GLUCOLON 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Glucolón 5 mg tablets

Glibenclamide

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Glucolón and what is it used for

Glucolón is an oral antidiabetic that decreases your blood sugar (glucose) level by stimulating the release of insulin from the pancreas. It is used in the treatment of non-insulin-dependent diabetes.

Strict adherence to the diet indicated by your doctor is the basis of all antidiabetic treatment. Under no circumstances should Glucolón be administered as an alternative to not following the diet.

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

Do not take Glucolón

• If you are allergic (hypersensitive) to glibenclamide or any of the other components of Glucolón.
• If you have type 1 (insulin-dependent) diabetes.
• If you have a very large alteration in blood sugar levels (severe metabolic acidotic decompensation) that can produce precoma and diabetic coma, and a reaction to low blood sugar called diabetic ketoacidosis.
• If you have severe kidney or liver disease. In these cases, insulin is recommended.
• If you are taking miconazole (to treat a fungal infection) or bosentan (to treat pulmonary arterial hypertension).
• If you are pregnant or breastfeeding.

Be careful with Glucolón

There is an increased risk of you suffering from hypoglycemia if:

• You do not maintain regularity in meals, delay a meal, take an inadequate amount of food, if the food does not have many carbohydrates or if you are on a low-calorie diet.
• You engage in a lot of physical exercise.
• You have any kidney or liver disorder.
• You take more Glucolón than your doctor has told you.
• You have any metabolic disorder.
• You take Glucolón with other medications (see “Use of other medications”).
• You receive treatment with Glucolón without it being indicated in your case.
• If you drink alcohol.
• If you have diabetic neuropathy (nerve damage) or if you are taking medications for high blood pressure (antihypertensives) such as beta blockers, clonidine, or similar-acting drugs, as the symptoms of hypoglycemia may not appear or be masked.
• If you lack the G6PD enzyme, as it can lead to hemolytic anemia (decrease in the number of red blood cells in the blood due to their destruction).

You and your family members should know how to recognize the symptoms and treatment of hypoglycemia (see ‘Possible side effects’).

In the event that Glucolón becomes ineffective in controlling your diabetes, your doctor will advise you to change the treatment. Glucolón, due to its long duration of action in the blood, can cause severe hypoglycemia more frequently than other sulfonylureas that have a shorter duration of action in the blood.

If you have risk factors for hypoglycemia, it may be necessary to adjust the dose of Glucolón or your entire treatment. This should also be done if you have any illness or if you change your lifestyle.

In elderly patients, the risk of hypoglycemia is higher.

If you are in special situations (you have an accident, surgery, have an infection with fever) it may be necessary to administer insulin temporarily.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used any other medications, including those obtained without a prescription.

If you take Glucolón with the following compounds, hypoglycemia (low blood sugar) may appear:

• anti-inflammatory drugs (phenylbutazone, azapropazone, and oxyphenbutazone; salicylates and p-amino-salicylic acid)
• antidiabetic drugs (oral antidiabetics, insulin, metformin)
• anabolic steroids and male sex hormones
• anticoagulants (to prevent blood clots)
• lipid-lowering drugs (fibrates) (to treat high cholesterol)
• medications for the treatment of certain heart diseases and high blood pressure
• certain antihypertensive drugs (those that act at the adrenergic level)
• cancer medications (cyclophosphamide, disopyramide, trofosfamide, and ifosfamide)
• anti-gout medications (probenecid)
• antibiotics (chloramphenicol, certain long-acting sulfonamides, tetracyclines, quinolone antibiotics, miconazole, fluconazole, clarithromycin, pentoxifylline at high parenteral doses)
• medications for the treatment of depression (fluoxetine)
• tritoqualine (medication for allergies)
• fenfluramine (medication to reduce appetite)

If you take Glucolón with the following compounds, hyperglycemia (high blood sugar) may appear:

