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Patient Information Leaflet

Metformin Sandoz 850 mg Film-Coated Tablets

metformin hydrochloride

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, ask 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 Metformin Sandoz is and what it is used for

2. What you need to know before you start 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. It 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 high levels of glucose in the blood. Metformin helps to reduce your blood glucose to a normal level as possible.

If you are an adult with obesity, taking metformin for a prolonged period also helps to reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight decrease in it.

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 levels. It is used especially in patients with obesity.

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 havea severe reduction in kidney function,
• If you have uncontrolled diabetes with, 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 a fruity odor to your breath,

• If you haveliver problems,
• If you regularly consume large amounts ofalcohol,
• If you have lost a lot of water from your body (dehydration), for example due to
• • a long 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 “Warnings and precautions”).

• If you are being treated foracute heart failureor if you have recently had aheart attack, have severe circulation problems (such as shock), or have difficulty breathing. 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 you have a severe infection, such as those affecting the lungs, airways, or kidneys. Severe infections can cause kidney problems, which can put you at risk of lactic acidosis (see “Warnings and precautions”).

If you have any of the conditions mentioned above, consult your doctor before starting to take this medication.

Make sure to consult your doctor if:

• You need an examination such as an X-ray or a scan that involves injecting a contrast medium containing iodine into your bloodstream.
• You need a major surgical intervention.

You should stop taking metformin for a certain period of time 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.

Warnings and precautions

Risk of lactic acidosis

Metformin can cause a rare but 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, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition where a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

Stop taking metformin for a short period of time 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 of the symptoms that cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• Vomiting,
• Abdominal pain (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.

Metformin by itself 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 meglitinides), 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, you can usually help by eating or drinking something containing sugar.

If you need to undergo a major surgical procedure, you should stop taking metformin during the procedure and for a period of time afterward. Your doctor will decide when to stop and when to restart metformin treatment.

Consult your doctor before starting to take metformina if you have any of the following conditions:

• If you have symptoms oflow blood sugar levelssuch as:
• Weakness,
• Dizziness,
• Increased sweating,
• Fast heart rate,
• Visual disturbances,
• Difficulty concentrating.

In this case, eating or drinking something with sugar can usually help. Metformin by itself does not cause a significant drop in blood sugar levels, but other diabetes medications may do so.

• Obesity,

Follow a low-calorie diet.

• If you are taking other medications,

See the section “Taking Metformina Sandoz with other medications”.

• 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.

Children under 10 years

Metforminis not recommendedin this age group.

Other medications and Metformina Sandoz

If you need to be administered an injection of a contrast medium containing iodine into your bloodstream, for example, during 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 treatment.

Inform your doctor or pharmacistif you are taking or have recently taken 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:

• Medications containingalcohol,
• glucocorticoids, medications used to prevent organ transplant rejection, reduce skin inflammation, or asthma;
• bronchodilatorssuch as salbutamol, fenoterol, and terbutaline;
• • diuretics (medications that increase urine production),
  • medicationsused to treat pain and inflammation(NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
  • antihypertensive medications(ACE inhibitors and angiotensin II receptor antagonists),
• medications that may change the amount of metformin in the blood,especially if you have a reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• medications to reduce blood sugar levelssuch as insulin or other oral antidiabetic medications.

Taking these medications with metformin can cause blood sugar levels to drop too low. See “Warnings and precautions”.

Taking Metformina Sandoz with alcohol

Avoid excessive alcohol consumption while taking metformin, as this can increase the risk of lactic acidosis (see the 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 making changes to your treatment or monitoring your blood glucose levels.

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

Driving and operating machines

Metformin by itself does not cause hypoglycemia,(low blood sugar). This means it will not affect your ability to drive or operate machines.

However, be extra careful if you take metformin with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machines if you start to feel these symptoms.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you have reduced renal function, your doctor may prescribe a lower dose.

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

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

*Also available in 500 mg and 1000 mg hydrochloride tablets of metformin as active substance, for individualized dose adjustment.

Adults

Children 10 years or older

• Initial normal dose: 500 mg* of hydrochloride metformin or 1 Metformina Sandoz 850 mg tablet per day.
• After the child has taken metformin for approximately 2 weeks, your doctor will measure your blood sugar levels and adjust your dose.
• Maximum dose: 2,000 mg* of hydrochloride metformin per day, divided into 2 or 3 doses.

Patients 65 years or older

Since the likelihood of renal insufficiency is higher in this age group, your doctor will decide on the metformin dose based on your renal function.

See also in section 2 "Warnings and precautions".

Administration form

Swallow the tablets with a glass of waterduring or after meals. This will help you avoid adverse effects during digestion. The groove is only for breaking the tablet if it is difficult to swallow whole.

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

• If you take a dose once a day, 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 one in the morning (breakfast), one at noon (lunch) and one in the evening (dinner).

If after some time, you think the effect of metformin is too intense or too weak, consult your doctor or pharmacist.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your metformin dose based on your blood sugar levels. 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.

Treatment duration

Your doctor will decide on the treatment duration.

If you take more Metformina Sandoz than you should

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

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

If you have taken more metformin than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Metformina Sandoz

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

Do not take a double dose to compensate for the missed doses. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Metformina Sandoz

If you interrupt treatment with metformin without your doctor's consent, your blood sugar levels may increase 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 medication, ask your doctor or pharmacist.

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

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

Metformin may cause a very rare but serious side effect (affecting up to 1 in 10,000 people), called lactic acidosis (see section “Warnings and precautions”), If this happens to you,you should stop taking metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Other possible side effects

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

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

These side effects appear more frequently at the beginning of treatment with metformin. Taking the doses throughout the day and taking metformin during or immediately after a meal may help reduce these side effects. If symptoms persist, stop taking metformin and consultyour doctor.

Common, may affect up to 1 in 10 people

-Changes in 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.

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

• lactic acidosis. It is a 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,
• skin rash with itching (urticaria),
• abnormalities in liver function tests or liver inflammation; this may

result in:

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

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

Children and adolescents

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. If a child is being treated with metformin, parents and caregivers are advised to supervise how this medication is used.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused

medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Metformina Sandoz

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

• The other components are:

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

Appearance of the product and contents of the package

Film-coated tablets, white in color, oval in shape, scored on one side, and with the imprint “M 850” on the other. Dimensions: 19 mm x 6.5 mm.

Metformina Sandoz 850 mg is available in:

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

Keep the desiccant packaging inside the bottle.

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.

Centro Empresarial Parque Norte

Edificio Roble

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 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) under the following names:

Bélgica:Metformine Sandoz 850 mg filmomhulde tabletten

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

Dinamarca:Metformin Sandoz

Eslovenia:Metforminijev klorid Lek 850 mg filmsko obložene tablete

Estonia:Glucoral 850mg

Finlandia:Oramet 850 mg tabletti, kalvopäällysteinen

Francia:METFORMINE SANDOZ 850 MG, COMPRIMÉ PELLICULÉ

Noruega:Metformin Sandoz 850 mg tabletter, filmdrasjerte

Polonia:Etform 850 , 850 MG, TABLETKI POWLEKANE

Portugal: METFORMINA ROMAC

Países Bajos:Metformine HCl Sandoz 850 mg , filmomhulde tabletten

Reino Unido:Metformin hydrochloride 850 mg film-coated tablets

República Checa: Metformin Sandoz

Suecia:Metformin Sandoz 850 mg filmdragerad tablett

This leaflet has been revised in:September 2023.

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