Pioglitazone Mylan

Patient Information Leaflet

Pioglitazone Mylan 15 mg tablets, 30 mg tablets, 45 mg tablets

Pioglitazone
Generic medicine
Please read this leaflet carefully before 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pioglitazone Mylan contains pioglitazone.

• It is an antidiabetic medicine used to treat type 2 diabetes mellitus (non-insulin-dependent) in adults when metformin is not suitable or has not worked adequately. This type of diabetes usually occurs in adults.
• Pioglitazone Mylan helps control your blood sugar level when you have type 2 diabetes by helping your body make better use of the insulin it produces. Your doctor will check whether Pioglitazone Mylan is working 3 to 6 months after starting treatment.
• Pioglitazone Mylan may be used alone in patients who cannot take metformin and when treatment with diet and exercise has failed to control blood sugar levels, or it may be used in combination with other therapies (such as insulin) that have not provided adequate blood sugar control.

2. What you need to know before taking Pioglitazone Mylan

Do not take Pioglitazone Mylan if:

• You are allergic to pioglitazone or to any of the other ingredients of this medicine (listed in section 6).
• You have heart failure or have previously had heart failure.
• You have liver problems.
• You have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).
• You have or have ever had bladder cancer.
• 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 Mylan

• If you retain fluid (fluid retention) or have heart failure problems, especially if you are over 75 years old. If you are taking non-steroidal anti-inflammatory drugs, including celecoxib and etoricoxib, which may also cause fluid retention and swelling, you should also inform your doctor.
• If you have ever had blood in your urine. If you notice blood in your urine or have other problems with urination while taking pioglitazone, contact your doctor.
• If you smoke (or have smoked in the past), or have undergone chemotherapy or radiotherapy (for cancer treatment).
• If you have a specific type of diabetic eye disease called macular edema (swelling at the back of the eye leading to worsening vision).
• If you have polycystic ovaries (polycystic ovary syndrome). The chance of becoming pregnant may increase, as ovulation may resume when you take pioglitazone. In this case, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
• If you have problems with your liver or heart. Before starting Pioglitazone Mylan, 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 and insulin 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 (edema).

If you take Pioglitazone Mylan together with other diabetes medicines, your blood sugar level is more likely to drop below normal (hypoglycemia).
You may also experience a decrease in blood cell count (anemia).
Bone fractures
An increased 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 under 18 years of age is not recommended.

Other medicines and Pioglitazone Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Generally, you can continue taking other medicines while being treated with Pioglitazone Mylan.
However, certain medicines may affect your blood sugar levels, such as:

• gemfibrozil (used to lower 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 the dose of Pioglitazone Mylan may need to be adjusted.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take pioglitazone during pregnancy because it is unclear whether the medicine could affect fetal development.
You must not take pioglitazone while breastfeeding because it is not known whether it passes into breast milk.

Driving and using machines
Pioglitazone Mylan normally has no effect on the ability to drive or operate machinery, but be cautious if you experience vision disturbances.

Pioglitazone Mylan contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take Pioglitazone Mylan

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is 15 mg or 30 mg of pioglitazone taken once daily. The dose may be increased up to a maximum of 45 mg of pioglitazone, taken once daily. Swallow the tablet with a glass of water, with or without food.
If necessary, your doctor may instruct you to take a different dose. If you feel that the effect of Pioglitazone Mylan is too weak, speak to your doctor.
When Pioglitazone Mylan 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 lower dose of these other medicines.
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Mylan. These tests are to monitor normal liver function.
If you are following a diabetic diet, you must continue it while taking Pioglitazone Mylan.
Your weight should be monitored at regular intervals; if you gain weight, inform your doctor.

If you take more Pioglitazone Mylan than you should
If you accidentally take too many tablets, or if someone else or a child takes your tablets, contact your doctor or go to a hospital emergency department immediately.
Your blood sugar level may drop below normal levels, which can be corrected by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or sugary fruit juices with you.

If you forget to take Pioglitazone Mylan
Take Pioglitazone Mylan every day as prescribed. However, if you forget to take a dose, continue as usual with your next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pioglitazone Mylan
Pioglitazone Mylan must be taken every day to work properly. If you stop taking Pioglitazone Mylan, your blood sugar level may rise. Talk to your doctor before stopping treatment.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking this medicine immediately and contact your doctor or go to the nearest Emergency Department.

• Heart failure (when pioglitazone is taken in combination with insulin); symptoms include unusual shortness of breath, rapid weight gain, or localized swelling (edema).
• Bladder cancer: signs and symptoms include blood in the urine, pain during urination, or sudden need to urinate.
• Localized swelling (edema) in patients taking pioglitazone in combination with insulin.
• Bone fractures (reported in both female and male patients).
• Blurred vision due to swelling (or fluid accumulation) in the back of the eye. If you already have blurred vision and symptoms worsen, inform your doctor as soon as possible.

Allergic reactions: symptoms of a severe allergic reaction, including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Other side effects
Common: may affect up to 1 in 10 people

• Abnormal vision
• Respiratory infections
• 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

Other side effects observed in some patients taking Pioglitazone Mylan 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 reduction in red blood cell count (anaemia)
• Flatulence
• Increased levels of enzymes

Uncommon: may affect up to 1 in 100 people

• Sugar in the urine, protein in the urine
• Dizziness
• Sweating
• Fatigue
• Increased appetite

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pioglitazone Mylan

Keep this medicine out of the sight and reach of children.
Blister packs: This medicine does not require any special storage conditions.
Bottles: after opening, keep the bottle tightly closed to protect it from moisture.
Do not use this medicine after the expiry date stated on the packaging after the word "Exp." The expiry date refers to the last day of that month.
Bottles: use within 90 days of opening.
Do not dispose of medicines 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 Mylan contains
The active substance is pioglitazone. Each tablet contains 15 mg, 30 mg, or 45 mg of
pioglitazone (as hydrochloride).
The excipients are lactose monohydrate, hypromellose (E464), anhydrous colloidal silica,
sodium croscarmellose, polysorbate 80 (E433), and magnesium stearate.

Description of the appearance of Pioglitazone Mylan and contents of the pack
Pioglitazone Mylan 15 mg tablets are white to off-white, uncoated, round, biconvex tablets,
marked with “PG” above “15” on one side and “G” on the other.
Pioglitazone Mylan 30 mg tablets are white to off-white, uncoated, round, biconvex tablets,
marked with “PG” above “30” on one side and “G” on the other.
Pioglitazone Mylan 45 mg tablets are white to off-white, uncoated, round, biconvex tablets,
marked with “PG” above “45” on one side and “G” on the other.
Pioglitazone Mylan is available in blister packs containing 10, 14, 28, 30, 56, 84, 90, 98 tablets,
and in bottles containing 500 tablets (hospital pack). Do not eat the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Responsible Person for Batch Release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area Member States under the
following names: