GLUINTOL 50 g ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

GLUINTOL 50 g Oral Solution

Glucose Monohydrate

Contents of the Package Leaflet:

1. What is GLUINTOL 50 and what is it used for
2. What you need to know before taking GLUINTOL 50
3. How to take GLUINTOL 50
4. Possible side effects
5. Storage of GLUINTOL 50
6. Package Contents and Additional Information

1. What is Gluintol 50 and what is it used for

GLUINTOL 50 is a glucose solution that belongs to the group of tests for diabetes and is indicated for use before the O'Sullivan Test for screening or pre-diagnosis of gestational diabetes.

2. What you need to know before taking Gluintol 50

Do not take GLUINTOL 50:

• If you are allergic to glucose or any of the components of this medication (listed in section 6).

• If you have hypotonic dehydration (loss of water along with electrolytes), electrolyte imbalance, and in patients who have intracranial or intra-spinal hemorrhage and in cases of delirium tremens with dehydration.

• In patients with anuria (suppression of urine formation) and in diabetic or hepatic coma.

• In patients with ischemic stroke (deficient blood supply, and therefore oxygen, to an area of the brain), as excess glucose worsens ischemia and recovery.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before taking GLUINTOL 50.

In patients with sodium deficiency, the administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (decreased urine output).

Taking GLUINTOL 50 with other medications

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or may need to take any other medication.

There are certain medications that alter glucose metabolism and can affect the test results. Therefore, it is essential to limit the use of certain medications with hyperglycemic or hypoglycemic action during the 3 days prior to the test.

Medications with hyperglycemic action: Acetazolamide, adrenaline, etacrynic acid, nalidixic acid, nicotinic acid, tricyclic antidepressants, lithium carbonate, diazoxide, diphenylhydantoin, thiazide diuretics, estrogens, phenothiazines, furosemide, glucagon, glucocorticoids, heparin, indomethacin, morphine, nitrofurantoin, reserpine, etc.

Medications with hypoglycemic action (apart from sulfonylureas): Acetylsalicylic acid, amphetamines, clofibrate, cyproheptadine, ethanol, fenfluramine, guanethidine, haloperidol, MAO inhibitors, marijuana, oxytetracycline, propranolol, etc.

Taking GLUINTOL 50 with food, drinks, and alcohol

Glucose, as a carbohydrate, is present in most foods and beverages, alcoholic and non-alcoholic. To avoid glucose in the diet distorting the test result, the test will be preceded by a 10-12 hour overnight fast, during which only water can be consumed.

For the test to be representative of the individual's real state, it should be performed with the glucose solution after at least 3 days of an unrestricted diet (more than 150g of carbohydrates per day) and normal physical activity.

Pregnancy, Breastfeeding, and Fertility

GLUINTOL 50 is used in pregnant women for the pre-diagnosis of gestational diabetes.

Glucose crosses the placenta, while insulin does not, so the fetus itself is responsible for insulin synthesis. For this reason, it should be administered with caution in pregnant and breastfeeding women.

Driving and Using Machines

There is no indication that the glucose solution GLUINTOL 50 may affect the ability to drive or use machines.

3. How to take Gluintol 50

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for pre-diagnosis or screening of gestational diabetes is 50g; therefore, the contents of the bottle should be consumed in its entirety in a single use.

Between 7 and 9 am and after 30 minutes of rest, a blood sample is taken to determine basal glucose levels, and the patient ingests the glucose load 5 minutes later, with the first blood sample taken at a specific time after the basal sample, depending on the criteria used for interpreting the results. Generally, blood will be drawn at the time of glucose administration.

Use in Children and Adolescents

There is no specific recommendation for the use of GLUINTOL 50 in pregnant women under 18 years of age.

If you take more GLUINTOL 50 than you should

If you have used more GLUINTOL 50 than you should, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and package leaflet to the healthcare professional.

