Nitrolingual

Glyceryl trinitrate.

Nitrolingual Spray is a clear, colourless to slightly yellow solution with an aromatic odour in a glass bottle with a transparent, red plastic overwrap.
The active substance is 0.4 mg glyceryl trinitrate per actuation (puff).
Excipients/Inactive Ingredients: Medium-chain triglycerides, medium-chain partial glycerides, ethanol, peppermint oil, sodium-(S)-lactate solution, (S)-lactic acid, water.

The active substance is called glyceryl trinitrate. It relaxes the muscles of the blood vessels, thereby making it easier for the heart to work.

Nitrolingual Spray is a sublingual spray used: for the treatment of sudden chest pain caused by coronary artery disease (acute angina attacks); as a preventive measure, taken immediately before physical exertion or other situations known to trigger sudden chest pain (angina attacks) (angina prophylaxis); in acute heart attacks; in acute heart failure (weak heart), with reduced function of the heart's left chamber (acute left heart failure); for catheter-induced narrowing of the coronary arteries (coronary spasms) during coronary angiography.

Nitrolingual Spray should always be used exactly as prescribed. Patients should seek medical advice if they are not sure.
The spray should be sprayed under the tongue. Patients should take care not to inhale it. Whenever possible, patients should be sitting down while using Nitrolingual Spray.
Recommended dose: At the start of an angina attack or immediately before stress known to trigger an angina attack, 1-3 actuations (puffs) of Nitrolingual Spray (equivalent to 0.4-1.2 mg glyceryl trinitrate) are used, depending on the severity.
For acute heart failure (weak heart) and acute heart attack, 1-3 actuations (puffs) of Nitrolingual Spray (equivalent to 0.4-1.2 mg glyceryl trinitrate) are given, depending on the severity, with monitoring of the blood circulation (systolic blood pressure higher than 100 mmHg). If there is no response, treatment with the same dose can be repeated after 10 minutes.
As a preventive measure before coronary angiography, 1-2 actuations (puffs) of Nitrolingual Spray (equivalent to 0.4-0.8 mg glyceryl trinitrate) are given.
Use in children and adolescents: There are no data from the use of glyceryl trinitrate in children.
Method of administration: To get used to handling the Nitrolingual Spray and to ensure that the dosing chamber is completely filled for initial use, firstly prime the valve and spray the contents into the air until liquid appears (fully depress the spray nozzle quickly and then release). This may also be required if the spray has not been used for a long time.
As the opening can be easily felt with the finger, it also acts as a reliable aid for guiding the spray if used at night.
1. It is preferable to be sitting down.
2. Remove the protective cap.
3. Hold the bottle upright with the finger on the spray nozzle. Do not shake the spray before use.
4. Open the mouth and place the bottle as close to the chin as possible.
5. Whilst holding the breath, press on the spray nozzle, so that the spray containing the active substance goes under the tongue.
6. Wait for 30 seconds before applying the next actuation (puff).
The transparent container allows constant monitoring of how much is left. The bottle contents can only be sprayed for as long as the opening, located at the bottom end of the feeder pipe, remains fully immersed in the liquid. As with all other sprays, it is not possible to spray the remaining liquid at the bottom. This is taken into account when the bottle is filled, so that the declared amount can be withdrawn. A new Nitrolingual Spray should be obtained in good time.
Duration of use: The treating doctor will decide how long this medicine should be used.
Forgetting Nitrolingual Spray: Patients should not use a double dose to make up for a forgotten dose.
Stopping Nitrolingual Spray: Patients should not stop their treatment without asking their doctor.

Patients must tell their doctor immediately if they suspect an overdose with larger amounts of Nitrolingual Spray.
Depending on the extent of overdose, side effects may occur in exaggerated form, e.g. sharp drop in blood pressure (hypotension), with a reflex increase in pulse rate, feeling weak, light-headed and drowsy, as well as headache, skin redness, nausea, vomiting and diarrhoea.

