NITROPRUSSIDE FIDES 50 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Leaflet: Information for the user

NITROPRUSSIAT FIDES 50 mg powder for injectable solution

Sodium nitroprusside

Read the entire leaflet carefully before starting to use the 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 or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are serious and not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Nitroprussiat Fides Injectable and what is it used for
2. What you need to know before starting to use Nitroprussiat Fides Injectable
3. How to use Nitroprussiat Fides Injectable
4. Possible side effects
5. Storage of Nitroprussiat Fides Injectable
6. Package contents and additional information

1. What is Nitroprussiat Fides Injectable and what is it used for

Nitroprussiat Fides Injectable, whose active ingredient is sodium nitroprusside, belongs to a group of medicines called antihypertensives, which help control high blood pressure (hypertension).

Nitroprussiat Fides Injectable is indicated for:

• Treatment of hypertensive crises and malignant hypertension that does not respond to other treatments.
• Controlled hypotension during anesthesia to reduce bleeding during surgical procedures. The surgeon and anesthesiologist should evaluate the suitability of treatment with nitroprusside in each individual case.

2. What you need to know before starting to use Nitroprussiat Fides Injectable

Do not useNitroprussiatFides Injectable

• If you are allergic to nitroprusside or any of the other components of this medicine (listed in section 6).
• If you have compensatory hypertension, such as arteriovenous shunts or aortic coarctation (narrowing of a segment of the aortic artery).
• If there is a risk of ASA grade 5, equivalent to moribund patients who are not expected to survive without surgical intervention.
• If you have uncorrected anemia or hypovolemia (decreased circulating blood volume).
• If cerebral circulation is inadequate (cerebrovascular insufficiency).
• The use of nitroprusside to induce controlled hypotension during anesthesia is contraindicated if you have liver disease, severe kidney disease, Leber's optic atrophy (degeneration of retinal cells leading to vision loss), tobacco amblyopia (dark vision due to tobacco consumption), or diseases associated with vitamin B12 deficiency.
• If you are taking riociguat, a soluble guanylate cyclase stimulator.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nitroprussiat Fides

• Nitroprussiat Fides Injectable should never be administered undiluted, but as an intravenous infusion diluted in glucose solution.

• During treatment with Nitroprussiat Fides Injectable, your doctor should monitor your blood pressure (every 5 minutes at the start of the infusion and then every 15 minutes), heart rate, and acid-base balance.

• During treatment, side effects due to cyanide or thiocyanate (potentially toxic products derived from nitroprusside metabolism) may appear (see section 4: Possible side effects). In the presence of renal and/or hepatic insufficiency, or when treatment is longer than 3 days or high doses of Nitroprussiat Fides Injectable are used, your doctor may consider it necessary to monitor blood levels of cyanide and thiocyanate.

• Sudden interruption of intravenous infusion could cause rebound hypertension. Therefore, it should be interrupted gradually over 15-30 minutes.

• The dosage of NITROPRUSSIAT Fides Injectable should be carefully monitored in cases of acute coronary and cerebrovascular insufficiency, and in patients with renal or hepatic insufficiency.

• In chronic treatments, at high doses, and/or in patients with renal or hepatic insufficiency, accumulation of cyanide or thiocyanate, potentially toxic products derived from nitroprusside metabolism, may occur.

• Hypertensive patients are more sensitive to the effect of sodium nitroprusside than those with normal blood pressure. Patients receiving antihypertensives are also more sensitive to the hypotensive effect of sodium nitroprusside. In these cases, the dose of nitroprusside should be reduced.

• In patients with anemia or hypovolemia, these should be corrected as much as possible before administering sodium nitroprusside - or any vasodilator - to control hypotension during anesthesia.

• The administration of Nitroprussiat Fides Injectable should be supervised by specialized personnel and performed only in places equipped with devices for constant monitoring of blood pressure.

Use ofNitroprussiat Fides withother medicines

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

Nitroprussiat Fides Injectable is totally incompatible with other medications; therefore, it should always be administered separately. It should not be administered directly, but as an intravenous infusion, diluted with an isotonic glucose solution (sterile glucose solution in water at 4.7-5%).

The combined use of sodium nitroprusside and other antihypertensives may produce an increased hypotensive effect.

The use of Nitroprussiat Fides with riociguat, a soluble guanylate cyclase stimulator, is contraindicated, as concomitant use may cause hypotension (see also "Do not use Nitroprussiat Fides Injectable").

Pregnancy, breastfeeding, and fertility

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

The potential use of Nitroprussiat Fides Injectable in pregnant women is not well established. Therefore, it will only be used when the potential benefits outweigh the possible risks.

It is not known whether sodium nitroprusside is excreted in significant amounts in breast milk; therefore, its use is not recommended during breastfeeding.

Driving and using machines

It is not known how this medicine affects driving or operating machinery; therefore, tasks that require special attention should not be performed until it is verified how the medicine is tolerated.

Nitroprussiat Fides Injectable contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; i.e., it is essentially "sodium-free".

