Glurenorm

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Glurenorm, 30 mg, Tablets

Gliquidonum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Glurenorm and what is it used for

Glurenorm is a medication that lowers blood sugar levels, belonging to the group of sulfonylurea derivatives.
Glurenorm is indicated for the treatment of type 2 diabetes in adult patients, in whom dietary control is no longer sufficient to regulate carbohydrate metabolism.

2. Important information before taking Glurenorm

When not to take Glurenorm

• If you are allergic to glibenclamide, sulfonylurea derivatives, or any of the other ingredients of this medication (listed in section 6).
• If you have type 1 diabetes.
• If your type 2 diabetes is complicated by increased blood acidity or increased ketone levels in the blood.
• If you have diabetic coma (a life-threatening complication of diabetes that causes loss of consciousness) and pre-coma (partial loss of consciousness preceding coma).
• If you have severe infections.
• If you have acute porphyria (a genetic disorder that causes abdominal pain and neurological symptoms).
• If you have had a pancreas removal.
• If you are about to undergo surgery.
• If you have liver failure.
• If you have any genetic disorder that may cause incompatibility with one of the ingredients of the medication (see also "Glurenorm contains lactose monohydrate").

Warnings and precautions

Before starting treatment with Glurenorm, discuss it with your doctor, pharmacist, or nurse.

• if you experience symptoms of hypoglycemia, such as loss of consciousness, rapid heartbeat, sweating, anxiety, hyperactive reflexes (e.g., trembling), or gastrointestinal disorders - you should immediately consume food containing sugar. If low blood sugar levels persist, consult your doctor or go to the nearest hospital, as intensified treatment and monitoring may be necessary;
• if you have a fever, skin rash, or nausea - you should contact your doctor immediately;
• if you have severe kidney dysfunction - your doctor will closely monitor your condition;
• physical exertion may enhance the blood sugar-lowering effect of the medication;
• stress may enhance or weaken the blood sugar-lowering effect of the medication;
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that causes red blood cell destruction) - combined treatment with blood sugar-lowering medications from the sulfonylurea derivative group may lead to hemolytic anemia (reduced hemoglobin levels and red blood cell destruction). Alternative treatment methods should be considered;
• if you are taking other medications - many medications can affect the blood sugar-lowering effect of Glurenorm (see also "Glurenorm and other medications");
• if you are pregnant, you should consult your doctor immediately, as a change in medication will be necessary (see also "Pregnancy and breastfeeding").

Treatment of diabetes requires regular medical care. Remember to have regular check-ups with your doctor, especially when changing the dose of the medication or switching from another medication to Glurenorm (see "Driving and using machines").

Glurenorm and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Many medications have a proven effect on glucose metabolism. Therefore, your doctor should be aware of the medications you are taking - otherwise, it will not be possible to take into account potential interactions between medications.
Concomitant use of the following medications may enhance the effect of Glurenorm:
ACE inhibitors (used to treat hypertension), allopurinol (used to treat high uric acid levels in the blood, including gout), painkillers and non-steroidal anti-inflammatory medications (used to treat rheumatic diseases and pain), antifungal medications, chloramphenicol, clarithromycin, fluoroquinolones, sulfonamides, and tetracyclines (all antibiotics used to treat infections), clofibrate (used to treat high cholesterol levels), anticoagulant medications (coumarin derivatives), heparin, and sulfinpyrazone (blood thinners), MAO inhibitors, and tricyclic antidepressants (used to treat depression), cyclophosphamide and its derivatives (used to treat cancer), insulin, and other blood sugar-lowering medications.
The following medications used to treat hypertension may potentially enhance the blood sugar-lowering effect and mask symptoms of hypoglycemia: beta-adrenergic receptor blockers, clonidine, reserpine, and guanethidine.
Concomitant use of the following medications may weaken the blood sugar-lowering effect of Glurenorm: aminoglutethimide (used to treat cancer), corticosteroids (used to treat inflammatory conditions), diazoxide, thiazide diuretics, and loop diuretics (used to treat hypertension), oral contraceptives (to prevent pregnancy), sympathomimetics (such as bronchodilators used to treat asthma), rifampicin and rifabutin (used to treat tuberculosis), thyroid hormones, glucagon (a pancreatic hormone), phenothiazines (used to treat mental illnesses), nicotinic acid (used as a vitamin supplement and to treat high cholesterol and other fat levels), barbiturates (used as sedatives), and phenytoin (used to treat epilepsy).
Enhanced or reduced effect of Glurenorm has been reported after administration of H receptor antagonists (e.g., cimetidine, ranitidine - to reduce stomach acid secretion) and alcohol.

