Metformin Almus Pharma 850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metformina Almus Pharma 850 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Metformina Almus Pharma is and what it is used for

What Metformina Almus Pharma is

Metformina Almus Pharma 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 prolonged period also helps reduce the risk of diabetes-related complications. Metformina Almus Pharma is associated with maintenance of body weight or a slight reduction in body weight.

Metformina Almus Pharma 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 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 taking Metformina Almus Pharma

Do not take Metformina Almus Pharma:

• if you are allergic to metformin or to any of the other ingredients 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 disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid 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 repeated vomiting. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• if you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• if you are receiving treatment for heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have difficulty breathing. These conditions may reduce oxygen supply to 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 need an imaging procedure such as an X-ray or scan involving the injection of iodine-containing contrast agents into the bloodstream.
• you need major surgery.

You must stop taking metformin for a certain period before and after the 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

Consult your doctor or pharmacist before starting this medicine.

Risk of lactic acidosis

This medicine may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as acute and severe heart diseases).

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

Contact your doctor promptly for advice if:

• you are known to have a hereditary disease affecting mitochondria (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 metformin treatment: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

Stop taking metformin for a short period if you develop an illness that may lead to 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.

Stop taking metformin and contact a doctor or 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 profound fatigue
• difficulty breathing
• reduced body temperature and heart rate

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

If you need to undergo 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). However, if you take metformin together with other diabetes medications that may 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 generally 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 elderly and/or if your kidney function is deteriorating.

Taking Metformina Almus Pharma with other medicines

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Taking Metformina Almus Pharma 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

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

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

Driving and using machines

Treatment with metformin alone does not cause low blood sugar (hypoglycemia) and therefore does 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, meglitinides). Symptoms of hypoglycemia 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 Almus Pharma

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

Metformin 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 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 metformin two or three times daily. 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 metformin.

Monitoring

• Your doctor will 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 elderly.
• Your doctor will also check at least once a year how well 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 Metformina Almus Pharma:

The tablets should be taken with, or just after, meals. This will help prevent gastrointestinal side effects.

Do not split or chew the tablets before swallowing. Swallow the tablet whole 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 at night (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and at night (dinner).

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

If you take more Metformina Almus Pharma 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 this medicine 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 Almus Pharma

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.

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 this medicine and contact a doctor or 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, abdominal pain, and loss of appetite. These adverse effects occur more frequently at the beginning of treatment. They improve if the tablets are taken during or immediately after meals. If symptoms persist, stop treatment 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”).

• changes in liver function 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 happens to you, stop taking this medicine and speak to your doctor.

• skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).

• low blood concentration of vitamin B12.

Children and adolescents

Limited clinical 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, pharmacist, or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Almus Pharma

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging. 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 collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Metformina Almus Pharma

The active substance is metformin hydrochloride. Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin.

The other components (excipients) are povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 6000 and talc.

Appearance of the product and contents of the package

Film-coated tablets, white or almost white, oval-shaped (19.0 mm x 9.8 mm), marked with ‘Rx’ on one side and ‘850’ on the other.

The tablets are presented in blisters and in pack sizes of: 28, 30, 40, 50, 56, 84 and 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

Rx Farma (Malta) Limited

Kw20a, Zona Industrijali Ta’Kordin, Paola, PLA 3000, Malta

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

Spain: Metformina Almus Pharma 850 mg film-coated tablets EFG

Italy: Metformina Almus

France: Metformine ALMUS 850 mg, comprimé

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

Detailed and up-to-date 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/