Leaflet: information for the user

Glucosa Physan 10%, solution for perfusion

Dehydrated glucose

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Glucosa Physan 10% and what it is used for.

2. What you need to know before starting to use Glucosa Physan 10%

3. How to use Glucosa Physan 10%

4. Possible adverse effects

5. Storage of Glucosa Physan 10%

6. Contents of the package and additional information

Glucosa Physan 10% belongs to the group of parenteral nutrition solutions intended for the provision of water and energy.

It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating, gastrointestinal fistulas), as an energy supplement in parenteral nutrition, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, acetone vomiting) and as a vehicle for the administration of compatible medications.

No use Glucosa Physan 10%:

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

- If you have been diagnosed with hypotonic dehydration, loss of electrolytes, or decreased urine volume.

- In the first 24 hours after a head trauma.

- In states of hyperglycemia.

- In states of hyperhydration, generalized edema.

- If you have hyperlactacidemia.

- If you have significant alterations in glucose tolerance, including hyperosmolar coma.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Glucosa Physan 10%.

-The blood glucose level must be carefully controlled in cases of intracranial hypertension.

- In the case of acute ischemic attacks (decrease or absence of circulation in arteries), since hyperglycemia has been related to an increase in ischemic brain damage and difficulty in recovery.

- In shock and alterations of acid-base balance, patients should be treated by administering electrolytes before administering glucose solutions. In patients with sodium deficiency, the administration of solutions without sodium may cause peripheral circulatory collapse and oliguria (low urine output).

- Regularly scheduled controls of blood glucose, serum electrolytes, water balance, and acid-base balance are recommended, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, electrolyte supplements will be necessary.

- To avoid hypokalemia caused by prolonged parenteral nutrition with glucose, potassium may be added to the glucose solution as a safety measure.

- If you are malnourished, you may have a deficiency of vitamin B1. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.

- If you have diabetes. In this case, glucose solutions can be used as long as initial appropriate treatment (insulin) has been established. Blood glucose levels should be regularly monitored in diabetic patients and insulin requirements adjusted.

- Do not administer blood simultaneously using the same infusion equipment due to the risk of pseudoagglutination and/or hemolysis.

- If administered continuously in the same infusion site, it may cause thrombophlebitis (inflammation of the veins).

- Special attention should be given if used in elderly patients, as they may have impaired liver and/or kidney function.

- Do not administer by intramuscular route.

Glucose solutions for intravenous infusion are generally isotonic. However, in the body, glucose solutions can become extremely hypotonic physiologically due to the rapid metabolism of glucose.

Depending on the tonicity of the solution, the volume, and the rate of infusion, as well as the initial clinical condition of the patient and their ability to metabolize glucose, intravenous administration of glucose may cause electrolyte imbalances, the most important of which is hyponatremic hyperosmolarity.

Hyponatremia:

Patients with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and CNS diseases) have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering severe and potentially fatal cerebral edema caused by acute hyponatremia.

Use of Glucosa Physan 10% with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is essential to inform your doctor if you are using any of the following medications:

- Insulin or oral antidiabetic agents (biguanides, sulfonylureas): Intravenous administration of glucose in patients treated with insulin or oral antidiabetic agents may decrease their efficacy (antagonistic action).

- Corticosteroids: Intravenous administration of glucose solutions in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may lead to a significant increase in plasma glucose levels due to the hypoglycemic action of these substances. In the case of corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.

- Digitalis glycosides (digoxin): If intravenous administration of glucose coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with a risk of developing digitalis toxicity. This is due to the hypokalemia that may be caused by glucose administration, unless potassium is added to the solution.

In any case, the doctor should check the compatibility of the added medications.

Medications that potentiate the effect of vasopressin

The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital hyponatremia after inadequate treatment with intravenous infusion solutions.

• Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics
• Medications that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin

Other medications known to increase the risk of hyponatremia, such as diuretics in general and antiepileptic drugs like oxcarbazepine.

Pregnancy, lactation, and fertility

Glucosa Physan 10% should be administered with special caution in pregnant women during delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using any medication.

In the case of pregnancy, your doctor will decide whether to use a 10% glucose solution, as it should be used with caution in this case. Administration of glucose by intravenous route during pregnancy can elevate glucose and insulin levels, as well as acidic components in the fetus's blood.

There is no evidence to suggest that 10% glucose may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and operating machinery:

No.

