Pioglitazone and metformin Teva: detailed information

Package leaflet: Information for the patient

Pioglitazone and Metformin Teva 15 mg/850 mg film-coated tablets

pioglitazone/metformin hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pioglitazone and Metformin Teva is and what it is used for
What you need to know before taking Pioglitazone and Metformin Teva
How to take Pioglitazone and Metformin Teva
Possible side effects
How to store Pioglitazone and Metformin Teva
Contents of the pack and other information

1. What Pioglitazone and Metformin Teva is and what it is used for

Pioglitazone and Metformin Teva contains pioglitazone and metformin. It is an antidiabetic medicine
used in adults for the treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes) when
treatment with metformin alone is not sufficient. This type of diabetes usually occurs in adults,
particularly as a consequence of being overweight, and where the body either does not produce enough
insulin (a hormone that controls blood sugar levels), or is unable to use the insulin it produces effectively.
Your doctor will check whether Pioglitazone and Metformin Teva is working 3-6 months after starting
treatment.
Pioglitazone and Metformin Teva helps control your blood sugar levels in patients with type 2 diabetes
by enabling your body to make better use of the insulin it produces.

2. What you need to know before taking Pioglitazone and Metformin Teva

Do not take Pioglitazone and Metformin Teva

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 or have severe circulatory problems including shock, or breathing difficulties;
if you have liver disorders;
if you drink alcohol in excess (either on a daily basis or only occasionally);
if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusual fruity odour;
if you have or have ever had bladder cancer (bladder tumour);
if you have blood in your urine for which your doctor has not yet carried out investigations;
if you have severely reduced kidney function;
if you have a serious infection or are dehydrated;
if you are undergoing a radiological examination using an injectable contrast agent; consult your doctor, as you will need to stop treatment with Pioglitazone and Metformin Teva for a certain period of time before and after the examination;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pioglitazone and Metformin Teva (also see
section 4)

if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin together developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localized swelling (oedema);
if you retain fluid (fluid retention) or have heart failure problems, especially if you are elderly. You should also inform your doctor if you are taking anti-inflammatory medicines, which may also cause fluid retention and swelling;
if you have a specific type of diabetic eye disease called macular oedema (swelling at the back of the eye), consult your doctor if you notice any changes in your vision;
if you have ovarian cysts (polycystic ovary syndrome). The chance of becoming pregnant may increase, as ovulation may resume when you take Pioglitazone and Metformin Teva. If this applies to you, use an appropriate contraceptive method to avoid the risk of an unplanned pregnancy;
if you have liver problems. Before starting Pioglitazone and Metformin Teva, you will have a blood test to check your liver function. This test needs to be repeated periodically. Inform your doctor immediately if you experience symptoms suggesting liver problems (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite and/or dark urine), as your liver function should then be checked.

A reduction in the number of blood cells (anaemia) may also occur.
Risk of lactic acidosis
Pioglitazone and Metformin Teva may cause a very rare but very serious side effect called lactic acidosis, particularly if your kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart diseases).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
Stop taking Pioglitazone and Metformin Teva temporarily if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, or if you are drinking less fluids than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Pioglitazone and Metformin Teva and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma. Symptoms of lactic acidosis include:

vomiting;
stomach pain (abdominal pain);
muscle cramps;
a general feeling of illness associated with severe fatigue;
difficulty breathing;
reduced body temperature and slower heart rate.

Lactic acidosis is a medical emergency and must be treated in hospital.
During treatment with Pioglitazone and Metformin Teva, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function worsens.
If you are undergoing major surgery, you must stop taking Pioglitazone and Metformin Teva during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Pioglitazone and Metformin Teva.
Hypoglycaemia
If you take Pioglitazone and Metformin Teva together with other diabetes medicines, your blood sugar level is more likely to drop below normal (hypoglycaemia). If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or difficulty concentrating, you should eat sugar to raise your blood sugar level. If you have any doubts about how to recognise hypoglycaemia, ask your doctor or pharmacist for further information. It is advisable to carry sugar lumps, sweets, biscuits or sugary fruit juices with you.
Bone fractures
A higher number of bone fractures has been observed in patients, particularly in women taking pioglitazone. Your doctor will take this into account when managing your diabetes.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Other medicines and Pioglitazone and Metformin Teva
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Pioglitazone and Metformin Teva before or during the injection. Your doctor will decide when to stop and when to restart treatment with Pioglitazone and Metformin Teva.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of Pioglitazone and Metformin Teva. It is particularly important to mention the following:

