Leaflet: information for the user

Dianben 850 mg film-coated tablets

hydrochloride of metformin

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

1.What Dianben is and what it is used for

2.What you need to know before you start taking Dianben

3.How to take Dianben

4.Possible side effects

5.Storage of Dianben

6.Contents of the pack and additional information

Dianben contains metformin, a medication to treat 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 properly. This causes high levels of glucose in the blood. Dianbenhelps to reduce your blood glucose to a normal level as possible.

If you are an adult with overweight, taking Dianben for a prolonged time also helps to reduce the risk of complications associated with diabetes. Dianbenis associated with weight maintenance or a slight weight decrease.

Dianben is used to treat patients with type2 diabetes (also called “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 overweight.

Adults can takeDianbenalone or with other medications to treat diabetes (oral medications or insulin).

Children aged 10years and older, and adolescents can takeDianbenalone or with insulin.

Do not take Dianben

• If you are allergic (hypersensitive) to metformin, or to any of the other components of this medication (listed in section6).
• If you have liver problems
• If you have severe kidney function reduction;
• If you have uncontrolled diabetes with, 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 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 water from your body (dehydration), for example, due to prolonged or intense 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, a lung, bronchial, or kidney infection. 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 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 tissue hypoxia, 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 medication.

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 Dianben 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 that you follow your doctor's instructions precisely.

Warnings and precautions

Stop taking Dianben and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain (stomach 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.

Consult your doctor quickly to determine how to proceed if:

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

If you need to undergo a major surgical intervention, stop taking Dianben while the procedure is being performed and for a period of time after it. Your doctor will decide when to stop and when to restart Dianben treatment.

Dianben itself does not cause hypoglycemia (low blood glucose). However, if you take Dianben with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or 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.

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.

Other medications and Dianben

If you need to receive an injection of contrast media containing iodine into your bloodstream, for example, in the context of an X-ray or examination, stop taking Dianben before the injection or at the time of the injection. Your doctor will decide when to stop and when to restart Dianben treatment.

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 Dianben. It is especially important to mention the following:

• Diuretics that increase urine production
• Medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• Certain medications 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)
• Medications that can alter the amount of Dianben in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, or olaparib).
• Other medications used to treat diabetes.

Taking Dianben with alcohol

Avoid excessive alcohol consumption while taking Dianben, 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 are planning to have a baby, talk to your doctor about making changes to your treatment or monitoring your blood glucose levels.

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

Driving and using machines

Dianben itself does not cause hypoglycemia (low blood glucose). This means it will not affect your ability to drive or use machines.

However, be cautious if you take Dianben with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or use machines if you start to experience these symptoms.

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

Dianben cannot replace the benefits of a healthy lifestyle. Continue following any dietary advice given by your doctor and practice regular exercise.

Recommended dose

Children aged 10 years and above and adolescentsusually start with 500mg or 850mg of Dianben 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 Dianben, 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 also taking insulin, your doctor will instruct you on how to start taking Dianben.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your Dianben dose according to your blood glucose levels. Be sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check, at least once a year, how your kidneys are functioning. 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 after meals. This will prevent you from experiencing adverse effects that affect your digestion. Do not bite or chew the tablets. Swallow each tablet with a glass of water.

• If taking a daily dose, take it in the morning (breakfast).
• If taking two doses a day, take them in the morning (breakfast) and in the evening (dinner).
• If taking 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 Dianben is too intense or too weak, consult your doctor or pharmacist.

If taking more Dianben than you should

If you have taken more Dianben than you should, you may experience lactic acidosis. 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 immediate medical attentionas 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 Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dianben

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 can cause side effects, although not everyone will experience them. The following side effects may occur:

Dianben may cause a very rare but serious side effect called lactic acidosis (see the "Warnings and precautions" section). If this happens to you,you should stop taking Dianben and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to 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 Dianben. Taking the doses throughout the day and taking Dianben during or immediately after a meal may help reduce these side effects.If symptoms persist, stop takingDianbenand consult your doctor.

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

• changes in taste.
• low or decreased levels of vitamin B12 in the blood (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia) or yellow or pale skin). Your doctor may schedule some tests to find the cause of your symptoms, as some of them may be caused by diabetes or other unrelated health problems.

Rare side effects (may affect up to1 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 the "Warnings and precautions" section).
• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without a yellowish tone of the skin orthe whiteof the eyes). If this happens to you,stop taking Dianben and talk to your doctor.
• skin reactions such as skin redness (erythema), itching or a 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use: 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.If a child is treated with Dianben, parents and caregivers are advised to supervise how this medication is used.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Dianben

• The active ingredient is hydrochloride of metformin. A tablet covered with Dianben 850 filmmg contains850mgofhydrochloride of metformin, corresponding to662.9mg of metformin base.
• The other components are povidoneK30, magnesium stearate and hypromellose.

Appearance of the product and contents of the package

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

The tablets aredeliveredinblister packs of1 (x100),8,9, 10, 14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120,300,600or1000tablets, andin plastic bottles with child-resistant closures of30, 60,200, 300or600 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Merck Santé s.a.s.

37 Rue Saint Romain

F-69008 Lyon

France

Responsible for manufacturing

Merck Santé s.a.s.

2 rue du Pressoir Vert

45400 Semoy

France

or

Merck Healthcare KGaA

Frankfurter Str. 250

64293 Darmstadt

Germany

or

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés

(Barcelona)

Spain

or

N. Petsiavas S.A.

Agion Anargiron 21, Kaliftaki

Kato Kifisia Attiki 14564

Greece

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area 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

Last review date of this leaflet:03/2025.

Other sources of information

Detailed and updated information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/