Patient Information Leaflet

GLUINTOL 50 g Oral Solution

Glucose Monohydrate

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

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 present with intracranial or intraspinal hemorrhages 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 cerebrovascular accidents (deficient blood flow, and therefore oxygen, to an area of the brain), as excessive glucose worsens ischemia and recovery.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take GLUINTOL 50.

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

Taking GLUINTOL 50 with other medications

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

There are certain medications that alter glucose metabolism and, therefore, may affect test results. 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): Aspirin, amphetamines, clofibrate, ciproheptadine, ethanol, fenfluramine, guanetidine, haloperidol, MAO inhibitors, marijuana, oxitetracycline, propranolol, etc.

Taking GLUINTOL 50 with food, drinks, and alcohol

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

To ensure the test is representative of the individual's actual state, the test should be performed with the glucose solution after at least 3 days of an unrestricted diet (more than 150 g 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. Therefore, the fetus is responsible for synthesizing insulin. For this reason, it should be administered with caution in pregnant women and during breastfeeding.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Between 7 and 9 in the morning and after 30 minutes of rest, a blood sample is obtained to determine the basal glucose and the patient ingests the glucose load 5 minutes later, taking the first blood sample a certain time after the basal sample was obtained, a specific time that will depend on the criteria used for the interpretation of 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 GLUITOL 50 in pregnant women under 18 years old.

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 Toxicological Information Service, phone 91-562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the leaflet to the healthcare professional.

The symptoms of excessive glucose include:

• excessive urine that can lead to severe dehydration
• alterations in the balance of salts in the blood (hyperosmolar plasma) that occurs with alterations in consciousness, seizures, and coma.

Like all medications, this medication may produce adverse effects, although not all people 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 hyperactivity of the vegetative nervous system occurs, a blood sample should be taken immediately and the test should be interrupted, repeating it later if considered appropriate. Other adverse effects that may occur include headache, feeling of fatigue, abdominal discomfort, and sensation of swelling.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears 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 observe visible signs of deterioration on the packaging or if the solution appears cloudy.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

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), carminic acid (colorant E-120) and pharmaceutical-grade water.

Appearance of the product and contents of the package

The GLUINTOL 50 g oral solution product is presented in the form of a transparent, reddish or orange-colored solution without particles in suspension.

Each bottle contains 200 ml of oral solution.

Holder of the marketing authorization

INDUSEN, S.A.

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

09001 Burgos.

SPAIN

Responsible for manufacturing

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

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments.

Date of the last review of this prospectus:May 2015

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This information is intended solely for healthcare professionals:

Dosage

200 ml administered over a period of 5 minutes.

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

Administration form

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 must be consumed in its entirety in a single use.

Patient preparation

To obtain reliable data, several norms must be observed rigorously. During the 3 days preceding the test, a diet containing at least 150g of carbohydrates per day must be applied. If the patient has not previously followed a diet rich in carbohydrates, the aforementioned regimen must be maintained for 2 additional days. The presence of anorexia or any other circumstance that prevents adequate ingestion automatically invalidates the test. It has been proven that inactivity, such as bed rest, reduces glucose tolerance; therefore, glucose tolerance tests should not be performed on hospitalized patients. During the 10-12 hours preceding the test, the patient must observe strict fasting, even excluding coffee. On the other hand, smoking and exercise, even light, are prohibited. The test should not be applied to patients who have been ill in the 2 weeks preceding the test. Certain endocrine disorders, such as acromegaly, hyperthyroidism, or Cushing's syndrome, are frequently 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 must be avoided for at least 3 days before the test, as well as all non-essential medications.

Conduct and interpretation of the test

Between 7 and 9 in the morning and after 30 minutes of rest, a blood sample is obtained to determine the basal glucose and the patient ingests the glucose load at 5 minutes, taking the first blood sample a certain time after the basal sample was obtained, a specific time that will depend on the criteria used for the interpretation of the results. In general, for the O'Sullivan test, blood will be drawn at the time of glucose administration.

One hour later, a venous blood sample is drawn, and the glucose concentration is measured. If this concentration is equal to or greater than 7.8 mmol/L (140mg/dl), the result is considered positive, and the diagnostic test with a 100g glucose overload must be performed.