METFORMIN SANDOZ 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Metformin Sandoz 850 mg Film-Coated Tablets EFG

metformin hydrochloride

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the Package Leaflet:

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 further information

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

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

Insulin is a hormone produced by the pancreas that makes your body take up 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 leads to high blood glucose levels. Metformin helps reduce your blood glucose levels to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight decrease in body weight.

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 levels. It is especially used in patients with overweight.

Adultscan take metformin alone or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Childrenfrom 10 years old and adolescents can take metformin alone or together with 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,large amounts of alcohol,dehydration), for example due to
• • a prolonged or severe diarrhea, or

Dehydration can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions").

acute heart failureor if you have recently had a heart attack, have severe circulation problems (such as shock) or have breathing difficulties. This can lead to a lack of oxygen in the tissues, which can put you at risk of developing lactic acidosis (see below "Warnings and precautions"),

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

Make sure to consult your doctor if:

• you need an examination that involves injecting a contrast medium containing iodine into your bloodstream, such as an X-ray or scan.
• you need to have a major surgical operation.

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

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 by uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see below), liver problems, and any medical condition in which a part of your body has a reduced supply of oxygen (such as severe and acute heart disease).

Consult your doctor immediately if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting metformin treatment: convulsions, cognitive impairment, difficulty with body movements, symptoms indicating 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 condition 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 of lactic acidosis, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• a general feeling of discomfort, with intense fatigue,
• difficulty breathing,
• decreased body temperature and heart rate.

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

Metformin 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 meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

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.

Consult your doctor before starting to take metformin if you are in any of the following situations:

• if you have symptoms of low blood sugar levelssuch as:
• weakness,
• dizziness,
• increased sweating,
• rapid heartbeat,
• vision disorders,
• difficulty concentrating.

If this happens, eat or drink something that contains sugar. Metformin alone does not cause a marked decrease in blood sugar levels; however, other diabetes medicines can.

• overweight,

Follow your low-calorie diet.

• if you are taking other medicines,

See section "Taking Metformin Sandoz with other medicines".

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

Children under 10 years

Metformin is not recommendedfor this age group.

Other medicines and Metformin Sandoz

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking metformin before 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 or pharmacist if you are taking or 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 your metformin dose. It is especially important to mention the following:

• Medicines that contain alcohol,
• glucocorticoids, medicines used to prevent transplant rejection, reduce skin inflammation or asthma;
• medicines that dilate the airwayssuch as salbutamol, fenoterol, and terbutaline;
• • 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 used to treat high blood pressure(ACE inhibitors and angiotensin II receptor antagonists),
• medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• medicines to lower blood sugar levelssuch as insulin or other oral antidiabetics.

Taking these medicines with metformin may cause your blood sugar levels to drop too low. See "Warnings and precautions".

Taking Metformin Sandoz with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine is not recommended if you are breastfeeding or planning to breastfeed 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 careful if you take metformin with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

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

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

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

*500 mg and 1000 mg metformin hydrochloride tablets are also available for individual dose adjustment.

Adults

• Normal dose: 1 metformin 850 mg tablet 2 or 3 times a day.
• After taking metformin for about 2 weeks, your doctor will measure your blood sugar levels and adjust your dose.
• Maximum dose: 3000 mg* of metformin hydrochloride per day, divided into 3 doses.

Children from 10 years old

• Normal initial dose: 500 mg* of metformin hydrochloride or 1 Metformin Sandoz 850 mg tablet per day.
• After the child has taken metformin for about 2 weeks, your doctor will measure their blood sugar levels and adjust the dose.
• Maximum dose: 2000 mg* of metformin hydrochloride per day, divided into 2 or 3 doses.

Patient over 65 years

Since the likelihood of kidney impairment is greater in this age group, the doctor will decide the metformin dose based on your kidney function.

See also section 2 "Warnings and precautions".

Method of administration

Swallow the tablets with a glass of water during or after meals. This will help you avoid side effects during digestion. The score line is only to help you break the tablet if you have difficulty swallowing it whole.

