METFORMIN SANDOZ 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Sandoz 1000 mg film-coated tablets EFG

metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Metformin Sandoz and what is it used for
2. What you need to know before you take Metformin Sandoz
3. How to take Metformin Sandoz
4. Possible side effects
5. Storage of Metformin Sandoz
6. Contents of the pack and other information

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

Metformin Sandoz contains metformin, a medicine used to treat diabetes. Metformin belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not produce enough insulin or your body cannot use the insulin it produces properly. This causes a high level of glucose in the blood. Metformin helps to lower your blood glucose to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps to reduce the risk of complications associated with diabetes. Metformin is associated with both stable body weight and moderate weight loss.

Metformin is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone are not enough to control their blood glucose level. It is especially used in patients with overweight.

• Adults can take metformin alone or with other medicines to treat diabetes (medicines taken by mouth or insulin).

• Children aged 10 years and older, and adolescents, can take metformin alone or accompanied by insulin.

2. What you need to know before you take Metformin Sandoz

Do not take Metformin Sandoz

• If you are allergicto metformin or any of the other ingredients of this medicine (listed in section 6),
liver problems,uncontrolled diabeteswith, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or an unusual fruity odor in your breath,lost too much waterfrom your body (dehydration) for example due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can trigger kidney problems, which can put you at risk of developing lactic acidosis (see below "Be especially careful"),severe infection, for example an infection that affects your lungs, bronchi or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis(see below "Warnings and precautions"),alcohol.

If any of the above circumstances apply to you, consult your doctor before starting to take this medicine.

Make sure to ask your doctor for advice if:

• you need an examination such as an X-ray or scan that involves injecting a contrast mediumcontaining iodineinto your bloodstream,
• you need a major surgical intervention.

You should stop taking metformin for a certain period before and after the examination or surgical intervention. Your doctor will decide if you need any other treatment during this time. It is important that you follow your doctor's instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

Consult your doctor immediately if:

• You know that you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).

• You experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

If any of the above applies to you, consult your doctor for further instructions.

Stop taking metformin for a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain,
• muscle cramps,
• general feeling of discomfort with intense fatigue,
• difficulty breathing,
• reduction of body temperature and heart rate.

Lactic acidosis is a medical emergency and should be treated in a hospital.

If you need to undergo major surgery, you should stop taking metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking metformin and when you can restart it.

During treatment with metformin, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is deteriorating.

Metformin Sandoz alone does not cause hypoglycemia (a blood glucose level that is too low). However, if you take metformin with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, or glinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

Other medicines and Metformin Sandoz

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or examination, you should stop taking metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking metformin and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of metformin. It is especially important to mention the following:

• medicines that increase urine production (diuretics),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib),
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• beta-2 agonistssuch as salbutamol or terbutalol (used to treat asthma),
• corticosteroids(used to treat various conditions, such as severe skin inflammation or asthma),
• medicinesthat can change the amount of metformin in the blood, especially if your kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Taking Metformin Sandoz with alcohol

Avoid excessive alcohol consumption while taking Metformin Sandoz, as this can increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy andbreast-feeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor, as your treatment may need to be altered or your blood glucose levels monitored.

It is not recommended to take this medicine if you are breast-feeding or planning to breast-feed your baby.

Driving and using machines

Metformin alone does not cause hypoglycemia (a blood glucose level that is too low). This means it will not affect your ability to drive or use machines.

However, be especially careful if you take metformin with other diabetes medicinesthat can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Sandoz

Follow the instructions for administration given by your doctor. Ask your doctor or pharmacist if you have any doubts.

Metformin cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and exercise regularly.

The recommended dose is:

Children aged 10 years and older and adolescentsusually start with 500 mg or 850 mg of metformin per day. The maximum daily dose is 2000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Adultsusually start with 500 mg or 850 mg of metformin 2 or 3 times a day. The maximum daily dose is 3000 mg divided into 3 doses.

*For individual dose adjustment, tablets containing 500 mg and 850 mg of the active ingredient metformin hydrochloride are available.

If you are also using insulin, your doctor will tell you how to start taking metformin.

If you have reduced kidney function, your doctor may prescribe a lower dose.

