TRINISPRAY 0.4 mg / 0.05 ml SUBLINGUAL SPRAY SOLUTION

2. What you need to know before starting to use Trinispray

Do not use Trinispray:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• patients being treated with this medicine should never take medications that contain sildenafil, vardenafil, tadalafil... (medicines used for erection problems) at the same time.
• if you have obstructive cardiomyopathy (a disease characterized by the obstruction of blood flow in the heart).
• if you have cranial hypertension (high blood pressure in the brain), cerebral lesions, cerebral hemorrhage.
• if you are in a state of shock (a situation in which the body is not receiving enough blood flow and is characterized by low blood pressure, anxiety, confusion, pale skin, dizziness, sweating, chest pain, sometimes loss of consciousness).
• acute circulatory failure.
• if you have severe anemia (decrease in the number of red blood cells in the blood).
• if you have hypovolemia (decrease in total blood volume).
• if you have mitral or aortic stenosis (narrowing of a heart valve)
• if you have constrictive pericarditis (inflammation of the heart).
• if your blood pressure is very low.
• if you have had an acute myocardial infarction with right ventricular involvement (see section "Warnings and precautions").
• if you are using soluble guanylate cyclase stimulators, e.g., riociguat, used in the treatment of pulmonary hypertension, due to an increased risk of hypotension.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Trinispray

• tolerance may occur. Sudden discontinuation of treatment should be avoided.
• to avoid the risk of an angina attack, another type of treatment should be started when Trinispray administration is stopped.
• reflex tachycardia (rapid heart rate) and hypotension (see section 4 "Possible side effects") may occur, increasing the heart's oxygen demand. These situations can lead to cardiac arrhythmias (alteration of the heart rate) with ventricular fibrillation (irregular movements of the heart's ventricles), sometimes fatal in patients with acute myocardial infarction with right ventricular involvement (see section 2 "Do not use Trinispray").
• if shock occurs, treatment should be interrupted.
• if you are using other medications such as vasodilators, antihypertensives, or diuretics, or if you drink alcohol, as it may increase the hypotension caused by Trinispray, especially in patients over 65 years old.
• if you have hypoxemia (lack of oxygen in the blood) that may reduce the effect of Trinispray.
• if you have cyanosis (blue-purple skin and mucous membrane discoloration due to insufficient oxygen supply to the tissues) due to treatment with high doses, it is essential to assess whether you also have methemoglobinemia (a disease of the red blood cells that prevents oxygen from being transported to the body's tissues).
• headaches or symptoms of hypotension (low blood pressure), especially when standing up, may be due to an overdose, requiring a dose adjustment.
• if you have incipient glaucoma (eye disease caused by high pressure in the eye).

Due to the lack of data on safety and efficacy, its use is not recommended in children.

Using Trinispray with other medicines

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

Do not use Trinispray if you are being treated with medicines used for erection problems (see section 2 "Do not use Trinispray").

Trinispray should not be used with soluble guanylate cyclase stimulators, e.g., riociguat, due to the possible potentiation of the hypotensive effect (see section 2 "Do not use Trinispray").

Trinispray should be used with caution when used with medications that decrease blood pressure (antihypertensive medications, hypotensive medications, e.g., tricyclic antidepressants, neuroleptics), as well as alcohol, as it may potentiate the hypotensive effects (see section 2 "Warnings and precautions").

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.

Trinispray should not be used by pregnant women. Your doctor will tell you if you can or cannot use it if necessary.

Trinispray is not recommended for use by breastfeeding mothers.

Driving and using machines

Observe your response to the medication because, in some cases, symptoms of hypotension and dizziness may occur, especially at the start of treatment, which could affect your ability to drive vehicles or use machines. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medicine.

Trinispray contains alcohol

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per spray.

3. How to use Trinispray

Follow the administration instructions of this medicine indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

This medicine should only be administered sublingually.

Treatment of acute attacks of angina pectoris and treatment of acute left ventricular failure

If you are performing any physical activity, you should stop it immediately and sit down. You should remember the exact moment when the symptoms started (hour and minutes).

