Metformin Stadafarma 850 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metformina Stadafarma 850 mg film-coated tablets EFG

Metformina Stadafarma 1,000 mg film-coated tablets EFG

metformin hydrochloride

Read the entire 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.

Leaflet contents:

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

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

Metformina Stadafarma 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 lower your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin over a long period of time also helps reduce the risk of diabetes-related complications. Metformin is associated with maintenance of body weight 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 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 starting Metformina Stadafarma

DO NOT take Metformina Stadafarma

• 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 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 fruity-smelling 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 repeatedly. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”)
• 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”)
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have severe circulatory 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 below “Warnings and precautions”)
• If you drink large amounts of alcohol

If any of the above circumstances 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 the bloodstream of iodine-containing contrast agents.
• You require major surgery.

You must stop taking metformin for a certain period of time before and after the imaging 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 exactly.

Warnings and precautions

Stop taking metformin 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 severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

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

Stop taking metformin temporarily if you develop an illness that could 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.

Contact your doctor promptly for advice if:

• You are known to have a genetic mitochondrial disease (a disorder affecting the energy-producing components 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 treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Please keep the following in mind:

• If you require major surgery, you must stop taking metformin during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart metformin treatment.

• Metformin alone does not cause hypoglycemia (low blood glucose levels). 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, rapid heartbeat, vision disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

• During treatment with metformin, your doctor will monitor 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 Stadafarma

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example during an X-ray or imaging 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.

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 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 for treating 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 Stadafarma 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 might be pregnant, or are planning to have a baby, speak with 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 planning to breastfeed.

Driving and using machines

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

However, take special care if you take metformin together with other diabetes medicines that may cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Metformina Stadafarma

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

Metformin cannot replace the benefits of a healthy lifestyle. Continue to follow any dietary advice given to you 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 recommended only 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.

Metformina Stadafarma 1,000 mg film-coated tablets:

The tablets can be divided into equal doses.

Monitoring

• Your doctor will carry out regular blood glucose tests and adjust your dose of metformin 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 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 metformin

The tablets are for oral use.

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 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 (with breakfast) and at night (with dinner).
• If you take three doses per day, take them in the morning (with breakfast), at midday (with lunch), and at night (with dinner).

If, after some time, you feel that the effect of metformin is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformina Stadafarma 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 cramps, a general feeling of being unwell 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 metformin immediately and contact your doctor or 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 Stadafarma

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.

Symptoms of lactic acidosis include:

• Vomiting
• Stomach pain (abdominal pain)
• Muscle cramps
• Feeling unwell with severe tiredness
• Difficulty breathing
• Reduced body temperature and slower heart rate

Other possible side effects are listed below by frequency:

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

• Digestive problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain), and loss of appetite

These adverse effects occur more frequently at the beginning of treatment with metformin. Spreading the doses throughout the day and taking metformin during or immediately after meals may help reduce these adverse effects. If symptoms persist, stop taking metformin and consult your doctor.

Common (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 other unrelated health problems.

Very rare (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 functioning 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 occurs, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Stadafarma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

HDPE bottles: After first opening, the bottle can be used for up to 90 days.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Metformina Stadafarma

Metformina Stadafarma 850 mg film-coated tablets EFG

The active substance is metformin hydrochloride. One film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 663 mg of metformin base. The other ingredients are magnesium stearate, povidone (E1201), hypromellose 2910 (E464), titanium dioxide (E171) and macrogol 3350.

Metformina Stadafarma 1,000 mg film-coated tablets EFG

The active substance is metformin hydrochloride. One film-coated tablet contains 1,000 mg of metformin hydrochloride, equivalent to 780 mg of metformin base. The other ingredients are magnesium stearate, povidone (E1201), hypromellose 2910 (E464), titanium dioxide (E171) and macrogol 3350.

Appearance of the product and contents of the pack

Description

Metformina Stadafarma 850 mg film-coated tablets EFG:

Film-coated tablets, round, white to off-white, engraved with "002" on one side and "850" on the other. Approximate dimensions of the tablets are 13 mm in diameter and 7 mm in thickness.

Metformina Stadafarma 1,000 mg film-coated tablets EFG:

Film-coated tablets, white to off-white, oval-shaped, biconvex, engraved with "003" on one side and "1000" on the other, scored on both sides. The tablet can be divided into equal doses. Approximate dimensions of the tablets are 19 mm in length and 10 mm in width.

Contents of the pack

Metformina Stadafarma 850 mg film-coated tablets EFG:

Blister packs (PVC-aluminum) containing 18, 30, 40, 50, 56, 60, 90, 100, 120 and 180 film-coated tablets.

HDPE bottles with child-resistant closure made of polypropylene, white opaque cap, translucent inner cap and liner containing 100 film-coated tablets.

HDPE bottles with polypropylene screw cap, white opaque cap, translucent inner cap and liner containing 500 film-coated tablets.

Metformina Stadafarma 1,000 mg film-coated tablets EFG:

Blister packs (PVC-aluminum) containing 18, 30, 50, 60, 90, 120, 180 and 1,500 film-coated tablets.

HDPE bottles with child-resistant closure made of polypropylene, white opaque cap, translucent inner cap and liner containing 100 film-coated tablets.

HDPE bottles with polypropylene screw cap, white opaque cap, translucent inner cap and liner containing 500 film-coated tablets.

Pack sizes containing 500 tablets (in HDPE bottles) and 1,500 tablets (in blisters) are intended exclusively for hospitals and personalized dosing systems.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Nieuwe Donk, 9

4879 AC Etten-Leur

The Netherlands

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

Date of latest revision of this leaflet: May 2025

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