Metformin Kern Pharma 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina Kern Pharma 1,000 mg film-coated tablets EFG

metformin hydrochloride

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

• Keep this leaflet. 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, because 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 Kern Pharma is and what it is used for
2. What you need to know before taking Metformina Kern Pharma
3. How to take Metformina Kern Pharma
4. Possible adverse effects
5. How to store Metformina Kern Pharma
6. Contents of the pack and other information

1. What Metformina Kern Pharma is and what it is used for

Metformina Kern Pharma is a medicine used to treat diabetes. It belongs to a group of medicines called biguanides (a class of oral antidiabetic agents).

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 a high concentration of glucose in the blood.

Metformina Kern Pharma helps lower your blood glucose to as near-normal levels as possible.

If you are an overweight adult, taking Metformina Kern Pharma over a prolonged period also helps reduce the risk of diabetes-related complications. Metformina Kern Pharma is associated with maintenance of body weight or a slight reduction in body weight.

Metformina Kern Pharma is used to treat patients with type 2 diabetes (also called "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 Metformina Kern Pharma alone or in combination with other antidiabetic medicines (oral medications or insulin).

Children aged 10 years and older, and adolescents, may take Metformina Kern Pharma alone or together with insulin.

2. What you need to know before taking Metformina Kern Pharma

Do not take Metformina Kern Pharma

• If you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems.
• If you have severely reduced kidney function.
• 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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity odor on your breath.
• If you have lost a large amount of fluid from your body (dehydration), for example due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may lead to kidney problems, increasing your risk of lactic acidosis (see “Warnings and precautions”).
• If you are receiving treatment for acute heart failure, have recently had a heart attack, have severe circulation problems (such as shock), or have difficulty breathing. These conditions may result in poor tissue oxygenation, increasing your risk of lactic acidosis (see “Warnings and precautions” below).
• If you drink large amounts of alcohol.

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

Make sure to consult your doctor if:

• You need an examination such as an X-ray or scan involving the injection of iodine-containing contrast agents into your bloodstream.
• You need major surgery.

You must stop taking Metformina for a certain period of time before and after the examination or surgical procedure. 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 serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see further information below), liver problems, or any medical condition in which part of the body receives reduced oxygen supply (such as acute and severe heart diseases). If any of these apply to you, consult your doctor for further instructions.

Contact your doctor immediately for guidance if:

• You are known to have a genetic mitochondrial disease (components that produce energy inside 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, movement difficulties, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking Metformina Kern Pharma temporarily if you develop a condition 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 Metformina Kern Pharma 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 (abdominal 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 Metformina during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart metformin treatment.

Metformin alone does not cause hypoglycemia (blood glucose levels too low). However, if you take metformin together 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, vision 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 elderly and/or if your kidney function is deteriorating.

Taking Metformina Kern Pharma with other medicines

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:

• medications that increase urine production (diuretics).
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medications 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).
• medications that may alter 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).
• other medications used to treat diabetes.

Taking Metformina Kern Pharma with alcohol

Avoid excessive alcohol consumption while taking metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility

Pregnant women with diabetes or those planning to become pregnant should not be treated with metformin. Instead, insulin should be used to keep 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 switched to insulin.

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

Driving and using machines

Metformin alone does not cause hypoglycemia (low blood glucose levels). 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 medications that may cause hypoglycemia (such as sulfonylureas, insulin, or 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 Kern Pharma

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Recommended dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once daily. The maximum daily dose is 2,000 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 daily. The maximum daily dose is 3,000 mg, divided into 3 doses.

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

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

Monitoring

• Your doctor will carry out regular blood glucose tests and adjust your dose of metformin according to your blood glucose levels. Be sure to speak regularly with your doctor. This is particularly 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 do not function normally.

How to take Metformin Kern Pharma

Take metformin with meals or immediately after meals. This will help prevent gastrointestinal side effects. Do not chew or crush the tablets. Swallow each tablet 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 at night (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and at night (dinner).

If, after some time, you think the effect of metformin is too strong 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 develop lactic acidosis. Symptoms of lactic acidosis are nonspecific and include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with severe 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metformin Kern Pharma

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

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

4. Possible adverse effects

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

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 Metformina Kern Pharma and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common adverse effects (affects more than 1 in 10 people):

• gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These adverse effects occur most frequently at the beginning of treatment with Metformin. Taking the daily dose in divided amounts and taking Metformin during or immediately after meals may help reduce these adverse effects. If symptoms persist, stop taking Metformina Kern Pharma and consult your doctor.

Common adverse effects (affects less than 1 in 10 people):

• changes in taste sensation.

Very rare adverse effects (affects less than 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not working properly.
• the symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this occurs, stop taking Metformina Kern Pharma and speak to your doctor.
• skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).
• low blood concentration of vitamin B12.

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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformina Kern Pharma

Keep this medicine out of the sight and reach of children.

If a child is being treated with Metformina, parents and caregivers are advised to supervise the use of this medicine.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Kern Pharma

• The active substance is metformin hydrochloride.

Each Metformina Kern Pharma film-coated tablet contains 1,000 mg of metformin hydrochloride, 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 pack contents

Metformina Kern Pharma is presented as film-coated tablets, white-yellow in colour, oval and biconvex, with "MC" on one side and a score line on the other.

Blister pack (PVC/PVdC Aluminium) containing 30, 50 and 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

SAG MANUFACTURING S.L.U

Carretera Nacional 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 was last approved in: March 2025

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