Package Leaflet: Information for the User

Metformin Sandoz 1,000 mg Film-Coated Tablets EFG

hydrochloride of metformin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Metformin Sandoz

3. How to take Metformin Sandoz

4. Possible side effects

5. Storage of Metformin Sandoz

6. Contents of the pack and additional information

Metformina Sandoz contains metformin, a medication for treating diabetes. Metformin belongs to a group of medications called biguanides.

Insulin is a hormone produced by the pancreas that makes your body capture 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 effectively. This causes a high concentration of glucose in the blood. Metformin helps to reduce your blood glucose concentration to a normal level as possible.

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

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

• Adults can take metformin alone or with other diabetes medications (oral medications or insulin).

- Children aged 10 years and older, and adolescents, can take metformin alone or with insulin.

Do not take Metformina Sandoz

• If you areallergicto metformin or any of the other components of this medication (listed in section 6),
• If you have a severe reduction in kidney function,
• If you haveliver problems,
• If you haveuncontrolled 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 diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor,
• If you havelost too much waterfrom your body (dehydration) for example due to prolonged or intense 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"),
• If you have aserious infection, for example a lung, bronchial, or kidney infection. Serious infections can trigger kidney problems, which can put you at risk of developinglactic acidosis(see below "Be especially careful"),
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have severe circulation problems or if you have difficulty breathing. This can make it difficult to supply oxygen to tissues, which can put you at risk of developing lactic acidosis (see below "Advertencias and precautions"),
• If you drink a large amount ofalcohol.

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

Make sure to ask your doctor for advice if:

• You need an examination such as an X-ray or scan that involves the injection of acontrast agentcontaining iodineinto your bloodstream,
• You need amajor 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 essential to follow your doctor's instructions precisely.

Advertencias 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 functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting, or alcohol consumption, dehydration (see below "Be especially careful"), liver problems, and any medical condition 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 you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and deafness (MIDD).

• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with movement, 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 condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less than usual. Consult your doctor for further instructions.

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

The symptoms of lactic acidosis include:

• Vomiting,
• Stomach pain,
• Muscle cramps,
• General feeling of discomfort with intense fatigue,
• Difficulty breathing,
• Reduced body temperature and heart rate.

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

If you need to undergo a major surgery, stop taking metformin while the procedure is being performed and for a period after. Your doctor will decide when to stop and when to restart metformin.

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

Metformin Sandoz alone does not cause hypoglycemia (low blood sugar). However, if you take metformin with other diabetes medications 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, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

Other medications and Metformin Sandoz

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

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. 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:

• Diuretics that increase urine production,
• Medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib),
• Certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• Beta-2 agonistssuch as salbutamol or terbutaline (used to treat asthma),
• Corticosteroids(used to treat various conditions, such as severe skin inflammation or asthma),
• Medicationsthat can change the amount of metformin in the blood, especially if kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• Other medications 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 "Advertencias and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor about whether you need to make changes to your treatment or monitor your blood glucose levels.

This medication is not recommended if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin alone does not cause hypoglycemia (low blood sugar). This means it will not affect your ability to drive or use machines.

However, be especially careful if you take metformin withother diabetes medicationsthat can cause hypoglycemia (such as sulfonylureas, insulin, or glinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Metformin cannot replace the benefits of a healthy lifestyle. Continue following any dietary advice given by your doctor and practice regular exercise.

The recommended dose is:

Children aged 10 years and over 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 two or three times a day. The maximum daily dose is 3000 mg divided into three doses.

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

If you are also taking insulin, your doctor will instruct you on how to start taking metformin.

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

Monitoring:

• Your doctor will adjust your metformin dose according to your blood glucose concentration. Make sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are an elderly person.
• Your doctor will also check, at least once a year, how your kidneys are functioning. You may need more frequent check-ups if you are an elderly person or if your kidneys do not function normally.

How to take Metformin Sandoz:

Take Metformin Sandoz with meals or after meals. This will prevent you from experiencing adverse effects that affect your digestion.

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

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

If, after some time, you think the effect of Metformin Sandoz is too intense or too weak, consult 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 experience lactic acidosis. The symptoms of lactic acidosis are nonspecific 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, you may need immediate hospital treatment, as lactic acidosis can lead to 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, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Metformin Sandoz

Do not take a double dose to compensate for the missed dose. Take the next dose at the usual time.

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

Like all medicines, this one may cause side effects, although not everyone will experience them.

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

Very common,can 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. Help distribute the doses throughout the day and if you take the tablets during or immediately after a meal.If symptoms persist, stop taking metformin and consult your doctor.

Common, can affect up to 1 in 10 people

• Changesin taste,
• low or decreased levels of vitamin B12 in the blood (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia), or yellow or pale skin). Your doctor may schedule some tests to find the cause of your symptoms because some of them may be caused by diabetes or other unrelated health problems.

Veryrare, can affect up to 1 in 10,000 people

• lactic acidosis. It is a rare but serious complication, particularly if your kidneys do not function properly. The symptoms of lactic acidosis are not specific (see the "Warnings and precautions" section),
• abnormalities in liver function tests or hepatitis (inflammation of the liver, which can cause fatigue, loss of appetite, weight loss, with or without yellow discoloration of the skin or the white of the eyes).

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

• skin reactions such as skin redness (erythema), itching, or hives with itching (urticaria).

Children and adolescents

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children. If a child is treated with metformina, it is recommended that parents and caregivers supervise how this medication is used.

No special storage conditions are required

Do not use this medication after the expiration date that appears on the packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Metformin Sandoz

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

Appearance of the product and contents of the package

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

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

Dimensions: approximately 19 mm x 10 mm.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Business Park North

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Meglucon Sandoz 1000 mg - Filmtabletten

Slovenia:Metformin Lek 1000 mg filmsko obložene tablete

Estonia:Metformin Sandoz

France:METFORMINE SANDOZ 1000 mg, comprimé pelliculé sécable

Italy:METFORMINA HEXAL

Norway:Metformin Sandoz 1000 mg filmdrasjerte tabletter

Netherlands:METFORMINE HCL SANDOZ 1000 MG, FILMOMHULDE TABLETTEN

Poland:Etform

Portugal:METFORMINA SANDOZ 1000 MG COMPRIMIDOS REVESTIDOS

Czech Republic:Metformin Sandoz

Sweden:Metformin Sandoz 1000 mg filmdragerade tabletter

Last review date of thisleaflet:April 2025

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/