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PIOGLITAZONE 30 MG TABLETS

Active substance: PIOGLITAZONE HYDROCHLORIDE

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1. WHAT PIOGLITAZONE IS AND WHAT IT
IS USED FOR

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Pioglitazone 15 mg tablets
Pioglitazone 30 mg tablets
Pioglitazone 45 mg tablets
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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Pioglitazone is and what it is used for
2. Before you take Pioglitazone
3. How to take Pioglitazone
4. Possible side effects
5. How to store Pioglitazone
6. Further information

Pioglitazone tablets contain pioglitazone. It is an
anti-diabetic medicine used to treat type 2 (noninsulin dependant) 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 excercise has failed to
control blood sugar or may be added to other therapies (such as gliclazide, glibenclamide, glipizide,
tolbutamide or insulin) which have
failed to provide sufficient control of blood sugar.
Pioglitazone may also be used in combination
with insulin.
2. Before you take PIOGLITAZONE
Do not take Pioglitazone
• if you are hypersensitive (allergic) to
pioglitazone or any of the other ingredients of
Pioglitazone. (See section 6 for a list of the
ingredients)

• 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 has not been
checked by your doctor.
Take special care with Pioglitazone
Tell your doctor before you start to take this
medicine:
• 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.
• 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 will 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).
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
Use in children under 18 years is not recommended.
Taking other medicines
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.

Taking Pioglitazone with food and drink
You may take your tablets with or without food. You
should swallow the tablets whole with a glass of
water.
Pregnancy and breast-feeding
Tell your doctor if
• you are pregnant, think you might be pregnant
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.
Important information about some of the
ingredients of Pioglitazone
This medicine 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
One tablet of 15 mg, 30 mg or 45 mg 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 Pioglitizone 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
Pioglitizone 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, Pioglitazone 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
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 pain
shortness of breath
small reduction in red blood cell count
flatulence (wind)

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
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. How to store Pioglitazone
Keep out of the reach and sight of children.
Do not use Pioglitazone after the expiry date which
is stated on the carton and the blister pack after the
word “EXP”. The expiry date refers to the last day of
that month.
This medicine does not require any special storage
precautions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Pioglitazone contains
• 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,
hydroxypropylcellulose, croscarmellose sodium,
magnesium stearate.
What Pioglitazone looks like and contents of
the pack
15 mg: White to almost white round tablets with
beveled edges, engraved “15” on one side
(diameter 7.0 mm).
30 mg: White to almost white round tablets with
beveled edges (diameter 8.0 mm).
45 mg: White to almost white round tablets with
beveled edges, engraved “45” on one side
(diameter 10.0 mm).
The tablets are available in boxes of 14, 28, 30, 56,
60, 90 and 98 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Ltd., 5th Floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland.
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501
Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
This leaflet was last revised in May 2014.
P0254

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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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