METFORMINA PHARMCONSUL 1000 mg FILM-COATED TABLETS

2. What you need to know before you take Metformin PharmConsul

Do not take Metformin PharmConsul

• If you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6)
• • If you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), 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 a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or your breath developing an unusual fruity odor.

• If you have severe kidney function impairment
• 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, an infection that affects your lungs, bronchi, or kidneys. 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 breathing difficulties. This can lead to a lack of oxygen in the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• • If you have liver problems
  • If you drink excessive amounts of alcohol (either every day or only occasionally).

If any of the above applies 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 injecting a contrast medium into your blood that contains iodine.

• you need major surgery.

You should stop taking Metformin for a certain period before and after the examination or surgery. Your doctor will decide whether you need any other treatment during this time. It is essential that you 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 working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol intake, dehydration (see more information below), 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).

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

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

Stop taking metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

? vomiting

? stomach pain (abdominal pain)

? muscle cramps

? general feeling of discomfort with intense fatigue

? difficulty breathing

? reduction in body temperature and heart rate

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

If you need to undergo major surgery, you should stop taking Metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking Metformin and when you can restart it.

Metformin alone does not cause hypoglycemia (a concentration of glucose in the blood that is too low). However, if you take this medicine with other diabetes medicines 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 disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

During treatment with Metformin, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Other medicines and Metformin PharmConsul

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or an examination, you should stop taking Metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking Metformin and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might 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).
• 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 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)
• 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.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Metformin PharmConsul with alcohol

Avoid excessive alcohol intake while taking this medicine, as this can increase the risk of lactic acidosis. Alcohol can increase the risk of lactic acidosis, especially if you have liver problems or malnutrition. This also applies to medicines that contain alcohol. (See the section "Warnings and precautions").

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor, as it may be necessary to make changes to your treatment or monitor your blood glucose levels.

This medicine is not recommended if you are breast-feeding or planning to breast-feed your baby.

Driving and using machines

Metformin alone does not cause hypoglycemia (a concentration of glucose in the blood that is too low). This means it will not affect your ability to drive or use machines.

However, be careful if you take this medicine with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin PharmConsul

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

This medicine 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 Metformin once a day. The maximum daily dose is 2000 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 usually start with 500 mg or 850 mg of Metformin, 2 or 3 times a day. The maximum daily dose is 3000 mg divided into 3 doses.

In patients taking a high dose of metformin tablets (2-3 grams per day), two 500 mg metformin tablets can be replaced by one 1000 mg metformin tablet.

If you have reduced kidney function, your doctor may prescribe a lower dose.

If you are also taking insulin, your doctor will tell you how to start taking this medicine.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your Metformin dose according to your blood glucose levels. Make sure to talk to your doctor regularly. This is especially important for children, adolescents, or if you are an elderly person.

• Your doctor will also check how well your kidneys are working at least once a year. You may need more frequent checks if you are an elderly person or if your kidneys are not working normally. If you have reduced kidney function, your doctor may prescribe a lower dose.

How to take Metformin PharmConsul

Take Metformin with meals or after meals. This will prevent you from experiencing side effects that affect your digestion. Do not chew or crush the tablets.

Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (at breakfast)
• If you take two doses a day, take them in the morning (at breakfast) and at night (at dinner).
• If you take three doses a day, take them in the morning (at breakfast), at noon (at lunch), and at night (at dinner).

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

If you take more Metformin PharmConsul than you should

If you have taken more Metformin than you should, you may experience lactic acidosis.

The symptoms of lactic acidosis are non-specific, such as vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking Metformin 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 Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metformin PharmConsul

Do not take a double dose to make up for forgotten doses. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Metformin can cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, stop taking Metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a 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 start of treatment with Metformin. Spreading the doses throughout the day and taking Metformin during or immediately after a meal can help reduce these side effects. If the symptoms persist, stop taking Metformin and consult your doctor.

Common side effects (affecting less than 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, tingling, or yellowish or pale skin). Your doctor may schedule some tests to find the reason for your symptoms because some of them may be caused by diabetes or other health problems unrelated to this medicine.

Very rare side effects (affecting less than 1 in 10,000 people)

• Lactic acidosis. It 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 can cause fatigue, loss of appetite, weight loss, with or without a yellowish tint to the skin or the whites of the eyes). If this happens to you, stop taking Metformin and talk to your doctor.
• Skin reactions such as skin redness (erythema), itching, or an itchy rash (urticaria)

Children and adolescents

Limited data in children and adolescents showed that the side effects were similar in nature and severity to those observed in adults.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformina PharmConsul

This medicinal product does not require any special storage conditions.

Keep out of the sight and reach of children. If a child is treated with Metformina PharmConsul, it is advised that parents and caregivers supervise how this medicinal product is used.

Do not use Metformina PharmConsul after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Package contents and additional information

Composition of Metformina PharmConsul

• The active substance is metformin hydrochloride.

• Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin base.

The other ingredients are povidone, pregelatinized maize starch, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol (E1521).

Appearance of Metformina PharmConsul and package contents

White to off-white, round, biconvex film-coated tablet, 10.90 mm in diameter, engraved with the letters "G" and "50" on one side and smooth on the other.

20 film-coated tablets (10 tablets in PVC-aluminum blister packs)

30 film-coated tablets (15 tablets in PVC-aluminum blister packs)

120 film-coated tablets (10 tablets in PVC-aluminum blister packs)

180 film-coated tablets (10 tablets in PVC-aluminum blister packs)

60 tablets in HDPE (high-density polyethylene) bottles with child-resistant closures (polypropylene) in cardboard boxes.

1000 tablets in HDPE (high-density polyethylene) bottles with continuous thread closures (polypropylene).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

PharmConsul s.r.o.

Krcmarovska 223/33,

Miskovice, Prague

196 00 Czech Republic

Manufacturer:

Pharmazet Group s.r.o.,

Trtinová 260/1

Prague 19600

Czech Republic

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

or

Torrent Pharma (Malta) Limited

Central Business Centre, Level 2,

Triq Hal Tarxien,

Il-Gudja, GDJ 1907,

Malta

This medicinal productis authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: November 2024

Other sources of information

Detailed 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/.