Glurenorm

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Glurenorm

30 mg, tablets

Gliquidonum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 medicine 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 measures alone are not sufficient to control carbohydrate metabolism.

2. Important information before taking Glurenorm

When not to take Glurenorm:

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

Warnings and precautions

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

• if clinical symptoms of hypoglycemia occur, such as loss of consciousness, rapid heartbeat, sweaty skin, anxiety, hyperactive reflexes (e.g., tremors), or gastrointestinal disorders - you should immediately consume food containing sugar. If low blood sugar levels persist, consult a doctor or go to the nearest hospital, due to the need for intensified treatment and monitoring
• if the patient has a fever, skin rash, or nausea - they should contact their doctor immediately
• if the patient has severe kidney dysfunction - the doctor will closely monitor the patient's condition
• in case of physical exertion, the blood sugar-lowering effect may be enhanced
• stress may enhance or weaken the blood glucose-lowering effect
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that causes destruction of red blood cells) - combined treatment with blood sugar-lowering medicines from the sulfonylurea derivative group may lead to hemolytic anemia (reduced hemoglobin levels and destruction of red blood cells). Alternative treatment methods should be considered
• if the patient is taking other medicines - many medicines can affect the blood sugar-lowering effect of Glurenorm (see also: "Glurenorm and other medicines")
• if the patient is pregnant, they should immediately consult their doctor, as a change of medicine 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 medicine or changing to Glurenorm (see: "Driving and using machines").

Glurenorm and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Many medicines have a proven effect on glucose metabolism. Therefore, the doctor should be aware of the medicines you are taking - otherwise, it will not be possible to take into account potential interactions between medicines.
Concomitant use of the following medicines 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 medicines (used to treat rheumatic diseases and pain), antifungal medicines, chloramphenicol, clarithromycin, fluoroquinolones, sulfonamides, and tetracyclines (all antibiotics used to treat infections), clofibrate (used to treat high cholesterol levels), anticoagulant medicines (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 medicines.
The following medicines used to treat hypertension may potentially enhance the blood sugar-lowering effect and mask the symptoms of hypoglycemia: beta-adrenergic receptor blockers, clonidine, reserpine, and guanethidine.
Concomitant use of the following medicines 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 dietary 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, lowering blood sugar levels, has been reported after the use of H receptor antagonists (e.g., cimetidine, ranitidine - to reduce stomach acid secretion) and alcohol.

Glurenorm with food and drink

Glurenorm should be taken with strict adherence to the diet, as recommended by the doctor. After taking Glurenorm, never skip or delay a meal, as this may significantly lower blood sugar levels and potentially lead to loss of consciousness (e.g., when taking the tablet before a meal instead of at the start of the meal).
Adhere to the diet, as in the case of diabetes, the diet is mainly aimed at controlling the patient's body weight and is independent of the treatment prescribed by the doctor.
Alcohol may enhance or weaken the blood glucose-lowering effect of Glurenorm.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will advise stopping Glurenorm and changing the treatment to insulin.
In pregnant women, particularly careful and intensive control of blood glucose levels is necessary. When taking oral blood sugar-lowering medicines, 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 effect on the ability to drive and use machines. If drowsiness, dizziness, and vision disturbances or other clinical symptoms of hypoglycemia occur while taking Glurenorm, it is essential to avoid performing potentially hazardous activities, such as driving and using machines.

Glurenorm contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Glurenorm

This medicine should always be taken exactly as advised by the doctor. In case of doubt, consult the 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. Glurenorm should be taken at the start of a meal. After taking Glurenorm, never skip a meal.
If treatment with half a tablet during breakfast is insufficient, the doctor will gradually increase the dose. If the prescribed dose is not 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 medicine 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 should not be used in children and adolescents due to the lack of data on its safety and efficacy.

Overdose of Glurenorm

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

Missed dose of Glurenorm

In case of a missed 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 Glurenorm

Before stopping Glurenorm, consult a doctor.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, 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:
reduced white blood cell count (agranulocytosis), reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia)
Metabolism and nutrition disorders
Common:
Rare:
low blood sugar levels
decreased appetite
Nervous system disorders
Uncommon:
Rare:
drowsiness, dizziness, headache
tingling sensation
Eye disorders
Uncommon:
vision disturbances
Cardiac disorders
Rare:
angina pectoris, arrhythmias (heart rhythm disorders)
Vascular disorders
Rare:
cardiovascular failure (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:
reduced bile flow
Skin and subcutaneous tissue disorders
Uncommon:
Rare:
rash, itching
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 any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 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 medicine.

5. How to store Glurenorm

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

6. Contents of the pack and other information

What Glurenorm contains

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

What Glurenorm looks like and contents of the pack

Blister packs in a cardboard box.
Each 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
1831 Machelen
Belgium

Manufacturer

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Belgium, the country of export: BE111851
Parallel import authorization number: 244/18

Date of approval of the leaflet: 07.06.2023

[Information about the trademark]
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Information intended for healthcare professionals only:
Overdose of sulfonylurea medicines may cause hypoglycemia.
Symptoms
Possible occurrence of a hypoglycemic reaction (also prolonged), such as loss of consciousness, tachycardia, sweaty skin, anxiety, hyperactive reflexes, and gastrointestinal disorders.
Treatment
Immediate oral or intravenous administration of glucose. Control of blood glucose levels and further administration of glucose may be necessary.