Patient Information Leaflet

Metformina Pharma Combix 1.000 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 pass it on to others even if they have similar symptoms, 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.

Table of Contents

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

Metformina Pharma Combix 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 levels to as normal a level as possible.

If you are an adult with overweight, 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 sufficient to control their blood glucose levels. It is used especially in patients with overweight.

Adults can take metformin alone or with other medications for treating diabetes (oral medications or insulin).

Children aged 10 years and above, and adolescents can takemetforminalone or with insulin.

Do not takeMetformina 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 severe kidney function reduction
• 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, which can lead to diabetic pre-coma. 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 water from your body (dehydration), for example due to prolonged or severe 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, a lung, bronchial, or kidney infection. 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 if you 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 medicine.

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
• if 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 very rare but very 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 in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

Consult your doctor for more instructions if any of the above applies to you.

Consult your doctor immediately if:

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

Stop takingmetforminand 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
• stomach pain (abdominal 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.

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 severe vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. Consult your doctor for more instructions.

If you need to undergo a major surgical procedure, stop taking metformin while the procedure is being performed and for a time after it. Your doctor will decide when to interrupt metformin treatment and when to restart it.

Metformin alone does not cause hypoglycemia (low blood glucose). However, if you take metformin 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, 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 an older person and/or if your kidney function is deteriorating.

Other medicines andMetformina PharmaCombix

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

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine. 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
• 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 can 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.

TakingMetformina PharmaCombix with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor to see if you need to make any changes to your treatment or monitor your blood glucose levels.

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

Driving and operating machinery

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

However, be cautious if you take metformin 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, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to feel these symptoms.

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

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

Recommended dose

Children aged 10 years and above and adolescents

They usually 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

They 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 insulin is also administered, 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 check-ups if you are an elderly person or if your kidneys do not function normally.

How to take Metformin Pharma Combix

Take metformin with meals or after meals. This will prevent you from experiencing adverse effects that affect your digestion. Do not bite or chew 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 doses a day, take them in the morning (breakfast) and in the evening (dinner).
• If you take three doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner).

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

If you take more Metformin Pharma Combix than you should

If you have taken more metformin than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are nonspecific such as vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of discomfort with intense fatigue and difficulty breathing. Additional symptoms may be 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 takingmetforminimmediately and contact your doctor or the nearest hospital immediately.

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

If you forgot to take Metformin Pharma Combix

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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 called lactic acidosis (see the "Warnings and precautions" section). 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.

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

• gastrointestinal 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 metformin with meals or immediately after a meal may help reduce these side effects.If symptoms persist, stop taking metformin and consult your doctor.

Common side effects (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, as some of them may be caused by diabetes or other unrelated health problems.

Rare side effects (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 nonspecific (see the "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 metforminand talk to your doctor
• skin reactions such as redness of the skin (erythema), itching or a pruritic rash (urticaria).

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 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 Vigilance of Medicines for Human Use:https://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, parents and caregivers are advised to supervise how this medication is used.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofMetformina PharmaCombix 1.000 mg

• The active ingredient is metformin hydrochloride. A 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 product and contents of the packaging

Film-coated tablets.

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

Metformina Pharma Combix 1.000 mg is presented in packaging of 30, 50, or 60 tablets.

Only some packaging sizes may be commercially available.

Holder of themarketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: 03/2025

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/