Monitoring:

• Your doctor will adjust your metformin dose to your blood glucose level. Make sure to talk to your doctor regularly. This is especially important for children, adolescents, or if you are an elderly person.
• Your doctor will also check how well your kidneys are working at least once a year. You may need more frequent checks if you are an elderly person or if your kidneys are not working normally.

How to take Metformin Sandoz:

Take Metformin Sandoz with meals or after meals. This will help prevent digestive side effects.

Do not break or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (at breakfast).
• If you take two doses a day, take them in the morning (at breakfast) and at night (at dinner).
• If you take three doses a day, take them in the morning (at breakfast), at noon (at lunch), and at night (at dinner).

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If, after some time, you think that the effect of Metformin Sandoz is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metformin Sandoz than you should

If you have taken more Metformin Sandoz than you should, you may suffer from lactic acidosis. The symptoms of lactic acidosis are non-specific, such as vomiting, abdominal pain with cramps, a feeling of discomfort with fatigue, and difficulty breathing. Other symptoms are decreased body temperature and heart rate. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to a coma.Stop taking Metformin Sandoz immediately and contact your doctor or the nearest hospital right away.

If you have taken more Metformin Sandoz than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Metformin Sandoz

Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.

If you have any further questions on 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.

Metformin can cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you must stop taking metformin and contact a doctor or the nearest hospital immediately,as lactic acidosis can lead to a coma.

Very common, may affect more than 1 in 10 people

• Digestive problems, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects occur more frequently when starting treatment. It helps to spread the doses throughout the day and if you take the tablets during or immediately after a meal. If the symptoms persist, stop taking metformin and consult your doctor.

Common, may affect up to 1 in 10 people

• Changes in taste,
• low or reduced vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and painful tongue, numbness or tingling, or pale or yellowish skin). Your doctor may schedule some tests to find the reason for your symptoms because some of them may be caused by diabetes or other unrelated health problems.

Very rare, may affect up to 1 in 10,000 people

• lactic acidosis. It is a very rare but serious complication, especially if your kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions"),
• liver function test disorders or hepatitis (inflammation of the liver, which can produce fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes).

If this happens to you, stop takingthis medicine and consult your doctor,

• skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).

Children and adolescents

Limited data in children and adolescents showed that the side effects were similar in nature and severity to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Sandoz

Keep this medicine out of the sight and reach of children. If a child is being treated with metformin, it is recommended that parents and caregivers supervise how this medicine is used.

No special storage conditions are required

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and any remaining medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the cartons and any remaining medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Metformina Sandoz

• The active ingredient is metformin hydrochloride. Each tablet contains 1,000 mg of metformin hydrochloride equivalent to 780 mg of metformin.
• The other components are: povidone K 90, magnesium stearate, hypromellose, macrogol 4000, colorant titanium dioxide (E 171).

Appearance of the Product and Container Content

The tablets are white, oval, film-coated, scored, marked with "M 1G" on one side and smooth on the other side, available in:

• Aluminum/PVC blister packs of 20, 30, 60, 90, 120, 180, and 300 tablets.
• HDPE bottles with LDPE or PP caps and desiccant, containing 100 and 200 tablets.

Dimensions: approximately 19 mm x 10 mm.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

or

Lek S.A.

Ul. Domaniewska, 50 C

02-672 Warszawa

Poland

or

Lek S.A.

ul. Podlipie 16,

95-010 Stryków

Poland

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57,

1526 Ljubljana

Slovenia

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

Austria: Meglucon Sandoz 1000 mg - Filmtabletten

Slovenia: Metformin Lek 1000 mg film-coated tablets

Estonia: Metformin Sandoz

France: METFORMINE SANDOZ 1000 mg, scored film-coated tablet

Italy: METFORMINA HEXAL

Norway: Metformin Sandoz 1000 mg film-coated tablets

Netherlands: METFORMINE HCL SANDOZ 1000 MG, film-coated tablets

Poland: Etform

Portugal: METFORMINA SANDOZ 1000 MG coated tablets

Czech Republic: Metformin Sandoz

Sweden: Metformin Sandoz 1000 mg film-coated tablets

Date of the last revision of this leaflet:April 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/