Metformin hidrohloride Inventia

Leaflet accompanying the packaging: information for the user

Metformin hydrochloride Inventia, 500 mg, prolonged-release tablets

Metformin hydrochloride Inventia, 750 mg, prolonged-release tablets

Metformin hydrochloride
The medicine is intended only for adultpatients.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Metformin hydrochloride Inventia, prolonged-release tablets and what is it used for
• 2. Important information before taking Metformin hydrochloride Inventia, prolonged-release tablets
• 3. How to take Metformin hydrochloride Inventia, prolonged-release tablets
• 4. Possible side effects
• 5. How to store Metformin hydrochloride Inventia, prolonged-release tablets
• 6. Contents of the packaging and other information

1. What is Metformin hydrochloride Inventia, prolonged-release tablets and what is it used for

what it is used for
Metformin hydrochloride Inventia, prolonged-release tablets contains the active substance metformin hydrochloride and belongs to a group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent).
Metformin hydrochloride Inventia, prolonged-release tablets is used to treat patients with type 2 diabetes, in whom diet and physical activity alone do not provide adequate control of blood sugar levels. Insulin is a hormone that allows the body's tissues to take up glucose from the blood and use it for energy or store it for future use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to a buildup of glucose in the blood, which can cause a range of serious and long-term complications. Therefore, it is important to continue taking the medicine, even if the patient does not experience any obvious symptoms.
Metformin hydrochloride Inventia, prolonged-release tablets increases the body's sensitivity to insulin and helps restore the normal use of glucose by the body.
Taking Metformin hydrochloride Inventia, prolonged-release tablets is associated with stabilization of body weight or slight weight loss.
The tablets of Metformin hydrochloride Inventia, prolonged-release tablets are specially designed to provide slow release of the medicine in the body and therefore differ from many other types of tablets containing metformin.

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

prolonged-release tablets

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

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, itching or shortness of breath,
• if the patient has liver function disorders,
• if the patient has severe kidney function disorders,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,
• if the patient has lost too much water from the body (dehydration). Dehydration can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions"),
• if the patient has a severe infection, such as pneumonia, bronchitis or kidney infection. Severe infection can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions"),
• if the patient has been treated for acute heart failure or has recently had a heart attack or has severe circulatory problems or breathing difficulties. This can lead to tissue hypoxia, which can put the patient at 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 side 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 information below), liver function disorders and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g. acute, severe heart disease).
If any of the above situations apply to the patient, they should contact their doctor for more detailed instructions.

The patient should temporarily stop taking Metformin hydrochloride Inventia, prolonged-release tablets if they experience a condition that may be associated with

dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to high temperatures or taking less fluid than usual. To get more detailed instructions, the patient should consult their doctor.

The patient should stop taking Metformin hydrochloride Inventia, prolonged-release tablets and immediately contact their doctor or the nearest hospital if they experience

symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe fatigue
• breathing difficulties
• low body temperature and slow heart rate.

Lactic acidosis is a sudden condition that threatens health or life and requires hospital treatment.
If the patient needs to undergo a major surgical procedure, they should stop taking Metformin hydrochloride Inventia, prolonged-release tablets during the procedure and for some time after its completion. 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 often if the patient is elderly and/or has deteriorating kidney function.
Tablet residues may be visible in the stool. This is a normal phenomenon when taking this type of tablet.
The patient should continue to follow any dietary recommendations made by their doctor and remember to eat carbohydrates regularly throughout the day.
The patient should not stop taking this medicine without consulting their doctor.

Metformin hydrochloride Inventia, prolonged-release tablets and other medicines

If it is necessary to inject a contrast agent containing iodine into the bloodstream for an X-ray examination or computed tomography (CT) scan, the patient should stop taking Metformin hydrochloride Inventia, prolonged-release tablets before the injection or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Inventia, prolonged-release tablets.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It may be necessary to perform more frequent blood sugar tests or kidney function tests, or to modify the dose of Metformin hydrochloride Inventia, prolonged-release tablets.
It is especially important to inform the doctor about the use of the following medicines:

• diuretics (e.g. furosemide)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, e.g. ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• corticosteroids, e.g. prednisolone, mometasone, beclometasone
• sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also found in some anesthetics used in dentistry
• medicines that may change the level of Metformin hydrochloride Inventia, prolonged-release tablets in the blood, 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 with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Inventia, prolonged-release tablets, as this may increase the risk of lactic acidosis (see "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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Metformin hydrochloride Inventia, prolonged-release tablets used in monotherapy does not cause hypoglycemia (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, the patient should remember that Metformin hydrochloride Inventia, prolonged-release tablets taken in combination with other antidiabetic medicines may cause hypoglycemia, so in this case, the patient should be particularly careful when driving or operating machinery.

