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PIOGLITAZONE/METFORMIN 15 MG/850 MG FILM-COATED TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / PIOGLITAZONE HYDROCHLORIDE

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Package leaflet: Information for the patient
Pioglitazone/Metformin 15 mg/850 mg Film-coated Tablets
pioglitazone/metformin 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 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. See section 4.
What is in this leaflet
1. What Pioglitazone/Metformin is and what it is used for
2. What you need to know before you take Pioglitazone/Metformin
3. How to take Pioglitazone/Metformin
4. Possible side effects
5 How to store Pioglitazone/Metformin
6. Contents of the pack and other information

1.

What Pioglitazone/Metformin is and what it is used for

Pioglitazone/Metformin contains pioglitazone and metformin. It is an anti-diabetic medicine used in
adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone
is not sufficient. This type 2 diabetes usually develops in adulthood particularly as a result of the
person being overweight and where the body either does not produce enough insulin (a hormone that
controls blood sugar levels), or cannot effectively use the insulin it produces. Your doctor will check
whether Pioglitazone/Metformin is working 3 to 6 months after you start taking it.
Pioglitazone/Metformin 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.

2.

What you need to know before you take Pioglitazone/Metformin

Do not take Pioglitazone/Metformin
if you are allergic to pioglitazone, metformin 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 recently had a heart attack, have severe circulatory problems including shock, or breathing
difficulties.
if you have liver disease.
if you drink alcohol excessively (either every day or only from time to time).
if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood
glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic
acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone
bodies' accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include

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stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity
smell.
if you have or have ever had bladder cancer.
if you have blood in your urine that your doctor has not checked.
if you have severely reduced kidney function.
if you have a severe infection or are dehydrated.
if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you
must stop taking Pioglitazone/Metformin for a certain period of time before and after the
examination.
if you are breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pioglitazone/Metformin (see also section 4)
if you have a problem with your heart. Some patients with long-standing type 2 diabetes mellitus
and heart disease or previous stroke who were treated with pioglitazone and insulin together
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 retain water (fluid retention) or have heart failure problems in particular if you are over 75
years old. If you take anti-inflammatory medicines which can also cause fluid retention and
swelling, you must also tell your doctor.
if you have a special type of diabetic eye disease called macular oedema (swelling of the back of
the eye), talk to your doctor if you notice any change to your vision.
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/Metformin. If this applies to you, use appropriate contraception to avoid the
possibility of an unplanned pregnancy.
if you have a problem with your liver. Before you start taking Pioglitazone/Metformin you will
have a blood sample taken to check your liver function. This check should be repeated at
intervals. Inform your doctor as soon as possible if you develop symptoms suggesting a problem
with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of
appetite and/or dark urine) as your liver function should be checked.
You may also experience a reduction in blood count (anaemia).
Risk of lactic acidosis
Pioglitazone/Metformin may cause a very rare, but very serious side effect called lactic acidosis,
particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also
increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake,
dehydration (see further information below), liver problems and any medical conditions in which a
part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Pioglitazone/Metformin for a short time if you have a condition that may be associated
with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure
to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking Pioglitazone/Metformin and contact a doctor or the nearest hospital immediately if you
experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of
lactic acidosis include:
vomiting

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stomach ache (abdominal pain)
muscle cramps
a general feeling of not being well with severe tiredness
difficulty in breathing
reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.
During treatment with Pioglitazone/Metformin, your doctor will check your kidney function at least
once a year or more frequently if you are elderly and/or if you have worsening kidney function
If you need to have major surgery you must stop taking Pioglitazone/Metformin during and for some
time after the procedure. Your doctor will decide when you must stop and when to restart your
treatment with Pioglitazone/Metformin.
Hypoglycaemia
If you take Pioglitazone/Metformin with other medicines for diabetes, it is more likely that your blood
sugar could fall below the normal level (hypoglycaemia). If you experience symptoms of
hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or
difficulty in concentration, you should take some sugar to increase your blood sugar level again. Ask
your doctor or pharmacist for more information if you are not sure how to recognise this. It is
recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice
Broken bones
A higher number of bone fractures was seen in patients, particularly women 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/Metformin
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for
example in the context of an X-ray or scan, you must stop taking Pioglitazone/Metformin before or at
the time of the injection. Your doctor will decide when you must stop and when to restart your treatment
with Pioglitazone/Metformin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust
the dosage of Pioglitazone/Metformin. It is especially important to mention the following:
gemfibrozil (used to lower cholesterol)
rifampicin (used to treat tuberculosis and other infections)
cimetidine (used to reduce stomach acid)
glucocorticoids (used to treat inflammation)
beta-2-agonists (used to treat asthma)
medicines which increase urine production (diuretics)
medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen
and celecoxib
certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II

