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PIOGLITAZONE AUROBINDO 30 MG TABLETS

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Pioglitazone 15 mg tablets
Pioglitazone 30 mg tablets
Pioglitazone 45 mg tablets
Pioglitazone
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 further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Pioglitazone is and what it is used for
2. What you need to know before you take Pioglitazone
3. How to take Pioglitazone
4. Possible side effects
5. How to store Pioglitazone
6. Contents of the pack and other information
1. What Pioglitazone is and what it is used for
Pioglitazone contains pioglitazone. It is an anti-diabetic medicine
used to treat type 2 (non-insulin dependent) diabetes mellitus,
when metformin is not suitable or has failed to work adequately.
This is the diabetes that usually develops in adulthood.
Pioglitazone helps control the level of sugar in your blood when you
have type 2 diabetes by helping your body make better use of the
insulin it produces. Your doctor will check whether Pioglitazone is
working 3 to 6 months after you start taking it.
Pioglitazone may be used on its own in patients who are unable to
take metformin and where treatment with diet and exercise has
failed to control blood sugar or may be added to other therapies
(such as insulin) which have failed to provide sufficient control in
blood sugar.
2. What you need to know before you take Pioglitazone
Do not take Pioglitazone:
- 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 liver disease.
- 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.
- if you have blood in your urine that your doctor has not
checked.
Warning and precautions:
Tell your doctor before you start to take this medicine
- if you retain water (fluid retention) or have heart failures
problems in particular if you are over 75 years old.
- 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 your ovaries (polycystic ovary syndrome).
There may be an increased possibility of becoming pregnant
because you may ovulate again when you take Pioglitazone. If
this applies to you, use appropriate contraception to avoid the
possibility of an unplanned pregnancy.
- if you have a problem with your liver or heart. Before you start
taking Pioglitazone you will have a blood sample taken to check
your liver function. This check may be repeated at intervals.
Some patients with long-standing type 2 diabetes mellitus and
heart disease or previous stroke who were treated with
Pioglitazone and insulin experienced the development of heart
failure. Inform your doctor as soon as possible if you experience
signs of heart failure such as unusual shortness of breath or
rapid increase in weight or localised swelling (oedema).
If you take Pioglitazone with other medicines for diabetes, it is more
likely that your blood sugar could fall below the normal level
(hypoglycaemia).

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P150

P150

Pioglitazone tablets

Milpharm
Package leaflet: Information for the user

Pioglitazone tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

You may also experience a reduction in blood count (anaemia).
Broken bones
A higher number of bone fractures was seen in women (but not in
men) taking pioglitazone. Your doctor will take this into account
when treating your diabetes.
Children
Use in children under 18 years is not recommended.
Other medicines and Pioglitazone:
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
You can usually continue to take other medicines whilst you are
being treated with Pioglitazone. However, certain medicines are
especially likely to affect the amount of sugar in your blood:
- 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. Your
blood sugar will be checked, and your dose of Pioglitazone may
need to be changed.
Pioglitazone with food and drink:
You may take your tablets with or without food. You should swallow
the tablets with a glass of water.
Pregnancy and breast-feeding
Tell your doctor if
- you are, you think you might be or are planning to become
pregnant.
- you are breast-feeding or if you are planning to breast-feed your
baby.
Your doctor will advise you to discontinue this medicine.
Driving and using machines
Pioglitazone will not affect your ability to drive or use machines but
take care if you experience abnormal vision.
Pioglitazone contains lactose monohydrate
Pioglitazone contains lactose monohydrate. If you have been told
by your doctor that you have intolerance to some sugars, contact
your doctor before taking Pioglitazone.
3. How to take Pioglitazone
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
One tablet of pioglitazone should be taken once daily. If necessary
your doctor may tell you to take a different dose.
If you have the impression that the effect of Pioglitazone is too
weak, talk to your doctor.
When Pioglitazone is 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 smaller dose of your medicines.
Your doctor will ask you to have blood tests periodically during
treatment with Pioglitazone. This is to check that your liver is
working normally.
If you are following a diabetic diet, you should continue with this
while you are taking Pioglitazone.
Your weight should be checked at regular intervals; if your weight
increases, inform your doctor.
If you take more Pioglitazone than you should:
If you accidentally take too many tablets, or if someone else or a
child takes your medicine, talk to a doctor or pharmacist
immediately. Your blood sugar could fall below the normal level and
can be increased by taking sugar. It is recommended that you carry
some sugar lumps, sweets, biscuits or sugary fruit juice.
If you forget to take Pioglitazone:
Take Pioglitazone daily as prescribed. However if you miss a dose,
just carry on with the next dose as normal. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Pioglitazone
Pioglitazone should be used every day to work properly. If you stop
using Pioglitazone, your blood sugar may go up. Talk to your doctor
before stopping this treatment.
If you have any further questions on 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.