• estrogen and progestogen hormones
• certain antihypertensive medications (such as diuretics and thiazide diuretics)
• drugs that enhance thyroid function
• glucocorticoids, tetracosactide
• medications for mental illnesses such as phenothiazine derivatives (chlorpromazine)
• adrenaline and drugs that reduce the size of blood vessels (vasoconstrictors), heart stimulants, bronchodilators (increase the size of the bronchi) or uterine relaxants
• nicotinic acid (high doses) and its derivatives
• laxatives (prolonged use)
• barbiturates (sedatives)
• phenytoin
• diazoxide
• glucagon (hormone that increases blood sugar levels)
• rifampicin (antibiotic)
• acetazolamide (medication to eliminate fluids)
• alcohol
• medications for high blood pressure (high blood pressure), cardiac ischemia (decreased blood flow to the heart), and arrhythmias such as clonidine and reserpine.

If you take Glucolón with the following compounds, both hypoglycemia and hyperglycemia may appear:

• drugs that inhibit gastric secretion
• medications for hypertension, cardiac ischemia, and arrhythmias, clonidine, and reserpine. Their combined administration may mask the warning signs of possible hypoglycemia.
• alcohol

If you take Glucolón with oral anticoagulants (medications that prevent blood clots), their action may increase or decrease.

If you take glibenclamide with cyclosporin, it may increase cyclosporin levels and increase its toxicity. Therefore, monitoring and adjustment of the cyclosporin dose are necessary.

Colesevelam (cholesterol medication) binds to glibenclamide and reduces its absorption in the gastrointestinal tract. No interaction has been observed when glibenclamide is taken at least 4 hours before colesevelam.

Therefore, glibenclamide should be taken at least 4 hours before colesevelam.

Taking Glucolón with food and drinks

You should follow your doctor's instructions regarding the dose of Glucolón, the time of intake, and the diet to follow. Never stop taking the medication without first consulting your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

The use of Glucolón is not recommended during pregnancy. You should switch to insulin during pregnancy. If you want to become pregnant, you should switch your treatment to insulin.

Breastfeeding

The use of Glucolón is not recommended during breastfeeding to avoid it passing into breast milk. To prevent the infant from taking it through breast milk, it is advised to switch to insulin or stop breastfeeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to the symptoms caused by hypoglycemia or hyperglycemia, such as vision difficulties. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

Important information about some of the components of Glucolón

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking it.

3. How to take Glucolón

Follow your doctor's instructions for taking Glucolón exactly. Consult your doctor or pharmacist if you have any doubts.

The initial dose of Glucolón is generally determined by your condition (blood glucose and urine levels). The dose of Glucolón should be the lowest possible effective dose.

The initial dose is 0.5 to 1 tablet per day, which should be taken before the first large meal.

The initial dose may be gradually increased, if necessary and always under medical supervision, up to 3 tablets per day.

The tablets should be swallowed whole with some liquid. Unless your doctor tells you otherwise, doses of up to 2 tablets per day should be taken immediately before the first large meal. For doses above 10 mg (2 tablets), the first two tablets should be taken before the first large meal and the rest before dinner. It is very important that you follow the schedule for taking the tablets that your doctor has told you.

In elderly patients, it is recommended to start treatment with half the adult dose, i.e., 1.25 to 2.5 mg (a quarter to half a tablet) per day.

The need for Glucolón may decrease as you take it for a longer time. To avoid hypoglycemia, your doctor will consider whether to lower the dose or tell you to stop taking Glucolón.

Use in children and adolescents

This medication is not recommended for children and adolescents since its efficacy and safety have not been established in this age group.

If you take more Glucolón than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medication and the amount used.

An overdose or prolonged treatment with too high a dose of glibenclamide can lead to severe, prolonged, and life-threatening hypoglycemia (low blood sugar).

As soon as a Glucolón overdose is discovered, you should urgently inform your doctor. You should immediately take sugar, preferably in the form of glucose.

Your glucose levels will be monitored until the doctor is sure you are out of danger. You should be aware that hypoglycemia and its symptoms can occur again even though you seem to have recovered.

Severe overdoses and serious reactions with symptoms such as loss of consciousness or other severe neurological disorders are medical emergencies and require immediate treatment and hospitalization.

If you forget to take Glucolón

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Glucolón can cause side effects, although not everyone gets them.