Your doctor will tell you the most suitable dose for your needs. Generally, intravenous administration drop by drop is recommended according to your age, body weight, clinical condition, and metabolic state.

In adults, the maximum dose is 20 ml/kg body weight/day and the maximum perfusion rate is

2.5 ml/kg body weight/hour = 0.25 g/kg body weight/hour.

Use in children

In children, the perfusion rate depends on the child's age and weight, and generally should not exceed 10-18 mg of glucose (0.1-0.18 ml of solution)/kg/min.

0-10 kg: 50 ml/kg/24h

10-20 kg: 500 ml + 25 ml/kg/24 h for the weight above 10 kg.

More than 20 kg: 750 ml + 10 ml/kg/24h for the weight above 20 kg.

(See also section 6).

If you have been given moreGlucosa Physan 10%than you should have:

In case ofoverdose, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. Administration will be suspended and symptomatic treatment will be sought.

In case of overdose, consult the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

It may cause hyperglycemia, glucosuria (glucose in urine) or alterations in the balance of fluids or electrolytes if administered too quickly or if the volume of liquid is excessive, or in cases of metabolic insufficiency.

On the other hand, the resulting hyperglycemia from a rapid infusion or excessive volume must

be monitored in severe cases of diabetes mellitus, and may be prevented by reducing the dose and infusion rate or by administering insulin.

A local reaction may occur at the site of injection.

Whenever any of these adverse reactions occur, you must inform your doctor, who

will evaluate the need to discontinue the medication.

If used as a vehicle for the administration of other medications, the nature of the added medications will determine the probability of other adverse reactions.

If these adverse effects or any other not described in this prospectus are observed, consult with your doctor or pharmacist.

Adverse Reactions

Metabolic and nutritional disorders with hospital-acquired hyponatremia** of unknown frequency.

Nervous system disorders with hypnatremic encephalopathy** of unknown frequency.

** Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the onset of acute hypnatremic encephalopathy

Reporting 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 prospectus. You may also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Glucose Physan 10% Composition

• The active principle is glucose. Each 100 ml of solution contains 10 g of anhydrous glucose (11 g as monohydrate glucose).
• The other components (excipients) are: water for injectable preparations, hydrochloric acid (for pH adjustment).

Theoretical osmolarity: 556 mosm/l.Theoretical calories: 400 kcal/l.

pH: 3.5-6.5

Product Appearance and Packaging Content

Transparent, hypertonic, apyrogenic, and sterile solution.

Glucose Physan 10% is an intravenous perfusion solution that is presented in 250 ml and 500 ml containers.

For single-use containers:

It is presented in bottles: Type II glass and polypropylene (PP).

Also in bags: Polypropylene (PP) and polyvinyl chloride (PVC).

In the following capacities:

-Bottle and Bag of 250 ml

-Bottle and Bag of 500 ml

For Clinical Containers:

With the following presentations:

1.- Glass Bottles:

-24 bottles of 250 ml

-10 bottles of 250 ml

-10 bottles of 500 ml

2.- PP Bottles:

-20 bottles of 250 ml

-24 bottles of 250 ml

-10 bottles of 500 ml

20 bottles of 500 ml

3.- PP and PVC Bags:

-30 bags of 250 ml

-20 bags of 500 ml

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

LAPHYSAN, S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D

28108 Alcobendas – Madrid, Spain

Responsible for Manufacturing:

S.M. FARMACEUTICI SRL

Zona industriale

85050 TITO – POTENZA, Italy

or

SALF SPA LABORATORY PHARMACEUTICAL

Via Marconi 2

24069 Cenate Sotto (Bergamo), Italy

or

PARACELSIA INDUSTRY PHARMACEUTICAL

Rua Antero de Quental, 639

P-4200-068 Porto, Portugal

or

LABORATORIOS BASI - INDUSTRY PHARMACEUTICAL, S.A.
Parque Industrial Manuel Lourenço Ferreira, Nº 8 Nº 15 and Nº 16
3450-232 Mortágua – Portugal

Last Review Date of this Prospectus: March 2019

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This information is intended solely for healthcare professionals:

This medication will be administered always by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

The solution must be transparent and not contain precipitates. Do not administer otherwise. The content of each bottle, vial or bag is for a single perfusion, discard the unused fraction.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for incompatibilities.

You may need to monitor the water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring serum sodium is especially important when administering hypotonic physiological solutions. Glucose Physan 10% perfusion solution can become extremely hypotonic after administration due to glucose metabolism in the body.