Patient Information Leaflet

Trinispray 0.4 mg / 0.05 ml Sublingual Spray

Nitroglycerin

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What Trinispray is and what it is used for

2.What you need to know before you start using Trinispray

3.How to use Trinispray

4.Possible side effects

5Storage of Trinispray

6.Contents of the pack and additional information

It belongs to a group of medications called vasodilators, which relax the muscle tissue of blood vessels, widening arteries and veins. Trinispray increases the flow of blood to the heart and improves its performance when there is a deficit of blood flow in the coronary arteries (arteries that carry blood to the heart).

Trinispray is used for:

-treatment of acute attacks of angina pectoris, which consist of sudden episodes of oppressive chest pain due to a lack of blood flow in the coronary arteries.

-acute left ventricular heart failure (decrease in the heart's ventricle ability to pump blood) with dyspnea (difficulty breathing), with or without precordial pain (angina pectoris).

-it is also usedto prevent the occurrence of acute attacks of angina pectoris administeredminutes before starting the effort or work that may trigger the pain.

Do not use Trinispray:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• patients taking this medicationmust nevertake medications that contain sildenafilo, vardenafilo, tadalafilo… (medications used for erectile dysfunction).
• if you have obstructive cardiomyopathy (a disease characterized by the obstruction of blood flow in the heart).
• if you have increased intracranial pressure (high pressure in the brain), brain injuries, cerebral hemorrhage.
• if you are in shock (a situation in which the body is not receiving sufficient 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 the total volume of blood).
• 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 inferior 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 appear. Discontinuation of treatment should be avoided.
• to avoid the risk of an angina attack, another type of treatment should be initiated upon cessation of Trinispray administration.
• tachycardia (acceleration of heartbeats) and hypotension (see section 4 “Possible adverse effects”) may appear, increasing the heart's demand for oxygen. These situations may lead to cardiac arrhythmias (alteration of heart rhythm) with ventricular fibrillation (irregular movements of the heart's ventricles), sometimes fatal in patients with acute inferior myocardial infarction with right ventricular involvement (see section 2 “Do not use Trinispray”).
• if shock appears, treatment should be interrupted.
• if you are using other medications such as vasodilators, antihypertensives, or diuretics, or if you consume 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) which may reduce the effect of Trinispray.
• if you have cyanosis (blue-violet discoloration of the skin and mucous membranes due to insufficient oxygen supply to the tissues) due to high doses, it is essential to assess whether you also have methemoglobinemia (disease of red blood cells that prevents oxygen transport to the body's tissues).
• headaches or symptoms of hypotension (low blood pressure), especially upon standing, may be due to overdose, requiring 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, it is not recommended for use in children.

Use of Trinispray with other medications

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

Do not use Trinispray if you are being treated with medications for erectile dysfunction (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”).

Use of Trinispray with ergotamine-derived alkaloids should be avoided due to the decrease in the effect of both medications.

Trinispray should be used with caution when used with medications that lower blood pressure (antihypertensives, hypotensive medications, for example tricyclic antidepressants, neuroleptics), as well as alcohol, as it may potentiate the hypotensive effects (see section 2 “Warnings and precautions”).

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.

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

It is not recommended to use Trinispray by breastfeeding women.

Driving and operating machinery

Observe your response to the medication because, in some cases, symptoms of hypotension and dizziness may appear, especially at the beginning of treatment, which may affect your ability to drive vehicles or operate machinery. Therefore, do not drive or operate potentially hazardous machinery until you check how you tolerate the medication.

Trinispray contains alcohol

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication must be administered only sublingually.

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

If you are engaging in physical activity, you must stop immediately and sit down. You must remember the exact moment when the symptoms began (hour and minutes).

1-2 sprays will be administered. This operation can be repeated as needed at 5-10 minute intervals, up to 3 or 4 times, until the chest 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) you must seek immediate medical attention. In the case of difficulty breathing due to acute left ventricular failure, you must seek medical attention.

Prevention of acute angina pectoris attacks

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

Administration method

During administration, the patient must be at rest, preferably in a seated position.

To use correctly, the following steps will be followed:

1. Remove the plastic cap.
2. Hold the container in a vertical position with the index finger placed over the actuator (button with a central groove), with the nozzle of the bottle facing upwards.
3. Open your mouth and bring the nozzle of the spray as close as possible to the sublingual region (area under the tongue). Then, 1 or 2 actuations will be performed by pressing the actuator with your index finger, directing the spray 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 medication.

Replace the cap on the nozzle of the spray and store in a safe place.

Patients must familiarize themselves with feeling the finger on the button to be able to use the aerosol in the dark if necessary.

Patients must familiarize themselves with the position of the orifice of the nozzle of the spray to facilitate the administration of the product.

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

To check if the content is almost depleted, gently move the container. In this way, you will check if there is little or no solution left.

If you use more Trinispray than you should

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

Due to the brevity of its effects, 30 to 60 minutes, and its rapid metabolism, true intoxications are not usually presented. Frequent applications can cause mucosal irritation and dryness.

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

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

If you forgot to use Trinispray

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

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

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

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

The observed adverse 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); infrequent (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); unknown frequency (cannot be estimated from available data), have been:

Frequent:

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

Infrequent:

Nervous system disorders: dizziness.

Cardiovascular disorders: hypotension sometimes severe, including orthostatic hypotension (abnormal decrease in blood pressure when changing from a seated to a standing position) that may be associated with reflex tachycardia (abnormally fast heart rate) or reflex bradycardia (abnormally slow heart rate).

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

Rare:

Gastrointestinal disorders: nausea or vomiting.

Cardiovascular disorders: flushing of the face and neck (erythema).

Very rare:

Skin and subcutaneous tissue disorders: allergic reactions to nitroglycerin.

Unknown frequency:

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

Reporting Adverse Effects:

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

No special storage conditions are required.

Keep out of sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Trinispray

Each spray contains:

-The active ingredient is nitroglycerin. Each spray releases 0.05 ml of nitroglycerin solution with an active pharmaceutical ingredient 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 packaging

Trinispray is a transparent solution presented in an aluminum bottle with a dosing spray system.

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

Each spray supplies 0.4 mg of nitroglycerin.

Each bottle contains approximately 200 dosages.

Holder of the marketing authorization and responsible for manufacturing

Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing:

Laboratoires Chemineau

93, Route de Monnaie

F-37210 Vouvray (France)

Last review date of this leaflet: June 2017

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