Gluco test

Package leaflet: Information for the patient

Gluco test
75 g/300 ml, oral solution
Glucosum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Gluco test is and what it is used for

The active substance in Gluco test is glucose (sugar) in the form of an oral solution.
Gluco test is intended for performing the oral glucose tolerance test (OGTT), also known as the glucose curve test, in cases of suspected diabetes or impaired glucose tolerance in adults.
The glucose contained in the solution is absorbed by the body after ingestion, leading to an increase in its blood concentration. Based on blood glucose measurements, the doctor can assess whether the patient has diabetes or impaired glucose tolerance.
Gluco test is intended for use in adults.

2. Important information before using Gluco test

When not to use Gluco test:

• if the patient is allergic to glucose or any of the ingredients of this medicine (listed in section 6);
• in patients diagnosed with diabetes;
• if the patient has glucose-galactose malabsorption syndrome;
• if the patient has acute gastrointestinal disorders (e.g. vomiting, diarrhea);
• if part of the patient's gastrointestinal tract has been surgically removed (gastrointestinal resection);
• if the patient has an infection with fever;
• in case of poor general condition and nutritional status of the patient.

The OGTT test should also not be performed in case of potassium, magnesium, and phosphate deficiency.

Warnings and precautions

Before starting the use of Gluco test, discuss this with your doctor or pharmacist.

Exercise caution when performing the OGTT test.

The time between blood draws should be spent near the laboratory, at rest, without eating or drinking.

Sometimes during or after the test, hypoglycemia (low blood glucose concentration) may occur, related to increased insulin secretion. Symptoms of hypoglycemia include, among others: feeling of weakness, drowsiness, nausea, excessive sweating, and dizziness. If such symptoms occur, contact immediately the medical staff performing the test or a doctor. Hypoglycemia can be relieved by consuming carbohydrate-rich meals (e.g. a sugar cube, fruit juice, fruits, a sandwich) immediately after the test. Artificial sweeteners are not suitable.

Children and adolescents

Gluco test is not indicated for use in children and adolescents under 18 years of age.

Gluco test and other medicines

Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take.

Some medicines may affect the results of the OGTT test.

Medicines that may lead to falsely positive OGTT results (falsely elevated blood glucose concentration) in individuals without metabolic disorders:

• laxatives,
• certain diuretics (thiazide diuretics, furosemide),
• certain drugs used in the treatment of HIV infection (protease inhibitors),
• glucocorticosteroids,
• thyroid hormones,
• certain hormones such as corticotropin, somatropin, and contraceptive agents (estrogens).

Medicines that may lead to normal OGTT results despite the presence of metabolic disorders (diabetes, impaired glucose tolerance):

• caffeine,
• certain antihypertensive drugs (reserpine),
• antidepressants (monoamine oxidase inhibitors),
• certain hormones such as gonadotropins,
• medium-chain fatty acids,
• certain blood glucose-lowering drugs (metformin, sulfonylurea derivatives).

The use of the above-mentioned medicines by the patient should be taken into account when interpreting the test result.

Gluco test with food and drink

See section 3. "Preparation for the OGTT test".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

The OGTT test in pregnant and breastfeeding women is performed according to medical indications.

Driving and operating machinery

During or after the OGTT test, hypoglycemia may occur, manifesting as weakness, drowsiness, nausea, excessive sweating, and dizziness, which may impair the ability to drive or operate machinery.

Gluco test contains sodium benzoate (E 211) and sodium

Sodium benzoate (E 211)
The medicine contains 500 mg of benzoic acid salt in 300 ml of solution, equivalent to 1.64 mg per 1 ml.

Sodium
The medicine contains 80 mg of sodium (main component of table salt) in 300 ml, equivalent to 4% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Gluco test

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The OGTT test is performed by trained medical personnel.
The glucose dose administered during the test is 1.75 g/kg body weight, up to a maximum of 75 g.
Adults:
After measuring fasting venous blood glucose, the patient should drink the entire contents of the bottle (75 g glucose) within a maximum of 5 minutes. Measurement of venous blood glucose concentration is performed after 120 minutes.
The contents of the bottle are intended for single use only.

