazone Accord

Patient Information Leaflet

Pioglitazone Accord 15 mg tablets, 30 mg tablets, 45 mg tablets

Pioglitazone
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Pioglitazone Accord is and what it is used for
2. What you need to know before taking Pioglitazone Accord
3. How to take Pioglitazone Accord
4. Possible side effects
5. How to store Pioglitazone Accord
6. Contents of the pack and other information

1. What Pioglitazone Accord is and what it is used for

Pioglitazone Accord contains pioglitazone. It is an antidiabetic medicine used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes) in adults when metformin is unsuitable or has not worked adequately. This type of diabetes usually occurs in adults.
Pioglitazone Accord helps control blood sugar levels in patients with type 2 diabetes by helping the body make better use of the insulin it produces. Your doctor will check whether Pioglitazone Accord is working 3–6 months after starting treatment.
Pioglitazone Accord can be used alone in patients who cannot take metformin and in whom diet and exercise alone have not achieved adequate blood glucose control. It can also be added to other therapies (such as metformin, a sulphonylurea, or insulin) when these have not provided sufficient blood glucose control.

2. What you need to know before taking Pioglitazone Accord

Do not take Pioglitazone Accord

• if you are allergic to pioglitazone or to any of the other ingredients of this medicine (listed in section 6).
• if you have heart failure or have previously had heart failure.
• if you have liver problems.
• 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 (tumour of the bladder).
• if you have blood in your urine and your doctor has not yet investigated the cause.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pioglitazone Accord (also see section 4)

• if you retain water (fluid retention) or have heart failure problems, especially if you are over 75 years old. You must also inform your doctor if you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling.
• if you have a specific type of diabetic eye disease called macular oedema (swelling at the back of the eye).
• if you have ovarian cysts (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, as ovulation may resume when taking Pioglitazone Accord. If this applies to you, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
• if you have liver or heart problems. Before starting Pioglitazone Accord, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with Pioglitazone Accord and insulin have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).

If you take Pioglitazone Accord with other diabetes medicines, your blood sugar level is more likely to drop below normal levels (hypoglycaemia).
You may also experience a reduced blood cell count (anaemia).
Bone fractures
A higher number of bone fractures has been observed in patients, particularly in women taking pioglitazone. Your doctor will take this into account when managing your diabetes.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Other medicines and Pioglitazone Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Generally, you can continue taking other medicines while being treated with Pioglitazone Accord.
However, certain medicines are likely to affect your blood sugar levels:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections)
  Inform your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be monitored and it may be necessary to adjust the dose of Pioglitazone Accord.

Pioglitazone Accord with food and drink
You may take the tablets with or without food. Take the tablets with a glass of water.
Pregnancy and breastfeeding
Inform your doctor if

• you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• you are breastfeeding or planning to breastfeed. Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
This medicine has no effect on the ability to drive or operate machinery, but be cautious if you experience vision disturbances.
Pioglitazone Accord contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking Pioglitazone Accord.

3. How to take Pioglitazone Accord

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The usual starting dose is one 15 mg or 30 mg pioglitazone tablet taken once
daily. Your doctor may increase the dose up to a maximum of 45 mg per day. Your doctor will
tell you what dose to take.
If you feel that the effect of Pioglitazone Accord is too weak, talk to your doctor.
When Pioglitazone Accord tablets are taken in combination with other medicines used
for the treatment of diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide),
your doctor will tell you whether you need to take a lower dose of the other medicines.
Your doctor will ask you to have periodic blood tests during treatment with
Pioglitazone Accord. This is to monitor normal liver function.
If you are following a special diet for diabetes, you must continue it while taking Pioglitazone
Accord.
Body weight should be monitored at regular intervals; if weight increases, inform your doctor.
If you take more Pioglitazone Accord than you should
If you accidentally take too many tablets, or if someone else or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
could drop below normal levels and may be raised by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or sugared fruit juices with you.
If you forget to take Pioglitazone Accord
Take Pioglitazone Accord every day as prescribed. However, if you forget to take a dose,
take the next dose as scheduled. Do not take a double dose to make up for
the forgotten tablet.
If you stop taking Pioglitazone Accord
Pioglitazone Accord must be taken every day for it to work properly. If you stop taking
Pioglitazone Accord, your blood sugar level may increase. Talk to your doctor
before stopping treatment.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In particular, the following serious side effects have been observed in some patients:

Common cases (may affect up to 1 in 10 people) of heart failure have occurred in patients taking Pioglitazone Accord in combination with insulin. Symptoms include unusual shortness of breath, rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, consult your doctor immediately.

Uncommon cases (may affect up to 1 in 100 people) of bladder cancer (bladder tumour) have been reported in patients treated with Pioglitazone Accord. Signs and symptoms include blood in the urine, pain during urination, or a sudden need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Very common cases of localized swelling (edema) (may affect more than 1 in 10 people) have also occurred in patients taking Pioglitazone Accord in combination with insulin. If you experience this side effect, consult your doctor immediately.

Common cases (may affect up to 1 in 10 people) of bone fractures have been reported in female patients taking Pioglitazone Accord, as well as in male patients (frequency cannot be determined based on available data). If you experience this side effect, consult your doctor immediately.

Blurred vision due to swelling (or fluid accumulation) in the back of the eye (frequency cannot be determined based on available data) has also been reported in patients taking Pioglitazone Accord. Consult your doctor immediately if you notice the onset of these symptoms for the first time. Also consult your doctor immediately if you already have blurred vision and the symptom worsens.

Allergic reactions (frequency cannot be determined based on available data) have been reported in patients taking Pioglitazone Accord. If you experience a severe allergic reaction including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor as soon as possible.

Other side effects observed in some patients taking Pioglitazone Accord are:

Common (may affect up to 1 in 10 people)

• respiratory infections
• 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 determined based on available data)

• increased liver enzymes
• allergic reactions

Other side effects observed in some patients when taking Pioglitazone Accord together with other antidiabetic medicines are:

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

• decrease in blood sugar (hypoglycaemia)

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• sugar in urine, protein in urine
• increased enzymes
• sensation of dizziness (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pioglitazone Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after "Exp." and on the blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pioglitazone Accord contains

• The active substance of Pioglitazone Accord is pioglitazone.
• Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
• Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
• Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
• The other components are monohydrate lactose, calcium carmellose, hydroxypropylcellulose (E 465), magnesium stearate (E 572).

Description of the appearance of Pioglitazone Accord and contents of the pack

• Pioglitazone Accord 15 mg tablets are white to off-white, round, biconvex, uncoated, with 'P' engraved on one side and '15' on the other side.
• Pioglitazone Accord 30 mg tablets are white to off-white, flat, round, uncoated with bevelled edges, with 'PIO' engraved on one side and '30' on the other side.
• Pioglitazone Accord 45 mg tablets are white to off-white, flat, round, uncoated with bevelled edges, with 'PIO' engraved on one side and '45' on the other side.

Pioglitazone Accord is available in aluminium/aluminium blister packs containing 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,
The Netherlands

More detailed information on this medicine is available on the website of the European Medicines Agency:
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.