PIOGLITAZONE 15 mg Tablet

Зміст інструкції

1. Pioglitazone Mylan 15 mg tablets, 30 mg tablets, 45 mg tablets
   1. What is Pioglitazone Mylan and what is it 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

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

Pioglitazone

Generic medicine

Read this leaflet carefully before you start taking this medicine, as 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 pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Pioglitazone Mylan and what is it used for

Pioglitazone Mylan contains pioglitazone

• It is an anti-diabetic drug used for the treatment of 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 to control the level of sugar in your blood when you suffer from type 2 diabetes by helping your body to make better use of the insulin produced. The doctor will check if Pioglitazone Mylan is working 3 to 6 months after the start of treatment.
• Pioglitazone Mylan can be used alone in patients who cannot take metformin and when diet and exercise treatment has failed to control blood sugar or can be used in combination with other therapies (such as insulin), which have not provided sufficient 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 any of the other ingredients of this medicine (listed in section 6).
• You suffer from heart failure or have suffered from heart failure in the past,
• You suffer from liver disorders,
• You have suffered from diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting),
• You have or have ever had bladder cancer.
• You have blood in your urine for which your doctor has not yet carried out investigations.

Warnings and Precautions
Consult your doctor or pharmacist before taking Pioglitazone Mylan

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. If you are taking non-steroidal anti-inflammatory drugs, including celecoxib and etoricoxib, which can also cause fluid retention and swelling, you should also inform your doctor
• if you have ever had blood in your urine. If you find blood in your urine or have other problems with urination while taking pioglitazone, you should contact your doctor
• if you smoke (or have smoked in the past), have undergone chemotherapy or radiotherapy (for cancer treatment)
• if you have a particular type of diabetic eye disease, called macular edema (swelling of the back of the eye with worsening vision)
• if you have cysts on the ovaries (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, because ovulation may resume when you take pioglitazone. If this is the case, use adequate contraception to avoid the risk of an unwanted pregnancy.
• if you have problems with your liver or heart. Before starting to take Pioglitazone Mylan, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with type 2 diabetes mellitus of long duration and heart disease or previous stroke who have been treated with pioglitazone 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 or rapid weight gain or localized swelling (edema).

If you take Pioglitazone Mylan with other medicines for diabetes, your
blood sugar level is more likely to drop below normal (hypoglycemia).
You may also experience a decrease in the number of blood cells (anemia).
Bone fractures
A higher number of bone fractures have been found in patients, especially women who
take pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents
Use in children under 18 years of age is not recommended.

Other medicines and Pioglitazone Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
As a rule, you can continue to take other medicines while being treated with Pioglitazone
Mylan.
However, some medicines, in particular, are likely to affect the amount of sugar in
your blood as:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections)

Tell your doctor or pharmacist if you are taking any of these medicines. Your blood
sugar level will be checked and the dose of Pioglitazone Mylan may need to
be adjusted.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. You should not take pioglitazone during pregnancy because it is not clear whether the medicine
may affect the growth of the fetus.
You should not take pioglitazone if you are breastfeeding because it is not known whether it can be present in
breast milk.

Driving and using machines
Pioglitazone Mylan does not normally affect the ability to drive vehicles or operate
machinery, but be careful if you experience visual disturbances.

Pioglitazone Mylan contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, like lactose, contact
your doctor before taking this medicine.

3. How to take Pioglitazone Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The usual starting dose is 15 mg or 30 mg of pioglitazone taken once a day. The dose
may be increased up to a maximum of 45 mg of pioglitazone, to be taken once a
day. Swallow the tablet with a glass of water, on a full or empty stomach.
If necessary, your doctor may tell you to take a different dose. If you feel that
the effect of Pioglitazone Mylan is too weak, talk to your doctor.
When Pioglitazone Mylan 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 if it is necessary to take a lower dose of the other medicines.
Your doctor will ask you to have blood tests periodically during treatment with
Pioglitazone Mylan. This is to check the normal functioning of the liver.
If you are following a diet for diabetics, you should continue it while taking Pioglitazone
Mylan.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Pioglitazone Mylan than you should
If you accidentally take too many tablets, or if another person or a child takes your
tablets, contact your doctor or a hospital emergency room immediately.
Your blood sugar level may drop below normal levels and can be increased by taking sugar. It is advisable to carry sugar lumps with you,
candies, biscuits or sugary fruit juices.

If you forget to take Pioglitazone Mylan
Take Pioglitazone Mylan every day as prescribed. However, if you forget to take a
dose, continue normally with the next dose. Do nottake a double dose to
make up for a missed tablet.

If you stop taking Pioglitazone Mylan
Pioglitazone Mylan must be used every day to work properly. If you stop
using Pioglitazone Mylan, your blood sugar level may increase. Talk to your
doctor before stopping treatment.
If you have any doubts regarding the use of 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 and contact your doctor or go immediately to the nearest emergency room.

• Heart failure (when taking pioglitazone in combination with insulin), symptoms are unusual shortness of breath or rapid weight gain or localized swelling (edema).
• Bladder cancer: signs and symptoms include blood in the urine, pain during urination or the sudden need to urinate.
• Localized swelling (edema) in patients taking pioglitazone in combination with insulin.
• Bone fractures (have been reported in both female and male patients)
• Blurred vision due to swelling (or presence of fluid) in the back of the eye. If you already have blurred vision and the 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 that can 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 available data

• increased liver enzymes.
• allergic reactions

Other side effects that have occurred in some patients when taking Pioglitazone Mylan together with other antidiabetic medicines are:

Very common: may affect more than 1 in 10 people

• decreased blood sugar (hypoglycemia).

Common: may affect up to 1 in 10 people

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• a slight decrease in the number of red blood cells in the blood (anemia)
• flatulence
• increased enzyme levels

Uncommon: may affect up to 1 in 100 people

• sugar in the urine, protein in the urine
• feeling of spinning (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 .
Blisters: This medicine does not require any special storage conditions.
Bottles: Once opened, keep the bottle tightly closed to protect it from moisture.
Do not use this medicine after the expiry date which is stated on the pack after the inscription
“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. Contents of the pack and other information

What Pioglitazone Mylan contains
The active ingredient is pioglitazone. Each tablet contains 15 mg, 30 mg, 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 in colour, uncoated, round, biconvex, with
“PG” above “15” on one side and “G” on the other.
Pioglitazone Mylan 30 mg tablets are white to off-white in colour, uncoated, round, biconvex, with
“PG” above “30” on one side and “G” on the other.
Pioglitazone Mylan 45 mg tablets are white to off-white in colour, uncoated, round, biconvex, 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 Milano

Manufacturer Responsible 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 Member States of the European Economic Area with the
following denominations: