Package Insert: Information for the User

Glucolón 5 mg Tablets

Glibenclamide

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

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

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 recommended by your doctor is the basis of all antidiabetic treatment. In no case should Glucolón be administered as an alternative to not following the diet.

Do not take Glucolón

• If you are allergic (hypersensitive) to glibenclamide or to any of the other components of Glucolón.
• If you have type 1 diabetes (insulin-dependent).
• If you have a very large alteration in blood sugar levels (severe metabolic acidosis) that can cause 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 especially careful with Glucolón

There is an increased risk of you experiencing hypoglycemia if:

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

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

If Glucolón is not effective in controlling your diabetes, your doctor will advise you to change your treatment. Glucolón, because it remains in your blood for a long time, can cause severe hypoglycemia more frequently than other sulfonylureas that last less time in the blood.

If you have risk factors for hypoglycemia, it may be necessary to adjust your Glucolón dose or your entire treatment. This should also be done if you have a disease 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

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those acquired without a prescription.

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

• anti-inflammatory agents (phenylbutazone, azapropazone, and oxifenbutazone; salicylates and p-amino-salicylic acid)
• antidiabetic agents (oral antidiabetics, insulin, metformin)
• anabolic steroids and male sex hormones
• oral anticoagulants (to prevent thrombus formation)
• lipid-lowering agents (fibrates) (to treat high cholesterol levels)
• medications for certain heart diseases and hypertension
• certain anti-hypertensive medications (those acting at the adrenergic level)
• chemotherapy medications (cyclophosphamide, disopyramide, thiothepa, and ifosfamide)
• antigout medications (probencid)
• antibiotics (chloramphenicol, certain sulfonamides with prolonged action, tetracyclines, quinolone antibiotics, miconazole, fluconazole, clarithromycin, and pentoxifylline parenterally at high doses)
• antidepressant medications (fluoxetine)
• tritoqualine (allergy medication)
• fenfluramine (appetite suppressant)

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

• estrogen and progesterone hormones
• certain medications for hypertension (anti-hypertensives) such as thiazide diuretics and saluretics
• thyroid function-enhancing medications
• glucocorticoids, tetracosactide
• medications for mental illnesses such as phenothiazine derivatives (chlorpromazine)
• adrenaline and medications that reduce blood vessel size (vasoconstrictors), heart stimulants, bronchodilators (increase bronchus size), 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 liquids)
• alcohol
• medications for hypertension (high blood pressure), heart 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:

• gastrointestinal secretion inhibitors
• medications for hypertension, heart 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 thrombus formation), the action of these medications may increase or decrease.

If you take glibenclamide with cyclosporine, it may increase cyclosporine levels and increase its toxicity. Therefore, monitoring and adjusting the cyclosporine dose is 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.

Glucolón with food and beverages

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

Breastfeeding

Glucolón is not recommended for use during breastfeeding to prevent it from passing through breast milk. To prevent the infant from taking it through breast milk, it is recommended to change to insulin or stop breastfeeding.

Driving and operating machines

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

Important information about some components of Glucolón

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

Follow exactly the administration instructions for Glucolón as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The initial dosage of Glucolón is generally given based on your condition (blood glucose and urine levels). The dose of Glucolón should be the lowest effective dose.

The initial dose is half 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.

You should swallow the tablets whole with some liquid. Unless your doctor tells you otherwise, doses up to 2 tablets per day are taken immediately before the first large meal. For doses above 10 mg (2 tablets), the first two tablets are taken before the first large meal and the rest before dinner. It is very important that you follow the schedule to take the tablets as told by your doctor.

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.

Your needs 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 Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

A Glucolón overdose or prolonged treatment at too high doses of glibenclamide may lead to severe, prolonged, and life-threatening hypoglycemia.

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

Your blood glucose levels will be monitored until your doctor is sure you are out of danger. You should be aware that hypoglycemia and its symptoms may recur even if you seem to have recovered.

Severe overdoses and severe reactions with symptoms such as loss of consciousness or other severe neurological alterations are medical emergencies and require immediate treatment and hospital admission.

If you forgot to take Glucolón

Do not take a double dose to compensate for the missed doses.

Like all medications, Glucolón may cause side effects, although not everyone will experience them.

The side effects of glibenclamide are usually infrequent, but moderately important. In most cases, they are a prolongation of the pharmacological action, they are dose-dependent and decrease with dose reduction.

The side effects are listed below, in accordance with 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 sensation, skin rashes and redness, skin inflammatory processes.

• 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 due to destruction), aplastic anemia (decrease in the number of red blood cells in the blood due to decreased production), 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 deficiency of certain enzymes, in which hemoglobin is not produced adequately), reversible syndrome of inadequate ADH secretion (disease caused by excessive production of antidiuretic hormone or ADH that manifests with fluid retention), intense 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 hepatic insufficiency (liver failure); erythema multiforme (form of allergic reaction that occurs in response to medications or diseases, such as infections), Stevens-Johnson syndrome (the most severe manifestation of erythema multiforme), erythema nodosum (inflammatory disorder consisting of the appearance of red and sensitive bumps under the skin), exfoliative dermatitis (generalized peeling of the skin), increase in liver enzyme values.

• Unknown frequency: blurred vision, photosensitivity reactions (exaggerated skin response to sunlight), increase in alkaline phosphatase.

Blood alterations usually appear in the first 6 weeks of treatment and reverse upon suspension of the medication.

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

Treatment with glibenclamide may cause hypoglycemia when there is a mismatch between the dose of glibenclamide, carbohydrate intake, exercise, and other factors that influence metabolism. The following signs and symptoms of hypoglycemia are included: headache, intense hunger sensation, nausea, vomiting, drowsiness, nervousness, irritability, reduced concentration, depression of the central nervous system, confusion, visual disturbances, tremors, vertigo, excessive sweating, tachycardia (increased heart rate), anxiety, hypertension, 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 resolve upon discontinuation of treatment, although it may also lead to liver insufficiency that may put the patient's life at risk.

The incidence of gastrointestinal side effects may be reduced by dividing the daily dose into two administrations. In case of cholestatic jaundice or persistent skin alterations, treatment should be suspended.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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 contents of the packaging

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Generfarma S.L..

Ronda Isaac Peral 6 –Parc Tecnológic-

46980 – Paterna (Valencia)

Responsible manufacturer:

Generfarma S.L..

Ronda Isaac Peral 6 –Parc Tecnológic-

46980 – Paterna (Valencia)

Last review date of this leaflet: November 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.