gemfibrozil (used to reduce cholesterol levels);
rifampicin (used to treat tuberculosis and other infections);
cimetidine (used to reduce gastric acidity);
glucocorticoids (used to treat inflammation);
beta-2-agonists (used to treat asthma);
medicines that increase urine production (diuretics);
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Pioglitazone and Metformin Teva and alcohol
Avoid excessive alcohol consumption during treatment with Pioglitazone and Metformin Teva, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Pioglitazone and Metformin Teva is not recommended during pregnancy. If you are planning a pregnancy, your doctor will advise you to stop treatment with this medicine.
Breastfeeding
Do not use Pioglitazone and Metformin Teva if you are breastfeeding or planning to breastfeed your baby (see “Do not take Pioglitazone and Metformin Teva”).
Driving and using machines
This medicine does not affect your ability to drive or use machines, but be cautious if you experience vision disturbances.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Pioglitazone and Metformina Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet taken twice daily. If necessary, your doctor may
instruct you to take a different dose. If you have reduced kidney function, your doctor may
prescribe a lower dose, which may need to be taken as separate tablets of
pioglitazone and metformina.
You should take the tablets with a glass of water. The tablets may be taken during or
immediately after a meal to reduce the possibility of stomach upset.
If you are following a special diabetic diet, you should continue it while taking Pioglitazone and Metformina Teva.
Your weight should be monitored regularly; if you gain weight, inform your doctor.
Your doctor will ask you to have periodic blood tests during treatment with
Pioglitazone and Metformina Teva. These are to monitor normal liver function.
At least once a year (more frequently if you are elderly or have kidney problems), your doctor will check that your kidneys are functioning normally.
If you take more Pioglitazone and Metformina Teva than you should
If you accidentally take too many tablets, or if someone else or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
could drop below normal levels and can be raised by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or sugared fruit juices with you.
If you have taken more Pioglitazone and Metformina Teva than you should have, you may develop lactic acidosis (see “Warnings and precautions”).
If you forget to take Pioglitazone and Metformina Teva
Take Pioglitazone and Metformina Teva every day as prescribed. However, if you forget to
take a dose, skip the missed dose and continue with your next scheduled dose. Do not
take a double dose to make up for the forgotten tablet.
If you stop taking Pioglitazone and Metformina Teva
Pioglitazone and Metformina Teva must be taken every day to work properly. If
you stop taking Pioglitazone and Metformina Teva, your blood sugar level may
increase. Talk to your doctor before stopping treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking this medicine and contact a doctor immediately if you experience any of the following
side effects:

Pioglitazone and Metformina Teva may cause a very rare (affecting up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Pioglitazone and Metformina Teva and seek immediate medical attention at a doctor’s office or the nearest hospital, as lactic acidosis can lead to coma.
Allergic reactions (frequency cannot be estimated from the available data) have been reported in patients taking Pioglitazone and Metformina Teva. If you experience a severe allergic reaction including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately.

If you experience any of the following symptoms, speak to your doctor as soon as possible:

Cases of bladder tumours, uncommon (affecting up to 1 in 100 people), have been observed in patients treated with Pioglitazone and Metformina Teva. Signs and symptoms include blood in the urine, pain during urination, or a sudden need to urinate.
Common cases (affecting up to 1 in 10 people) of bone fractures have been reported in female patients and also in male patients taking Pioglitazone and Metformina Teva (available data do not allow for an estimation of frequency).
Blurred vision due to swelling (edema) at the back of the eye (macular edema) has been reported (frequency cannot be estimated from the available data). Inform your doctor as soon as possible if you notice these symptoms for the first time. Also inform your doctor promptly if you already have blurred vision and these symptoms worsen.

The following side effects have occurred in some patients taking Pioglitazone and Metformina Teva:
Very common (may affect more than 1 in 10 people)

stomach ache;
feeling unwell (nausea);
vomiting;
diarrhoea;
loss of appetite.

Common (may affect up to 1 in 10 people)

localized swelling (edema);
weight gain;
headache;
respiratory infection;
abnormal vision;
joint pain;
impotence;
blood in the urine;
reduced number of blood cells (anaemia);
numbness;
altered taste.

Uncommon (may affect up to 1 in 100 people)

inflammation of the sinuses (sinusitis);
intestinal gas;
difficulty sleeping (insomnia).

Very rare (may affect up to 1 in 10,000 people)

decreased levels of vitamin B12 in the blood;
skin redness;
skin itching;
raised, itchy rash (urticaria).

Not known (frequency cannot be estimated from the available data)

inflammation of the liver (hepatitis);
impaired liver function (changes in liver enzymes).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pioglitazone and Metformin Teva

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton, blister, and container after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pioglitazone and Metformin Teva contains

The active substances are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
The other components are: microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate, hypromellose, macrogol, talc, and titanium dioxide (E 171).

Description of the appearance of Pioglitazone and Metformin Teva and package contents
Pioglitazone and Metformin Teva tablets are white to off-white, film-coated, capsule-shaped, biconvex tablets, approximately 17.7 mm long and 9.7 mm wide, with "15/850" printed on one side and "1281" on the other.
Pioglitazone and Metformin Teva is packaged in blisters containing 56 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands

Manufacturers
McDermott Laboratories Ltd. T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

Torrent Pharma UK Limited
Unit 4, Charlwood Court,
County Oak Way,
Crawley, West Sussex,
RH11 7XA
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy Pioglitazone and Metformin Teva