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PIOGLITAZONE MORNINGSIDE 15 MG TABLETS

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

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Package leaflet: Information for the user

Pioglitazone 15 mg Tablets

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

Pioglitazone

If you take more Pioglitazone Tablets
Read all of this leaflet carefully before
failure. Inform your doctor as soon as
than you should
you start taking this medicine because it
possible if you experience signs of heart
If you accidentally take too many tablets, or
contains important information for you.
failure such as unusual shortness of
if someone else or a child takes your
!
Keep this leaflet. You may need to read it
breath or rapid increase in weight or
medicine, talk to a doctor or pharmacist
again.
localised swelling (oedema).
immediately. Your blood sugar could fall
!
If you have any further questions, ask
below the normal level and can be increased
your doctor, pharmacist or nurse.
If you take Pioglitazone Tablets with other
by taking sugar. It is recommended that you
!
This medicine has been prescribed for
medicines for diabetes, it is more likely that
carry some sugar lumps, sweets, biscuits or
you only. Do not pass it on to others. It
your blood sugar could fall below the normal
sugary fruit juice.
may harm them, even if their signs of
level (hypoglycaemia).
illness are the same as yours.
If you forget to take Pioglitazone Tablets
!
If you get any side effects, talk to your
You may also experience a reduction in
Take Pioglitazone Tablets daily as
doctor, pharmacist or nurse. This
blood count (anaemia).
prescribed. However if you miss a dose, just
includes any possible side effects not
carry on with the next dose as normal. Do
listed in this leaflet.
Broken bones
not take a double dose to make up for a
A higher number of bone fractures was seen
forgotten tablet.
What is in this leaflet
in patients, particularly women taking
1. What Pioglitazone Tablets are and what
they are used for
2. What you need to know before you take
Pioglitazone Tablets
3. How to take Pioglitazone Tablets
4. Possible side effects
5. How to store Pioglitazone Tablets
6. Contents of the pack and other
information
1. What Pioglitazone Tablets are and
what they are used for
Pioglitazone Tablets contain 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 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 Tablets are
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 metformin, sulphonylurea or
insulin) which have failed to provide
sufficient control of blood sugar.
2. What you need to know before you
take Pioglitazone Tablets

pioglitazone. Your doctor will take this into
account when treating your diabetes.
Children
Use in children under 18 years is not
recommended.
Other medicines and Pioglitazone Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

If you stop taking Pioglitazone Tablets
Pioglitazone Tablets should be used every
day to work properly. If you stop using
Pioglitazone Tablets, 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, pharmacist
or nurse.

The other side effects that have been
experienced by some patients when
pioglitazone is taken with other anti-diabetic
medicines are:

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,
!
flatulence.

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

4. Possible side effects
If you get any side effects, talk to your
You can usually continue to take other
doctor, pharmacist or nurse. This includes
medicines whilst you are being treated with
Like
all
medicines,
this
medicine
can
cause
any side effects not listed in this leaflet.
Pioglitazone Tablets. However, certain
side effects, although not everybody gets
medicines are especially likely to affect the
them.
5. How to store Pioglitazone Tablets
amount of sugar in your blood:
!
gemfibrozil (used to lower cholesterol),
In particular, patients have experienced the
Keep this medicine out of the sight and
!
rifampicin (used to treat tuberculosis and
following serious side effects:
reach of children.
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
Tablets may need to be changed.
Pioglitazone Tablets with food, drink and
alcohol
You may take your tablets with or without
food. You should swallow the tablets with a
glass of water.

Heart failure has been experienced
commonly (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.

Pregnancy, breast-feeding and fertility
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.
Your doctor will advise you to discontinue
this medicine.

Bladder cancer has been experienced
uncommonly (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.