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

The doctor may prescribe Metformin hydrochloride Inventia, prolonged-release tablets for use in monotherapy or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken according to the doctor's instructions.
If the patient has any doubts, they should consult their doctor or pharmacist.
The tablet should be swallowed whole, with a glass of water; do not chew.
Recommended dose
Treatment usually starts with a dose of 500 milligrams of Metformin hydrochloride Inventia, prolonged-release tablets taken once a day. After about 2 weeks of taking Metformin hydrochloride Inventia, prolonged-release tablets, the doctor may modify the dose based on blood sugar measurements. The maximum daily dose of Metformin hydrochloride Inventia, prolonged-release tablets is 2000 milligrams.
If the patient has kidney function disorders, the doctor may prescribe a lower dose. The tablets are usually taken once a day, during the evening meal.
In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with a meal.

Taking a higher dose of Metformin hydrochloride Inventia, prolonged-release tablets than recommended

If the patient accidentally takes extra tablets, they should not worry, but if they experience unusual symptoms, they should contact their doctor. In case of significant overdose, the risk of lactic acidosis increases. Symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue and breathing difficulties. Further symptoms are decreased body temperature and slow heart rate. If the patient experiences any of these symptoms, they should immediately consult their doctor, as lactic acidosis can lead to coma. The patient should stop taking Metformin hydrochloride Inventia, prolonged-release tablets and immediately contact their doctor or the nearest hospital.

Missing a dose of Metformin hydrochloride Inventia, prolonged-release tablets

If the patient misses a dose, they should take it as soon as possible with a meal. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Metformin hydrochloride Inventia, prolonged-release tablets

The patient should not stop taking this medicine without consulting their doctor. Stopping treatment with Metformin hydrochloride Inventia, prolonged-release tablets may lead to an increase in blood sugar levels again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Metformin hydrochloride Inventia, prolonged-release tablets and immediately contact their doctor:
Metformin hydrochloride Inventia, prolonged-release tablets may very rarely (less often than 1 in 10,000 patients) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). In this case, the patient should stop taking Metformin hydrochloride Inventia, prolonged-release tablets and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Metformin hydrochloride Inventia, prolonged-release tablets may cause abnormal liver test results and hepatitis, which can lead to jaundice (may occur less often than 1 in 10,000 patients). If the patient experiences yellowing of the eyes and/or skin, they should immediately contact their doctor.
Other possible side effects are listed below by frequency of occurrence:
Very common(may occur more often than 1 in 10 patients):

• diarrhea, nausea, vomiting, abdominal pain or loss of appetite. If such side effects occur, the patient should not stop taking the tablets, as these symptoms usually disappear within about 2 weeks. It is helpful to take the tablets with a meal or immediately after it.

Common(may occur less often than 1 in 10 patients):

• taste disorders.

Very rare(may occur less often than 1 in 10,000 patients):

• decreased vitamin B12 levels
• skin rashes, including redness, itching and hives.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 authorization holder. By reporting side effects, it is possible to gather more information on the safety of this medicine.

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

prolonged-release tablets

The medicine should be stored out of 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.
There are no special storage instructions for the medicine. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metformin hydrochloride Inventia, prolonged-release tablets contains

The active substance of the medicine 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 looks like and what the pack contains

500 mg tablets are white or almost white, capsule-shaped, biconvex, with beveled edges, sometimes mottled, with the inscription "
001" on one side and smooth on the other side.
750 mg tablets are white or almost white, capsule-shaped, biconvex, uncoated, smooth on both sides.
Metformin hydrochloride Inventia, prolonged-release tablets is available in:
500 mg and 750 mg:
Blisters of 30, 60, 90 prolonged-release tablets in a cardboard box.

Marketing authorization holder

Inventia Healthcare B.V.,
Graaf Engelbertlaan 75,
4837DS Breda,
Netherlands

Manufacturer

Flavine Pharma France
3, voie d’Allemagne
13127 Vitrolles
France
To obtain this leaflet in a different format or to report a complaint, the patient should contact the marketing authorization holder mentioned above.

Date of last revision of the leaflet: May 2024

Useful tips

• Smokers should try to quit.
• The patient should exercise regularly.
• The patient should limit their alcohol consumption as much as possible.
• The patient should take care of their feet. The patient should consult a clinic or hospital for foot care advice.
• The patient should carry a card, bracelet or ring with information that they have diabetes.
• The patient should regularly attend diabetes clinics.