The side effects of glibenclamide are usually infrequent, although moderately important. In most cases, they are an extension of the pharmacological action, are dose-dependent, and decrease with the reduction of the dosage.

The side effects are listed below, according to the following frequency categories:

• Very common (may affect more than 1 in 10 people): allergic reactions, nausea, vomiting, hyperacidity, abdominal pain, anorexia, constipation, diarrhea, itching, skin rashes, and skin inflammation.

• Common (may affect up to 1 in 10 people): headache, dizziness, paresthesia (tingling sensation), weight gain.

• Rare (may affect up to 1 in 1,000 people): hemolytic anemia (decrease in the number of red blood cells in the blood because they are destroyed), aplastic anemia (decrease in the number of red blood cells in the blood because their production decreases), leukopenia (decrease in the number of white blood cells in the blood), lymphocytosis (increase in the number of lymphocytes in the blood, a type of white blood cell), decrease in the number of platelets in the blood, porphyria crisis (metabolic disorder caused by the deficiency of certain enzymes, in which hemoglobin is not produced adequately), reversible syndrome of inadequate ADH secretion (disease caused by excess production of antidiuretic hormone or ADH, which manifests with fluid retention), severe and prolonged hypoglycemia.

• Very rare (may affect up to 1 in 10,000 people): liver disorders, such as cholestatic jaundice (obstruction of bile flow that gives a yellow color to the skin), hepatitis (inflammation of the liver), and liver failure (liver failure); erythema multiforme (a form of allergic reaction that appears in response to medications or diseases, such as infections), Stevens-Johnson syndrome (the most severe manifestation of erythema multiforme), erythema nodosum (inflammatory disorder that consists of the appearance of red and sensitive bumps under the skin), exfoliative dermatitis (generalized peeling of the skin), increased liver enzyme values.

• Frequency not known: blurred vision, photosensitivity reactions (exaggerated skin response to sunlight), increased alkaline phosphatase.

Blood disorders usually appear in the first 6 weeks of treatment and reverse when the medication is discontinued.

The syndrome of inadequate ADH secretion is reversible and is characterized by edema (swelling caused by fluid accumulation in tissues), hyponatremia (decrease in sodium levels in the blood), mental confusion, dizziness, nausea, and vomiting.

Treatment with glibenclamide can cause hypoglycemia when there is a mismatch between the dose of glibenclamide, carbohydrate intake, exercise, and other factors that influence metabolism. The possible signs and symptoms of hypoglycemia include: headache, intense hunger, nausea, vomiting, drowsiness, nervousness, aggression, reduced concentration, depression of the central nervous system, confusion, vision disorders, tremors, dizziness, excessive sweating, tachycardia (increased heart rate), anxiety, high blood pressure, palpitations, arrhythmia, delirium, convulsions, and bradycardia (decreased heart rate).

Especially at the beginning of treatment, temporary visual disturbances (such as blurred vision) may occur due to changes in blood glucose levels.

In isolated cases, elevation of liver enzyme levels, alteration of liver function (e.g., cholestasis, jaundice), and hepatitis may occur, which may remit when treatment is discontinued, although they can also lead to life-threatening liver failure.

The incidence of gastrointestinal adverse reactions can be reduced by dividing the daily dose into two doses. In case of cholestatic jaundice or persistent skin disorders, treatment should be discontinued.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Glucolón

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Expiration date

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.

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 the 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. Contents of the pack and other information

Composition of Glucolón

The active ingredient is glibenclamide. Each tablet contains 5 mg of glibenclamide.

The other components (excipients) are: lactose, wheat starch, talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and packaging contents

They are white, round tablets with a notch on one face. This medication is presented in polypropylene tubes containing 30 tablets and in PVC/Alu blisters containing 40 and 100 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Generfarma S.L.

Ronda Isaac Peral 6 –Parc Tecnológic-

46980 – Paterna (Valencia)

Manufacturer:

Generfarma S.L.

Ronda Isaac Peral 6 –Parc Tecnológic-

46980 – Paterna (Valencia)

Date of the last revision of this leaflet: November 2021

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