Metformin hidrohloride Inventia

Package Leaflet: 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.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, 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. Do not pass it on to others. The medicine may harm another person, 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.

Table of Contents of the Package 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 pack and other information

1. What is Metformin Hydrochloride Inventia, Prolonged-Release Tablets and what is it used for

What is it 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 exercise alone have not been able to control 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. 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 have 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 are specially designed to provide a 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

Important information

When not to take Metformin Hydrochloride Inventia, Prolonged-Release Tablets:

• if you are 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 difficulty breathing,
• if you have liver problems,
• if you have severe kidney problems,
• if you have 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 you have lost too much water from your body (dehydration). Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions"),
• if you have a severe infection, such as pneumonia, bronchitis or kidney infection. Severe infection can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions"),
• if you have been treated for acute heart failure or have recently had a heart attack or have severe circulatory problems or breathing difficulties. This can lead to tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions"),
• if you consume large amounts of alcohol,
• if you are under 18 years old.

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 you have kidney problems. 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 problems and any conditions in which a part of the body is not adequately supplied with oxygen (e.g. acute, severe heart disease).
If any of the above situations apply to you, you should contact your doctor for more detailed instructions.

You should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets for a short time if you have 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, you should consult your doctor.

You should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets and contact your doctor or the nearest hospital immediately if you

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 you need to undergo a major surgical procedure, you should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets during the procedure and for some time after it. Your doctor will decide when you should stop and resume treatment with Metformin Hydrochloride Inventia, Prolonged-Release Tablets.
During treatment with Metformin Hydrochloride Inventia, Prolonged-Release Tablets, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have deteriorating kidney function.
In the stool, you may see remains of the tablets. This is a normal phenomenon when taking this type of tablet.
You should continue to follow any dietary recommendations given by your doctor and remember to eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.

Metformin Hydrochloride Inventia, Prolonged-Release Tablets with 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, you should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets before the injection or at the latest at the time of the injection. Your doctor will decide when you should stop and resume treatment with Metformin Hydrochloride Inventia, Prolonged-Release Tablets.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
It may be necessary to check your blood sugar levels more frequently or check your kidney function or modify the dose of Metformin Hydrochloride Inventia, Prolonged-Release Tablets.
It is especially important to inform your 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 adrenaline and dopamine, used to treat heart attack and low blood pressure. Adrenaline is also found in some anesthetics used in dentistry
• medicines that may change the levels of Metformin Hydrochloride Inventia, Prolonged-Release Tablets in the blood, especially if you have kidney problems (e.g. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformin Hydrochloride Inventia, Prolonged-Release Tablets with alcohol

You 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 levels, such as fainting, disorientation and excessive sweating) and therefore should not affect your ability to drive or use machines.
However, you should be aware that Metformin Hydrochloride Inventia, Prolonged-Release Tablets taken in combination with other antidiabetic medicines may cause hypoglycemia, so you should be careful when driving or using machines.

3. How to take Metformin Hydrochloride Inventia, Prolonged-Release Tablets

Your doctor may prescribe Metformin Hydrochloride Inventia, Prolonged-Release Tablets to be taken alone or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken exactly as your doctor has told you.
If you are not sure, ask your 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, your doctor may adjust the dose based on blood sugar measurements. The maximum daily dose of Metformin Hydrochloride Inventia, Prolonged-Release Tablets is 2000 milligrams.
If you have kidney problems, your doctor may prescribe a lower dose. The tablets are usually taken once a day, during the evening meal.
In some cases, your 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 you have accidentally taken extra tablets, do not worry, but if you experience unusual symptoms, you should contact your doctor. In case of significant overdose, the likelihood 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 you experience any of these symptoms, you should immediately seek medical attention, as lactic acidosis can lead to coma. You should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets and contact your doctor or the nearest hospital immediately.

Missing a dose of Metformin Hydrochloride Inventia, Prolonged-Release Tablets

If you miss a dose, take it as soon as possible with a meal. Do not take a double dose to make up for the missed dose.

Stopping treatment with Metformin Hydrochloride Inventia, Prolonged-Release Tablets

Do not stop taking this medicine without consulting your doctor. Stopping treatment with Metformin Hydrochloride Inventia, Prolonged-Release Tablets may lead to a rise in blood sugar levels again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets and contact your doctor immediately:
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 such a case, you should stop taking Metformin Hydrochloride Inventia, Prolonged-Release Tablets and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Metformin Hydrochloride Inventia, Prolonged-Release Tablets may cause abnormal liver test results and liver inflammation, which can lead to jaundice (may occur less often than 1 in 10,000 patients). If you experience yellowing of the eyes and/or skin, you should contact your doctor immediately.
Other possible side effects are listed below by frequency of occurrence:
Very common(may affect more than 1 in 10 patients):

• diarrhea, nausea, vomiting, abdominal pain or loss of appetite. If you experience such side effects, do 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 affect up to 1 in 10 patients):

• taste disturbances.

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Metformin Hydrochloride Inventia, Prolonged-Release Tablets

Storage

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 month.
There are no special storage instructions for the medicine. Store in the original package to protect from moisture.
Medicines should 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 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 contents of the pack

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, you should contact the above-mentioned marketing authorization holder.

Date of last revision of the package leaflet: May 2024

Useful tips

• Smokers should try to quit.
• You should exercise regularly.
• You should limit your alcohol consumption as much as possible.
• You should take care of your feet. You should visit a clinic or hospital for foot care advice.
• You should carry a card, bracelet or disc with information that you have diabetes.
• You should regularly attend a diabetes clinic.