Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging is in a foreign language.
Glurenorm, 30 mg, tablets
Gliquidone
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Glurenorm is and what it is used for
Important information before taking Glurenorm
How to take Glurenorm
Possible side effects
How to store Glurenorm
Contents of the pack and other information

1. What Glurenorm is and what it is used for

Glurenorm is a blood glucose-lowering agent belonging to the sulfonylurea derivatives group.
Glurenorm is indicated for the treatment of type 2 diabetes in middle-aged and elderly patients in whom adherence to diet alone is no longer sufficient to control carbohydrate metabolism.

2. Important information before using Glurenorm

When not to use Glurenorm

If the patient is allergic to gliclazide, 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 elevated blood ketone levels.
If the patient is experiencing diabetic coma (a life-threatening complication of diabetes causing loss of consciousness) or pre-coma state (partial loss of consciousness preceding coma).
If the patient has severe infections.
If the patient suffers from acute intermittent porphyria (a hereditary disease causing abdominal pain and neurological symptoms).
If the patient has undergone pancreatectomy.
If the patient is preoperative.
If the patient has liver failure.
If the patient has any hereditary disease that may be incompatible with one of the components of the medicine (see also: "Glurenorm contains monohydrate lactose").

Warnings and precautions
Before starting treatment with Glurenorm, discuss this with your doctor, pharmacist, or nurse.

If symptoms of hypoglycaemia occur, such as loss of consciousness, rapid heartbeat, moist skin, restlessness, hyperactive reflexes (e.g. tremor), or gastrointestinal disturbances – 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 develops fever, skin rash, or nausea – contact a doctor immediately;
If the patient has severe kidney dysfunction – the doctor will closely monitor the patient's condition;
During physical exertion, the blood glucose-lowering effect may be enhanced;
Stress may enhance or weaken the glucose-lowering effect;
If the patient has glucose-6-phosphate dehydrogenase deficiency (a hereditary condition causing destruction of red blood cells) – combination therapy with blood glucose-lowering agents from the sulfonylurea derivatives group may lead to haemolytic anaemia (reduced haemoglobin concentration and breakdown of red blood cells). Consideration should be given to alternative treatment methods;
If the patient is taking other medicines – many drugs may affect the blood glucose-lowering action of Glurenorm (see also "Glurenorm with other medicines");
If the patient is pregnant, she should immediately consult a doctor, as a change of medication will be necessary (see also "Pregnancy and breastfeeding").

Diabetes treatment requires regular medical care. Remember to attend regular doctor’s visits, especially when changing the dose of medication or switching from another medicine to Glurenorm (see: "Driving and operating machinery").

Glurenorm with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Many medicines have a proven impact on glucose metabolism. Therefore, the doctor should be fully aware of all medicines taken by the patient – otherwise, potential drug interactions cannot be properly assessed.
Concomitant use of the following medicines may enhance the effect of Glurenorm:
ACE inhibitors (used to treat hypertension), allopurinol (used to treat high blood uric acid levels, including gout), analgesics and non-steroidal anti-inflammatory drugs (used to treat rheumatic diseases and pain), antifungal agents, chloramphenicol, clarithromycin, fluoroquinolones, sulfonamides and tetracyclines (all antibiotics used to treat infections), clofibrate (used to treat high cholesterol levels), anticoagulants (coumarin derivatives), heparin and sulfinpyrazone (blood-thinning agents), MAO inhibitors and tricyclic antidepressants (used to treat depression), cyclophosphamide and its derivatives (used to treat cancer), insulin, and other blood glucose-lowering agents.
The following antihypertensive agents: beta-adrenergic blocking agents, clonidine, reserpine, and guanethidine – may potentially enhance the blood glucose-lowering effect and mask symptoms of hypoglycaemia.
Concomitant use of the following medicines may reduce the blood glucose-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), rifamycins and rifampicin (used to treat tuberculosis), thyroid hormones, glucagon (a pancreatic hormone), phenothiazines (used to treat psychiatric disorders), nicotinic acid (used as a vitamin supplement and to treat high cholesterol and other fats), barbiturates (used as sedatives), and phenytoin (used to treat epilepsy).
Enhanced or reduced effects of Glurenorm on blood glucose reduction have been reported after concomitant use of H-receptor antagonists (e.g. cimetidine, ranitidine – to reduce gastric acid secretion) and alcohol.

