Metformina uxa 850 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the User

Metformina Uxa 850 mg Film-Coated Tablets EFG

Hydrochloride of metformin

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, 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.

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

2.What you need to know before you start taking Metformina Uxa

3.How to take Metformina Uxa

4.Possible side effects

5.Storage of Metformina Uxa

6.Contents of the pack and additional information

Metformina Uxa 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 to a level as normal as possible.

If you are an adult with obesity, 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.

Metformina Uxa 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 obesity.

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

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

Do not take Metformina Uxa

• If you are allergic (hypersensitive) to metformin, or to any of the other components of this medication (listed in section6).
• If you have liver problems
• If you have a severe reduction in 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, which can lead to diabetic precoma. 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 intense 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 “Advertencias 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 “Advertencias and precautions”).
• If you are receiving treatment for acute heart failure or 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 “Advertencias 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 medication.

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.
• You need a major surgical intervention.

You should stop taking Metformina Uxa 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 that you follow your doctor's instructions precisely.

Advertencias and precautions

Stop taking Metformina Uxa and 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
• Abdominal pain (stomach 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.

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

Metformina Uxa itself does not cause hypoglycemia (low blood glucose). However, if you take Metformina Uxa together 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, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

During treatment with Metformina Uxa, 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 medications and Metformina Uxa

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

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Metformina Uxa. It is especially important to mention the following:

• Diuretics that increase urine production
• Medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• Certain medications 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)
• Medications that can alter the amount of Metformina Uxa in your blood, especially if you have a reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• Other medications used to treat diabetes.

Taking Metformina Uxa with alcohol

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

Pregnancy and breastfeeding

During pregnancy, you need insulin to treat your diabetes. Inform your doctor if you are pregnant, if you think you may be pregnant, or if you plan to become pregnant, so that your treatment can be changed.

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

Driving and using machines

Metformina Uxa itself does not cause hypoglycemia (low blood glucose). This means that it will not affect your ability to drive or use machines.

However, be careful if you take Metformina Uxa together 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, visual disturbances, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

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

Metformin Uxa 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 adolescentsusually start with 500mg or 850mg of Metformin Uxa once a day. The maximum daily dose is 2000mg divided into 2or 3doses. 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.

Adultsusually start with 500mg or 850mg of Metformin Uxa, two or three times a day. The maximum daily dose is 3000mg divided into 3doses.

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 Uxa.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your Metformin Uxa dose 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, at least once a year, how your kidneys are functioning. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Uxa

Take Metformin Uxa 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 Uxa is too intense or too weak, consult your doctor or pharmacist.

If you take more Metformin Uxa than you should

If you have taken more Metformin Uxa than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are nonspecific such as vomiting, stomach pain (abdominal pain) with nausea, 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 attentionas lactic acidosis can lead to coma.Stop taking Metformin Uxa immediately and contact your doctor or the nearest hospital immediately.

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

If you forgot to take Metformin Uxa

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 "Warnings and precautions" section), which can occur in up to 1 person in 10,000. If this happens to you,you should stop taking Metformin Uxa and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• digestive 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 Uxa. Taking Metformin Uxa during or immediately after a meal may help reduce these side effects.If symptoms persist, stop takingMetformin Uxaand consult your doctor.

Common side effects (affecting less than 1 in 10 people):

• changes in taste.

Rare side effects (affecting less than 1 in 10,000 people):

• lactic acidosis. This is a rare but serious complication, especially if your kidneys do not function properly

The symptoms of lactic acidosis are nonspecific (see "Warnings and precautions" section).

• abnormal liver function test results or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without a yellowish tone of the skin orthe whiteof the eyes). If this happens to you,stop taking Metformin Uxa and talk to your doctor.
• skin reactions such as skin redness (erythema), itching, or a pruritic rash (urticaria).
• low vitamin B12 levels in the blood.

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 Pharmacovigilance of Medicinal Products for Human Use: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 Uxa,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, 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Metformina Uxa

• The active ingredient is hydrochloride of metformin. A tabletcoated with a film of Metformina Uxa 850contains850mgofhydrochloride of metformin, corresponding to662.9mg of metformin base.
• Theother components are :

In the core: sodium starch glycolate (type A) from potato, povidoneK30, cornstarch, anhydrous colloidal 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 packaging

Metformina Uxa 850mg tablets are presented in the form of coated tablets of white or off-white color, with an oblong shape, scored on one side and smooth on the other.

Intransparent PVC/PVDC-Aluminum blister packaging.

They are presented in packaging of 50 or 60tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

UXAfarma S.A.

Avda. San Francisco Javier 24

41018 Sevilla

Spain

Responsible for Manufacturing

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

Last review date of this leaflet: January 2025

Other sources of information

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/