receptor antagonists)
Pioglitazone/Metformin with alcohol
Avoid excessive alcohol intake while taking Pioglitazone/Metformin since this may increase the risk
of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breast-feeding
- you must tell your doctor if you are pregnant, think you may be pregnant or are planning to
have a baby. Pioglitazone/Metformin is not recommended in pregnancy. If you wish to
become pregnant, your doctor will advise you to discontinue this medicine.
- do not use Pioglitazone/Metformin if you are breastfeeding or are planning to breast-feed
(see above under ‘Do not take Pioglitazone/Metformin’).
Driving and using machines
This medicine will not affect your ability to drive or use machines but take care if you experience
abnormal vision.

3.

How to take Pioglitazone/Metformin

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 recommended dose is one tablet taken twice daily. If necessary your doctor may tell you to take a
different dose. If you have reduced kidney function, your doctor may prescribe a lower dose, which
may need to be given as separate tablets of pioglitazone and metformin.
You should swallow the tablets with a glass of water. You may take your tablets with or just after food
to reduce the chance of an upset stomach.
If you are following a special diet for diabetes, you should continue with this while you are taking
Pioglitazone/Metformin.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Your doctor will ask you to have blood tests periodically during treatment with
Pioglitazone/Metformin. This is to check that your liver is working normally. At least once a year
(more often if you are elderly or have kidney problems) your doctor will check that your kidneys are
working normally.
If you take more Pioglitazone/Metformin 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 have taken more Pioglitazone/Metformin that you should have, you may experience lactic
acidosis. (see above under “Warnings and precautions”).
If you forget to take Pioglitazone/Metformin

Take Pioglitazone/Metformin daily as prescribed. However if you miss a dose, skip the missed dose
and 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/Metformin
Pioglitazone/Metformin should be used every day to work properly. If you stop using
Pioglitazone/Metformin, 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.
Pioglitazone/Metformin may cause a very rare (may affect up to 1 in 10,000), but very serious side
effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop
taking Pioglitazone/Metformin and contact a doctor or the nearest hospital immediately, as lactic
acidosis may lead to coma.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients
taking Pioglitazone/Metformin. 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.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking
pioglitazone/metformin and have also been reported in male patients (frequency cannot be estimated
from the available data) taking pioglitazone/metformin. 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 (macular oedema) has been reported
(frequency cannot be estimated from available data). If you experience these symptoms for the first
time talk to your doctor as soon as possible. Also, if you already have blurred vision and the symptoms
get worse, talk to your doctor as soon as possible.
Allergic reactions have been reported (frequency cannot be estimated from available data) in patients
taking Pioglitazone/Metformin. 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 immediately.

The following side effects have been experienced by some patients taking Pioglitazone/Metformin:
Very common (may affect more than 1 in 10 people)
stomach ache
feeling sick (nausea)
vomiting
diarrhoea
loss of appetite
Common (may affect up to 1 in 10 people)

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localised swelling (oedema)
weight gain
headache
respiratory infection
abnormal vision
joint pain
impotence
blood in urine
reduction in blood count (anaemia)
numbness
taste disturbance

Uncommon
inflammation of the sinuses (sinusitis)
gas
difficulty sleeping (insomnia)
Very rare
decrease in amount of vitamin B12 in the blood
redness of the skin
itchy skin
raised and itchy rash (hives)
Not known (frequency cannot be estimated from the available data)
inflammation of the liver (hepatitis)
liver does not work as well as it should (changes in liver enzymes)
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 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/Metformin

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 after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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/Metformin contains

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The active substances are pioglitazone and metformin hydrochloride. Each tablet contains 15
mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
The other ingredients are microcrystalline cellulose, povidone (K 30), croscarmellose sodium
magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.

What Pioglitazone/Metformin looks like and contents of the pack
The tablets are white to off white, approx. 17.7 mm x 9.7 mm, capsule shaped, biconvex, film-coated,
debossed ‘15/850’ on one face and ‘1281’ on the other.
They are supplied in OPA/Al/PVC-Al blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, 196
and multipacks of 196 (2 packs of 98) tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
Torrent Pharma (UK) Ltd,
Unit 4, Charlwood Court,
Merlin Centre, County Oak Way,
Crawley, West Sussex,
RH11 7XA,
United Kingdom

This leaflet was last revised in 07/2017

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