3. How to use Nitroprussiat Fides Injectable

Follow your doctor's instructions for administering this medicine exactly. If in doubt, consult your doctor, pharmacist, or nurse again.

The dosage will be adjusted in each case by the doctor, according to the desired hypotensive effect, which will be monitored through frequent blood pressure measurements.

As a guideline, in patients who are not receiving any antihypertensive medication, the average dose of Nitroprussiat Fides Injectable is 3 (0.5-8) μg/kg/min, while in patients who are receiving concomitant oral antihypertensive agents, lower doses will be required.

It is recommended not to exceed a dose of 1.5 μg/kg/min to induce controlled hypotension during anesthesia.

The infusion of Nitroprussiat Fides Injectable can be continued until it is possible to treat the patient satisfactorily with oral antihypertensive medication.

Method of administration:

Preparation of the infusion solution and precautions:

Dissolve the contents of the vial in 5 ml of glucose solution in water at 5% (no other solvent should be used). This mother solution is diluted in 500-1000 ml of isotonic glucose solution (sterile glucose solution in water at 4.7-5%), taking care to keep the solution protected from light from this moment on (by wrapping the bottle with the aluminum foil included in the box). Once prepared, the solution should be used immediately.

From a microbiological point of view, the product should be used immediately. If it is not used immediately, the storage time and conditions prior to use are the responsibility of the user and will not normally exceed 24 hours at 2-8 °C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Nitroprussiat Fides Injectable starts acting quickly, so it should be administered as an infusion (drop by drop) and the entry speed of the solution should be regulated to achieve a gradual decrease in blood pressure to the desired level; therefore, the administration of Nitroprussiat Fides Injectable should be supervised by specialized technical personnel, who should also monitor blood pressure.

Use in children

In children who do not receive antihypertensive medication, the average dose of Nitroprussiat Fides Injectable is 3 (0.5-8) μg/kg/min, while in patients who receive concomitant oral antihypertensive agents, lower doses will be required.

The potential use of Nitroprussiat Fides Injectable in young children is not well established.

Use in patients over 65 years

The elderly may be more sensitive to the hypotensive effects of sodium nitroprusside.

If you use moreNitroprussiatFides Injectable than you should

Signs of overdose may manifest as excessive hypotension or signs of cyanide or thiocyanate poisoning (see section 4: Possible side effects).

In case of overdose with Nitroprussiat Fides Injectable, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount taken). Bring this leaflet with you.

If you forget to useNitroprussiatFides Injectable

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects are listed below, according to the following frequency categories:

• Very common (more than 1 in 10 patients): hypotensive crises (especially associated with too rapid intravenous infusion), which resolve quickly when the administration of the medicine is decreased or stopped. Nervousness, disorientation, headache, nausea, vomiting, and abdominal pain.

• Uncommon (less than 1 in 100 patients, but more than 1 in 1000 patients): signs of cyanide or thiocyanate poisoning, such as tinnitus (ringing or buzzing in the ears), blurred vision, hypothyroidism, metabolic acidosis (decrease in blood pH), confusion, psychosis (mental state consisting of a loss of contact with reality), ataxia (lack of coordination in body movements), and dyspnea (difficulty breathing or shortness of breath). The risk of these adverse reactions increases in very prolonged treatments, at high doses, and/or in patients with renal or hepatic insufficiency. The potential adverse effects of cyanide can be minimized if hydroxocobalamin (vitamin B12) is administered concomitantly with Nitroprussiat Fides Injectable.

• Rare (less than 1 in 1000 patients, but more than 1 in 10,000 patients): methemoglobinemia (blood disorder in which the body cannot recycle hemoglobin), hyperreflexia (exaggeration of reflexes), somnolence, miosis (pupillary constriction), tachycardia (rapid heart rate), arrhythmias (alterations in heart rhythm), hyperventilation (faster and/or deeper breathing than normal), rash (change in skin color, appearance, and texture), and weakness.

• Very rare (frequency not known): hypoxia (lack of oxygen), myasthenia (disease characterized by weakness in the body's muscles), muscle cramps, excessive sweating, loss of consciousness.

The mandatory monitoring of the effects of the medication by specialized personnel makes it very unlikely that there will be a risk of poisoning with Nitroprussiat Fides Injectable.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nitroprussiat Fides Injectable

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the packaging after "EXP" or "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofNitroprussiatFides Injectable

• The active ingredient is sodium nitroprusside. Each vial contains 50 mg of sodium nitroprusside.
• The other components are: sodium citrate, anhydrous citric acid, and water for injections.

Appearance of the product and package contents

Orange-pink lyophilized powder.

Nitroprussiat Fides 50 mg powder for injectable solution is presented in boxes containing 1 vial with lyophilized powder and aluminum foil to protect the infusion solution from light once prepared.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

LABORATORIO REIG JOFRE, S.A.

C/ Gran Capitán, 10, 08970 Sant Joan Despí

Barcelona - Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet: August 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/