1-2 sprays will be administered. This operation can be repeated if necessary at 5-10 minute intervals, up to 3 or 4 times, until the angina pectoris pain or difficulty breathing due to acute left ventricular failure disappears.

If, after doing this, the chest pain does not disappear (pain lasting more than 20 minutes) or difficulty breathing due to acute left ventricular failure, you should seek immediate medical attention.

Prevention of acute attacks of angina pectoris

To prevent acute attacks of angina pectoris, 1-2 sprays will be administered about 10 minutes before starting the effort or work that may trigger the angina pectoris pain.

Method of administration

During administration, the patient should be at rest, preferably in a sitting position.

To use it correctly, follow these steps:

1. Remove the plastic cap.
2. Hold the container in a vertical position with your index finger on the actuator (button with a central groove), with the spray nozzle facing up.
3. Open your mouth and bring the spray nozzle as close as possible to the sublingual region (area under the tongue). Then, perform 1 or 2 sprays by pressing the spray actuator with your index finger, directing the spray jet to the sublingual region.
4. Remove the spray. Close your mouth and remain for a few seconds without swallowing (without swallowing) to facilitate the absorption of the medicine.

Put the cap back on the spray nozzle and store it in a safe place.

Patient should become familiar with the feeling of the finger on the button to be able to use the aerosol in the dark if necessary.

Patient should become familiar with the position of the spray nozzle orifice to facilitate the administration of the product.

The spray should not be inhaled and should be kept away from the eyes.

To check if the content is about to run out, gently move the container. This way, you will check if there is little solution left or not.

If you use more Trinispray than you should

If you have used more Trinispray than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the container and the leaflet of the medicine to the healthcare professional.

Due to the short duration of its effects, 30 to 60 minutes, and its rapid metabolism, real intoxications are not usually present. Frequent applications can cause irritation and dryness of the mucosa.

The symptoms of overdose are mainly related to vasodilation, which can lead to reflex tachycardia (rapid heart rate), headache, nausea, dizziness, and hypotension. Cases of methemoglobinemia (blood problem in oxygen transport) have been associated.

In case of overdose, the symptoms should be treated by interrupting the treatment and administering the necessary symptomatic treatment.

If you forget to use Trinispray

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

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

If you have any other doubts about the use of 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.

The observed side effects, according to their frequency of presentation: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from the available data), have been:

Frequent:

Nervous system disorders: headache at the start of treatment, which usually disappears after a few days.

Uncommon:

Nervous system disorders: dizziness.

Vascular disorders: hypotension, sometimes severe, including orthostatic hypotension (abnormal decrease in blood pressure when changing from a sitting to a standing position), which may be associated with reflex tachycardia (abnormally rapid heart rate) or paradoxical reflex bradycardia (abnormally slow heart rate).

General disorders and administration site conditions: asthenia (fatigue or weakness).

Rare:

Gastrointestinal disorders: nausea or vomiting

Vascular disorders: flushing of the face and neck (rubor).

Very rare:

Skin and subcutaneous tissue disorders: allergic skin reactions to nitroglycerin.

Frequency not known:

Immune system disorders: anaphylactic reactions, angioedema, inflammation of the lips and tongue, and urticaria (itching).

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Trinispray

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the package and additional information

Composition of Trinispray

Each spray contains:

• The active substance is nitroglycerin. Each spray releases 0.05 ml of nitroglycerin solution with an active substance content of 0.4 mg.
  • The other component (excipient) is ethanol 96º (c.s.p. 0.05 ml)

Appearance of the product and contents of the container

Trinispray is a clear solution presented in an aluminum container with a dosing spray system.

Each spray container contains 85 mg of nitroglycerin in 10.5 ml of solution (concentration of 8 mg/ml).

Each spray delivers 0.4 mg of nitroglycerin.

Each container contains approximately 200 doses.

Marketing authorization holder and manufacturer

Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

Laboratoires Chemineau

93, Route de Monnaie

F-37210 Vouvray (France)

Date of the last revision of this leaflet: June 2017

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