Preparation for the OGTT test:

• Discontinue, if safe for health, any medications that may affect the OGTT result (see section 2. "Gluco test and other medicines") at least 3 days before the scheduled test. Decisions regarding discontinuation of medications prior to the test should be discussed with your doctor or pharmacist.
• Do not restrict carbohydrate intake (≥ 150 g carbohydrates/day) for 3 days before the scheduled test, or follow the diet recommended by your doctor or pharmacist.
• Maintain normal physical activity until the start of the OGTT test.
• Do not eat or drink for 8 to 14 hours before the test (exception: still water).
• Do not smoke cigarettes!

Performing the OGTT test:

• The patient should be rested and have had a full night's sleep.
• The patient must be fasting.
• The test should begin before 9 a.m.
• During the OGTT test, the patient should remain seated or lying down, without eating or drinking, without smoking, and without engaging in physical activity.
• The first blood sample is taken fasting, before administration of Gluco test (time 0 minutes).
• The patient should then drink the entire contents of the Gluco test bottle within 5 minutes.
• Another blood sample is taken 120 minutes after the start of the test (time 120 minutes).
• In pregnant women, an additional blood sample should also be taken 60 minutes after the start of the test (time 60 minutes).
• The test results are interpreted by a doctor.

Evaluation of OGTT in adults and pregnant women
(according to guidelines of the Polish Diabetological Association).

• Diagnostic criteria for diabetes:

Plasma glucose concentration
[mg/dl] [mmol/l]
Fasting ≥ 126 ≥ 7.0
120th minute ≥ 200 ≥ 11.1

If the OGTT result does not clearly indicate diabetes but clinical symptoms suggest metabolic disturbances, repeating the test on another day should be considered.

• Diagnostic criteria: impaired fasting glycaemia (IFG), impaired glucose tolerance (IGT):

Plasma glucose concentration
[mg/dl] [mmol/l]
IFG Fasting 100–125 5.6–6.9
IGT 120th minute 140–199 7.8–11.0
In cases of impaired fasting glycaemia or impaired glucose tolerance, the glucose tolerance test should be repeated after 6–12 months.

• Diagnostic criteria for gestational diabetes:

Plasma glucose concentration
[mg/dl] [mmol/l]
Fasting 92–125 5.1–6.9
60th minute ≥ 180 ≥ 10.0
120th minute 153–199 8.5–11.0

Gestational diabetes is diagnosed if at least one of the criteria listed in the table is met.

Factors affecting OGTT results:

• Gastrointestinal disorders (e.g. malabsorption syndrome) affecting glucose absorption from the gastrointestinal tract,
• Infections (e.g. gastrointestinal infections leading to absorption disturbances),
• Medications interfering with glucose metabolism (see section 2. "Gluco test and other medicines"),
• Deficiency of potassium, magnesium, or phosphates,
• Stress (e.g. following surgery, accidents, or psychological stress),
• Reduced physical activity.

Use in children and adolescents
Gluco test is not intended for use in children and adolescents under 18 years of age.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, listed from most to least frequent:

Common (may affect up to 1 in 10 patients):

• symptoms of hypoglycaemia during or after the examination, manifesting as weakness, drowsiness, nausea, excessive sweating, and dizziness. To avoid these symptoms, eat a high-carbohydrate meal (e.g. sandwiches, biscuits, fruit juice) immediately after the examination.

Uncommon (may affect up to 1 in 100 patients):

• stomach discomfort, nausea, vomiting.

Rare (may affect up to 1 in 1,000 patients):

• allergic reactions, e.g. skin redness.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
Phone: +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.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Gluco test

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and bottle.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Gluco test contains

• The active substance is glucose in the form of glucose monohydrate. 300 ml of solution contains 75 g of glucose.
• Other components are: citric acid, sodium benzoate (E 211), natural orange flavour (lemon oil, grapefruit oil, orange oil, maltodextrin, gum arabic, triacetin) and purified water.

What Gluco test looks like and contents of the pack
Gluco test is a colourless to light yellow sweet-tasting solution with an orange flavour and odour.
The pack consists of a type III amber glass bottle with a polypropylene child-resistant closure, a polyethylene liner and a tamper-evident ring, placed in a cardboard box.
Pack size:
300 ml bottle
Marketing Authorisation Holder
Miralex Sp. z o.o.
Lotnicza 4, 64-920 Pila
tel.: + 48 61 832 90 60
e-mail: [email protected]
Manufacturer
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52
62-081 Przezmierowo
marketing authorisation holder.