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PIOGLITAZONE ARROW 15MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pioglitazone 15 mg tablets
Pioglitazone 30 mg tablets
Pioglitazone 45 mg tablets
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, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.
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 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 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.

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
Use in children under 18 years is not recommended.

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 metformin or insulin) which have
failed to provide sufficient control in blood sugar.

Other medicines and Pioglitazone Tablets
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 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PIOGLITAZONE TABLETS

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.

Pioglitazone tablets 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.

Do not take Pioglitazone tablets
- if you are hypersensitive (allergic) to pioglitazone or any of the
other ingredients of Pioglitazone tablets.

Text free area
(Pharmacodes printed on reverse)

- 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 or pharmacist before taking Pioglitazone
Tablets:
- 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).

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask you doctor or pharmacist for
advice before taking 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 tablets
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 tablets.
3. HOW TO TAKE PIOGLITAZONE TABLETS
Always take Pioglitazone tablets exactly as your doctor has told
you. You should check with your doctor if you are not sure. The
starting dose is one tablet of 15 mg or 30 mg of pioglitazone
once daily. The maximum recommended dose is 45 mg of
pioglitazone per day. If you have the impression that the effect
of Pioglitazone tablets is too weak, talk to your doctor.
When Pioglitazone tablets 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 tablets. 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.
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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 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 or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pioglitazone tablets 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 (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.
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.
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 (may affect 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.
The other side effects that have been experienced by some
patients taking pioglitazone are:
common (may affect up to 1 in 10 people)
- respiratory infection
- abnormal vision
- weight gain
- numbness

5. HOW TO STORE PIOGLITAZONE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Pioglitazone tablets 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pioglitazone Tablets contains
- The active substance 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, carmellose
calcium, hydroxypropylcellulose and magnesium stearate.
What Pioglitazone Tablets looks like and contents
of the pack
Pioglitazone 15 mg tablets are white, round, flat tablets,
with “15” embossed on one side and a diameter of
approximately 5.5 mm.
Pioglitazone 30 mg tablets are white, round, flat tablets, with a
break line on one side, “30” embossed on the other side and a
diameter of approximately 7.0 mm. The tablets can be divided
into equal halves.
Pioglitazone 45 mg tablets are white, round, flat tablets,
with “45” embossed on one side and a diameter of
approximately 8.0 mm.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56,
90 or 98 tablets in PA/Aluminium/PVC/Aluminium blisters.
The blisters are subsequently packed into cardboard boxes.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder
Arrow Generics Limited
Unit 2, Eastman Way, Stevenage
Hertfordshire, SG1 4SZ, United Kingdom
Manufacturer
Specifar S.A.
1,28 Octovriou str.
123 51 Ag. Varvara
Athens- Greece
This leaflet was last
approved in 01/2013.

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
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
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
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.

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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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