Package Leaflet: Information for the User

Metformin Almus Pharma 1,000 mg Film-Coated Tablets EFG

Metformin hydrochloride

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Metformin Almus Pharma

3. How to take Metformin Almus Pharma

4. Possible side effects

5. Storage of Metformin Almus Pharma

6. Contents of the pack and additional information

What is Metformina Almus Pharma

Metformina Almus Pharma 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 normal level 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. Metformina Almus Pharma is associated with maintaining body weight or a slight decrease in it.

Metformina Almus Pharma is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not enough to control their blood glucose levels. It is used especially in patients with obesity.

Adults can take metformin alone or with other diabetes medications (oral medications or insulin).

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

Do not take Metformina 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 severe kidney function reduction.
• if you have uncontrolled diabetes, 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 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 body fluid (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, a lung, bronchial, or kidney infection. 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 have recently had a heart attack, if you have severe circulation problems (such as shock) or if you have difficulty breathing. This can reduce oxygen supply to 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 the injection of contrast media containing iodine into your bloodstream.
• you need a major surgical intervention.

You should stop taking metformin 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 to 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 may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), 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.

Consult your doctor immediately to tell you what to do if:

• You know you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive impairment, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking metformin for a short period of time if you have a condition that may be associated with dehydration (significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less 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 cause lactic acidosis, as this condition can lead to coma.The symptoms of lactic acidosis include:

•vomiting

•stomach pain (abdominal 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 major surgery, stop taking metformin while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt metformin treatment and when to restart it.

Metformin itself does not cause hypoglycemia (low blood sugar). However, if you take metformin 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 metformin treatment, 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.

Use of Metformina Almus Pharma with other medicines

If you need to be administered an injection of a contrast medium containing 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 to interrupt metformin treatment 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 metformin.

It is especially important to mention the following:

• diuretics that increase urine production
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• some 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 can 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 used recently, or may need to use any other medication.

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 your diabetes. Inform 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 operating machinery

Metformin treatment itself does not cause low blood sugar (hypoglycemia) and therefore does not affect your ability to drive vehicles and operate machinery.

However, be careful if you take metformin with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to feel these symptoms.

Follow exactly the administration instructions of this medication 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 following any dietary advice given by your doctor and exercise regularly.

Recommended dose

Children aged 10 years and above and adolescentsusually start with 500mg or 850mg of metformin 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, 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.

Monitoring

• Your doctor will adjust your metformin dose according to your blood glucose level. Make sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are an elderly person.
• Your doctor will also check, at least once a year, how your kidneys are functioning. You may need more frequent checks if you are an elderly person or if your kidneys do not function normally.

How to take Metformin Almus Pharma:

The tablets should be taken with, or immediately after, meals. This will prevent you from experiencing

side effects that affect your digestion.

Do not break or chew the tablets before swallowing. Swallow the tablet whole 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 midday (lunch) and in the evening (dinner).

If after some time, you believe the effect of this medication is too intense or too weak, consult your doctor or pharmacist.

If you take more Metformin Almus Pharma 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 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 medical attention immediately as lactic acidosis can lead to coma. Stop taking this medication 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 Almus Pharma

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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Metformin may cause a very rare but serious side effect (affecting up to 1 user in 10,000), called lactic acidosis (see section “Warnings and precautions”), if this occurs,you should stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• digestive problems such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects appear more frequently at the beginning of treatment. They improve if the tablets are taken during or immediately after meals.If symptoms persist, interrupt 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. This is a rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
• liver function abnormalities or hepatitis (inflammation of the liver; this can cause fatigue, loss of appetite, weight loss, with or without yellow discoloration of the skin or the white of the eyes). If this occurs,stop taking this medicine and talk to your doctor.

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

Children and adolescents

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date marked on the packaging. 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 the packaging and the

medications you no longer need at your local SIGRE collection point.Ask your

pharmacist how to dispose of the packaging and the medications you no longer need. This will help protect the environment.

Composition of Metformina Almus Pharma

The active ingredient is metformin hydrochloride. Each film-coated tablet contains 1,000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.

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

Appearance of the product and contents of the packaging

Film-coated tablets of white or almost white color, oval (19.0 mm x 9.8 mm), marked with ‘Rx’ on one face and ‘1000’ on the other.

The tablets are presented in blisters and in packs of: 28, 30, 50, 56, 60, 84, and 90 tablets.

Only some pack sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Park, Paola, PLA 3000, Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Metformina Almus Pharma 1,000 mg film-coated tablets EFG

Italy:Metformina Almus

France:Metformine ALMUS 1,000 mg, tablet

Last review date of this leaflet:March 2025

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/