Metformin Uxa 850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metformina Uxa 850 mg film-coated tablets EFG

Metformin hydrochloride

Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet:

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

1. What Metformina Uxa is and what it is used for

Metformina Uxa 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 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 high levels of glucose in the blood. Metformin helps to 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 to reduce the risk of diabetes-related complications. Metformin is associated with maintenance of body weight or a slight reduction in body weight.

Metformina Uxa 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 particularly used in overweight patients.

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

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

2. What you need to know before starting to take Metformina Uxa

Do not take Metformina Uxa

• If you are allergic (hypersensitive) to metformin or to any of the other components 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 hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or breath developing an unusual fruity odour.
• If you have lost a large amount of fluid from your body (dehydration), for example due to prolonged or severe diarrhoea, 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" below).
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• 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 breathing difficulties. These conditions may lead to tissue hypoxia (lack of oxygen in 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 situations apply to you, consult your doctor before starting this medicine.

Make sure to consult your doctor if

• you require a diagnostic procedure such as an X-ray or scan involving the injection into the bloodstream of iodine-containing contrast agents.
• you require major surgery.

You must stop taking Metformina Uxa for a certain period of time before and after such a 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

Stop taking Metformin Uxa and contact a doctor or go to the nearest hospital immediately if you experience any of the 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 intense fatigue
• difficulty breathing
• decreased body temperature and heart rate

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

If you are undergoing major surgery, you must stop taking Metformin Uxa during the procedure and for some time afterwards. Your doctor will decide when to stop and when to restart treatment with Metformin Uxa.

Metformin Uxa alone does not cause hypoglycaemia (low blood glucose levels). However, if you take Metformin Uxa together with other diabetes medications that can cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, 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 Uxa, 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 Metformin Uxa

If you need to receive an intravenous injection of an iodine-containing contrast medium, for example during an X-ray or scan, you must stop taking Metformin Uxa before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Metformin Uxa.

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 dose of Metformin Uxa. 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 Uxa 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 Metformin Uxa with alcohol

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

Pregnancy and breastfeeding

During pregnancy, insulin is required to treat diabetes. Inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy, so that your treatment can be changed.

This medicine is not recommended if you are breastfeeding or planning to breastfeed.

Driving and using machines

Metformin Uxa alone does not cause hypoglycaemia (low blood glucose levels). This means it will not affect your ability to drive or use machines.

However, take special care if you take Metformin Uxa together with other diabetes medications that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia 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 Uxa

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

Metformina Uxa cannot replace the benefits of 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 Metformina Uxa once daily. The maximum daily dose is 2000 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 Metformina Uxa, two or three times a day. The maximum daily dose is 3000 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 advise you on how to start taking Metformina Uxa.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your dose of Metformina Uxa according to your blood glucose levels. Make sure to speak with your doctor regularly. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check at least once a year how well your kidneys are working. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformina Uxa

Take Metformina Uxa 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 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 the effect of Metformina Uxa is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformina Uxa than you should

If you have taken more Metformina Uxa than you should, you may develop lactic acidosis. Symptoms of lactic acidosis are non-specific 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 Metformina Uxa immediately and contact your doctor or go to 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 Metformina Uxa

Do not take a double dose to make up for a missed dose. Take the next dose at the 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 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 occurs, you must stop taking Metformina Uxa 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 Metformina Uxa. Taking the doses throughout the day and taking Metformina Uxa during or immediately after meals may help reduce these adverse effects. If symptoms persist, stop taking Metformina Uxa 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 functioning properly.

The symptoms of lactic acidosis are nonspecific (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 Uxa and speak to your doctor.
• skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).
• low blood levels 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 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformina Uxa

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformina Uxa, 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, following “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 medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, please 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 Uxa

• The active substance is metformin hydrochloride. One 850 mg film-coated tablet of Metformina Uxa contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are:

In the core: sodium starch glycolate (type A) from potato, povidone K 30, corn starch, colloidal anhydrous silica, magnesium stearate.

In the coating: hypromellose (HPMC), titanium dioxide (E-171), purified talc, macrogol 6000 and propylene glycol.

Appearance of the product and contents of the pack

Metformina Uxa 850 mg tablets are presented as white or almost white, oblong, film-coated tablets, with one side scored and the other smooth.

Packaged in transparent PVC/PVDC-Aluminum blister packs.

Available in packs of 50 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

UXAfarma S.A.

Avda. San Francisco Javier 24

41018 Sevilla

Spain

Manufacturer

Industria Química y Farmacéutica VIR.

C/ Laguna 66-70. P.I. URTINSA II. 28923 Alcorcón (Madrid) - Spain.

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108, Madrid

or

Laboratorio Fundación DAU

C/ de la lletra C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona, Spain

Date of the most recent review of this leaflet: January 2025

Other sources of information

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