Metformin hidrohloride Sandoz Gmbh

Leaflet attached to the packaging: patient information

Metformin hydrochloride Sandoz GmbH, 500 mg, prolonged-release tablets

Metformin hydrochloride Sandoz GmbH, 750 mg, prolonged-release tablets

Metformin hydrochloride Sandoz GmbH, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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.
In case of 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.
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 Sandoz GmbH and what is it used for
• 2. Important information before taking Metformin hydrochloride Sandoz GmbH
• 3. How to take Metformin hydrochloride Sandoz GmbH
• 4. Possible side effects
• 5. How to store Metformin hydrochloride Sandoz GmbH
• 6. Contents of the packaging and other information

1. What is Metformin hydrochloride Sandoz GmbH and what is it used for

Metformin hydrochloride Sandoz GmbH in the form of 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 Sandoz GmbH is used in combination with diet and physical exercise to
reduce the risk of developing type 2 diabetes in adults with overweight, when diet and physical exercise
alone have not been sufficient to control blood sugar levels for 3 to 6 months. There is a high risk of
developing type 2 diabetes if the patient has additional risk factors, such as high blood pressure, age over
40, abnormal lipid levels (fats) in the blood, or a history of gestational diabetes.
The medicine is particularly effective if the patient is under 45 years old, has significant overweight, high
blood sugar levels after meals, or has a history of gestational diabetes.
Metformin hydrochloride Sandoz GmbH is used to treat adult patients with type 2 diabetes, when diet and
physical exercise alone are not sufficient to achieve adequate blood sugar control. It is used especially in
patients with overweight.
Insulin is a hormone that allows the body's tissues to absorb glucose from the blood and use it for
energy or store it for later use.
In people with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to
use the produced insulin properly. This leads to a buildup of glucose in the blood, which can cause a range
of serious, long-term complications, which is why it is important for the patient to continue taking the
medicine, even if they do not have any obvious symptoms.
Metformin hydrochloride Sandoz GmbH increases the body's sensitivity to insulin and helps restore the
normal use of glucose by the body.
Taking Metformin hydrochloride Sandoz GmbH is associated with either maintaining a stable body weight
or a slight reduction in body weight.
The prolonged-release tablets of Metformin hydrochloride Sandoz GmbH are specially designed to release
the medicine slowly in the body, which is why they differ from many other types of tablets containing
metformin.

2. Important information before taking Metformin hydrochloride Sandoz GmbH

When not to take Metformin hydrochloride Sandoz GmbH

Warnings and precautions

Before starting to take Metformin hydrochloride Sandoz GmbH, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Metformin hydrochloride Sandoz GmbH may cause a very rare but very serious side effect called lactic acidosis, especially in patients with kidney function disorders. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration, 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 consult their doctor for more detailed instructions.
The patient should contact their doctor immediately for further instructions if they have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.

The patient should stop taking Metformin hydrochloride Sandoz GmbH for a short time,

(significant water loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Metformin hydrochloride Sandoz GmbH and contact their doctor or the nearest hospital immediately if they experience any

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

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general malaise with severe fatigue
• breathing difficulties
• lowered body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that must be treated in a hospital.
If the patient is to undergo a major surgical procedure, they must stop taking Metformin hydrochloride Sandoz GmbH during and for some time after the procedure. The doctor will decide when the patient should stop and resume taking Metformin hydrochloride Sandoz GmbH.
During treatment with Metformin hydrochloride Sandoz GmbH, 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 impaired kidney function.
Metformin hydrochloride Sandoz GmbH does not cause hypoglycemia (low blood sugar levels). However, if the patient takes Metformin hydrochloride Sandoz GmbH in combination with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If hypoglycemia symptoms occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
Patient over 75 years old should not start treatment with Metformin hydrochloride Sandoz GmbH to reduce the risk of developing type 2 diabetes.
Tablet residues may be visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.
The patient should continue to follow any dietary recommendations given by their doctor and ensure they eat carbohydrates regularly throughout the day.
The patient should not stop taking Metformin hydrochloride Sandoz GmbH without consulting their doctor.

Metformin hydrochloride Sandoz GmbH and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, e.g., for an X-ray examination or computed tomography, they must stop taking Metformin hydrochloride Sandoz GmbH before or at the latest during the administration. The doctor will decide when the patient should stop and resume taking Metformin hydrochloride Sandoz GmbH.
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. The patient may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Metformin hydrochloride Sandoz GmbH by their doctor. It is especially important to inform about the use of:
diuretics (such as furosemide)
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 (ACE inhibitors and angiotensin II receptor antagonists)
corticosteroids, such as prednisolone, mometasone, beclomethasone
sympathomimetics, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some anesthetics used in dentistry.
medicines that may change the amount of Metformin hydrochloride Sandoz GmbH in the blood, especially in patients with impaired kidney function (e.g., verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
other medicines used to treat diabetes.

