Trinspray 0.4 mg/0.05 ml solution for sublingual spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trinispray 0,4 mg / 0,05 ml solution for sublingual spray

Nitroglycerin

Read all of 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Trinispray is and what it is used for

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

Trinispray is used for:

• the treatment of acute angina attacks, which consist of sudden episodes of oppressive chest pain caused by inadequate blood flow in the coronary arteries.
• acute left ventricular failure (reduced ability of the heart's ventricle to pump blood) with dyspnea (difficulty breathing), with or without precordial pain (angina pectoris).
• prevention of acute angina attacks when administered a few minutes before starting physical exertion or activity that may trigger the pain.

2. What you need to know before using 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 must never take together medications containing sildenafil, vardenafil, tadalafil, etc. (medications used for erectile dysfunction).
• if you have obstructive cardiomyopathy (a disease characterized by obstruction of blood flow in the heart).
• if you have intracranial hypertension (elevated pressure in the brain), cerebral lesions, or cerebral hemorrhage.
• if you are in shock (a condition in which the body is not receiving sufficient blood flow, characterized by low blood pressure, anxiety, confusion, pale skin, dizziness, sweating, chest pain, and sometimes loss of consciousness).
• acute circulatory failure.
• if you suffer from severe anemia (reduction in the number of red blood cells in the blood).
• if you suffer from hypovolemia (decreased 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 acute inferior myocardial infarction with right ventricular involvement. (See section “Warnings and precautions”).
• if you are taking soluble guanylate cyclase stimulators, e.g. riociguat used in the treatment of pulmonary hypertension, due to an increased risk of hypotension.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Trinispray

• tolerance may develop. Sudden discontinuation of treatment must be avoided.
• to prevent the risk of angina attack, another type of treatment should be initiated when stopping Trinispray administration.
• reflex tachycardia (increased heart rate) and hypotension may occur (see section 4 “Possible side effects”), increasing the heart's oxygen demand. These conditions may lead to cardiac arrhythmias (abnormal heart rhythms) 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 occurs, treatment must be discontinued.
• if you are taking other medications such as vasodilators, antihypertensives, or diuretics, or if you consume alcohol, as these may increase the hypotensive effect of Trinispray, especially in patients over 65 years of age.
• if you suffer from hypoxemia (lack of oxygen in the blood), which may reduce the effect of Trinispray.
• if you develop cyanosis (bluish-purple discoloration of the skin and mucous membranes due to inadequate oxygen supply to tissues) due to high-dose treatment, it is essential to assess whether you also have methemoglobinemia (a blood disorder of red blood cells that impairs oxygen delivery to body tissues).
• headaches or symptoms of hypotension (low blood pressure), particularly upon standing, may indicate overdose, requiring dose adjustment.
• if you have early-stage glaucoma (an eye disease caused by high intraocular pressure).

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

Use of Trinispray with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not use Trinispray if you are being treated with medications for erectile dysfunction (see section 2 “Do not use Trinispray”).

Trinispray must not be used concomitantly with soluble guanylate cyclase stimulators, e.g. riociguat, due to the potential enhancement of the hypotensive effect (see section 2 “Do not use Trinispray”).

The use of Trinispray with ergotamine-derived alkaloids should be avoided due to reduced effectiveness of both medications.

Caution is required when using Trinispray together with medications that lower blood pressure (antihypertensive drugs, hypotensive agents, e.g. tricyclic antidepressants, neuroleptics), as well as alcohol, since these may potentiate hypotensive effects (see section 2 “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility

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

Trinispray must not be used by pregnant women. Your doctor will advise you whether or not you may use it if necessary.

Use of Trinispray by breastfeeding mothers is not recommended.

Driving and use of machines

Observe your response to the medication, as hypotension and dizziness may occur, albeit infrequently, especially at the beginning of treatment, which could affect your ability to drive or operate machinery. Therefore, do not drive or operate potentially dangerous machinery until you know how you react to the medicine.

Trinispray contains alcohol

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

3. How to use Trinispray

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine must be administered only sublingually.

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

If you are performing any physical activity, stop immediately and sit down. Remember the exact moment when symptoms began (hour and minutes).

Administer 1-2 sprays. This may be repeated if necessary after 5-10 minutes, up to 3 or 4 times, until chest pain due to angina or breathing difficulty due to acute ventricular failure subsides.

If chest pain persists after this (pain lasting more than 20 minutes) seek immediate medical attention. In the case of breathing difficulty due to acute ventricular failure, seek immediate medical attention.

Prevention of acute angina attacks

To prevent acute angina attacks, administer 1-2 sprays approximately 10 minutes before beginning any physical effort or activity that may trigger angina pain.

Method of administration

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

For correct use, follow these steps:

1. Remove the plastic cap.
2. Hold the container in an upright position with your index finger placed on the spray button (button with a central groove), with the nozzle of the bottle pointing upward.
3. Open your mouth and bring the spray nozzle as close as possible to the sublingual area (the area under the tongue). Then press the spray button once or twice with your index finger, directing the spray jet toward the sublingual region.
4. Remove the spray. Close your mouth and remain for a few seconds without swallowing to facilitate absorption of the medicine.

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

Patients should become familiar with the feel of their finger on the button so they can use the spray in the dark if necessary.

Patients should become familiar with the position of the spray nozzle opening to facilitate administration of the product.

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

To check whether the contents are running low, gently shake the bottle. This will allow you to determine whether only a small amount of solution remains.

If you use more Trinispray than you should

If you have used more Trinispray than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used. It is recommended to bring the package and the package leaflet to the healthcare professional.

Due to the short duration of its effects (30 to 60 minutes) and rapid metabolism, true intoxications are uncommon. Frequent applications may cause irritation and dryness of the mucosa.

Symptoms of overdose are mainly related to vasodilation, which may lead to reflex tachycardia (rapid heartbeat), headache, nausea, dizziness, and hypotension. Cases of methemoglobinemia (a blood disorder affecting oxygen transport) have been reported.

In case of overdose, symptoms should be managed by discontinuing treatment and administering necessary symptomatic therapy.

If you forget to use Trinispray

Do not use a double dose to make up for a missed dose.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Common:

Nervous system disorders: headache at the beginning 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 sitting to standing position), which may be associated with reflex tachycardia (abnormally rapid heartbeat) or paradoxical reflex bradycardia (abnormally slow heartbeat).

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

Rare:

Gastrointestinal disorders: nausea or vomiting.

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

Very rare:

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

Frequency not known:

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

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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trinispray

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Trinispray

Each spray contains:

• The active substance is nitroglycerin. Each spray delivers 0.05 ml of nitroglycerin solution containing 0.4 mg of active drug.
  • The other component (excipient) is 96º ethanol (q.s. to 0.05 ml)

Appearance of the product and contents of the container

Trinispray is a clear solution presented in an aluminum bottle with a metered spray pump.

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

Each spray delivers 0.4 mg of nitroglycerin.

Each bottle 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 most recent revision of this leaflet: June 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/