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PIOGLITAZONE DR. REDDYS 45MG TABLETS

Active substance(s): PIOGLITAZONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pioglitazone 15 mg, 30 mg & 45 mg Tablets
Pioglitazone
Read all of this leaflet carefully before you start taking this medicine.





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. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
If you get any of the side talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet.

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 Tablets contain pioglitazone. It is an antidiabetic 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 your medicine 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 metformin,
sulphonylurea or 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).
have heart failure or have had heart failure in the
past.
have liver disease.
have had diabetic ketoacidosis (a complication of
diabetes causing rapid weight loss, nausea or
vomiting).
have or have ever had bladder cancer.
have blood in your urine that your doctor has not
checked.

Warnings and precautions
Talk to your doctor before taking Pioglitazone if
you







retain water (fluid retention) or have heart failure
problems in particular if you are over 75 years old. If
you take anti-inflammatory medicines which can also
cause fluid retention and swelling, you must also tell
your doctor.
have a special type of diabetic eye disease called
macular oedema (swelling of the back of the eye).
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.
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.

Conditions to look out for


Heart failure:
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).






Hypoglycaemia:
If you take Pioglitazone with other medicines for
diabetes, it is more likely that your blood sugar could
fall below the normal level (hypoglycaemia).
Anaemia:
You may also experience a reduction in blood count
(anaemia).
Broken bones:
A higher number of bone fractures was seen in
patients, particularly women taking pioglitazone. Your
doctor will take this into account when treating your
diabetes.

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

Other medicines and Pioglitazone
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
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
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to become pregnant to have a
baby, ask your doctor or pharmacist for advice before
taking 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.
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.
The recommended dose is one tablet of 15 mg of
pioglitazone to 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.
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
Uncommon (affects 1 to 10 users in 1,000)
 inflammation of the sinuses (sinusitis)
 difficulty sleeping (insomnia)
Not known (frequency cannot be estimated from the
available data)
 increase in liver enzymes
 allergic reactions
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 painshortness 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,
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE PIOGLITAZONE
Keep the medicine out of the sight and reach of children.
Do not use Pioglitazone tablets after the expiry date
which is stated on the carton and the blister pack after
“EXP”. The expiry date refers to the last day of that
month.
This medicine does not require any special storage
precautions.
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 Tablets contain
The active substance is pioglitazone.
Each tablet contains 15 mg, 30 mg or 45 mg of
pioglitazone (as hydrochloride). The other ingredients
are lactose monohydrate, hydroxypropyl cellulose,
carmellose calcium and magnesium stearate.

What Pioglitazone looks like and contents of the
pack





Pioglitazone 15 mg tablets: white to off-white,
modified capsule shaped, flat, beveled edged tablet
debossed with ‘P’ on one side and ‘15’ on the other
side.
Pioglitazone 30 mg tablets: white to off-white,
modified capsule shaped, biconvex tablet debossed
with ‘P’ on one side and ‘30’ on the other side.
Pioglitazone 45 mg tablets: white to off-white, oval,
biconvex tablet debossed with ‘P’ on one side and
‘45’ on the other side.

The tablets are supplied in blister packs of 28, 30, 98
100, 112, 196 and 200 tablets. Not all the pack sizes
may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD, UK.

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Germany: Pioglitazon beta Tabletten
Romania: Pioglitazonă Dr. Reddy’s comprimate
This leaflet was last revised in 07/2014

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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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