Taking Glurenorm with food and drink

Take Glurenorm and strictly follow your diet, as recommended by your doctor. After taking Glurenorm, never skip or delay a meal, as this may significantly lower your blood sugar levels and potentially lead to loss of consciousness (e.g., if you take the tablet before a meal instead of at the start of the meal).
Follow your diet, as the goal of the diet in diabetes is mainly to control the patient's body weight and is independent of the prescribed treatment.
Alcohol may enhance or weaken the blood sugar-lowering effect of Glurenorm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Your doctor will advise you to stop taking Glurenorm and switch to insulin.
In pregnant women, particularly close and intensive monitoring of blood glucose levels is necessary. When taking oral blood sugar-lowering medications, this is not possible.
Therefore, Glurenorm should not be used during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Glurenorm on the ability to drive and use machines. If you experience drowsiness, dizziness, or impaired accommodation, or other symptoms of hypoglycemia while taking Glurenorm, you should avoid performing potentially hazardous activities, such as driving or operating machines.

Glurenorm contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medication.
One 30 mg tablet contains 180 mg of lactose monohydrate, which corresponds to 720 mg of lactose monohydrate per maximum recommended daily dose. Patients with rare hereditary problems of galactose intolerance, such as galactosemia, Lapp lactase deficiency, or glucose-galactose malabsorption, should not take this medication.

3. How to take Glurenorm

Always take this medication exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The tablet can be divided into equal doses.
Initial treatment
Treatment with Glurenorm usually starts with half a tablet (15 mg) during breakfast.
Take Glurenorm at the start of a meal. After taking Glurenorm, never skip a meal.
If treatment with half a tablet during breakfast is insufficient, your doctor will gradually increase the dose. If the prescribed dose is no more than two tablets (60 mg), the daily dose of Glurenorm can be taken once a day during breakfast. If higher daily doses are necessary, better control can be achieved by taking the medication in two or three divided doses throughout the day. In this case, the largest dose should be taken during breakfast.
The maximum recommended daily dose is 4 tablets (120 mg).

Use in children and adolescents

Glurenorm is not recommended for use in children and adolescents due to the lack of data on its safety and efficacy.

Overdose of Glurenorm

In case of overdose, consult your doctor or pharmacist.
Overdose of Glurenorm may cause low blood sugar levels - also prolonged - with symptoms such as loss of consciousness, rapid heartbeat, sweating, anxiety, hyperactive reflexes (e.g., trembling), or gastrointestinal disorders.

Missing a dose of Glurenorm

If you miss a dose, take the missed dose as soon as possible, but do not take a double dose to make up for the missed dose. Remember to take Glurenorm tablets only at the start of a meal. Take the next dose at the usual time.

Stopping treatment with Glurenorm

Before stopping treatment with Glurenorm, consult your doctor.
If you have any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Glurenorm can cause side effects, although not everybody gets them.
The following frequency classification has been used:
very common: more than 1 in 10 patients;
common: more than 1 in 100 patients, but less than 1 in 10 patients;
uncommon: more than 1 in 1000 patients, but less than 1 in 100 patients;
rare: more than 1 in 10,000 patients, but less than 1 in 1000 patients;
very rare: less than 1 in 10,000 patients.
Blood and lymphatic system disorders
Rare: decreased white blood cell count (agranulocytosis), decreased white blood cell count (leukopenia), decreased platelet count (thrombocytopenia)
Metabolism and nutrition disorders
Common: low blood sugar levels
Rare: decreased appetite
Nervous system disorders
Uncommon: drowsiness, dizziness, headache
Rare: tingling sensation
Eye disorders
Uncommon: accommodation disorders
Cardiac disorders
Rare: angina pectoris, arrhythmias (heart rhythm disorders)
Vascular disorders
Rare: cardiac and vascular disorders (heart and circulation disorders), low blood pressure
Gastrointestinal disorders
Uncommon: diarrhea, vomiting, abdominal discomfort, nausea, constipation, dryness of the mucous membranes in the mouth
Hepatobiliary disorders
Rare: decreased bile flow
Skin and subcutaneous tissue disorders
Uncommon: rash, itching
Rare: Stevens-Johnson syndrome (a severe skin disease in which the top layer of the skin dies and peels off), photosensitivity, urticaria
General disorders and administration site conditions
Rare: chest pain, feeling of tiredness

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Glurenorm

Keep the medication out of the sight and reach of children.
Store in a room temperature (15-25°C).
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Glurenorm contains

• The active substance is glibenclamide. One tablet contains 30 mg of glibenclamide (Gliquidonum).
• The other ingredients are: lactose monohydrate, cornstarch, magnesium stearate, colloidal anhydrous silica, talc.

What Glurenorm looks like and contents of the pack

Blister packs in a cardboard box.
1 pack contains 50 tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Menarini Benelux N.V./S.A.
De Kleetlaan 3
B-1831 Machelen
Belgium

Manufacturer:

Qualiphar N.V.
Rijksweg 9
B-2880 Bornem
Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE111851
Parallel import authorization number:114/17
Date of leaflet approval: 09.03.2022
[Information about the trademark]
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Information intended for healthcare professionals only:
Overdose of sulfonylurea medications may cause hypoglycemia.
Symptoms
Possible symptoms of a hypoglycemic reaction (also prolonged) include loss of consciousness, rapid heartbeat, sweating, anxiety, hyperactive reflexes, and gastrointestinal disorders.
Treatment
Immediate oral or intravenous administration of glucose. Monitoring of blood glucose levels and further administration of glucose may be necessary.