PIOGLITAZONE HYDROCHLORIDE 30MG TABLETS

Active substance: PIOGLITAZONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Pioglitazone hydrochloride 30 mg or 45 mg Tablets
Pioglitazone hydrochloride
(referred to as Pioglitazone Tablets in the remainder of this leaflet)
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 of the side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.

8th fold

(26.25mm)

7th fold

(26.25mm)

6th fold

(26.25mm)

5th fold

(26.25mm)

4th fold

(26.25mm)

3rd fold

(26.25mm)

2nd fold

(26.25mm)

1st fold

(26.25mm)

Neutral code not required on the leaflet artworks.

What is in this leaflet:
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 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 Tablets 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 Tablets
Do not take Pioglitazone Tablets
• if you are hypersensitive (allergic) to pioglitazone or any of the
other ingredients of Pioglitazone Tablets.
• 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 Tablets if any of the following applies to you:
• 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.
Use in children and adolescents
Use in children under 18 years is not recommended.
Other medicines and Pioglitazone Tablets
Tell your doctor or pharmacist if you are taking or 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.
Taking 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 and breastfeeding
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.
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 this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor, pharmacist or nurse if you
are not sure.
One tablet of 15 mg, 30 mg or 45 mg 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.
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.
105895/2

ART WORK CHECK BOX

Process
Black

PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Pioglitazone hydrochloride - 30mg/45mg Tablet
Wockhardt UK
FP3824; FP3825; FP3826
L1
(w)148 x (h)210mm
2438
219031
7 pt.
Pioglitazone_Leaflet_105895-2.ai
Adobe Illustrator CS5
Myriad Pro Regular / Bold
11th & 21st October, 2013
 1st PDF sent on - 22ND OCT. 2013
 2nd PDF sent on - 29TH OCT. 2013

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends
• Pharmacode re-positioned at 7mm from the cutting edge

pg1/2

1st fold

(26.25mm)

2nd fold

(26.25mm)

3rd fold

(26.25mm)

4th fold

What Pioglitazone Tablets contains
The active substance is pioglitazone hydrochloride.
Each 30mg tablet contains 33.06mg pioglitazone hydrochloride,
equivalent to 30mg pioglitazone.
Each 45mg tablet contains 49.59mg pioglitazone hydrochloride,
equivalent to 45mg piogitazone.
The other ingredients are lactose monohydrate, carboxymethylcellulose
calcium, hydroxypropyl cellulose, and magnesium stearate
What Pioglitazone Tablets looks like and contents of the pack
Pioglitazone Tablets 30 mg tablets are white to off-white, round, flat
beveled tablet debossed with ‘ W ’ on one side and plain on other side.
977
Pioglitazone Tablets 45 mg tablets are white to off-white, round, flat
beveled tablet debossed with ‘ W ’ on one side and plain on other side.
978
The tablets are supplied in blister packs of 28, 56 or 84 tablets.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF.
This Medicinal Product is authorised in the Member States under
the following names:
UK and Ireland: Pioglitazone hydrochloride 30mg, 45mg Tablets
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Reference number
Pioglitazone hydrochloride 30mg Tablets
29831/0528
Pioglitazone hydrochloride 45mg Tablets
29831/0529

(26.25mm)

6. Contents of the pack and other information

5th fold

Keep this medicine out of the sight and reach of children.
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.
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.

(26.25mm)

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 Tablets 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 Tablets. 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 Tablets in combination
with insulin. If you experience this side effect, talk to your doctor
as soon as possible.
Broken bones have been reported commonly (1 to 10 users in
100) in women patients taking Pioglitazone Tablets. 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 Tablets. 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 Tablets are:
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
• allergic reactions
The other side effects that have been experienced by some
patients when Pioglitazone Tablets is taken with other
antidiabetic medicines are:
Very common (affects more than 1 user in 10)
• decreased blood sugar (hypoglycaemia)

6th fold

5. How to store Pioglitazone Tablets

(26.25mm)

4. Possible side effects

7th fold

Common (affects 1 to 10 users in 100)
• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• small reduction in red blood cell count
• flatulence
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 of the side effects, talk to your doctor, pharmacist
or nurse. This includes any side effects not listed in this leaflet.

(26.25mm)

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 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.

This is a service provided by the Royal National Institute of Blind
People.

8th fold

(26.25mm)

For the Republic of Ireland please call +353 52 6186000
This leaflet was last revised in
105895/2
219031

pg2/2

Expand view ⇕

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.

Hide
(web4)