Pioglitazone/metformin Aristo 15 mg/850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pioglitazone/Metformin Aristo 15 mg/850 mg film-coated tablets EFG

pioglitazone/metformine 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Pioglitazone/Metformin Aristo is and what it is used for
2. What you need to know before taking Pioglitazone/Metformin Aristo
3. How to take Pioglitazone/Metformin Aristo
4. Possible side effects
5. How to store Pioglitazone/Metformin Aristo
6. Contents of the pack and other information

1. What Pioglirazona/Metformina Aristo is and what it is used for

This medicine contains pioglitazone and metformin. It is an antidiabetic medicine used in adult patients to treat type 2 diabetes mellitus (non-insulin-dependent diabetes) when treatment with metformin alone is not sufficient. This type of type 2 diabetes usually occurs in adults, primarily as a consequence of overweight and when the body either does not produce enough insulin (a hormone that controls blood sugar levels) or is unable to use the produced insulin effectively. Your doctor will monitor the effect of this medicine between 3 and 6 months after starting treatment.

This medicine helps control blood sugar levels in type 2 diabetes, allowing your body to use insulin more effectively.

2. What you need to know before taking Pioglitazone/Metformin Aristo

Do not take Pioglitazone/Metformin 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 had it in the past.
• if you have recently had a heart attack, have serious circulation problems such as shock, or breathing difficulties.
• if you have any liver disease.
• if you drink excessive alcohol (daily or even occasionally).
• if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling breath.
• if you have or have had bladder cancer.
• if you have unexplained blood in your urine.
• if you have severely reduced kidney function.
• if you have a serious infection or are dehydrated.
• if you are scheduled to undergo contrast radiography (a specific type of diagnostic X-ray test using an injectable contrast agent), consult your doctor, as you will need to stop taking this medicine for a certain period before and after the procedure.
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine (also see section 4).

• if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or previous stroke who received pioglitazone together with insulin 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 have fluid retention or heart problems, particularly if you are over 75 years old. If you are taking anti-inflammatory medicines that may also cause fluid retention and swelling, discuss this with your doctor.
• 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 changes in your vision.
• if you have ovarian cysts (polycystic ovary syndrome). Your chance of becoming pregnant may increase, as ovulation may resume while taking pioglitazone/metformin. If this applies to you, use appropriate contraceptive methods to avoid unplanned pregnancy.
• if you have liver problems. Before starting treatment with pioglitazone/metformin, you will have a blood test to check your liver function. These tests should be repeated periodically. Inform your doctor immediately if you develop symptoms suggesting liver problems (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite, and/or dark urine), as your liver function should be checked.

You may also experience a reduced blood cell count (anaemia).

Risk of lactic acidosis

Pioglitazone/metformin may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body has reduced oxygen supply (such as acute and serious heart conditions).

If any of the above apply to you, consult your doctor for further instructions.

Stop taking Pioglitazone/Metformin Aristo temporarily if you develop a 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 normal. Consult your doctor for further instructions.

Stop taking Pioglitazone/Metformin Aristo and contact a doctor or go to the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• Vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

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 your kidney function is deteriorating.

If you need to undergo major surgery, you must stop taking pioglitazone/metformin during the procedure and for a period afterwards. Your doctor will decide when to interrupt and when to restart treatment with pioglitazone/metformin.

Hypoglycaemia

If you take pioglitazone/metformin 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, blurred vision, or difficulty concentrating, take some sugar to raise your blood sugar level. Consult your doctor or pharmacist if you are unsure how to recognise these symptoms. It is advisable to carry sugar lumps, sweets, biscuits, or a sugary fruit juice 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

Not recommended for children and adolescents under 18 years of age.

Other medicines and Pioglitazone/Metformin Aristo

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking pioglitazone/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with pioglitazone/metformin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose 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 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 inhibitors (ACE inhibitors) and angiotensin II receptor antagonists)

Taking Pioglitazone/Metformin Aristo with alcohol

Avoid excessive alcohol consumption while taking pioglitazone/metformin, as this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor. Pioglitazone/metformin is not recommended during pregnancy. If you plan to become pregnant, your doctor will advise you to stop taking this medicine.
• Do not take pioglitazone/metformin if you are breastfeeding or plan to breastfeed (see section “Do not take Pioglitazone/Metformin Aristo”).

