Label: information for the user

NITROPRUSSIAT FIDES 50 mg powder for injectable solution

Sodium nitroprusside

Read this label carefully before starting to use the medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are severe and do not appear in this label. See section 4.

1. What isNitroprussiatFides Injectable and for what it is used

2. What you need to know before starting to useNitroprussiatFides Injectable

3. How to useNitroprussiatFides Injectable

4. Possible adverse effects

5. Storage ofNitroprussiatFides Injectable

6. Contents of the package and additional information

NitroprussiatFides Inyectable, whose active ingredient is sodium nitroprusside, belongs to a group of medications called antihypertensives, which help control high blood pressure (hypertension).

NitroprussiatFides Inyectable is indicated for:

· The treatment of hypertensive crises and malignant hypertension that is refractory (does not respond to other treatments).

· Controlled hypotension during anesthesia, to reduce bleeding in surgical procedures. The surgeon and anesthesiologist should evaluate the suitability of nitroprusside treatment on an individual basis in each case.

No useNitroprussiatFides Inyectable

• If you are allergic to nitroprusside or any of the other components of this medication (listed in section 6).
• If you have compensatory hypertension, such as arteriovenous shunts or aortic coarctation (narrowing of a segment of the aorta).
• 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 retina 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 Inyectable should never be administered directly without dilution, but only as an intravenous infusion diluted in glucose solution.

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

-During treatment, potential cyanide or thiocyanate adverse effects (toxic products derived from nitroprusside metabolism) may occur (see section 4: Possible adverse effects). In the presence of renal and/or hepatic insufficiency, or when treatment exceeds 3 days or high doses of Nitroprussiat Fides Inyectable are used, your doctor may consider monitoring cyanide and thiocyanate blood levels.

The abrupt interruption of the intravenous infusion could cause rebound hypertension. Therefore, it should be interrupted progressively over 15-30 minutes.

Carefully monitor the dosing of NITROPRUSSIAT Fides Inyectable in cases of acute coronary and cerebral 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. They are also more sensitive to the hypotensive effect of sodium nitroprusside than those receiving antihypertensive medications. In these cases, the dose of nitroprusside should be reduced.

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

The administration ofNitroprussiatFides Inyectable must be strictly supervised by specialized personnel and performed only in places equipped with equipment for constant monitoring of blood pressure.

Use ofNitroprussiat Fides withother medications

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

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

The concomitant use of sodium nitroprusside and other antihypertensive medications may increase the 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 Inyectable”).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The excretion of sodium nitroprusside in breast milk is unknown; therefore, its use is not recommended during lactation.

Driving and operating machinery

The effect of this medication on driving or operating machinery is unknown; therefore, tasks that require special attention should not be performed until it is confirmed how the medication is tolerated.

Nitroprussiat Fides Inyectable contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be administered exactly as indicated by your doctor.In case of doubt, consult your doctor, pharmacist, or nurse again.Consult your doctor, pharmacist, or nurse again in case of doubt.

The dosage will be adjusted in each case by your doctor, in accordance with the desired hypotensive effect, which will be controlled by frequent blood pressure determinations.

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 concomitantly an oral antihypertensive agent, lower doses will be required.

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

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

Administration Form :

Preparation of the infusion solution and precautions:

The contents of the vial are dissolved in 5 ml of a 5% glucose solution in water (do not use any other solvent). This mother solution is then diluted in 500-1000 ml of isotonic glucose solution (sterile 4.7-5% glucose solution in water), taking care to keep the solution protected from light (wrapping the bottle with aluminum paper that is included in the box) from this moment on. Once prepared, the solution must be used immediately.

From a microbiological point of view, the product must be used immediately. If it is not used immediately, the storage time and previous conditions of use are the responsibility of the user and are normally not greater than 24 hours at 2-8 °C, unless the reconstitution/dilution has been performed in controlled and validated aseptic conditions.

Nitroprussiat Fides Injectable begins to act rapidly, so it must be administered in the form of an infusion (drop by drop) and the speed of entry of the solution must be regulated in order to achieve a gradual decrease in blood pressure to the desired level; for this reason, the administration of Nitroprussiat Fides Injectable must be supervised by specialized technical personnel, who must also monitor the blood pressure in parallel.

Use in children

In children who are not receiving antihypertensive medication, the average dose of Nitroprussiat Fides Injectable is 3 (0.5-8) μg/kg/min, while in patients who are receiving concomitantly an oral antihypertensive agent, lower doses will be required.

The possible use of Nitroprussiat Fides Injectable in young children has not yet been well established.

Use in patients over 65 years old

Older adults may be more sensitive to the hypotensive effects of sodium nitroprusside.

If you use more Nitroprussiat Fides Injectable than you should

The signs of overdose may manifest as excessive hypotension or signs of cyanide or thiocyanate poisoning (see section 4: Possible adverse 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 medication and the amount ingested). Bring this leaflet with you.

If you forgot to use Nitroprussiat Fides Injectable

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The 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 quickly resolve upon reducing or stopping the medication. Nervousness, disorientation, headache, nausea, vomiting, and abdominal pain.

-Uncommon (less than 1 in 100 patients, but more than 1 in 1,000 patients): Signs of cyanide or thiocyanate poisoning, such as tinnitus (ringing or buzzing in the ears), blurred vision, hypothyroidism, metabolic acidosis (decreased blood pH), confusion, psychosis (a mental state characterized by a loss of contact with reality), ataxia (discoordination of body parts), and dyspnea (difficulty breathing or lack of air). The risk of experiencing these adverse reactions increases in prolonged treatments, at high doses, and/or in patients with renal or hepatic insufficiency. Any potential adverse effects of cyanide can be minimized by administering hydroxocobalamin (vitamin B12) concurrently withNitroprussiatFides Injectable.

-Rare (less than 1 in 1,000 patients, but more than 1 in 10,000 patients): Methemoglobinemia (a blood disorder in which the body cannot recycle hemoglobin), hyperreflexia (exaggeration of reflexes), somnolence, miosis (pupil constriction), tachycardia (rapid pulse), arrhythmias (alterations in heart rhythm), hyperventilation (abnormally rapid and/or deep breathing), rash (skin change affecting color, appearance, and texture), and weakness.

-Very Rare (unknown frequency): Hypoxia (oxygen deficiency), myasthenia (a disease characterized by muscle weakness), muscle cramps, excessive sweating, loss of consciousness.

The mandatory monitoring of medication effects by specialized personnel makes it very unlikely for the risk of poisoning byNitroprussiatFides Injectable.

Reporting of adverse effects:

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

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after “CAD or EXP”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nitroprussiat Fides 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 contents of the packaging

Pink-orange lyophilized powder.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

LABORATORIO REIG JOFRE, S.A

C/ Gran Capitán, 10, 08970 Sant Joan Despí

Barcelona - Spain

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this prospectus : August 2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/