Package leaflet: information for the patient

Pioglitazone and Metformina Aristo 15 mg/850 mg film-coated tablets

pioglitazone/metformin hydrochloride
Equivalent medicine
Please read this entire leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pioglitazone and Metformin Aristo 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
in association with overweight, and where the body is unable to produce sufficient amounts of insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. Your doctor will assess whether Pioglitazone and Metformin Aristo is working 3–6 months after starting treatment.
Pioglitazone and Metformin Aristo helps control blood sugar levels in patients with type 2 diabetes by enabling the body to make better use of the insulin it produces.

2. What you should know before taking Pioglitazone and Metformina Aristo

Do not take Pioglitazone and Metformina Aristo

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 previously had heart failure.
if you have recently had a heart attack or have serious circulatory problems including shock, or breathing difficulties.
if you have liver disorders.
if you drink alcohol excessively (whether 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 section “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 unusually fruity odour.
if you have or have ever had bladder cancer.
if you have blood in your urine and your doctor has not yet investigated the cause.
if you have severely reduced kidney function.
if you have a serious infection or are dehydrated.
if you are scheduled to undergo a radiological examination involving an injectable contrast agent; consult your doctor, as you will need to stop treatment with Pioglitazone and Metformina Aristo for a certain period before and after the examination.
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pioglitazone and Metformina Aristo (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 have 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 over 75 years old. 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 likelihood of becoming pregnant may increase, as ovulation may resume when taking Pioglitazone and Metformina Aristo. If this applies to you, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
if you have liver problems. Before starting Pioglitazone and Metformina Aristo, 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 decrease in blood cell count (anaemia) may also occur.
Risk of lactic acidosis
Pioglitazone and Metformina Aristo may cause a very rare but very serious side effect called lactic acidosis, particularly if the 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 characterized by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
Temporarily stop taking Pioglitazone and Metformina Aristo if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Pioglitazone and Metformina Aristo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. Symptoms of lactic acidosis include:

vomiting
stomach pain (abdominal pain)
muscle cramps
a general feeling of malaise associated with severe fatigue
difficulty breathing
reduced body temperature and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
While taking Pioglitazone and Metformina Aristo, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.
If you are scheduled for major surgery, you must stop taking Pioglitazone and Metformina Aristo during and for a certain period after the procedure. Your doctor will decide when to stop and when to restart treatment with Pioglitazone and Metformina Aristo.
Hypoglycaemia
If you take Pioglitazone and Metformina Aristo together with other diabetes medicines, your blood sugar level is more likely to fall 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 are unsure how to recognize hypoglycaemia, ask your doctor or pharmacist for further information. It is advisable to carry sugar cubes, sweets, biscuits, or sugary fruit juices with you.
Bone fractures
An increased 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 Metformina Aristo
If you are scheduled to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Pioglitazone and Metformina Aristo before or during the injection. Your doctor will decide when to stop and when to restart treatment with Pioglitazone and Metformina Aristo.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to have more frequent blood sugar and kidney function tests, or your doctor may decide to adjust the dose of Pioglitazone and Metformina Aristo. It is particularly important to mention the following:

gemfibrozil (used to lower cholesterol levels)
rifampicin (used to treat tuberculosis and other infections)
cimetidine (used to reduce stomach 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)
certain medicines used to treat high blood pressure (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists)

Pioglitazone and Metformina Aristo with alcohol
Avoid excessive alcohol consumption during treatment with Pioglitazone and Metformina Aristo, as this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, inform your doctor. Pioglitazone and Metformina Aristo is not recommended during pregnancy. If you wish to become pregnant, your doctor will advise you to stop treatment with this medicine.
Do not use Pioglitazone and Metformina Aristo if you are breastfeeding or planning to breastfeed (see section “Do not take Pioglitazone and Metformina Aristo”).

Driving and using machines
This medicine does not affect your ability to drive or use machines, but be cautious if you experience vision disturbances.

3. How to take Pioglitazone and Metformina Aristo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet to be 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 meals, to reduce the possibility of stomach upset.
If you are following a special diet for diabetes, you must continue it while taking Pioglitazone and Metformina Aristo.
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 Aristo. These tests 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 Aristo than you should
If you accidentally take too many tablets, or if another person or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
could drop below normal levels, and this can be corrected 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 Aristo than you should have, you may develop
lactic acidosis (see section “Warnings and precautions”).
If you forget to take Pioglitazone and Metformina Aristo
Take Pioglitazone and Metformina Aristo 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 a forgotten tablet.
If you stop taking Pioglitazone and Metformina Aristo
Pioglitazone and Metformina Aristo must be taken every day to work properly. If
you stop taking Pioglitazone and Metformina Aristo, 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 everyone gets them.
Pioglitazone and Metformina Aristo may cause a very rare (may affect 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 Aristo and seek immediate medical attention from your doctor or the nearest hospital, as lactic acidosis can lead to coma.
Uncommon cases of bladder cancer (may affect up to 1 in 100 people) have been observed in patients treated with Pioglitazone and Metformina Aristo. Signs and symptoms include blood in the urine, pain during urination, or sudden need to urinate. If you experience any of these symptoms, speak to your doctor as soon as possible.
Common cases (may affect up to 1 in 10 people) of bone fractures have been reported in female patients and also in male patients taking Pioglitazone and Metformina Aristo (available data do not allow an estimate of frequency). If you experience this side effect, inform your doctor as soon as possible.
Blurred vision due to swelling (edema) at the back of the eye (macular edema) has been reported (frequency cannot be determined from the available data). Inform your doctor as soon as possible if you notice the onset of these symptoms for the first time. Also inform your doctor as soon as possible if you already suffer from blurred vision and these symptoms worsen.
Allergic reactions have been reported with unknown frequency (frequency cannot be determined from the available data) in patients taking Pioglitazone and Metformina Aristo. 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.
The following side effects have been observed in some patients taking Pioglitazone and Metformina Aristo:
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 B in the blood
skin redness
itching of the skin
raised, itchy rash (urticaria)

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

inflammation of the liver (hepatitis)
liver not functioning properly (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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pioglitazone and Metformin Aristo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pioglitazone and Metformina Aristo contains

The active substances are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
The other components are: microcrystalline cellulose, povidone (K30), sodium croscarmellose, magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).

Description of the appearance of Pioglitazone and Metformina Aristo and package contents
The film-coated tablets (tablets) are white, oblong, biconvex, marked with '15/850' on one side and smooth on the other.
Pioglitazone and Metformina Aristo 15/850 mg is available in packs containing 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin
Germany
Manufacturer
Genepharm S.A.
18 km Marathonos Avenue
15351 Pallini Attiki
Greece
This medicinal product is authorized in the European Economic Area countries under the
following names:
Spain Pioglitazona/Metformina hidrocloruro Aristo 15/850 mg
Comprimidos recubiertos con película EFG
Italy Pioglitazone e Metformina Aristo