The symptoms of excess glucose include:

• excessive urine production that can lead to severe dehydration
• alterations in the balance of salts in the blood (plasma hyperosmolarity) that can cause alterations in consciousness, convulsions, and coma.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

GLUINTOL 50 may cause nausea, sweating, dizziness, or fainting after ingesting the glucose solution. If nausea, dizziness, sweating, or any other manifestation of vegetative nervous system hyperactivity occurs, a blood sample should be taken immediately, and the test should be interrupted and repeated later if deemed necessary. Other side effects that may occur include headache, feeling of fatigue, abdominal discomfort, and feeling of bloating.

After taking the glucose oral solution, an increase in heart rate without an increase in blood pressure has been observed in some cases.

Taking the glucose solution GLUINTOL 50 may cause a significant delay in gastric emptying in normal subjects.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gluintol 50

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated. No special storage conditions are required.

Do not use this medication if you notice that the packaging shows visible signs of deterioration or if the solution is cloudy.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of GLUINTOL 50 g Oral Solution

• The active ingredient is glucose monohydrate. Each 100 ml of solution contains 25 g of glucose monohydrate.

• The other components (excipients) are: citric acid, sodium benzoate (E-211), carmine acid (colorant E-120), and pharmaceutical-grade water.

Appearance of the Product and Package Contents

The product GLUINTOL 50 g Oral Solution is presented as a clear, reddish or orange solution without particles in suspension.

Each bottle contains 200 ml of oral solution.

Marketing Authorization Holder

INDUSEN, S.A.

Polígono Industrial Monte de la Abadesa, Unidad de Ejecución 38-02, parcela 3

09001 Burgos.

SPAIN

Manufacturer

INDUSEN, S.A.

Polígono Industrial Monte de la Abadesa, Unidad de Ejecución 38-02, parcela 3

09001 Burgos. SPAIN

or

IDIFARMA DESARROLLO FARMACÉUTICO, S.L.

Polígono Mocholí, Calle Noáin Nº1

31110 Noáin

Navarra - SPAIN

Detailed information on this medication is available on the website of the Spanish Agency for Medicines.

Date of the Last Revision of this Package Leaflet: May 2015

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This information is intended only for healthcare professionals:

Dosage

200 ml administered over a period of 5 minutes.

The contents of the bottle should be consumed in its entirety.

Method of Administration

The O'Sullivan test consists of administering 278 mmol (50g) of glucose orally within the period between the 24th and 28th weeks of gestation, which is the period of maximum glucose intolerance.

The contents of the bottle should be consumed in its entirety in a single use.

Patient Preparation

To obtain reliable data, several rules must be strictly observed. During the 3 days preceding the test, a diet containing at least 150g of carbohydrates per day must be followed. If the patient has not previously followed a sufficiently carbohydrate-rich diet, the aforementioned regimen must be maintained for two more days. The presence of anorexia or any other circumstance that prevents adequate intake invalidates the test. It has been found that inactivity, such as bed rest, reduces glucose tolerance; therefore, glucose tolerance tests should not be performed in hospitalized patients. During the 10-12 hours preceding the test, the patient must fast strictly, even avoiding coffee. Smoking and exercise, even light, are also prohibited. The test should not be applied to patients who have been ill in the two weeks prior. Certain endocrine disorders, such as acromegaly, hyperthyroidism, or Cushing's syndrome, are often associated with abnormal glucose tolerance; therefore, before performing the test, the corresponding endocrine dysfunction must be corrected. Many medications, such as salicylates, diuretics, and anticonvulsants, decrease insulin secretion; they should be avoided for at least 3 days before the test, as well as all non-essential medications.

Performance and Interpretation of the Test

Between 7 and 9 am and after 30 minutes of rest, a blood sample is taken to determine basal glucose levels, and the patient ingests the glucose load 5 minutes later, with the first blood sample taken at a specific time after the basal sample, depending on the criteria used for interpreting the results. Generally, for the O'Sullivan test, blood will be drawn at the time of glucose administration.

After one hour, a venous blood sample is taken, and the glucose concentration is measured. If this concentration is greater than or equal to 7.8 mmol/L (140mg/dl), the result is considered positive, and the diagnostic test with a 100g glucose load should be performed.