Metformin Sandoz 1,000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metformina Sandoz 1,000 mg film-coated tablets EFG

metformin hydrochloride

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

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

Leaflet Contents

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

1. What Metformin Sandoz is and what it is 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 enables your body to 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 properly use the insulin it produces. This leads to high levels of glucose in the blood. Metformin helps lower your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin over a prolonged period also helps reduce the risk of diabetes-related complications. Metformin is associated with both stable body weight and 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 sufficient to control blood glucose levels. It is especially used in overweight patients.

• Adults may take metformin alone or in combination with other antidiabetic medicines (oral medications or insulin).

• Children aged 10 years and older, and adolescents, may take metformin alone or together with insulin.

2. What you need to know before taking Metformina Sandoz

Do not take Metformina Sandoz

• If you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6),
• if you have severely reduced kidney function,
• if you have liver problems,
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or an unusual fruity odor on your breath,
• if you have lost too much fluid from your body (dehydration), for example due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Special precautions”),
• if you have a severe infection, for example an infection affecting your lungs, bronchi, or kidneys. Severe infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Special precautions”),
• if you are receiving treatment for acute heart failure or have recently had a heart attack, if you have serious circulation problems, or if you have difficulty breathing. These conditions may impair oxygen delivery to tissues, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions”),
• if you drink large amounts of alcohol.

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

Make sure to seek advice from your doctor if:

• you require an imaging procedure such as an X-ray or scan involving the injection of a contrast agent containing iodine into your bloodstream,
• you require major surgery.

You must stop taking metformin for a certain period before and after the procedure or surgery. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformin may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body has reduced oxygen supply (such as severe acute heart disease).

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disease (mitochondria are energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).

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

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

Temporarily stop taking metformin if you develop an illness that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. 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 may lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• stomach pain,
• muscle cramps,
• general feeling of malaise with severe fatigue,
• difficulty breathing,
• decreased body temperature and heart rate.

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

If you need to undergo major surgery, you must stop taking metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart metformin treatment.

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 deteriorating.

Metformina Sandoz alone does not cause hypoglycemia (low blood glucose). However, if you take metformin together 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, vision disturbances, or difficulty concentrating, it is generally helpful to eat or drink something containing sugar.

Other medicines and Metformina Sandoz

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

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require 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 increase urine production (diuretics),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib),
• certain medicines for high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter 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 Metformina Sandoz with alcohol

Avoid excessive alcohol consumption while taking Metformina Sandoz, as this may increase the risk of lactic acidosis (see section “Warnings 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 changes to your treatment or monitoring of your blood glucose levels are needed.

This medicine 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 glucose). This means it will not affect your ability to drive or operate machinery.

However, take special care if you take metformin together with other diabetes medicines that may cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Metformin Sandoz

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

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

The recommended dose is:

Children aged 10 years and older and adolescents usually 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 of age is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Adults usually 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 adjustment, tablets containing 500 mg and 850 mg of the active substance metformin hydrochloride are available.

If you are also using insulin, your doctor will advise you on 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 according to your blood glucose levels. Make sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check at least once a year how well your kidneys are functioning. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Sandoz:

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

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

• If you take one dose per day, take it in the morning (with breakfast).
• If you take two doses per day, take them in the morning (breakfast) and in the evening (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and in the evening (dinner).

The score line is intended solely for easier swallowing and allows the tablet to be divided if you have difficulty swallowing it whole.

If, after some time, you think that the effect of Metformin Sandoz is too strong 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 develop lactic acidosis. Symptoms of lactic acidosis are nonspecific and may include vomiting, abdominal pain with cramps, a general feeling of malaise with fatigue and difficulty breathing. Other symptoms include decreased body temperature and heart rate. If this occurs, you may require 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 prescribed, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount taken.

If you forget to take Metformin Sandoz

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

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

4. Possible adverse effects

Like all medicines, this one can produce adverse effects, although not everyone will experience them.

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

Very common, may affect more than 1 in 10 people

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These adverse effects occur most frequently when starting treatment. It may help to spread the doses throughout the day and to take the tablets during or immediately after meals. If symptoms persist, stop taking metformin and consult your doctor.

Common, may affect up to 1 in 10 people

• Changes in taste sensation,
• low or decreased levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and painful tongue (glossitis), tingling (paraesthesia), or yellowish or pale skin). Your doctor may schedule some tests to determine the cause of your symptoms, as 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. This is a very rare but serious complication, particularly if your kidneys are not functioning properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”),
• abnormalities in liver function tests or hepatitis (liver inflammation, which may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes).

If this happens to you**, stop taking** this 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 adverse effects were similar in nature and severity to those observed in adults.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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, parents and caregivers are advised to supervise the use of this medicine.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Instead, dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Sandoz

• The active substance 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, and the colouring agent titanium dioxide (E 171).

Appearance of the product and contents of the pack

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

• Aluminium/PVC blisters containing 20, 30, 60, 90, 120, 180 and 300 tablets.
• HDPE bottles with LDPE cap or PP cap and desiccant, containing 100 and 200 tablets.

Dimensions: approximately 19 mm x 10 mm.

Only certain pack 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 S.A

ul. Podlipie 16,

95-010 Stryków

Poland

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57,

1526 Ljubljana

Slovenia

This medicinal product is authorised in the European Economic Area member states under 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

Date of the most recent review of this leaflet: April 2025

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