PIOGLITAZONE 15 mg Tablets

Зміст інструкції

1. Pioglitazone Aurobindo 15 mg tablets, 30 mg tablets
   1. What Pioglitazone Aurobindo is and what it is used for
   2. What you need to know before taking Pioglitazone Aurobindo
   3. How to take Pioglitazone Aurobindo
   4. Possible side effects
   5. How to store Pioglitazone Aurobindo
   6. Contents of the pack and other information

Pioglitazone Aurobindo 15 mg tablets, 30 mg tablets

Generic medicine

Read this leaflet carefully before 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, as 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 Aurobindo is and what it is used for
• 2. What you need to know before you take Pioglitazone Aurobindo
• 3. How to take Pioglitazone Aurobindo
• 4. Possible side effects
• 5. How to store Pioglitazone Aurobindo
• 6. Contents of the pack and other information

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

Pioglitazone Aurobindo contains pioglitazone. It is an anti-diabetic medicine 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 Aurobindo 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 Aurobindo is working from 3 to 6 months after starting to take it.
Pioglitazone Aurobindo can be used alone in patients who are unable to take metformin and
where diet and exercise treatment has failed to control blood sugar or it can be
added to other therapies (such as metformin, sulfonylurea or insulin) that have not led to
sufficient control of blood sugar.

2. What you need to know before taking Pioglitazone Aurobindo

Do not take Pioglitazone Aurobindo:

• if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from heart failure or have suffered from heart failure in the past.
• if you suffer from liver problems.
• if you have suffered from diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• if you have or have ever had bladder cancer.
• if you have blood in your urine for which your doctor has not yet carried out investigations.

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

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. You should also inform your doctor if you are taking anti-inflammatory medicines that can also cause fluid retention and swelling,
• if you have a particular type of diabetic eye disease called macular edema (swelling of the back of the eye).
• 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 Aurobindo. 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 Aurobindo, 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 Aurobindo 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 or rapid weight gain or localized swelling (edema).

If you take Pioglitazone Aurobindo 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 in women taking
pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and Pioglitazone Aurobindo:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those obtained without a prescription.
As a rule, you can continue to take other medicines while being treated with Pioglitazone Aurobindo.
However, some medicines in particular are likely to affect your blood sugar levels:

• gemfibrozil (used to reduce cholesterol)
• 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 Aurobindo may need to be adjusted.

Pioglitazone Aurobindo with food and drink
You can take the tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breastfeeding
Tell your doctor if

• you are pregnant, if you think you may be pregnant or if you are planning to become pregnant.
• you are breastfeeding or if you are planning to breastfeed your baby. Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
Pioglitazone will not affect your ability to drive vehicles or use machines but be careful
if you have vision problems.

Pioglitazone Aurobindo contains lactose monohydrate
Pioglitazone Aurobindo contains lactose monohydrate. If you have been told by your doctor that you have an intolerance
to certain sugars, contact your doctor before taking Pioglitazone Aurobindo.

3. How to take Pioglitazone Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. Check with your doctor or
pharmacist if you are not sure.
The usual initial dose is one 15 mg or 30 mg pioglitazone tablet once a day. Your doctor may
increase the dose up to a maximum of 45 mg once a day. Your doctor will tell you which dose to take.
If you feel that the effect of Pioglitazone Aurobindo is too weak, talk to your doctor.
When Pioglitazone Aurobindo is 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
Aurobindo. This is to check the normal functioning of your liver.
If you are following a special diet for diabetes, you should continue it while taking Pioglitazone
Aurobindo.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Pioglitazone Aurobindo than you should
If you accidentally take too many tablets, or if another person or a child takes your tablets, contact your doctor or
pharmacist immediately. The blood sugar level may decrease below
normal levels and may 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 Aurobindo
Take Pioglitazone Aurobindo every day as prescribed. However, if you forget to take a dose,
continue normally with the next dose. Do not take a double dose to make up for a missed
tablet.

If you stop taking Pioglitazone Aurobindo
Pioglitazone Aurobindo must be used every day to work properly. If you stop using
Pioglitazone Aurobindo, it is possible that the blood sugar level will increase. Talk to your doctor before
stopping treatment.
If you have any doubts about the use of this medicine, 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, the following side effects have occurred in some patients:
Heart failure has occurred commonly (may affect up to 1 in 10 people) in patients treated with pioglitazone in
combination with insulin. Symptoms are unusual shortness of breath or rapid weight gain or swelling in the
legs or ankles (edema). If you experience any of these symptoms, especially if you are over 65 years of age,
consult a doctor immediately.
Bladder cancer has occurred uncommonly (may affect up to 1 in 100 people) in patients treated with
pioglitazone. Signs and symptoms include blood in the urine, pain during urination or a sudden need to
urinate. If you experience any of these symptoms, see your doctor as soon as possible.
Swelling in the legs or ankles (edema) has occurred very commonly (may affect more than 1 in 10 people) in
patients treated with pioglitazone in combination with insulin. If you experience this side effect, see your
doctor as soon as possible.
Common bone fractures have been reported (may affect up to 1 in 10 people) in female patients and also in
male patients taking Actos (available data do not allow an estimate of the frequency). If you experience this
side effect, inform your doctor as soon as possible.
Blurred vision due to swelling (or fluid) in the back of the eye has also been reported (frequency cannot be
defined based on available data) in patients treated with pioglitazone. If you experience this symptom for the
first time, see your doctor as soon as possible. Also, if you already have blurred vision and the symptom
worsens, see your doctor as soon as possible.
Allergic reactions have been reported (frequency cannot be defined based on available data) in patients taking
Pioglitazone Aurobindo. If you have a severe allergic reaction including hives and swelling of the face, lips,
tongue or throat which can cause difficulty in breathing or swallowing, stop taking this medicine and contact
your doctor as soon as possible.
Other side effects that have been experienced by some patients taking pioglitazone 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 defined based on the available data)

• increased liver enzymes
• allergic reactions

Other side effects that have occurred in some patients when pioglitazone is taken with other antidiabetic
medicines are:
Very common (may affect more than 1 in 10 users)

• low 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
• flatulence

Uncommon (may affect up to 1 in 100 people)

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

If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects to 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 Aurobindo

Keep out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package, blister or label of the
bottle after “EXP.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Aurobindo contains

• The active ingredient is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride). Each tablet contains 30 mg of pioglitazone (as hydrochloride).
• The other ingredients are lactose monohydrate, calcium carmellose, hydroxypropylcellulose, magnesium stearate.

Description of the appearance of Pioglitazone Aurobindo and contents of the pack
Tablet

Pioglitazone Aurobindo 15 mg tablets:
Uncoated tablets, white to off-white, round, biconvex, with '31' imprinted on one side and 'H'
on the other side.

Pioglitazone Aurobindo 30 mg tablets:
Uncoated tablets, white to off-white, round, flat-faced, beveled edge, with '32' imprinted on
one side and 'H' on the other side.
Pioglitazone Aurobindo tablets are available in transparent PVC/PVDC/Aluminum blisters or
in HDPE bottles with a polypropylene closure.

Blister packs: 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.

HDPE bottle packs:
15 mg and 30 mg: 30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Vicolo San Giovanni sul Muro, 9
20121 Milano
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Germany Pioglitazon Aurobindo 15 mg / 30 mg Tabletten
Italy Pioglitazone Aurobindo 15 mg / 30 mg compresse
Netherlands Pioglitazon Aurobindo 15 mg / 30 mg tabletten
Portugal Pioglitazona Aurobindo
Spain Pioglitazona Aurobindo 15 mg / 30 mg comprimidos EFG