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PIOGLITAZONE BROWN & BURK UK LTD 15 MG TABLET

Active substance(s): PIOGLITAZONE HYDROCHLORIDE / PIOGLITAZONE HYDROCHLORIDE / PIOGLITAZONE HYDROCHLORIDE

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MICRO LABS LIMITED
Bangalore, INDIA

Colours used
Black

1) Product

: Pioglitazone Tablets - BBUK

2) Strength

: 15/30/45 mg

3) Component

: Leaflet

4) No. of Colours

: 1

5) Dimension

: 150 x 420 mm (Folded at 195 mm)

6) Artwork Code

: NA

7) Pharma code

: NA

8) Font Type and Size

: Arial, 9pts

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 : 06-09-2016

NA
Head Production/
Packing (Site)

Packaging
Development

Head QC
(Site)

Head QA
(Site)

Sign/
Date

150mm

150mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

before stopping this treatment.

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

Scheme
Website: www.mhra.gov.uk/yellowcard

If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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

4. Possible side effects

5. How to Store Pioglitazone

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

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.

Pioglitazone tablets contains 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.

Folding
here

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
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 take Pioglitazone with other medicines
for diabetes, it is more likely that your blood

Heart failure has been experienced commonly
(may affect up to 1 in 10 people) 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.

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. 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.

Localised swelling (oedema) has also been
experienced very commonly (may affect more
than 1 in 10 people) 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
(may affect up to 1 in 10people) in female
patients taking Pioglitazone and have also been
reported in male patients (frequency cannot be
estimated from the available data) taking
Pioglitazone. 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.
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.

Folding
here

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.

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

Allergic reactions have been reported
(frequency cannot be estimated from the
available data) 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.

common (may affect up to 1 in 10 people)
- weight gain
- respiratory infection
- numbness
- abnormal vision

The usual starting dose is one tablet of 15 mg or
30 mg of pioglitazone should be taken once
daily. Your doctor may increase the dose to a
maximum of 45 mg once a day. Your doctor will
tell you the dose to take.

uncommon (may affect up to 1 in 100 people)
- inflammation of the sinuses (sinusitis)
- difficulty sleeping (insomnia)

If you have the impression that the effect of
Pioglitazone is too weak, talk to your doctor.

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

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.

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

Blurred vision due to swelling (or fluid) at the
back of the eye (frequency cannot be estimated
from the available data) 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.

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

3. How to take Pioglitazone

Your doctor will ask you to have blood tests
periodically during treatment with Pioglitazone.
This is to check that your liver is working
normally.

Bladder cancer has been experienced
uncommonly (may affect up to 1 in 100 people)
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.

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.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
UK: Pioglitazone Brown and Burk UK Ltd
15mg/30mg/45mg Tablets
This leaflet was last revised in September
2016

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

Your weight should be checked at regular
intervals; if your weight increases, inform your
doctor.

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
- flatulence
- joint pain
- impotence
- small reduction in red blood cell count
- back pain
- shortness of breath

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 (may affect up to 1 in 100 people)
- spinning sensation (vertigo)
- sweating
- tiredness
- sugar in urine, proteins in urine
- increased appetite
- increase in enzymes

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.

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

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
BBUK Code

Artwork Code

6 mm

Size: 150 x 420 mm
Front Side

Size: 150 x 420 mm
Back Side

420mm

1. What Pioglitazone is and what it is used
for

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

195 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

sugar could fall below the normal level
(hypoglycaemia).

225 mm

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.

420 mm

190 mm

(Pioglitazone)

Expand Transcript

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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