PATIENT INFORMATION LEAFLET

Metformin Kern Pharma 1,000 mg Film-Coated Tablets EFG

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).

MetforminaKern Pharmais a medication for treating diabetes. It belongs to a group of medications called biguanides (a class of oral antidiabetic medications).

Insulin is a hormone produced by the pancreas that makes the body capture glucose (sugar) from the blood. The 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.

MetforminaKern Pharmahelps to reduce your blood glucose to a level as normal as possible.

If you are an adult with obesity, takingMetformina Kern Pharmafor a prolonged period also helps to reduce the risk of complications associated with diabetes.Metformina Kern Pharmais associated with maintaining body weight or a slight decrease in it.

Metformina Kern Pharmais 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 their blood glucose levels. It is used especially in patients with obesity.

Adults can takeMetformina Kern Pharmaalone or in combination with other diabetes medications (oral medications or insulin).

Children aged 10 years and older, and adolescents can takeMetformina Kern Pharmaalone or in combination with insulin.

Do not take Metformina Kern Pharma

• If you areallergic (hypersensitive)to metformin, or to any of the other components of this medication (listed in section 6).
• If you have liver problems.
• If you have severe kidney function reduction.
• If you have uncontrolled diabetes, 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 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 have lost a lot of body water (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 "Warnings and precautions").
• If you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions").
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have severe circulation problems (such as shock) or if you have difficulty breathing. This can lead to tissue hypoxia, which can put you at risk of developing lactic acidosis (see below "Warnings and precautions").
• If you drink a lot of alcohol.

If any of the above circumstances apply to you, 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 the injection of contrast media containing iodine into your bloodstream.
• You need a major surgical intervention.

You should stop taking Metformina 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 that you follow your doctor's instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformin may 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 more information below), 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). If any of the above applies to you, consult your doctor for further instructions.

Consult your doctor immediately to determine how to proceed if:

• You have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking Metformina Kern Pharma 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 liquid than normal. Consult your doctor for further instructions.

Stop taking Metformina Kern Pharma 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.

If you need to undergo a major surgical procedure, you should stop taking Metformina while the procedure is being performed and for a period of time after it. Your doctor will decide when to interrupt treatment with Metformina and when to resume it.

Metforminby itself does not cause hypoglycemia (low blood glucose). However, if you take Metforminalong with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, 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, it is usually helpful to eat or drink something containing sugar.

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.

Taking Metformina Kern Pharma with other medications

If you need to receive an injection of contrast media containing iodine into your bloodstream, for example, in the context of an X-ray or examination, you should stop taking Metformina before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Metformina and when to resume it.

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 agonists, such as salbutamol or terbutaline (used to treat asthma).
• Corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma).
• Medications that can alter the amount of Metforminin your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, or olaparib).
• Other medications used to treat diabetes.

Taking Metformina Kern Pharma with alcohol

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

Pregnancy, breastfeeding, and fertility

Women with diabetes who are pregnant or planning to become pregnant should not receive treatment with metformin. Instead, insulin should be used to maintain blood glucose levels as close to normal as possible. Inform your doctor if you are pregnant or planning to become pregnant so that your treatment can be changed to insulin.

This medication should not be used during breastfeeding. If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Metforminby itself does not cause hypoglycemia (low blood glucose). This means that it will not affect your ability to drive or operate machinery.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Metformin Kern Pharma cannot replace the benefits derived from a healthy lifestyle. Continue following any dietary advice given by your doctor and exercise regularly.

Recommended dose

Children aged 10 years and older and adolescentsusually start with 500 mg or 850 mg of Metformin once a day. The maximum daily dose is 2,000 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.

Adults usually start with 500 mg or 850 mg of Metformin, two or three times a day. The maximum daily dose is 3,000 mg divided into 3 doses.

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.

Monitoring

• Your doctor will perform regular blood glucose tests and 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 an elderly person.
• Your doctor will also check, at least once a year, how your kidneys are functioning. You may need more frequent checks if you are an elderly person or if your kidneys do not function normally.

How to take Metformin Kern Pharma

Take Metformin with meals or after meals. This will help prevent digestive side effects. Do not chew or crush 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 daily doses, take them in the morning (breakfast) and in the evening (dinner).
• If you take three daily doses, take them in the morning (breakfast), at noon (lunch), and 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.

If you take more Metformin Kern Pharma than you should

If you have taken more Metformin than you should, you may experience lactic acidosis. Symptoms of lactic acidosis are nonspecific 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 Kern Pharma immediately and contact your doctor or the nearest hospital right away.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Metformin Kern Pharma

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

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

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

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

Very common side effects (affecting more than 1 in 10 people):

• digestive problems, such as nausea, vomiting, diarrhea, stomach pain (abdominal pain) and loss of appetite. These side effects occur 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 Kern Pharma and consult your doctor.

Common side effects (affecting less than 1 in 10 people):

• changes in taste.

Rare side effects (affecting less than 1 in 10,000 people):

• lactic acidosis. This is a rare but serious complication, especially if your kidneys do not function properly.
• the symptoms of lactic acidosis are nonspecific (see "Warnings and precautions" section).
• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without a yellowish tone of the skin or the white of the eyes). If this happens to you,stop taking Metformin Kern Pharma and talk to your doctor.
• skin reactions such as skin redness (erythema), itching or a pruritic rash (urticaria).
• low blood vitamin B12 levels.

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 leaflet. You can also report them directly through the Spanish System for the 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 Metformina, it is recommended that parents and caregivers supervise the use of this medication.

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

This medication does not require special conditions for conservation.

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

Composition of Metformina Kern Pharma

• The active ingredient is hydrochloride of metformin.

Each film-coated tablet of Metformina Kern Pharma contains 1,000 mg of hydrochloride of metformin, equivalent to 780 mg of metformin base.

• The other components are: povidone, magnesium stearate, hypromellose, macrogol 400, and macrogol 6000.

Appearance of the product and content of the packaging

Metformina Kern Pharma is presented in the form of film-coated tablets, white-yellow in color, oval, and biconvex with MC on one side and a groove on the other side.

PVC/PVdC aluminum blister packaging with 30, 50, and 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

SAG MANUFACTURING S.L.U

National Highway I, Km 36

San Agustín de Guadalix 28750

Madrid, Spain

GALENICUM HEALTH S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950, Barcelona

Spain

This leaflet has been approved in: March 2025

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