Taking Glurenorm with food and drink
Take Glurenorm and strictly follow dietary recommendations as advised by your doctor. After taking Glurenorm, never skip or delay meals, as this may significantly reduce blood glucose levels and potentially lead to loss of consciousness (e.g. if a tablet is taken before a meal instead of at the beginning of a meal).
Follow dietary recommendations, as in diabetes, diet primarily 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 glucose-lowering effect of Glurenorm.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The doctor will recommend discontinuing Glurenorm and switching treatment to insulin.
In pregnant women, particularly close and intensive monitoring of plasma glucose levels is required. This is not feasible with oral blood glucose-lowering agents.
Therefore, Glurenorm should not be used during pregnancy or breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of Glurenorm on the ability to drive or operate machinery. If symptoms such as drowsiness, dizziness, accommodation disturbances, or other clinical symptoms of hypoglycaemia occur during treatment with Glurenorm, potentially dangerous activities such as driving or operating machinery must be avoided.

Glurenorm contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
One 30 mg tablet contains 180 mg of monohydrate lactose, equivalent to 720 mg of monohydrate lactose based on the maximum recommended daily dose. Patients with rare hereditary disorders of galactose intolerance, such as galactosaemia, Lapp-type lactase deficiency, or glucose-galactose malabsorption, should not take this medicine.

3. How to take Glurenorm

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The tablet may be divided into equal doses.
Initial treatment
Treatment with Glurenorm usually starts with half a tablet (15 mg) taken with breakfast.
Glurenorm should be taken at the beginning of a meal. After taking a Glurenorm tablet, a meal should
never be skipped.
If treatment with half a tablet taken with breakfast proves insufficient, your doctor will gradually
increase the dose. If the prescribed dose does not exceed two tablets (60 mg), the daily dose of
Glurenorm may be taken once daily with breakfast. If higher daily doses are required, better control
may be achieved by taking the medicine in two or three divided doses throughout the day. In such
cases, the largest dose should be taken with breakfast.
The maximum recommended daily dose is four tablets (120 mg).
Use in children and adolescents
Glurenorm is not recommended for use in children or adolescents due to lack of data on safety and
efficacy.
Taking more Glurenorm than prescribed
If more Glurenorm than prescribed has been taken, consult your doctor or pharmacist immediately.
Overdose of Glurenorm may cause low blood sugar levels – even prolonged – with symptoms such as
loss of consciousness, rapid heartbeat, moist skin, anxiety, hyperreflexia (e.g. tremor), or gastrointestinal
disturbances.
If you miss a dose of Glurenorm
If you forget to take a dose, take it 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 Glurenorm
Before stopping treatment with Glurenorm, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following frequency classification has been used:
very common: affects more than 1 in 10 patients;
common: affects more than 1 in 100 patients, but less than 1 in 10 patients;
uncommon: affects more than 1 in 1,000 patients, but less than 1 in 100 patients;
rare: affects more than 1 in 10,000 patients, but less than 1 in 1,000 patients;
very rare: affects less than 1 in 10,000 patients.

Blood and lymphatic system disorders
Rare: decreased white blood cell count (agranulocytosis), reduced white blood cell count (leukopenia), decreased platelet count (thrombocytopenia)

Metabolism and nutrition disorders
Common: low blood sugar
Rare: decreased appetite

Nervous system disorders
Uncommon: drowsiness, dizziness, headache
Rare: tingling sensation

Eye disorders
Uncommon: accommodation disorders

Cardiac disorders
Rare: angina pectoris, extrasystoles (cardiac arrhythmias)

Vascular disorders
Rare: cardiac failure (heart and circulatory disorders), low blood pressure

Gastrointestinal disorders
Uncommon: diarrhoea, vomiting, abdominal discomfort, nausea, constipation, dryness of 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 outer layer of skin dies and sheds off), photosensitivity, urticaria

General disorders and administration site conditions
Rare: chest pain, feeling of fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glurenorm

Keep this medicine out of sight and reach of children.
Store at 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 stated month.
Medicines must 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 packaging and other information

What Glurenorm contains

The active substance is gliquidone. One tablet contains 30 mg of gliquidone ( Gliquidonum ).
The other ingredients are: lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silicon dioxide, talc.

What Glurenorm looks like and contents of the pack
Blister packs in a cardboard box.
One pack contains 50 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Belgium, the country of export: BE111851
Parallel Import Licence Number: 114/17
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Information intended exclusively for medical professionals:
Overdose of drugs from the sulfonylurea group may cause hypoglycaemia.
Symptoms
Hypoglycaemic reactions (including prolonged ones) may occur, such as loss of consciousness, tachycardia, moist skin, motor restlessness and hyperreflexia, gastrointestinal disturbances.
Treatment
Immediate oral or intravenous administration of glucose. Monitoring of plasma glucose concentration and further glucose administration may be necessary.