Metformin hidrohloride Sandoz

Leaflet accompanying the packaging: patient information

Metformin hydrochloride Sandoz, 500 mg, prolonged-release tablets

Metformin hydrochloride Sandoz, 750 mg, prolonged-release tablets

Metformin hydrochloride Sandoz, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, 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 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 and what is it used for
• 2. Important information before taking Metformin hydrochloride Sandoz
• 3. How to take Metformin hydrochloride Sandoz
• 4. Possible side effects
• 5. How to store Metformin hydrochloride Sandoz
• 6. Contents of the packaging and other information

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

Metformin hydrochloride Sandoz 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 is used to treat adult patients with type 2 diabetes, when diet and physical exercise alone are not enough to control blood sugar levels.
It is especially used in patients who are 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 insulin produced 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 essential for the patient to continue taking the medicine, even if they do not experience any obvious symptoms.
Metformin hydrochloride Sandoz increases the body's sensitivity to insulin and helps restore the proper use of glucose by the body.
Taking Metformin hydrochloride Sandoz is associated with either maintaining a stable body weight or a slight reduction in body weight.
The prolonged-release tablets of Metformin hydrochloride Sandoz are specially designed to release the medicine slowly in the body, which is why they differ from many other types of metformin tablets.

2. Important information before taking Metformin hydrochloride Sandoz

When not to take Metformin hydrochloride Sandoz

Warnings and precautions

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

Risk of lactic acidosis

Metformin hydrochloride Sandoz may cause a very rare but very serious side effect called lactic acidosis, especially in patients with kidney problems.
The risk of lactic acidosis also increases in cases of uncontrolled diabetes, severe infections, prolonged fasting, or excessive alcohol consumption, dehydration (see 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 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.
If the patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

The patient should stop taking Metformin hydrochloride Sandoz for a short time if they have a condition that may lead to dehydration

(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 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 feeling of being unwell, combined with extreme fatigue
• breathing difficulties
• low body temperature and slow heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
If the patient is to undergo a major surgical procedure, they must stop taking Metformin hydrochloride Sandoz during and for some time after the procedure. The doctor will decide when the patient should stop and resume taking Metformin hydrochloride Sandoz.
During treatment with Metformin hydrochloride Sandoz, 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.
Metformin hydrochloride Sandoz does not cause hypoglycemia (low blood sugar). However, if the patient takes Metformin hydrochloride Sandoz in combination with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If hypoglycemic symptoms occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
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 advice given by their doctor and ensure they eat carbohydrates regularly throughout the day.
The patient should not stop taking Metformin hydrochloride Sandoz without consulting their doctor.

Metformin hydrochloride Sandoz 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 before or at the latest during the administration of the contrast agent. The doctor will decide when the patient should stop and resume taking Metformin hydrochloride Sandoz.
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 by their doctor. It is particularly important to inform the doctor 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 in the blood, especially in patients with reduced 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 and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Sandoz, 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 used as monotherapy does not cause hypoglycemia (symptoms of low blood sugar, 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 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 symptoms of hypoglycemia.

3. How to take Metformin hydrochloride Sandoz

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 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 once a day. After about 2 weeks of taking Metformin hydrochloride Sandoz, the doctor may adjust the dose based on blood sugar measurements. The maximum daily dose of Metformin hydrochloride Sandoz is 2000 mg.
If the patient has reduced kidney function, the doctor may prescribe a lower dose.
Usually, the tablets are taken once a day, with the evening meal.
In some cases, the doctor may recommend taking the tablets twice a day, with the morning and evening meals. The tablets should always be taken with a meal.

Taking a higher dose of Metformin hydrochloride Sandoz than recommended

If the patient accidentally takes extra tablets, they should not be concerned, but if they experience unusual symptoms, 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, stomach pain with muscle cramps, general feeling of being unwell with extreme fatigue, and breathing difficulties. Later symptoms include low body temperature and slow heart rate. If the patient experiences any of these symptoms, they should seek medical help immediately, as lactic acidosis can lead to coma. The patient should stop taking Metformin hydrochloride Sandoz and seek medical help immediately or go to the nearest hospital.

Missing a dose of Metformin hydrochloride Sandoz

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

The patient should not stop taking this medicine without consulting their doctor. If the patient stops taking Metformin hydrochloride Sandoz, 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 can cause side effects, although not everybody gets them.
The following side effects may occur:
Metformin hydrochloride Sandoz 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 happens to the patient, they should stop taking Metformin hydrochloride Sandoz and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Metformin hydrochloride Sandoz may cause abnormal liver function test results and liver inflammation, 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, stomach 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 it.
Common side effects (may occur in less than 1 in 10 people):
taste disturbances
decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling). 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 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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, more information can be collected on the safety of the medicine.

5. How to store Metformin hydrochloride Sandoz

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 they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Metformin hydrochloride Sandoz contains

The active substance of the medicine is metformin hydrochloride (Metformin hydrochloride).
Metformin hydrochloride Sandoz, 500 mg
Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Metformin hydrochloride Sandoz, 750 mg
Each tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Metformin hydrochloride Sandoz, 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 anhydrous, magnesium stearate.
Coating:hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, talc.

What Metformin hydrochloride Sandoz looks like and contents of the pack

Metformin hydrochloride Sandoz, 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, 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, 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/importer

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