Glurenorm

Package Leaflet: Information for the Patient

Glurenorm, 30 mg, Tablets

Gliquidonum

Read the package 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please 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 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 blood sugar levels.

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 medicine (listed in section 6)
• If you have type 1 diabetes
• If you have type 2 diabetes with increased blood acidity or increased ketone levels
• 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 medicine (see also "Glurenorm contains lactose")

Warnings and precautions

Before starting treatment with Glurenorm, discuss 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., tremors), or gastrointestinal disorders - you should immediately consume sugary food. If low blood sugar levels persist, you should consult a doctor or go to the nearest hospital, due to the need for intensified treatment and monitoring
• 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
• in case of physical exertion, the blood sugar-lowering effect may be enhanced
• stress may enhance or weaken the blood sugar-lowering effect
• 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 medicines from the sulfonylurea 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 medicines - many medicines can affect the blood sugar-lowering effect of Glurenorm (see also "Glurenorm and other medicines")
• if you are pregnant, you should consult your doctor immediately, as a change of medicine will be necessary (see also "Pregnancy and breastfeeding")

Treatment of diabetes requires regular medical care. You should remember about regular visits to your doctor, especially when changing the dose of the medicine or switching from another medicine to Glurenorm (see "Driving and using machines").

Glurenorm and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Many medicines have a proven effect on glucose metabolism. Therefore, your 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 high blood pressure), 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), monoamine oxidase 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 high blood pressure: beta-adrenergic receptor blockers, clonidine, reserpine, and guanethidine - may potentially enhance the blood sugar-lowering effect and mask symptoms of hypoglycemia.
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 high blood pressure), oral contraceptives (preventing 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 weakened effect of Glurenorm, lowering blood sugar levels, has been reported after use of H receptor antagonists (e.g., cimetidine, ranitidine - to reduce stomach acid secretion) and alcohol.

Glurenorm with food and drink

You should take Glurenorm and strictly follow the diet, as recommended by your doctor. After taking Glurenorm, you should 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 a tablet before a meal, instead of at the beginning of a meal).
You should follow the diet, as in the case of diabetes, the diet aims to control the patient's body weight and is independent of the treatment prescribed by the doctor.
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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will advise you to stop taking Glurenorm and change 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 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 and using machines.

Glurenorm contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Glurenorm

This medicine should always be taken exactly as advised by your doctor. If you are unsure, ask 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. Glurenorm should be taken at the beginning of a meal. After taking a Glurenorm tablet, you should 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 not more than two tablets (60 mg) per day, 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 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., 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 beginning 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 questions on the use of this medicine, ask your 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:
low blood sugar levels
Rare:
reduced 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:
cardiovascular insufficiency (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:
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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glurenorm

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
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, corn starch, soluble corn starch, magnesium stearate.

What Glurenorm looks like and contents of the pack

Colorless or white PVC/Al blisters in a cardboard box.
1 pack contains 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany
Manufacturer:
Boehringer Ingelheim Ellas Single Member S.A.
5th km Paiania-Markopoulo
Koropi Attiki 19441
Greece
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

Date of last revision of the leaflet:

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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, 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.