METFORMIN RATIOPHARM 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin ratiopharm 850 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Metformin ratiopharm is a medication used to treat diabetes. It belongs to a group of medications called biguanides.

Insulin is a hormone produced by the pancreas that helps your body absorb 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 a high concentration of glucose in the blood. 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 have not been enough to control their blood glucose levels. It is especially used in patients with overweight.

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

Children aged 10 and over, and adolescents can take metformin alone or in combination with insulin.

2. What you need to know before taking Metformin ratiopharm

Do not take Metformin ratiopharm

• if you are allergic (hypersensitive) to metformin hydrochloride or any of the other components of this medication (see "Composition of Metformin ratiopharm 850 mg film-coated tablets", 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 too much 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 serious circulation problems (such as shock) or if you have difficulty breathing. This can make it difficult to supply oxygen to the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions").
• if you drink a large amount of alcohol.

If any of the above circumstances apply to you, consult your doctor before taking this medication.

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 containing iodine into your blood.
• you need major surgery.

You should stop taking Metformin ratiopharm 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 ratiopharm 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 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 disease).

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

Stop taking Metformin ratiopharm 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 ratiopharm 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.

Consult your doctor promptly so that they can indicate how to proceed 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.

If you need to undergo major surgery, you should stop taking Metformin ratiopharm during the procedure and for a period after it. Your doctor will decide when you should stop taking Metformin ratiopharm and when you can restart it.

Metformin ratiopharm alone does not cause hypoglycemia (a concentration of glucose in the blood that is too low). However, if you take Metformin ratiopharm with other medications for diabetes 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 disturbances, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

During treatment with Metformin ratiopharm, your doctor will regularly check your blood glucose levels and adjust your metformin dose according to your blood glucose levels. Make sure to talk to your doctor regularly. This is especially 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, or more frequently if you are an elderly person and/or if your kidney function is deteriorating.

Other medications and Metformin ratiopharm

If you need to be given 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 ratiopharm before the injection or at the time of the injection. Your doctor will decide when you should stop taking Metformin ratiopharm and when you can restart it.

Tell your doctor if you are taking, have recently taken, 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 ratiopharm. It is especially important to mention the following:

• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications 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).
• medications 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 medications used to treat diabetes.

Taking Metformin ratiopharm with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, think you may be pregnant, or plan to have a baby, talk to your doctor about whether you need to make changes to your treatment or monitor your blood glucose levels.

It is not recommended to take this medication if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin ratiopharm 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 careful if you take Metformin ratiopharm with other medications for diabetes that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin ratiopharm

Follow the instructions for taking this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Metformin cannot replace the benefits of a healthy lifestyle.

Continue with the diet that your doctor has indicated and exercise regularly:

The recommended dose is:

Children aged 10 and over, 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, two or three 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 using insulin, your doctor will indicate how to start taking metformin.

Monitoring

Your doctor will regularly check your blood glucose levels and adjust your metformin dose according to your blood glucose levels. Make sure to talk to your doctor regularly. This is especially 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, or more frequently if you are an elderly person or if your kidneys are not functioning normally.

How to take Metformin ratiopharm

Take the tablets with meals or after meals. This will help prevent digestive side effects. Do not break 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 ratiopharm 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, abdominal pain with cramps, a 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 Metformin ratiopharm immediately and contact your doctor or the nearest hospital right away.

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 amount ingested.

If you forget to take Metformin ratiopharm

Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The following side effects may occur.

Metformin ratiopharm may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see "Warnings and precautions"), if this happens to you, stop taking Metformin ratiopharm and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

Very common side effects (affect 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 start of treatment with Metformin ratiopharm. It helps to spread the doses throughout the day and if you take the tablets during or immediately after a meal. If the symptoms persist, stop taking Metformin ratiopharm and consult your doctor.

Common side effects (may affect up to 1 in 10 people)

• Taste disturbance.
• 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, as 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 function properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions")
• Abnormalities in liver function tests 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 medication and talk to your doctor.
• Skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).

Children and adolescents

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package 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 medication.

5. Storage of Metformin ratiopharm

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the label, carton, or blister after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Metformina ratiopharm 850 mg tablets

• The active ingredient is metformin hydrochloride.

Each tablet contains 850 mg of metformin hydrochloride equivalent to 663 mg of metformin.

• The other components (excipients) are:

Core:povidone, magnesium stearate. Coating:hypromellose, macrogol.

Appearance of the Product and Container Content:

White, round tablets with a diameter of 12.70 mm, biconvex, film-coated, with the letter "A" printed on one face and the number "61" on the other face.

Packages with 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 180, 200, 300 or 400 film-coated tablets in blister packs (clear PVC/PVdC/aluminum) or (PVC/aluminum), each blister containing 10 or 14 film-coated tablets.

HDPE white opaque bottle packs with 100, 400 or 500 film-coated tablets with a polypropylene closure containing activated carbon sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000. Malta

or

Merckle GmbH

Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren – Germany

or

Generis Farmacêutica, S.A.,

Rua João de Deus, n.o 19,

Venda Nova, 2700-487

Amadora, Portugal

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

Denmark: Metformin "Aurobindo"

Spain: Metformina ratiopharm 850 mg film-coated tablets EFG

France: METFORMINE ARROW LAB 850 mg, film-coated tablets

Ireland: Metformin Aurobindo 850 mg film-coated tablets

Italy: METFORMINA DOC Generici 850 mg, film-coated tablets

Latvia: Metformin Aurobindo 850 mg, film-coated tablets

Netherlands: Metformine 850 mg, film-coated tablets

Portugal: Metformina Aurobindo

Sweden: Metformin Pfizer 850 mg film-coated tablets

Date of the Last Revision of this Leaflet: March 2025

Detailed 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/