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PIOGLITAZONE BROWN & BURK UK LTD 15 MG TABLET

Active substance(s): PIOGLITAZONE HYDROCHLORIDE

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MICRO LABS LIMITED
Bangalore, INDIA

1) Product

: Pioglitazone Tablets Leaflet UK

2) Strength

: 15/30/45 mg

3) Component

: Leaflet

4) No of colours

: 1

5) Dimension

: 150 x 420 mm

6) Artwork Code

: NA

7) Pharma code

: NA

8) Font type and Size

: Arial, 9pts

Colours used
Black

Colours not for Printing
Keylines

9) Technical specification : NA
Code No. :

WOA ΓΌ
NA
WA

Reason for change
Approved
By

Contract Giver/
PL holder

Regulatory
Affairs

Revision : 00
Date : 17-10-2014

Change in text
Production
Head (Site)

Packaging
Development

Head
QC (Site)

Head
QA (Site)

Sign/
Date

150mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

dose as normal. Do not take a double dose to
make up for a forgotten tablet.

Pioglitazone 15 mg Tablets
Pioglitazone 30 mg Tablets
Pioglitazone 45 mg Tablets

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.

1. What Pioglitazone is and what it is used
for
Pioglitazone tablets 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
c h e c k w h e t h e r
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
metformin, sulphonylurea or insulin) which
have failed to provide sufficient control of blood
sugar.
2. What you need to know before you take
Pioglitazone
Do not take Pioglitazone
- if you are hypersensitive (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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Pioglitazone
- if you retain water (fluid retention) or have
heart failures problems, in particular if you are
over 75 years old. If you take antiinflammatory 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 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 have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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.

195 mm

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.

Keep this medicine out of the sight and reach of
children.

In particular, patients have experienced the
following serious side effects:

Do not use this medicine 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.

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.

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.

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

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.

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.

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.

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
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.

The other side effects that have been
experienced by some patients taking
Pioglitazone are:

3. How to take Pioglitazone

common (affects 1 to 10 users in 100)
- weight gain
- respiratory infection
- numbness
- abnormal vision

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
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.

By reporting side effects you can help provide
more information on the safety of this medicine.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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.

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.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via Yellow Card
Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to Store Pioglitazone

4. Possible side effects

You may also experience a reduction in blood
count (anaemia).

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 contains
- The active substance is pioglitazone. Each
tablet contains either 15 mg, 30 mg or 45 mg
of pioglitazone (as hydrochloride).
- The other ingredients are lactose
monohydrate, hydroxypropylcellulose,
carmellose calcium and magnesium stearate.
What Pioglitazone looks like and contents of
the pack
Pioglitazone 15 mg Tablets are white to off
white, circular, flat, beveled edged uncoated
tablets with '15' engraved on one face and plain
on other.
Pioglitazone 30 mg Tablets are white to off
white, circular, flat, beveled edged uncoated
tablets with 'B 30' engraved on one face and
plain on other.
Pioglitazone 45 mg Tablets are white to off
white, circular, flat, beveled edged uncoated
tablets with 'B 45' engraved on one face and
plain on other.
The tablets are supplied in blister packs of 10,
14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
They may also be supplied in tablet containers
of 500 or 1000 tablets.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.

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

225 mm

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

If you take Pioglitazone with other medicines for
diabetes, it is more likely that your blood sugar
could fall below the normal level
(hypoglycaemia).

420 mm

190 mm

(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, pharmacist or nurse.
- 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,
pharmacist or nurse.
- This includes any possible side effects not
listed in this leaflet. See section 4.

- increase in enzymes

The other side effects that have been
experienced by some patients when
Pioglitazone is taken with other antidiabetic
medicines are:

This medicinal product is authorised in the
Member States of the EEA under the
following names:
SE : Pioglitazone Brown 15mg/30mg/45mg
tabletter
UK : Pioglitazone Brown and Burk UK Ltd
15mg/30mg/45mg Tablets
DE : Pioglitazon-Micro Labs
15mg/30mg/45mg Tabletten
This leaflet was last approved in October 2014

very common (affects more than 1 user in 10)
- decreased blood sugar (hypoglycaemia)

If you are following a diabetic diet, you should
continue with this while you are taking
Pioglitazone.

common (affects 1 to 10 users in 100)
- headache
- dizziness
- flatulence
- joint pain
- impotence
- small reduction in red blood cell count
- back pain
- shortness of breath

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.

uncommon (affects 1 to 10 users in 1,000)
- spinning sensation (vertigo)
- sweating
- tiredness
- sugar in urine, proteins in urine
- increased appetite

If you forget to take Pioglitazone:
Take Pioglitazone daily as prescribed. However
if you miss a dose, just carry on with the next

BBUK Code

6 mm

Phramcode reading direction

Phramcode reading direction

Front

Back

Artwork Code

420mm

150mm

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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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