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PIOGLITAZONE TORRENT 30 MG TABLETS

Active substance(s): PIOGLITAZONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 further questions, please ask your doctor or
your 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 or
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 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 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.
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, sulphonylurea
or insulin) which have failed to provide sufficient control in
blood sugar.
2. What you need to know before you take Pioglitazone

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 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).

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 (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.
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.

Tell your doctor or pharmacist if you are taking any of these.
Your blood sugar will be checked, and your dose of
Pioglitazone needs to be changed.

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 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.

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, breastfeeding and fertility:
Tell your doctor if
- you are, you think you might be or are planning to become
pregnant.
- you are breastfeeding or if you are planning to breast-feed
your baby.

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.

Your doctor will advise you to discontinue this medicine.

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

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 lactose monohydrate
This medicinal product 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
One tablet of 15 mg, 30 mg or 45 mg 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.

When Pioglitazone tablets are taken in combination with
other medicines used to treat diabetes (such as insulin,
Do not take Pioglitazone tablets:
If you are allergic to pioglitazone or any of the other chlorpropamide, glibenclamide, gliclazide, tolbutamide) your
doctor will tell you whether you need to take a smaller dose of
ingredients of this medicine (listed in section 6).
If you have heart failure or have had heart failure in the past. your medicines.
If you have liver disease.
Your doctor will ask you to have blood tests periodically
If you have had diabetic ketoacidosis (a complication of during treatment with Pioglitazone. This is to check that your
diabetes causing rapid weight loss, nausea or vomiting).
liver is working normally.
If you have or have ever had bladder cancer.
If you have blood in your urine that your doctor has not If you are following a diabetic diet, you should continue with
this while you are taking Pioglitazone tablets.
checked.
Your weight should be checked at regular intervals; if your
Warnings and precautions
weight increases, inform your doctor.
Talk to your doctor before taking Pioglitazone:
If you retain water (fluid retention) or have had heart failures Always take this medicine exactly as described in this leaflet
problems in particular if you are over 75 years old.
or as your doctor or pharmacist or nurse has told you. Check
If you have a special type of diabetic eye disease called with your doctor or pharmacist or nurse if you are not sure.
macular oedema (swelling of the back of the eye).
If you have cysts on your ovaries (polycystic ovary syndrome). If you take more Pioglitazone tablets than you should:
There may be an increased possibility of becoming pregnant If you accidentally take too many tablets, or if someone else
because you may ovulate again when you take Pioglitazone. or a child takes your medicine, talk to a doctor or pharmacist
If this applies to you, use appropriate contraception to avoid immediately. Your blood sugar could fall below the normal
level and can be increased by taking sugar. It is
possibility of an unplanned pregnancy.
If you have a problem with your liver or heart. Before you recommended that you carry some sugar lumps, sweets,
start taking Pioglitazone you will have a blood sample taken biscuits or sugar fruit juice.
to check your liver function. This check may be repeated at If you forget to take Pioglitazone tablets:
intervals. Some patients with long-standing type 2 diabetes Take Pioglitazone tablets daily as prescribed. However if you
mellitus and heart disease or previous stroke who were miss a dose, just carry on with the next dose as normal. Do
treated with Pioglitazone and insulin experienced the not take a double dose to make up for a forgotten tablet.
development of heart failure. Inform your doctor as soon as
possible if you experience signs of heart failure such as If you stop taking Pioglitazone tablets:
unusual shortness of breath or rapid increase in weight or Pioglitazone tablets should be used every day to work
properly. If you stop taking Pioglitazone your blood sugar may
localized swelling (oedema).
go up. Talk to your doctor before stopping the treatment.
If you take Pioglitazone with other medicines for diabetes, it is
more likely that your blood sugar could fall below the normal If you have any further questions on the use of this medicine,
ask your doctor or pharmacist or nurse.
level (hypoglycaemia).

Colour: Pantone Reflex Blue U

4. Possible side effects

Common (affects 1 to 10 users in 100)
• respiratory infection
• abnormal vision
• weight gain
• numbness
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.
The other side effects have been experienced by some
patients when Pioglitazone is taken with other antidiabetic
medicines are:
Very common (affects more than 1 user in 10)
• decreased blood sugar (hypoglycaemia)
Common (affects 1 to 10 users in 100)
• headache
• dizziness
• joint pain
• impotence
• blood in urine
• back pain
• shortness of breath
• small reduction in red blood cell count
• flatulence

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 data refers to the last day of that month.
Store below 25 °C
Do not throw away any medicines of 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 15
mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).
The other ingredients are lactose monohydrate, carmellose
calcium, hydroxypropyl cellulose and magnesium stearate.
What Pioglitazone looks like and contents of the pack
Pioglitazone 15 mg: white to off-white, round, flat faced
beveled edge uncoated tablets debossed with ‘15’ on one
side and plain on the other side.
Pioglitazone 30 mg: white to off-white, round, flat faced
beveled edge uncoated tablets with breakline on both sides.
The tablet can be divided into equal halves.
Pioglitazone 45 mg: white to off-white, round, flat faced
beveled edge uncoated tablets debossed with ‘T’ shape
breakline on both sides. The tablet can be divided into equal
thirds.
Triplex (PVC/PE/PVdC)/Al blisters or OPA/Al/PVC/Al
blisters
Packs of 28, 30, 50, 98, 120 and 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex, RH11 7XA
United Kingdom
Tel. No: (01293) 574180
Fax: (01293) 533003
E-mail: drugsafety@torrentpharma.co.uk
This medicinal product is authorised in the Member
States of the EEA under the following names:
NL: Pioglitazon Torrent 15/30/45 mg tabletten
UK: Pioglitazone Torrent 15/30/45 mg Tablets
LT: Pioglitazono Torrent 15/30/45 mg tabletės
RO: Pioglitazona Torrent 15/30/45 mg comprimate
IT: Pioglitazone Torrent
This leaflet was last revised in 12/2015

Uncommon (affects 1 to 10 users in 1,000)
• sugar in urine, proteins in urine
• increase in enzymes
• spinning sensation (vertigo)
• sweating
• tiredness
• increased appetite
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national
reporting system
Yellow Card Scheme; Website: 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.

8042281-7803

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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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