Package leaflet: Information for the user

Metformin hydrochloride Inventia, 500 mg, prolonged-release tablets
Metformin hydrochloride Inventia, 750 mg, prolonged-release tablets
Metformini hydrochloridum
This medicine is intended only for adult patients.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Metformin hydrochloride Inventia prolonged-release tablets are and what they are used for
What you need to know before taking Metformin hydrochloride Inventia prolonged-release tablets
How to take Metformin hydrochloride Inventia prolonged-release tablets
Possible side effects
How to store Metformin hydrochloride Inventia prolonged-release tablets
Contents of the pack and other information

1. What Metformin hydrochloride Inventia prolonged-release tablets are and what they are used for

Metformin hydrochloride Inventia prolonged-release tablets contain the active substance metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of type 2 (insulin-independent) diabetes.

Metformin hydrochloride Inventia prolonged-release tablets are used to treat patients with type 2 diabetes in whom adequate control of blood glucose (sugar) levels cannot be achieved by diet and physical activity alone. Insulin is a hormone that enables body tissues to take up glucose from the blood and use it as an energy source, or store glucose for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin that is produced. This leads to accumulation of glucose in the blood, which may cause a number of serious and long-term complications. Therefore, it is important to continue taking the medicine even if you do not have any obvious symptoms.

Metformin hydrochloride Inventia prolonged-release tablets increase the body's sensitivity to insulin and help restore the normal way the body uses glucose.

Taking Metformin hydrochloride Inventia prolonged-release tablets is associated with stabilization of body weight or slight weight loss.

Metformin hydrochloride Inventia prolonged-release tablets are specially formulated to provide slow release of the active substance in the body and therefore differ from many other types of tablets containing metformin.

2. Important information before using Metformin hydrochloride Inventia, prolonged-release tablets

When not to use Metformin hydrochloride Inventia, prolonged-release tablets:

if the patient is allergic to metformine or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include, for example: rash, itching or difficulty breathing,
if the patient has liver function disorders,
if the patient has severe kidney function impairment,
if the patient has uncontrolled diabetes, e.g. severe hyperglycaemia (high blood glucose levels), 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 may lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of breath,
if the patient has lost too much water from the body (dehydration). Dehydration may lead to kidney function disorders, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions"),
if the patient has a severe infection, such as pneumonia, bronchitis or kidney infection. Severe infection may lead to kidney function disorders, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions"),
if the patient has been treated for acute heart failure or recently suffered a myocardial infarction or has serious circulatory disorders or breathing difficulties. This may lead to tissue hypoxia, which may expose the patient to the risk of lactic acidosis (see "Warnings and precautions"),
if the patient consumes large amounts of alcohol,
if the patient is under 18 years of age.

Warnings and precautions
Risk of lactic acidosis
Metformin hydrochloride Inventia, prolonged-release tablets may cause a very rare but very serious adverse effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver function disorders and any disease states in which a part of the body is insufficiently supplied with oxygen (e.g. acute, severe heart diseases).
If any of the above situations apply to the patient, contact a doctor for further instructions.
The use of Metformin hydrochloride Inventia, prolonged-release tablets should be temporarily discontinued if the patient develops a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperature or reduced fluid intake compared to usual. For further instructions, consult a doctor.
The use of Metformin hydrochloride Inventia, prolonged-release tablets should be discontinued and the patient should immediately contact a doctor or the nearest hospital if symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

vomiting
abdominal pain
muscle cramps
general malaise with severe fatigue
breathing difficulties
decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
If a major surgical procedure is required, the use of Metformin hydrochloride Inventia, prolonged-release tablets should be discontinued during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Inventia, prolonged-release tablets.
During treatment with Metformin hydrochloride Inventia, prolonged-release tablets, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has deteriorating kidney function.
Remnants of tablets may be visible in the stool. This is a normal phenomenon when taking this type of tablet.
Continue to follow all dietary recommendations provided by the doctor and remember to consume carbohydrates regularly throughout the day.
Do not discontinue this medicine without consulting a doctor.
Metformin hydrochloride Inventia, prolonged-release tablets and other medicines
If an iodine-containing contrast agent needs to be injected into the bloodstream for an X-ray examination (X-ray) or computed tomography (CT), the use of Metformin hydrochloride Inventia, prolonged-release tablets should be discontinued before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Inventia, prolonged-release tablets.
Inform the doctor about all medicines currently used, recently used, or planned for use.
More frequent blood glucose monitoring, kidney function tests or dose adjustments of Metformin hydrochloride Inventia, prolonged-release tablets may be necessary.
It is especially important to inform the doctor about the use of the following medicines:

medicines that increase urine production (diuretics, e.g. furosemide)
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, e.g. ibuprofen and celecoxib)
some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
steroids, e.g. prednisolone, mometasone, beclomethasone
sympathomimetic medicines, including epinephrine and dopamine, used to treat myocardial infarction and low blood pressure. Epinephrine is also present in some local anaesthetics used in dentistry
medicines that may alter the blood concentration of Metformin hydrochloride Inventia, prolonged-release tablets, especially if the patient has kidney function disorders (e.g. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformin hydrochloride Inventia, prolonged-release tablets and alcohol
Avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Inventia, prolonged-release tablets, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
Metformin hydrochloride Inventia, prolonged-release tablets should not be used during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Metformin hydrochloride Inventia, prolonged-release tablets used as monotherapy does not cause hypoglycaemia (symptoms of low blood sugar such as fainting, disorientation and excessive sweating) and therefore should not affect the ability to drive or operate machinery.
However, it should be remembered that Metformin hydrochloride Inventia, prolonged-release tablets taken in combination with other antidiabetic medicines may cause hypoglycaemia; therefore, particular caution should be exercised when driving or operating machinery in such cases.