Metformin hydrochloride Sandoz GmbH and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Sandoz GmbH, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor, as changes in treatment or blood sugar monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Metformin hydrochloride Sandoz GmbH used as monotherapy does not cause hypoglycemia (symptoms of low blood sugar levels, such as fainting, confusion, and excessive sweating), so it should not affect the ability to drive or use machines.
However, the patient should be aware that taking Metformin hydrochloride Sandoz GmbH with other diabetes medicines may cause hypoglycemia. In such cases, the patient should be particularly careful while driving or using machines.
The patient should not drive or use machines if they start to experience hypoglycemia symptoms.

3. How to take Metformin hydrochloride Sandoz GmbH

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor may prescribe Metformin hydrochloride Sandoz GmbH to be taken alone or in combination with other oral diabetes medicines or insulin.
The tablets should be swallowed whole with a glass of water. They should not be chewed, divided, or crushed.
Recommended dose
Treatment usually starts with 500 mg of Metformin hydrochloride Sandoz GmbH once a day.
After about 2 weeks of taking Metformin hydrochloride Sandoz GmbH, the doctor may adjust the dose based on blood sugar measurements. The maximum daily dose of Metformin hydrochloride Sandoz GmbH is 2000 mg.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
Tablets are usually taken once a day, with the evening meal.
In some cases, the doctor may recommend taking tablets twice a day, with breakfast and dinner. Tablets should always be taken with a meal.

Taking a higher dose of Metformin hydrochloride Sandoz GmbH than recommended

If the patient accidentally takes extra tablets, they should not be concerned, but if unusual symptoms occur, they should tell their doctor. In case of a large overdose, there is a higher risk of lactic acidosis. Symptoms of lactic acidosis are non-specific, e.g., vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and breathing difficulties. Later symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, the patient should seek medical help immediately, as lactic acidosis can lead to coma. The patient should stop taking Metformin hydrochloride Sandoz GmbH and seek medical help immediately or go to the nearest hospital.

Missing a dose of Metformin hydrochloride Sandoz GmbH

The next dose should be taken as soon as possible with a meal. The patient should not take a double dose to make up for the missed dose.

Stopping Metformin hydrochloride Sandoz GmbH

The patient should not stop taking this medicine without consulting their doctor. If the patient stops taking Metformin hydrochloride Sandoz GmbH, their blood sugar levels may rise again.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin hydrochloride Sandoz GmbH can cause side effects, although not everybody gets them.
The following side effects may occur:
Metformin hydrochloride Sandoz GmbH may very rarely (less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Metformin hydrochloride Sandoz GmbH and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Metformin hydrochloride Sandoz GmbH may cause abnormal liver function test results and hepatitis, which can lead to jaundice (may occur less than 1 in 10,000 people). If the patient experiences yellowing of the eyes and/or skin, they should contact their doctor immediately.
Other possible side effects are listed according to their frequency:
Very common side effects (may occur in more than 1 in 10 people):
diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. The patient should not stop taking the tablets if these symptoms occur, as they usually disappear after about 2 weeks. It helps to take the tablet with a meal or immediately after.
Common side effects (may occur in less than 1 in 10 people):
taste disturbances
reduced or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness, or pale or yellowish skin). The doctor may order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare side effects (may occur in less than 1 in 10,000 people):
skin rashes, including redness, itching, and hives.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Metformin hydrochloride Sandoz GmbH

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 or blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
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 Sandoz GmbH contains

The active substance of the medicine is metformin hydrochloride (Metformin hydrochloride)
Metformin hydrochloride SandozGmbH, 500 mg
Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Metformin hydrochloride Sandoz GmbH, 750 mg
Each tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Metformin hydrochloride Sandoz GmbH, 1000 mg
Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
Other ingredients are:
Core:stearic acid, shellac, povidone (K-30), colloidal silica, magnesium stearate.
Coating:hypromellose, hydroxypropyl cellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, talc.

What Metformin hydrochloride Sandoz GmbH looks like and contents of the pack

Metformin hydrochloride Sandoz GmbH, 500 mg, prolonged-release tablets
Almost white, oval, biconvex, film-coated tablets, smooth on both sides. Approximate dimensions: 15 mm x 8.5 mm.
Metformin hydrochloride Sandoz GmbH, 750 mg, prolonged-release tablets
Almost white, biconvex, film-coated tablets in the shape of a capsule, smooth on both sides. Approximate dimensions: 19.1 mm x 9.3 mm.
Metformin hydrochloride Sandoz GmbH, 1000 mg, prolonged-release tablets
Almost white, oval, biconvex, film-coated tablets, smooth on both sides. Approximate dimensions: 20.4 mm x 9.7 mm.
PVC/PVDC/Aluminum blisters
Pack sizes: 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland
Metformin hydrochloride Sandoz GmbH
Hungary
Metformin Sandoz 500 mg retard tablet
Metformin Sandoz 750 mg retard tablet
Metformin Sandoz 1000 mg retard tablet
Croatia
Meglucon 500 mg prolonged-release tablets
Meglucon 750 mg prolonged-release tablets
Meglucon 1000 mg prolonged-release tablets
Date of last revision of the leaflet:05/2025
Logo of the marketing authorization holder