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PIOGLITAZONE MYLAN 30MG TABLETS

Active substance(s): PIOGLITAZONE

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Package leaflet: Information for the patient

Pioglitazone 15 mg Tablets
Pioglitazone 30 mg Tablets
Pioglitazone 45 mg Tablets
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 tablets contain pioglitazone.
• 
It is an anti-diabetic medicine used to treat
type 2 (non-insulin dependent) diabetes
mellitus in adults, when metformin is not
suitable or has failed to work adequately.
This is the diabetes that usually develops in
adulthood.
• 
Pioglitazone tablets help 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 tablets may be used on their
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

If you take Pioglitazone with other medicines
for diabetes, it is more likely that your blood
sugar could fall below the normal level
(hypoglycaemia).
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
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 tablets. However, certain
medicines are especially likely to affect the
amount of sugar in your blood like:
• 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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
You should not take pioglitazone in pregnancy
as it is unsure whether the medicine can affect
the growth of your baby.
You should not take pioglitazone if you are
breast-feeding as it is not known whether it may
be present in the milk.
Driving and using machines
Pioglitazone will not normally affect your
ability to drive or use machines but take care
if you experience abnormal vision.
Pioglitazone tablets contain lactose.
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to 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),
• 
you have heart failure or have had heart
failure in the past,
• 
you have liver disease,
• 
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 that your
doctor has not checked.

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Warnings and precautions

When Pioglitazone 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 smaller dose of
your medicines.

Talk to your doctor or pharmacist before
taking Pioglitazone:
• If you retain water (fluid retention) or have
heart problems in particular if you are over
75 years old. If you take non-steroidal antiinflammatory medicines which can also
cause water (fluid retention) and swelling,
including celecoxib or etoricoxib, you must
also tell your doctor.
• If you have ever had blood in your urine. If
you find blood in your urine or have other
problems urinating while taking pioglitazone,
you should contact your doctor.
• If you smoke (or have smoked in the
past), have received chemotherapy or
radiotherapy (for cancer treatment).
• If you have a special type of diabetic eye
disease called macular oedema (swelling
of the back of the eye with worsening of
your vision).
• 
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).

Description Pioglitazone Hydrochloride 45/15/30mg 90/28/30/56/84/14/500/98/10
Component Type LeafletInsert
Affiliate Item Code 771687
Superceded Affiliate Item Code 583600
TrackWise PR No. 771687
MA No. 04569/0209
Packing Site/Printer Komarom
Supplier Code 50060645

Pharma Code 4507
SAP No. NA
Vendor Job No. 269359
Trackwise Proof No. 2
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

The starting dose is 15 mg or 30 mg of
pioglitazone taken once daily. Your dose
might be increased to 45 mg of pioglitazone
taken once daily. Swallow your tablet with a
glass of water with or without food.
If necessary your doctor may tell you to take
a different dose. If you have the impression
that the effect of your prescribed strength of
Pioglitazone is too weak, talk to your doctor.

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 tablets than
you should
If you accidentally take too many tablets, or if
someone else or a child takes your medicine,
contact your doctor or hospital emergency
department 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 tablets
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 dose.
If you stop taking Pioglitazone tablets
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.

Date: 17 DEC 15
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1

Time: 14:27
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1/2

Black

Non-Print
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Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 10.5 pt
Min Text Size used 9 pt

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v1/May 2015

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.
If you notice any of the following side
effects, stop taking this medicine and
contact your doctor or go to the nearest
hospital casualty department straight away.
• 
Heart failure (when taking pioglitazone
in combination with insulin): symptoms
are unusual shortness of breath or rapid
increase in weight or localised swelling
(oedema).
• 
Bladder cancer: signs and symptoms
include blood in your urine, pain when
urinating or a sudden need to urinate.
• 
Localised swelling (oedema) (when taking
pioglitazone in combination with insulin).
• 
Broken bones.
• 
Blurred vision due to swelling (or fluid) at
the back of the eye. Also, if you already
have blurred vision and the symptom
gets worse, talk to your doctor as soon as
possible.
• 
Allergic reactions: symptoms of a serious
allergic reaction include hives and swelling
of the face, lips, tongue, or throat that may
cause difficulty in breathing or swallowing.
Other possible side effects:
Common: may affect up to 1 in 10 people
• 
abnormal vision
• 
respiratory infection
• 
weight gain
• 
numbness
Uncommon: may affect up to 1 in
100 people
• 
inflammation of the sinuses (sinusitis)
• 
difficulty sleeping (insomnia).

6. Content of the pack and other
information
What Pioglitazone contains
The active substance is pioglitazone. Each
tablet contains 15 mg, 30 mg, 45 mg of
pioglitazone (as hydrochloride).
The other ingredients are lactose
monohydrate, hypromellose (E464), silica
colloidal anhydrous, croscarmellose sodium,
polysorbate 80 (E433), magnesium stearate.
What Pioglitazone looks like and contents
of the pack
Pioglitazone 15 mg Tablets are white to off
–white, round biconvex, uncoated tablets,
debossed with “PG” over “15” on one side and
“G” on the other side.
Pioglitazone 30 mg Tablets are white to off
–white, round biconvex, uncoated tablets,
debossed with “PG” over “30” on one side and
“G” on the other side.
Pioglitazone 45 mg Tablets are white to off
–white, round biconvex, uncoated tablets,
debossed with “PG” over “45” on one side and
“G” on the other side.
Pioglitazone is available in blisters 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
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft. H-2900 Komárom, Mylan
utca 1, Hungary.

Not known: frequency cannot be estimated
from the available data
• 
increase in liver enzymes
• 
allergic reactions
The following additional side effects have
been experienced by some patients when
Pioglitazone is taken with other antidiabetic
medicines.
Very common: may affect more than 1 in
10 people)
• 
decreased blood sugar (hypoglycaemia)
Common: may affect up to 1 in 10 people
• 
headache
• 
dizziness
• 
joint pain
• 
impotence
• 
back pain
• 
shortness of breath
• 
small reduction in red blood cell count
(anemia)
• 
flatulence
• 
increase in enzyme levels
Uncommon: may affect up to 1 in
100 people
• 
sugar in urine, proteins in urine
• 
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 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 this medicine out of the sight and reach
of children.
Blisters: This medicine does not require any
special storage conditions.
Bottles: Once open keep the bottle tightly
closed in order to protect from moisture.
Do not use this medicine after the expiry date
which is stated on the blister, carton, bottle
after EXP. The expiry date refers to the last day
of that month.
Bottles: Use within 90 days of opening.
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.

This leaflet was last revised in
11/2015

Description Pioglitazone Hydrochloride 45/15/30mg 90/28/30/56/84/14/500/98/10
Component Type LeafletInsert
Affiliate Item Code 771687
Superceded Affiliate Item Code 583600
TrackWise PR No. 771687
MA No. 04569/0209
Packing Site/Printer Komarom
Supplier Code 50060645

Pharma Code 4507
SAP No. NA
Vendor Job No. 269359
Trackwise Proof No. 2
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Date: 17 DEC 15
No. of colours
Colours

1

771687
50060645

Time: 14:27
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 10.5 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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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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