Gluintol 50 g oral solution

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

GLUINTOL 50 g oral solution

glucose monohydrate

Package leaflet contents:

1. What GLUINTOL 50 is and what it is 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. Contents of the pack and other information

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

GLUINTOL 50 is a glucose solution belonging to the group of tests for diabetes, indicated for oral intake prior to 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 to any of the components of this medicine (listed in section 6).

• If you have hypotonic dehydration (loss of water together with electrolytes), electrolyte imbalance, or in patients with intracranial or intraspinal hemorrhage, and in cases of delirium tremens associated with dehydration.

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

• In patients with ischemic cerebrovascular accidents (deficient blood supply, and thus oxygen, to an area of the brain), as excess 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 (reduced urine output).

Taking GLUINTOL 50 with other medicines

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

Certain drugs alter glucose metabolism and may therefore affect test results. Thus, it is important to limit the use of specific drugs with hyperglycemic or hypoglycemic effects during the 3 days prior to the test.

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

Drugs with hypoglycemic effects (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 alcoholic and non-alcoholic beverages. To avoid dietary glucose distorting the test result, the test must be preceded by a 10 to 12-hour overnight fast, during which only water may be consumed.

For the test to be representative of the individual's actual condition, it should be performed with the glucose solution after at least three 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, whereas insulin does not, so the fetus itself is responsible for insulin synthesis. For this reason, it should be administered with caution during pregnancy and breastfeeding.

Driving and use of machines

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

3. How to take Gluintol 50

Follow exactly the instructions for administration of this medicine provided 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 entire contents of the bottle must be consumed in a single use.

Between 7 and 9 a.m., and after 30 minutes of rest, a blood sample is taken to determine basal glucose levels. The patient ingests the glucose load within 5 minutes, and the first blood sample is taken at a certain time after the administration of glucose, the exact timing depending on the criteria used for interpreting the results. Generally, blood will be drawn one hour after 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, contact your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount used. It is recommended to bring the container and the package leaflet to the healthcare professional.

Symptoms of glucose overdose include:

• excessive urination, which may lead to severe dehydration
• disturbances in blood electrolyte balance (plasma hyperosmolarity), presenting with altered consciousness, seizures, and coma.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse 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 signs of overactivity of the autonomic nervous system occur, a blood sample should be taken immediately and the test should be stopped; the test may be repeated later if considered appropriate. Other adverse effects that may occur include headache, feeling of fatigue, abdominal discomfort, and sensation of bloating.

An increase in heart rate without a rise in blood pressure has also been observed in some cases after oral glucose solution intake.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gluintol 50

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. No special storage conditions are required.

Do not use this medicine if you notice visible signs of deterioration in the container or if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of GLUINTOL 50 g oral solution

• The active substance 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 (colouring agent E-120), and pharmaceutical quality water.

Appearance of the product and contents of the pack

GLUINTOL 50 g oral solution is presented as a clear, reddish or orange-coloured solution, free from 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 medicinal product is available on the website of the Spanish Agency of Medicines.

Date of latest review of this leaflet: May 2015

This information is intended for healthcare professionals only:

Dosage

200 ml administered within a 5-minute period.

The entire contents of the bottle must be consumed.

Method of administration

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

The entire contents of the bottle must be consumed in a single use.

Patient preparation

To obtain reliable results, several guidelines must be strictly followed. During the 3 days prior to the test, the patient must follow a diet containing at least 150 g of carbohydrates daily. If the patient has not previously followed a sufficiently carbohydrate-rich diet, this dietary regimen should be maintained for two additional days. The presence of anorexia or any other condition that prevents adequate intake automatically invalidates the test. It has been shown that physical 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 remain under strict fasting conditions, excluding even coffee. Smoking and physical exercise, even if mild, are prohibited. The test should not be performed in patients who have been ill within the previous two weeks. Certain endocrine disorders, such as acromegaly, hyperthyroidism, or Cushing's syndrome, are frequently associated with abnormal glucose tolerance; therefore, the corresponding endocrine dysfunction should be corrected before performing the test. Many drugs, such as salicylates, diuretics, and anticonvulsants, reduce insulin secretion and should be avoided at least 3 days prior to the test, along with all non-essential medications.

Performance and interpretation of the test

Between 7:00 and 9:00 a.m., and after 30 minutes of rest, a blood sample is taken to determine baseline glucose levels. The patient then ingests the glucose load within 5 minutes, and the first blood sample is taken a certain time after the baseline measurement; the exact timing depends on the criteria used for interpreting results. Generally, for the O’Sullivan test, blood is drawn at the time of glucose administration.

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