GLUCOSE SCLAVO DIAGNOSTICS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosio Sclavo Diagnostics 75g/150ml Syrup

Glucose
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

1. What Glucosio Sclavo Diagnostics Syrup is and what it is used for
2. What you need to know before using Glucosio Sclavo Diagnostics Syrup
3. How to use Glucosio Sclavo Diagnostics Syrup
4. Possible side effects
5. How to store Glucosio Sclavo Diagnostics Syrup
6. Contents of the pack and other information

1. What Glucosio Sclavo Diagnostics Syrup is and what it is used for

Glucosio Sclavo Diagnostics Syrup is a stable solution of glucose sugar in water,
ready for use in diagnostic tests based on oral glucose loading (in international English terminology: Oral Glucose Tolerance Test, OGTT).

2. What you need to know before using Glucosio Sclavo Diagnostics Syrup

Do not use Glucosio Sclavo Diagnostics Syrup

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you have gastrointestinal absorption disorders.
• if, when fasting, your plasma glucose level is repeatedly above 125 mg/dL (venous plasma), or above 120 mg/dL in capillary or venous whole blood.
• if, during a random (non-fasting) blood test, your blood glucose level is repeatedly above 200 mg/dL.

Warnings and precautions

• Consult your doctor or nurse before using Glucosio Sclavo Diagnostics Syrup.
• You must use Glucosio Sclavo Diagnostics Syrup only under the direct supervision of a doctor or nurse.
• During the test period, you must remain at rest. Avoid physical exercise or emotional stress, as these may interfere with the diagnostic result.
• The syrup contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
• If you are taking medications that affect blood glucose levels at the time of the test, it is advisable to postpone the test until you have discontinued such medications for a period deemed appropriate by your doctor. However, if discontinuation is not possible, the doctor may decide to proceed with the test, being aware that results may be altered.
• The test has no diagnostic value in conditions that may interfere with glucose absorption, such as febrile states, trauma, gastrointestinal disorders, etc.

Children and adolescents
See section 3.

Other medicines and Glucosio Sclavo Diagnostics Syrup

• Inform your doctor if you are taking, have recently taken, or might take any other medicines.
• All medications that alter physiological glucose tolerance may affect the results of the test performed with Glucosio Sclavo Diagnostics Syrup. The following drug classes reduce glucose tolerance: oral contraceptives, caffeine, nicotine, nicotinic acid, chlorpromazine, corticosteroids, thiazides, indomethacin, diphenylhydantoin. The following increase glucose tolerance: alcohol, insulin, oral antidiabetics, MAO inhibitors, sulfonamides, propranolol, salicylates.

Glucosio Sclavo Diagnostics Syrup with food and drink

• You must take Glucosio Sclavo Diagnostics on an empty stomach.

Pregnancy, breast-feeding and fertility

• There are no contraindications to the use of this medicine during pregnancy or breast-feeding. However, inform your doctor if you are pregnant or breastfeeding. There are no effects on fertility.

Driving and using machines

• During the two-hour waiting period between blood draws, physical activity—and therefore driving—should be avoided. No negative effects of Glucosio Sclavo Diagnostics Syrup on the ability to drive or operate machinery have been observed.

Glucosio Sclavo Diagnostics Syrup contains parahydroxybenzoates
The syrup contains parahydroxybenzoates, which may cause
allergic reactions (including delayed reactions).

Glucosio Sclavo Diagnostics Syrup contains sodium benzoate
This medicine contains 18.75 mg of sodium benzoate per 150 ml dose, equivalent to
0.125 mg/mL.

Glucosio Sclavo Diagnostics Syrup contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially
"sodium-free".

3. How to use Glucosio Sclavo Diagnostics Syrup

• Glucosio Sclavo Diagnostics Syrup is for oral use. It is taken to perform a diagnostic test under the direct supervision of a doctor, strictly following their instructions. If in doubt, ask your doctor or nurse.
• In the three days preceding the test, you should follow a normal diet containing at least 150 grams of carbohydrates per day. You should maintain your usual physical activity. Do not take medications that interfere with blood sugar measurement or physiological sugar tolerance, such as estroprogestins or cortisone.
• The test should be performed in the morning, after a fasting period of at least 10 hours, but not longer than 16 hours.
• During the test, you must remain seated and, if you are a smoker, refrain from smoking.
• The ingestion time of the prescribed dose of Glucosio Sclavo Diagnostics Syrup solution must not exceed 5 minutes.
• For the test, the start of ingestion is considered "time zero".
• If considered useful, the solution may be further diluted with 100–150 mL of water, maintaining the proportion between the dose and the ingested volume.
• Doses are as follows:
  • Adults: 75 g of glucose, equivalent to 150 mL of solution
  • Pregnant women: 100 g of glucose, equivalent to 200 mL of solution
  • Children: 1.75 g per kg of ideal body weight, calculated according to the subject's height, up to a maximum dose of 75 g, according to the following table.

If you use more Glucosio Sclavo Diagnostics Syrup than you should
If this occurs outside of direct medical supervision, inform your doctor immediately or go
to the nearest hospital.
Excessive intake by individuals with impaired insulin activity (the hormone that lowers blood glucose levels) causes an increase in blood glucose levels. This increase leads to greater urine production, potentially disrupting the balance of electrolytes in the blood. In patients with diabetes mellitus, accumulation of so-called ketone bodies in the blood and tissues may lead to a toxic condition, possibly resulting in coma—loss of consciousness, motor function, and sensation—and potentially death.

4. Possible side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Nausea and vomiting may occur. If vomiting occurs, the test must be discontinued.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system
at https://www.aifa.gov.it//content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glucosio Sclavo Diagnostics Syrup

Keep this medicine below 30°C.
Keep this medicine out of the sight and reach of children.
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 month indicated. After use, do not store any remaining product.

6. Contents of the pack and other information

What Glucosio Sclavo Diagnostics Syrup contains

• The active substance is glucose.
• The other components are: orange flavouring, citric acid, sodium chloride, sodium benzoate (E 211), methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of Glucosio Sclavo Diagnostics Syrup and contents of the pack
The pack of Glucosio Sclavo Diagnostics Syrup contains one bottle of syrup.
Each bottle contains 75 g of glucose in 150 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sclavo Diagnostics International S.r.l.
Località Pian dei Mori, via Po n. 26-28
53018 Sovicille (SI) – Italy
Telephone +39 0577 390 41
FAX +39 0577 390 444, -445
Manufacturer:
ABC Farmaceutici S.p.A.
Canton Moretti, 29
Loc.S. Bernardo d’Ivrea – 10015 Ivrea (TO)