3. How to use Metformin hydrochloride Inventia, prolonged-release tablets

Your doctor may prescribe Metformin hydrochloride Inventia, prolonged-release tablets to be used either as monotherapy or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken exactly as your doctor has instructed.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with a glass of water; do not chew.

Recommended dose
Treatment is usually initiated with a dose of 500 milligrams of Metformin hydrochloride Inventia, prolonged-release tablets taken once daily. After approximately 2 weeks of treatment with Metformin hydrochloride Inventia, prolonged-release tablets, your doctor may adjust the dose based on blood glucose measurements. The maximum daily dose of Metformin hydrochloride Inventia, prolonged-release tablets is 2000 milligrams.
If you have impaired kidney function, your doctor may prescribe a lower dose. The tablets are usually taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily. Tablets should always be taken with meals.

Taking more Metformin hydrochloride Inventia, prolonged-release tablets than prescribed
If you accidentally take extra tablets, do not be alarmed, but if unusual symptoms occur, contact your doctor. In case of significant overdose, the risk of lactic acidosis increases. Symptoms of lactic acidosis are nonspecific and include: vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Further symptoms include decreased body temperature and slowing of the heart rate. If any of these symptoms occur, seek immediate medical advice, as lactic acidosis may lead to coma. You must immediately stop taking Metformin hydrochloride Inventia, prolonged-release tablets and contact your doctor or the nearest hospital without delay.

Missing a dose of Metformin hydrochloride Inventia, prolonged-release tablets
If you miss a dose, take it as soon as possible with food. Do not take a double dose to make up for the missed dose.

Stopping Metformin hydrochloride Inventia, prolonged-release tablets
Do not stop taking this medicine without consulting your doctor. Discontinuation of Metformin hydrochloride Inventia, prolonged-release tablets may result in a recurrence of elevated blood glucose levels.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur in a patient, Metformin hydrochloride Inventia, prolonged-release tablets should be discontinued and medical advice should be sought immediately:
Metformin hydrochloride Inventia, prolonged-release tablets may very rarely (in no more than 1 in 10,000 patients) cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). In such a case, treatment with Metformin hydrochloride Inventia, prolonged-release tablets must be stopped immediately and a doctor or the nearest hospital should be contacted without delay, because lactic acidosis may lead to coma.
Metformin hydrochloride Inventia, prolonged-release tablets may cause abnormal liver function tests and hepatitis, which may lead to jaundice (may occur in no more than 1 in 10,000 patients). If yellowing of the eyes and/or skin occurs, medical advice should be sought immediately.
Other possible side effects are listed below by frequency of occurrence:
Very common ( may affect more than 1 in 10 patients):

diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these side effects occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. It is helpful to take the tablets during or immediately after a meal.

Common ( may affect no more than 1 in 10 patients):

taste disturbances.

Very rare ( may affect no more than 1 in 10,000 patients):

decreased vitamin B12 levels
skin rash, including redness, itching and urticaria.

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Metformin hydrochloride Inventia, prolonged-release tablets

Keep the 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 stated month.
No special temperature storage conditions are required. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metformin hydrochloride Inventia, prolonged-release tablets contain
The active substance is metformin hydrochloride. Each prolonged-release tablet contains
500 mg or 750 mg of metformin hydrochloride.
The other ingredients are:
Metformin hydrochloride Inventia, 500 mg
magnesium stearate, sodium carmellose and hypromellose 100,000 mPas.
Metformin hydrochloride Inventia, 750 mg
magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion 30%, macrogol
6000, povidone (K90), sodium carmellose and hypromellose 100,000 mPas.
What Metformin hydrochloride Inventia, prolonged-release tablets look like and contents of the pack
500 mg tablets are white or almost white, capsule-shaped, biconvex tablets with bevelled edges,
sometimes marbled, marked with the imprint “ 001” on one side and smooth on the other.
750 mg tablets are white or almost white, capsule-shaped, biconvex, uncoated tablets, smooth on both sides.
Metformin hydrochloride Inventia, prolonged-release tablets are supplied in:
500 mg and 750 mg:
Blister packs containing 30, 60 or 90 prolonged-release tablets in a cardboard box.
Marketing Authorisation Holder
Inventia Healthcare B.V.,
Graaf Engelbertlaan 75,
4837DS Breda,
The Netherlands
Manufacturer
Flavine Pharma France
3, voie d’Allemagne
13127 Vitrolles
France
To obtain this leaflet in another format or to report a complaint, please contact the Marketing Authorisation Holder listed above.
Helpful tips

Smokers should try to stop smoking.
Exercise regularly.
Limit alcohol consumption as much as possible.
Take care of your feet. Visit a clinic or hospital for advice on foot care.
Always carry a card, bracelet, or medallion indicating that you have diabetes.
Attend regular visits at the diabetes clinic.