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DIABIOM 30 MG TABLETS

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Package leaflet: Information for the user
Diabiom 15 mg tablets
Diabiom 30 mg tablets
Diabiom 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, ask your doctor or pharmacist.
- 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. This includes any possible side effects not listed
in this leaflet.

What is in this leaflet:
1. What Diabiom is and what it is used for
2. What you need to know before you take Diabiom
3. How to take Diabiom
4. Possible side effects
5. How to store Diabiom
6. Contents of the pack and other information
1. What Diabiom is and what it is used for
Diabiom 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.
Diabiom 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.
Diabiom 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.
2. What you need to know before you take
Diabiom
Do not take Diabiom
- 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 taking Diabiom:
- 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 Diabiom. 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 Diabiom 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 Diabiom 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 Diabiom 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 under 18 years is not recommended.
Other medicines and Diabiom
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 Diabiom. 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 Diabiom may need to be changed.
Diabiom 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
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
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.
Diabiom contains lactose monohydrate
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking Diabiom.
3. How to take Diabiom
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist 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
Diabiom is too weak, talk to your doctor.
When Diabiom 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 Diabiom. 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 Diabiom.
Your weight should be checked at regular intervals; if
your weight increases, inform your doctor.
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If you take more Diabiom 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.

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 forget to take Diabiom
Take Diabiom 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 get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

If you stop taking Diabiom
Diabiom should be used every day to work properly. If
you stop using Diabiom, your blood sugar may go up.
Talk to your doctor before stopping this treatment.

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

5. How to store Diabiom

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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.

4. Possible side effects

This medicine does not require any special storage
precautions.

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.
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 (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.
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 (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

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 to protect the environment.
6. Contents of the pack and other information
What Diabiom 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 Diabiom looks like and contents of the pack
Diabiom 15 mg tablets are white, round, flat tablets,
with “15” embossed on one side and a diameter of
approximately 5.5 mm.
Diabiom 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.
Diabiom 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 and Manufacturer
Specifar S.A.
1,28 Octovriou str.
123 51 Ag. Varvara
Athens- Greece
This leaflet was last approved in 05/2013.

The other side effects that 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
- back pain
- shortness of breath
- small reduction in red blood cell count
- flatulence
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Expand Transcript

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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