Metformin Alter 850 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metformina Alter 850 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, and you should not give it 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 the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What is Metformina Alter and what is it used for?

Metformina Alter contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that enables your body to absorb 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 causes 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 weight maintenance or a slight reduction in body weight.

Metformin 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 their blood glucose levels. It is especially used in overweight patients.

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

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

2. What you need to know before taking Metformina Alter

Do not take Metformina Alter

• 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, 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 condition in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling 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 trigger kidney problems, which could 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 may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you are being treated for acute heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have difficulty breathing. These conditions may lead to reduced oxygen supply to tissues, which could put you at risk of developing lactic acidosis (see “Warnings and precautions” below).
• If you drink alcohol excessively.

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

Make sure to consult your doctor if

• you require an imaging procedure such as an X-ray or a scan involving the injection into the bloodstream of iodine-containing contrast agents.
• you need 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 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 receives reduced oxygen supply (such as acute and severe heart diseases).

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

Stop taking metformin temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking metformin and contact your 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 discomfort with marked fatigue
• difficulty breathing
• reduced body temperature and reduced 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 treatment with metformin.

Metformin alone does not cause hypoglycemia (blood glucose level too low). However, if you take this medicine together with other diabetes treatments that may 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, vision disturbances, or difficulty concentrating, it is generally 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.

Contact your doctor promptly for advice 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 develop any of the following symptoms after starting metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Other medicines and Metformina Alter

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 treatment with metformin.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of this medicine. 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 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)
• medicines 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 medicines used to treat diabetes.

Taking Metformina Alter with alcohol

Avoid excessive alcohol consumption while taking this medicine, 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, consult your doctor about whether changes to your treatment or monitoring of your blood glucose levels are needed.

This medicine is not recommended during breastfeeding or if you plan to breastfeed your baby.

Driving and use of machines

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

However, take special care if you take this medicine together with other diabetes treatments 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 Metformina Alter

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

This medicine cannot replace the benefits of a healthy lifestyle. Continue to follow any dietary advice given by your doctor 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 2000 mg, divided into 2 or 3 doses. Treatment in children aged between 10 and 12 years is only recommended under specific medical advice, as clinical experience in this patient group is limited.

Adults usually start with 500 mg or 850 mg of metformin, taken 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 this medicine.

Monitoring

• Your doctor will regularly monitor your blood glucose levels and adjust your metformin dose accordingly. 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 your kidney function 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 Metformina Alter

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

Metformina Alter tablets have a score line. The score line is not intended for splitting the tablet.

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

If you take more Metformina Alter 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 muscle cramps, a general feeling of malaise 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 progress to coma.

Stop taking metformin immediately and contact your doctor or the nearest hospital without delay.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metformina Alter

Do not take a double dose to make up for missed doses. Take the next dose at your usual time. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Very common adverse effects (may affect 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 metformin treatment. Spreading the doses throughout the day and taking metformin during or immediately after a meal may help reduce these adverse effects. If symptoms persist, stop taking metformin and consult your doctor.

Common adverse effects (may affect up to 1 in 10 people):

• changes in taste sensation.
• low or reduced 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 adverse effects (may affect up to 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, especially 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; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this occurs, stop taking metformin and speak with your doctor.
• skin reactions such as redness of the skin (erythema), itching, or an 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 Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Alter

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Alter 850 mg

• The active substance is metformin hydrochloride. One Metformina Alter 850 mg film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are povidone, magnesium stearate, hypromellose, and macrogol.

Appearance of Metformina Alter 850 mg and contents of the pack

Metformina Alter 850 mg film-coated tablets EFG are white to yellowish, biconvex, oval-shaped tablets, with a notch between the M and B on one side and a notch on the other side.

This medicine is available in packs of 30, 40, 50, 60 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Manufacturer

SAG Manufacturing S.L.U
Crta. N-I, Km 36
San Agustín de Guadalix
28750 Madrid
Spain

or

Galenicum Health, S.L.U
Sant Gabriel, 50, Esplugues de Llobregat
08950 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: Metformina Alter 850 mg comprimés pelliculés
Italy: Metformina Alter 850 mg compresse rivestite con film
Portugal: Metformina Alter 850 mg comprimidos revestidos por película
Spain: Metformina Alter 850 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: 03/2025

Other source of information

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