METFORMIN ALMUS PHARMA 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Almus Pharma 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

What Metformin Almus Pharma is

Metformin 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 makes your body take in 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 properly. This causes high blood glucose levels. Metformin helps reduce your blood glucose to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps reduce the risk of complications associated with diabetes. Metformin Almus Pharma is associated with maintaining body weight or a slight decrease in body weight.

Metformin Almus Pharma is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone are not enough to control their blood glucose levels. It is especially used in patients with overweight.

Adults can take metformin alone or with other medicines to treat diabetes (oral medicines or insulin).

Children from 10 years old and adolescents can take metformin alone or with insulin.

2. What you need to know before you take Metformin Almus Pharma

Do not take Metformin Almus Pharma:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
• 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 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 an unusual fruity odor in your breath.
• 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 below "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 below "Warnings and precautions").
• if you are receiving treatment for heart failure or if you have recently had a heart attack, if you have severe circulation problems (such as shock) or if you have difficulty breathing. This can reduce the supply of oxygen to the tissues, which can put you at risk of developing lactic acidosis (see below "Warnings 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 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 to have major surgery.

You should stop taking metformin for a certain period before and after the examination or surgery. Your doctor will decide if you need any other treatment during this time. It is essential that you follow your doctor's instructions precisely.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Risk of lactic acidosis

This medicine can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder 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.

Consult your doctor immediately to indicate how to proceed if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You present any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and deafness.

Stop taking metformin for a short period if you have a disorder 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 produce lactic acidosis, as this disorder 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 metformin 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.

Using Metformina Almus Pharma with other medicines

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 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 metformin.

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 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.

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

Taking Metformina Almus Pharma with alcohol

Avoid excessive alcohol consumption while taking metformin, as this can increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

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

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

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 use machines.

However, be careful if you take metformin 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 Metformina Almus Pharma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 from 10 years old 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, 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 a lower dose.

If you are also given insulin, your doctor will tell you how to start taking metformin.

Monitoring

• Your doctor will adjust your metformin dose to your blood glucose level. Make sure to talk to your doctor regularly. This is particularly 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.

How to take Metformina Almus Pharma:

The tablets should be taken with or immediately after meals. This will avoid

adverse effects that affect your digestion.

Do not break or chew the tablets before swallowing. Swallow the whole 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 lunchtime, and at night (at dinner).

If after some time, you think 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 suffer from 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 this medicine immediately and contact your doctor or the nearest hospital as soon as possible.

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 Metformina Almus Pharma

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you have any further questions on 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.

Metformin can cause a very rare but very serious side 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 a coma.

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

• digestive problems such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects occur more frequently at the beginning of treatment. They improve if the tablets are taken during or immediately after meals. If the symptoms persist, stop treatment and consult your doctor.

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

• changes in taste.

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 do not work properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• liver function changes or hepatitis (inflammation of the liver; this can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes). If this happens to you, stop taking this medicine and talk to your doctor.

• skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).
• low vitamin B12 levels in the blood.

Children and adolescents

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Metformina Almus Pharma

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Metformina Almus Pharma

The active ingredient 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, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 6000, and talc.

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Park, Paola, PLA 3000, Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area with the Following Names:

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

Italy:Metformina Almus

France:Metformine ALMUS 850 mg, tablet

Date of the Last Revision of this Leaflet:March 2025

Detailed and updated 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/