PIOGLITAZONE 30 MG TABLETS

Active substance: PIOGLITAZONE HYDROCHLORIDE

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PACKAGE LEAFLET

Package leaflet: Information for the user
Pioglitazone 15 mg tablets
Pioglitazone 30 mg tablets
Pioglitazone 45 mg tablets
Pioglitazone (as hydrochloride)
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.
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 are 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 is working 3 to 6 months after you start taking it.
Pioglitazone tablets 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 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 tablets:
If you are 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 before you start to take this medicine:

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If you retain water (fluid retention) or have heart failure problems in particular if you are over
75 years old.
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
tablets. 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 tablets 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 tablets 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 tablets 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 women (but not in men) taking pioglitazone. Your
doctor will take this into account when treating your diabetes.
Children and adolescents
Use in children and adolescents 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.
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:
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 tablets may need to be changed.
Pioglitazone tablets with food and drink:
You may take your tablets with or without food. You should swallow the tablets with a glass of water.
Pregnancy, breastfeeding and fertility:
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.
Pioglitazone tablets contain lactose:
This medecine contains lactose monohydrate. If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking Pioglitazone tablets.

3.

How to take Pioglitazone

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
One tablet of 15mg, 30mg or 45mg 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
tablets is too weak, talk to your doctor.
Pioglitazone can be taken with or without food.
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.
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
tablets.
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, 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 tablets:
Take Pioglitazone tablets 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 tablets:
Pioglitazone 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 or pharmacist.

4.

Possible side effects

Like all medicines, this medicine 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 (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.
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 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 (up to 1 in 10 people) 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 some patients taking pioglitazone:
Common (may affect up to 1 in 10 people)
respiratory infection
abnormal vision
weight gain
numbness
Uncommon (may affect up to 1 in 100 people)
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 (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 (wind)
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

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 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.
This medicinal product does not require any special storage precautions.
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.
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 in Pioglitazone tablets is pioglitazone.
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Each tablet contains 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 tablets are white, round, flat, bevelled and marked ‘TZ15’ on one side.
Pioglitazone tablets are white, round, flat, bevelled and marked ‘TZ30’ on one side.
Pioglitazone tablets are white, round, flat, bevelled and marked ‘TZ45’ on one side.
The tablets are supplied in aluminium blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 100, 112 and 196
tablets.
The packs with 14, 28 56, 84, 98, 112 and 196 tablets contain blisters with abbreviations for days of
the week printed on the blister (MON, TUE, WED, THU, FRI, SAT, SUN).
Not all the pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Caduceus Pharma Limited
6th Floor, 94 Wigmore Street, London W1U 3RF
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
MALTA

This leaflet was last updated in.

November 2013

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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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