side effects you can help provide more information on the safety of
this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

In particular, patients have experienced the following serious side
effects:
Heart failure has been experienced commonly (1 to 10 users in
100) in patients taking pioglitazone in combination with insulin.
Symptoms are unusual shortness of breath or rapid increase in
weight or localised swelling (oedema). If you experience any of
these, especially if you are over the age of 65, seek medical advice
straight away.
Bladder cancer has been experienced uncommonly (1 to 10 users
in 1000) in patients taking pioglitazone. Signs and symptoms
include blood in your urine, pain when urinating or a sudden need
to urinate. If you experience any of these, talk to your doctor as
soon as possible.
Localised swelling (oedema) has also been experienced very
commonly in patients taking pioglitazone in combination with
insulin. If you experience this side effect, talk to your doctor as
soon as possible.
Broken bones have been reported commonly (1 to 10 users in 100)
in women patients taking pioglitazone. If you experience this side
effect, talk to your doctor as soon as possible.
Blurred vision due to swelling (or fluid) at the back of the eye
(frequency not known) has also been reported in patients taking
pioglitazone. If you experience this symptom for the first time, talk
to your doctor as soon as possible. Also, if you already have
blurred vision and the symptom gets worse, talk to your doctor as
soon as possible.
Allergic reactions have been reported (frequency not known) in
patients taking Pioglitazone. If you have a serious 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 talk to your doctor as soon as possible.
The other side effects that have been experienced by some
patients taking pioglitazone are
Common (affects 1 to 10 users in 100)
- respiratory infection
- abnormal vision
- weight gain
- numbness

5. How to store Pioglitazone
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
precautions.
Do not use this medicine after the expiry date which is stated on
the carton, blister or bottle label after EXP. The expiry date refers to
the last day of the month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Pioglitazone contains
- The active substance is pioglitazone.
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
-

The other ingredients are Lactose Monohydrate, Carmellose
Calcium, Hydroxypropylcellulose, Magnesium Stearate

What Pioglitazone looks like and contents of the pack
Tablet
Pioglitazone 15 mg Tablets:
White to off-white, round, biconvex, uncoated tablets debossed with
'31' on one side and 'H' on the other side.
Pioglitazone 30 mg Tablets:
White to off-white, round, flat faced, bevel edge, uncoated tablets
debossed with '32' on one side and 'H' on the other side.
Pioglitazone 45 mg Tablets:
White to off-white, round, flat faced, bevel edge, uncoated tablets
debossed with '33' on one side and 'H' on the other side.
Pioglitazone tablets are available in a Polyamide/ Aluminium/ PVC/
Aluminium blister or HDPE bottle with polypropylene closure.
Blister pack: 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.

Uncommon (affects 1 to 10 users in 1,000)
- inflammation of the sinuses (sinusitis)
- difficulty sleeping (insomnia)

HDPE Bottle pack:
15 mg & 30 mg: 30 & 500 tablets
45 mg: 30, 90 & 500 tablets

Not known (frequency cannot be estimated from the available data)
- increase in liver enzymes
- allergic reactions

Not all pack sizes may be marketed.

The other side effects that have been experienced by some
patients when pioglitazone is taken with other antidiabetic
medicines are:
Very common (affects more than 1 user in 10)
- decreased blood sugar (hypoglycaemia)
Common (affects 1 to 10 users in 100)
- headache
- dizziness
- joint pain
- impotence
- back pain
- shortness of breath
- small reduction in red blood cell count
- flatulence
Uncommon (affects 1 to 10 users in 1,000)
- sugar in urine, proteins in urine
- increase in enzymes
- spinning sensation (vertigo)
- sweating
- tiredness
- increased appetite
Reporting of side effects
If you get 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 (see details below). By reporting

Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last approved in 04/2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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