Metformin Pharma Combix 1,000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

metformin hydrochloride

Read all of this 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Metformina Pharma Combix 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 leads to high levels of glucose in the blood. Metformin helps reduce 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 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 Pharma Combix

Do not take Metformina PharmaCombix

• 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 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 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 several times in succession. 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 receiving treatment 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. This may result in inadequate oxygenation of tissues, which could put you at risk of developing 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 require an imaging procedure such as an X-ray or scan involving the injection into your blood of iodine-containing contrast media
• if you require major surgery.

You must stop taking metformin for a certain period of time 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 cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, 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.

Contact your doctor promptly 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, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking metformin and contact a doctor or go to 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 profound fatigue
• difficulty breathing
• reduced body temperature and heart rate

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

Stop taking metformin for a short period 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.

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.

Metformin alone does not cause hypoglycemia (blood glucose level 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 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.

Other medicines and Metformina PharmaCombix

If you need to receive an injection of iodine-containing contrast media 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.

Tell 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 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 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 PharmaCombix with alcohol

Avoid excessive alcohol consumption while taking metformin, 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 if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

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

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 Metformina Pharma Combix

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Metformin 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 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 a lower dose.

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

Monitoring

• Your doctor will regularly monitor your blood glucose levels and adjust your metformin dose accordingly. Make sure to consult your doctor regularly. 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 Pharma Combix

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 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).

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 Pharma Combix 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 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, seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking metformin immediately and contact your doctor or go to the nearest hospital without delay.

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

If you forget to take Metformina Pharma Combix

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 medicine, 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 metformin 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 treatment with metformin. Spreading the doses throughout the day and taking metformin with food 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 arrange some tests to determine the cause of your symptoms, as some of them may be caused by diabetes or due to other health problems unrelated to this medicine.

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 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 happens to you, stop taking metformin and speak to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformina Pharma Combix

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 how this medicine is used.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. 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 PharmaCombix 1.000 mg

• The active substance is metformin hydrochloride. One film-coated tablet of Metformina Pharma Combix 1.000 mg contains 1.000 mg of metformin hydrochloride, equivalent to 780 mg of metformin base.
• The other components are: povidone, magnesium stearate, hypromellose and macrogol.

Appearance of the medicinal product and contents of the pack

Film-coated tablets.

Metformina Pharma Combix 1.000 mg EFG film-coated tablets are white to yellowish, biconvex, oval-shaped tablets, with the imprint "MC" on one side and a functional score line on the other. The tablet can be divided into equal doses.

Metformina Pharma Combix 1.000 mg is available in packs containing 30, 50 or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª,

Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

Or

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

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

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