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

• If you take one dose a day, take it in the morning (breakfast),
• If you take two doses a day, take them in the morning (breakfast) and evening (dinner),

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

Monitoring

• Your doctor will regularly check your blood sugar levels and adjust your metformin dose to your blood sugar levels. Make sure you talk to your doctor regularly. This is especially important for children, adolescents, or if you are elderly.
• 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 elderly or if your kidneys are not working normally.

Duration of treatment

Your doctor will decide the duration of your treatment.

If you take more Metformin Sandoz than you should

If you have taken more metformin than you should, you may suffer from lactic acidosis.

The symptoms of lactic acidosis are non-specific, such as vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Additional symptoms may include decreased body temperature and heart rate. If you experience any of these symptoms, you should seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking metformin immediately and contact your doctor or the nearest hospital right away.

If you have taken more metformin than you should, talk to your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Metformin Sandoz

If you forget to take a dose, skip that dose and take the next one at the right time.

Do not take a double dose to make up for forgotten doses. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

If you stop taking Metformin Sandoz

If you stop taking metformin without your doctor's consent, your blood sugar levels may rise uncontrollably. This increases the risk of long-term complications, for example, in the eyes, kidneys, or blood vessels.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Metformin may cause a very rare (may affect up to 1 in 10,000 people), but very serious, adverse 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 coma.

Other Possible Adverse Effects

Very Common, may affect more than 1 in 10 people:

• nausea,
• vomiting,
• diarrhea,
• abdominal pain,
• loss of appetite.

These adverse effects appear more frequently at the start of treatment with metformin. Spreading the doses throughout the day and taking metformin during or immediately after a meal can help reduce these adverse effects. If the symptoms continue, stop taking metformin and consult your doctor.

Common, may affect up to 1 in 10 people

• changes in taste.
• low or decreased vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and painful tongue, tingling, or yellowish or pale 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 do not function properly.

The symptoms of lactic acidosis are non-specific (see section "Warnings and Precautions").

• skin redness,
• itching,
• itchy skin rash (urticaria),
• abnormal liver function tests or liver inflammation; this may

produce:

• fatigue,
• loss of appetite,
• weight loss,
• with or without a yellowish tone of the skin or the whites of the eyes.

Stop taking metformin and inform your doctor immediately if this happens to you.

Children and Adolescents

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

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting adverse effects, you can contribute to providing 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 advised that parents and caregivers supervise how this medicine is used.

Do not use this medicine after the expiration date that appears on the packaging, blister, or bottle after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Metformin Sandoz

• The active ingredient is metformin hydrochloride. Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.

• The other ingredients are:

povidone K 90 and magnesium stearate, hypromellose, macrogol 4000, and titanium dioxide.

Appearance of the Product and Package Contents

White, oval, film-coated tablets, scored on one side and with the imprint "M 850" on the other. Dimensions: 19 mm x 6.5 mm.

Metformin Sandoz 850 mg is available in:

• HDPE bottles with LDPE or PP caps and a desiccant container containing 30, 60, 100, 200, 250, 500 film-coated tablets,
• PVC/aluminum blisters with 20, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180, 250, 300

film-coated tablets. Keep the desiccant container inside the bottle.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, 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 Pharmaceuticals d.d.

Verovskova, 57

1526 Ljubljana

Slovenia

or

Lek S.A.

16 Podlipie. Str

95-010 Strykow

Poland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Belgium: Metformine Sandoz 850 mg filmomhulde tabletten

Bulgaria: ???????? 850 MG ????????? ????????

Denmark: Metformin Sandoz

Slovenia: Metforminijev klorid Lek 850 mg filmsko obložene tablete

Estonia: Glucoral 850mg

Finland: Oramet 850 mg tabletti, kalvopäällysteinen

France: METFORMINE SANDOZ 850 MG, COMPRIMÉ PELLICULÉ

Norway: Metformin Sandoz 850 mg tabletter, filmdrasjerte

Poland: Etform 850 , 850 MG, TABLETKI POWLEKANE

Portugal: METFORMINA ROMAC

Netherlands: Metformine HCl Sandoz 850 mg , filmomhulde tabletten

United Kingdom: Metformin hydrochloride 850 mg film-coated tablets

Czech Republic: Metformin Sandoz

Sweden: Metformin Sandoz 850 mg filmdragerad tablett

This leaflet was revised in:April 2025.

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