METFORMIN ALTER 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Alter 1,000 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 is Metformin Alter and what is it used for
2. What you need to know before you take Metformin Alter
3. How to take Metformin Alter
4. Possible side effects
5. Storage of Metformin Alter
6. Contents of the pack and other information

1. What is Metformin Alter and what is it used for

Metformin Alter 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 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 is associated with maintaining body weight or a slight decrease 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 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 aged 10 years and older, and adolescents can take this medicine alone or with insulin.

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

Do not take Metformin Alter

• If you are allergic (hypersensitive) 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 impairment.
• 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 of the 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 "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 difficulty breathing. This can lead to a lack of oxygenation in the tissues, which can put you at risk of developing lactic acidosis (see below "Warnings and precautions").
• If you drink excessive 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 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

Risk of lactic acidosis

Metformin 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 intake, 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.

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 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.

Consult your doctor immediately if:

• You know you have a genetic disorder 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 experience 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 hearing loss.

Other medicines and Metformin Alter

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 scan, 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)
• 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.

Taking Metformin Alter with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor to see if you need to make changes to your treatment or monitor your blood glucose levels.

It is not recommended to take this medicine if you are breastfeeding or plan to breastfeed 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 especially 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 Alter

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist.

This medicine cannot replace the benefits of a healthy lifestyle. 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 2,000 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 3,000 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 this medicine.

Monitoring

• Your doctor will regularly perform blood glucose tests and adjust your metformin dose according to your blood glucose levels. 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 do not work normally.

How to take Metformin Alter

Take the tablets with meals or after meals. This will help prevent digestive side effects. Do not crush or chew 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 Alter 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 muscle cramps, a general feeling of discomfort 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 should 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 taken.

If you forget to take Metformin Alter

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, you should 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 (may affect 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 beginning 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 (may affect up to 1 in 10 people):

• changes in taste.
• low or decreased vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and painful tongue, numbness or 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 unrelated health problems).

Very rare side effects (may affect up to 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 test changes 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, itching, or an itchy rash.

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.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them 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 Metformin Alter

Keep this medicine out of the sight and reach of children. If a child is being treated with this medicine, it is recommended that parents and caregivers supervise how this medicine is used.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Metformina Alter 1,000 mg

• The active ingredient is metformina hydrochloride. One film-coated tablet of Metformina Alter 1,000 mg contains 1,000 mg of metformina hydrochloride, corresponding to 780 mg of metformina base.
• The other components are povidone, magnesium stearate, hypromellose, and macrogol.

Appearance of Metformina Alter 1,000 mg and Package Contents

Metformina Alter 1,000 mg film-coated tablets EFG are white to yellowish, biconvex, oval-shaped tablets, with the inscription MC on one side and a functional score line on the other side. The tablet can be divided into equal doses.

This medication is available in packages of 30, 60, or 90 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

SAG Manufacturing S.L.U

N-I Highway, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U

Sant Gabriel, 50. Esplugues de Llobregat

08950 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

France: Metformina Alter 1,000 mg film-coated tablets

Italy: Metformina Alter 1,000 mg film-coated tablets

Portugal: Metformina Alter 1,000 mg film-coated tablets

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

Date of the Last Revision of this Leaflet

Other Source of Information

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