Localised swelling (oedema) has also been
Driving and using machines
experienced very commonly in patients
Do not take Pioglitazone Tablets
Pioglitazone will not affect your ability to
taking pioglitazone in combination with
!
if you are allergic to pioglitazone or any
drive or use machines but take care if you
insulin. If you experience this side effect, talk
of the other ingredients of this medicine
experience abnormal vision.
to your doctor as soon as possible.
(listed in section 6),
!
if you have heart failure or have had
Pioglitazone Tablets contain lactose
Broken bones have been reported
heart failure in the past,
monohydrate
commonly (up to 1 in 10 people) in female
!
if you have liver disease,
If you have been told by your doctor that you
patients taking pioglitazone and have also
!
if you have had diabetic ketoacidosis (a
have intolerance to some sugars, contact
been reported in male patients (frequency
complication of diabetes causing rapid
your doctor before taking Pioglitazone
cannot be estimated from the available data)
weight loss, nausea or vomiting),
Tablets.
taking pioglitazone. If you experience this
!
if you have or have ever had bladder
side effect, talk to your doctor as soon as
cancer,
3. How to take Pioglitazone Tablets
possible.
!
if you have blood in your urine that your
doctor has not checked.

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

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

Blurred vision due to swelling (or fluid) at the
back of the eye (frequency not known) has
Warnings and precautions
also been reported in patients taking
Tell your doctor, pharmacist or nurse before
pioglitazone. If you experience this symptom
taking Pioglitazone Tablets:
for the first time, talk to your doctor as soon
!
if you retain water (fluid retention) or
The usual starting dose is one tablet of 15
as possible. Also, if you already have blurred
have heart failure problems in particular if
mg or of 30 mg of pioglitazone to be taken
vision and the symptom gets worse, talk to
you are over 75 years old. If you take
once daily. Your doctor may increase the
your doctor as soon as possible.
anti-inflammatory medicines which can
dose to a maximum of 45 mg once a day.
also cause fluid retention and swelling,
Your doctor will tell you the dose to take.
Allergic reactions have been reported
you must also tell your doctor,
(frequency not known) in patients taking
!
if you have a special type of diabetic eye
If you have the impression that the effect of
Pioglitazone Tablets. If you have a serious
disease called macular oedema (swelling
Pioglitazone Tablets is too weak, talk to your
allergic reaction, including hives and
of the back of the eye),
doctor.
swelling of the face, lips, tongue, or throat
!
if you have cysts on your ovaries
that may cause difficulty in breathing or
(polycystic ovary syndrome). There may
When Pioglitazone Tablets is taken in
swallowing stop taking this medicine and talk
be an increased possibility of becoming
combination with other medicines used to
to your doctor as soon as possible.
pregnant because you may ovulate again
treat diabetes (such as insulin,

This medicinal product does not require any
special storage conditions.
Do not use this medicine after the expiry
date which is stated on the carton and on
the blister pack after the word “EXP”. The
expiry date refers to the last day of that
month.
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 Pioglitazone 15 mg tablet contains
15 mg of pioglitazone (as hydrochloride).
!
The other ingredients are lactose
monohydrate, hydroxypropylcellulose,
carmellose calcium and magnesium
stearate.
What Pioglitazone Tablets looks like and
contents of the pack
Pioglitazone 15 mg Tablets are round,
convex and white.
Pioglitazone 15 mg Tablets are provided in
blister packs of 14, 28, 30, 56, 84, 90 and 98
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
West Pharma Produções de Especialidades
Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova,
2700-486 Amadora, Portugal
Atlantic Pharma Produções Farmacêuticas,
S.A.
Rua da Tapada Grande, n.º 2, Abrunheira,
2710-089 Sintra, Portugal

when you take Pioglitazone Tablets. If
chlorpropamide, glibenclamide, gliclazide,
The other side effects that have been
this applies to you, use appropriate
tolbutamide) your doctor will tell you whether
experienced by some patients taking
contraception to avoid the possibility of
you need to take a smaller dose of your
pioglitazone are:
an unplanned pregnancy,
medicines.
This leaflet was last revised in August
!
if you have a problem with your liver or
common (may affect up to 1 in 10 people)
2016.
heart. Before you start taking
Your doctor will ask you to have blood tests
!
respiratory infection,
Pioglitazone Tablets you will have a blood
periodically during treatment with
!
abnormal vision,
sample taken to check your liver function.
Pioglitazone Tablets. This is to check that
!
weight gain,
This check may be repeated at intervals.
your liver is working normally.
!
numbness.
Some patients with long-standing type 2
diabetes mellitus and heart disease or
previous stroke who were treated with
Pioglitazone Tablets and insulin
experienced the development of heart

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

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

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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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