Driving and using machines

This medicine does not affect the ability to drive or use machines, but you should exercise caution if you experience visual disturbances.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Pioglitazone/Metformin Aristo

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet twice daily. If necessary, your doctor may prescribe a different dose. If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be administered using separate tablets of pioglitazone and metformin.

Take the tablets with a glass of water. You should take the tablets with meals or immediately after meals to reduce the risk of gastrointestinal discomfort.

If you are following a special diabetic diet, continue to follow it while taking this medicine.

You should monitor your weight regularly; if you gain weight, inform your doctor.

Your doctor will periodically request blood tests during treatment with pioglitazone/metformin to check that your liver is functioning properly.

At least once a year (more frequently if you are elderly or have kidney problems), your doctor will check that your kidneys are functioning properly.

If you take more Pioglitazone/Metformin Aristo than you should

If you accidentally take too many tablets, or if a child or another person takes your medicine, inform your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but this can be corrected by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or a sugary fruit juice.

If you have taken more pioglitazone/metformin than you should, you may experience lactic acidosis (see section “Warnings and precautions”).

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pioglitazone/Metformin Aristo

Take Pioglitazone/Metformin Aristo every day as prescribed. However, if you forget a dose, skip the missed dose and continue with your regular treatment schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Pioglitazone/Metformin Aristo

Take pioglitazone/metformin every day as prescribed. If you stop treatment with pioglitazone/metformin, your blood sugar level may increase. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Pioglitazone/metformin may cause a very rare (may affect up to 1 in 10,000 users), but very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking pioglitazone/metformin and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

Bladder cancer has been reported infrequently (may affect up to 1 in 100 patients) in patients taking pioglitazone/metformin. Signs and symptoms include blood in the urine, pain when urinating, or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Bone fractures: reported frequently (may affect up to 1 in 10 patients) in both women and men taking pioglitazone/metformin (frequency cannot be estimated from the available data). If you experience this adverse effect, consult your doctor as soon as possible.

Cases of blurred vision due to swelling (or fluid accumulation) in the back of the eye (macular edema) have been reported (frequency cannot be estimated from the available data). If you experience these symptoms for the first time, inform your doctor as soon as possible. If you have previously experienced blurred vision and your symptoms worsen, consult your doctor as soon as possible.

Allergic reactions have been reported with unknown frequency (cannot be estimated from the available data) in patients treated with pioglitazone/metformin. 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 consult your doctor immediately.

Some patients have experienced the following adverse effects while taking pioglitazone/metformin:

Very common (may affect more than 1 in 10 people)

• stomach pain
• nausea
• vomiting
• diarrhea
• loss of appetite

Common (may affect up to 1 in 10 people)

• localized swelling (edema)
• weight gain
• headache
• respiratory infection
• vision disorders
• joint pain
• impotence
• blood in the urine
• reduced red blood cell count (anemia)
• numbness
• taste disturbances

Uncommon (may affect up to 1 in 100 people)

• inflammation of the sinuses (sinusitis)
• flatulence
• difficulty sleeping (insomnia)

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

• decreased levels of vitamin B12 in the blood
• skin redness
• skin itching
• hives

Frequency not known (cannot be estimated from the available data)

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

5. Storage of Pioglitazone/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 the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pioglitazone/Metformin Aristo

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 (K 30), sodium croscarmellose, magnesium stearate, hypromellose, macrogol 8000, talc, and titanium dioxide (E171).

Appearance of the product and contents of the container

The film-coated tablets (tablets) are white, oblong, biconvex, and marked with '15 / 850' on one side and smooth on the other.

They are available in packs containing 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

Manufacturer

Genepham S.A
Marathonos Avenue 18 km
Pallini, Attiki
15351 Greece

Or

RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.
P.O. BOX 3012 Larissa Industrial Area,
Larissa, 41500, Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Italy: Pioglitazone/Metformin hydrochloride Aristo
Spain: Pioglitazone/Metformin Aristo 15 mg/850 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: January 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/