Dianben 850 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dianben 850 mg film-coated tablets

metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine, as 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dianben is and what it is used for

Dianben 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 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 properly use the insulin it produces. This leads to high levels of glucose in the blood. Dianben helps to reduce your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking Dianben over a long period of time also helps to reduce the risk of diabetes-related complications. Dianben is associated with maintenance of body weight or a slight decrease in body weight.

Dianben 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 especially used in overweight patients.

Adults may take Dianben alone or together with other medicines for treating diabetes (medicines taken by mouth or insulin).

Children aged 10 years and older, and adolescents, may take Dianben alone or together with insulin.

2. What you need to know before starting Dianben

Do not take Dianben

• If you are allergic (hypersensitive) 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 condition in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or a fruity odor on your breath.
• If you have lost a large amount of fluid from your body (dehydration), for example due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you are receiving treatment for acute 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 lead to tissue hypoxia (lack of oxygen in tissues), which could put you at risk of developing lactic acidosis (see “Warnings and precautions” below).
• If you drink large amounts of alcohol.

If any of the above situations apply to you, consult your doctor before starting this medicine.

Make sure to consult your doctor if

• you require an examination such as an X-ray or a scan involving the injection into the bloodstream of iodine-containing contrast agents.
• you require major surgery.

You must stop taking Dianben for a certain period of time before and after such an examination or surgical procedure. 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

Stop taking Dianben and contact a doctor or go to 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 being unwell, with severe fatigue
• difficulty breathing
• decreased body temperature and reduced heart rate

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

Contact your doctor promptly for advice if:

• You are known to have a genetic disorder affecting mitochondria (the components responsible for energy production inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You develop any of the following symptoms after starting metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you require major surgery, you must stop taking Dianben during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with Dianben.

Dianben alone does not cause hypoglycaemia (low blood glucose levels). However, if you take Dianben together with other antidiabetic medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, such as weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating, it is generally helpful to eat or drink something containing sugar.

During treatment with Dianben, 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 worsening.

Other medicines and Dianben

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Dianben before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Dianben.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust your Dianben 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 levels of Dianben 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 Dianben with alcohol

Avoid excessive alcohol consumption while taking Dianben, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or are planning to have a baby, talk to your doctor about whether changes to your treatment or monitoring of your blood glucose levels are needed.

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

Driving and using machines

Dianben alone does not cause hypoglycaemia (low blood glucose levels). This means it will not affect your ability to drive or operate machinery.

However, take special care if you take Dianben together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Dianben

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

Dianben cannot replace the benefits of a healthy lifestyle. Continue to follow any dietary advice given to you by your doctor and exercise regularly.

Recommended dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of Dianben once daily. The maximum daily dose is 2000 mg, divided into 2 or 3 doses. Treatment of children aged 10 to 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 Dianben 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 Dianben.

Monitoring

• Your doctor will carry out regular blood glucose tests and adjust your dose of Dianben 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 how well your kidneys are working at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Dianben

Take Dianben with meals or immediately after meals. This will help prevent gastrointestinal adverse effects. Do not chew or crush the tablets. Swallow each tablet 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 in the evening (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and in the evening (dinner).

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

If you take more Dianben than you should

If you have taken more Dianben 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 Dianben 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. Telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Dianben

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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur:

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

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

• gastrointestinal problems, such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects occur most frequently at the beginning of treatment with Dianben. Taking the doses throughout the day and taking Dianben during or immediately after meals may help reduce these side effects. If symptoms persist, stop taking Dianben and consult your doctor.

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

• changes in taste sensation.
• low or reduced levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and painful tongue (glossitis), tingling (paraesthesia), or yellowish or pale skin). Your doctor may schedule some tests to determine the cause of 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. This is a very rare but serious complication, especially if your kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• abnormalities in liver function tests 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 occurs, stop taking Dianben and speak to your doctor.
• skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).

Children and adolescents

Limited 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, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dianben

Keep this medicine out of the sight and reach of children. If a child is being treated with Dianben, parents and caregivers are advised to supervise the use of this medicine.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dianben

• The active substance is metformin hydrochloride. One Dianben 850 mg film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are povidone K 30, magnesium stearate and hypromellose.

Nature of the product and pack sizes

Dianben 850 mg film-coated tablets are white, circular and convex.

The tablets are supplied in blister packs of 1 (x100), 8, 9, 10, 14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 or 1000 tablets, and in plastic bottles with child-resistant caps containing 30, 60, 200, 300 or 600 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Merck Santé s.a.s.

37 Rue Saint Romain

F-69008 Lyon

France

Manufacturer

Merck Santé s.a.s.

2 rue du Pressoir Vert

45400 Semoy

France

or

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés

(Barcelona)

Spain

or (for Greece only)

• Petsiavas S.A.

Agion Anargiron 21, Kaliftaki

Kato Kifisia Attiki 14564

Greece

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Spain: Dianben

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Romania, Slovakia, Slovenia, Sweden, United Kingdom (Northern Ireland): Glucophage

Hungary: Merckformin

Portugal: Risidon

Date of latest review of this leaflet: 03/2025.

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/