Sodium Nitroprusside 50 mg/2 mL Concentrate For Solution For Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sodium Nitroprusside is and what it is used for
2. What you need to know before you use Sodium Nitroprusside
3. How to use Sodium Nitroprusside
4. Possible side effects
5. How to store Sodium Nitroprusside
6. Contents of the pack and other information

• if you are allergic to the active substance sodium nitroprusside.
• if you have high blood pressure due to hereditary abnormal narrowing of the aorta (aortic isthmus stenosis) or shunting between arterial and venous blood vessels.
• if you have a hereditary degeneration of fibres of the optic nerve (Leber's hereditary optic atrophy).
• if you have both-sided, usually irreversible decrease in colour vision due to long-lasting tobacco abuse (tobacco amblyopia). This condition may occur, when the body is unable to get rid of toxic cyanide from the tobacco.
• if you have vitamin B12 deficiency.
• If you have increased acid level of the blood and body (metabolic acidosis).
• If you have an underactive thyroid (hypothyroidism).
• If you have shunting between arterial and venous blood vessels inside the lungs (intrapulmonary arteriovenous shunts). Arterial vessels (arteries) are leading blood from the heart to your organs; venous vessels (veins) are leading blood from the organs to your heart.

Talk to your doctor or nurse before using Sodium Nitroprusside if you:

• have previously taken sildenafil or tadalafil or vardenafil. These medicines are used to achieve an erection in men or to lower blood pressure in blood vessels of the lungs. Sodium Nitroprusside should only be used after a strict benefit risk assessment, as it may lead to a pronounced increase in the blood pressure lowering effect in this case.
• have a disease associated with increased pressure in the skull.

Sodium nitroprusside infusions must only be administered with simultaneous administration of sodium thiosulfate solution. See information for healthcare professionals.

During the infusion of Sodium Nitroprusside, continuous monitoring of the ECG and of the blood flow is required.

The safety and efficacy of this drug in children and adolescents have not been demonstrated so far. No data are available. Therefore, this medicine should not be administered to children and adolescents.

If sodium nitroprusside is infused over several days (in case of high doses already within 24 hours), thiocyanate levels must be monitored especially in renally impaired patients and must not exceed 6 mg/100 mL .

Sodium Nitroprusside should be used with caution in patients with liver disease (hepatic impairment) and signs of cyanide toxicity should be monitored more closely (see section 4). If necessary, administration of sodium nitroprusside is to be gradually reduced or discontinued.

Tell your doctor if you are using, have recently used or might use any other medicines.

The concomitant administration of the following medicines can increase the blood pressure lowering effect of Sodium Nitroprusside:

• medicines to lower blood pressure and dilate blood vessels;
• medicines to lower blood pressure in blood vessels of the lung;
• sedatives
• anaesthetics

This especially applies after previous intake of sildenafil, tadalafil or vardenafil (see “Warnings and precautions”).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Experience during pregnancy and breast-feeding is insufficient, and Sodium Nitroprusside should only be used during this time if your doctor thinks it is absolutely necessary (that means, only following strictest indication).

Elderly patients frequently require lower doses.

Any intoxication can be avoided when the dosing instructions are observed.

Cyanide intoxication

In case of cyanide intoxication, the infusion dose of Sodium Nitroprusside should be reduced and, if necessary, cyanide should be removed from the body by an antidote. For further information, see “How to use Sodium Nitroprusside”.

In case of thiocyanate intoxication, the infusion of this drug should be discontinued and, if necessary, thiocyanate should be removed from the body via dialysis.

For symptoms of cyanide and thiocyanate toxicity, see section 4 “Possible side effects”.

Further possible side effects are:

• reactions at the application site (pain, skin reddening, itching)
• excessive blood pressure reduction
• nausea, vomiting, diarrhoea, incontinence
• ringing in the ears
• confusion
• hallucinations
• transient narrowing of the pupils
• increased tendency of reflexes
• temporary increase of signs of illness (rebound effect)

An insufficient decrease in blood pressure, decreased effect with repeated administration of this drug (tachyphylaxis) and tolerance are more commonly expected in younger than in older patients with high blood pressure.

• bright red venous blood
• flat and/or slow breathing (hypoventilation)
• increased lactate
• decreased oxygen uptake
• feeling your heartbeat (palpitations), irregular heartbeat
• headache
• metabolic increased acid level in the blood and body (metabolic acidosis)
• coma, breathing paralysis, seizures

Deaths have been reported.

Such signs of toxicity can occur if the amount of cyanide is so high that the human body is not able to manage such poisoning; thus a parallel administration of sodium thiosulfate is needed.

Cyanide intoxication is completely avoidable by simultaneously administering a sodium thiosulfate infusion.

Symptoms of thiocyanate toxicity that can occur in case of overdose - earlier in patients with kidney problems than in patients with healthy kidneys – include:

• dizziness, headache, loss of appetite
• sleep disorders, nervousness
• underactive thyroid
• diarrhoea, vomiting, incontinence
• psychosis
• paralysis and coma

Very high serum concentrations can lead to death.

The thiocyanate intoxication can be avoided when the dosing instructions are observed. In case of thiocyanate intoxication, the infusion of this drug should be discontinued and, if necessary, thiocyanate should be removed from the body via dialysis.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is sodium nitroprusside. Each vial contains 50 mg sodium nitroprusside dihydrate, equivalent to 44 mg anhydrous sodium nitroprusside.
• The other ingredient (excipient) is water for injections.

Clear reddish-brown solution for infusion in 2 mL amber-coloured glass vials with a rubber stopper and aluminium-plastic overseal.

Pack size: each carton contains 1 vial of 2 mL.

A light-protecting sleeve is included in the unit pack for overwrapping the infusion bag containing the solution for infusion with added sodium nitroprusside solution.

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Sodium Nitroprusside 50 mg/2 mL Concentrate For Solution For Infusion infusion PLGB 57592/0025