Do not use Nitrolingual Spray in patients with hypersensitivity (allergy) to glyceryl trinitrate, other nitrate compounds, peppermint oil or any of the other ingredients of this medicine (listed in Description).
Do not use Nitrolingual Spray in cases of acute circulatory failure (shock, circulatory collapse and forms of shock caused by a reduction in circulating blood volume).
Do not use Nitrolingual Spray in patients with very low blood pressure (marked hypotension), i.e. systolic blood pressure below 90 mmHg.
Do not use Nitrolingual Spray in cases of shock triggered by heart failure (cardiogenic shock), unless there are appropriate measures in place to ensure a sufficiently high filling pressure in the heart (left-ventricular end diastolic pressure).
Do not use Nitrolingual Spray in patients with heart muscle disease with narrowing of the heart's inner chambers (hypertrophic, obstructive cardiomyopathy).
Do not use Nitrolingual Spray in disorders associated with increased pressure inside the skull (e.g. head injuries, bleeding on the brain) (however, a further increase in pressure has so far only been observed when high doses of glyceryl trinitrate were administered into a vein).
Do not use Nitrolingual Spray in patients with severe anaemia.
Do not use Nitrolingual Spray in patients taking certain medicines (phosphodiesterase-5 inhibitors, e.g. sildenafil, vardenafil or similar products) for the treatment of erection problems (erectile dysfunction) or certain disorders of the blood vessels in the lung (pulmonary arterial hypertension), as these can significantly increase the blood pressure-lowering effect of Nitrolingual Spray. Therefore, patients with coronary heart disease should note the restrictions on the use of such medicines or talk to their doctor before taking such medicines. Similarly, do not use Nitrolingual Spray in patients who have taken these medicines (phosphodiesterase-5 inhibitors) and develop acute chest pain.

Exercise caution before using Nitrolingual Spray in case of constrictive pericarditis (inflammation of the sac surrounding the heart) or pericardial tamponade.
Exercise caution before using Nitrolingual Spray in case of low filling pressure, e.g. in acute heart attack, impaired function of the heart's left chamber (left-sided heart failure). A reduction in systolic blood pressure below 90 mmHg should be avoided.
Exercise caution before using Nitrolingual Spray in case of narrowing of the heart valves in the heart's left chamber (aortic and/or severe mitral valve stenosis).
Exercise caution before using Nitrolingual Spray in patients who are prone to orthostatic hypotension (a drop in blood pressure upon standing).
Exercise caution before using Nitrolingual Spray in case of a disorder affecting blood flow through the brain, as its symptoms can be brought on by low blood pressure (hypotension).
Exercise caution before using Nitrolingual Spray in case of early stages of glaucoma (increased inner eye pressure).
Exercise caution before using Nitrolingual Spray in case of enlarged left heart chamber (left ventricular hypertrophy) combined with narrowing of the aortic valve (aortic valve stenosis). In such cases, the use of Nitrolingual Spray can compromise blood supply to the heart due to a rapid pulse (tachycardia) and reduced diastolic aortic pressure.
Nitrolingual Spray contains small amounts (less than 10 mg per dose) of alcohol (ethanol).
Driving and using machines: This medicine may, even when used as directed, alter responsiveness to such an extent that the ability to drive, use machines or work without a secure foothold is impaired. Patients should wait for at least 5 minutes after using Nitrolingual Spray before driving or using machines. If patients feel weak, dizzy or unwell, they should wait until they feel better. Patients should be particularly careful at the start of treatment, whenever there is a dose increase or change in medication and in combination with alcohol.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, the patient should seek medical advice before using this medicine.
It is unknown whether glyceryl trinitrate or its metabolites are excreted in human milk. A risk to the breast-feeding infant cannot be ruled out.
There are no indications of any harmful effects on fertility.

Like all medicines, Nitrolingual Spray can cause side effects, although not everybody gets them.
The following frequency statements are used for evaluating side effects: Very common (more than 1 in 10 patients treated); Common (1 to 10 in 100 patients treated); Uncommon (1 to 10 in 1,000 patients treated); Rare (1 to 10 in 10,000 patients treated); Very rare (less than 1 in 10,000 patients treated); Not known (frequency cannot be estimated from the available data).
Common: Headache ("nitrate-induced headache") may very commonly occur at the start of treatment; based on experience, this mostly wears off after a few days with continued intake.
A fall in blood pressure and/or orthostatic hypotension (a drop in blood pressure upon standing) is commonly observed during initial use or after a dose increase, and may be accompanied by an increase in pulse rate, drowsiness, as well as feeling dizzy and weak.
Uncommon: Sharp drop in blood pressure with increased chest pain (angina symptoms); States of collapse, often with heart rhythm disorders together with a slow pulse rate and sudden loss of consciousness; Nausea, vomiting; Facial redness; Allergic reactions, such as skin reactions and, in isolated cases, swelling of the tongue.
Very rare: Severe inflammatory skin disease (exfoliative dermatitis); Reduced blood flow to tissue sections of the brain (cerebral ischaemia); Impaired breathing; Restlessness.
Not known: A decrease in effectiveness (tolerance development) and a weakening of the drug effect have been described during previous treatment with other nitrate medicines. To prevent any weakening or loss of effect, constantly high dosages should be avoided.
Other possible side effects: Peppermint oil can trigger hypersensitivity reactions (including shortness of breath) in sensitised patients.
Other information: When Nitrolingual Spray is administered, there may be a temporary reduction in oxygen levels in arterial blood, due to a relative redistribution of blood flow into underventilated areas of the lung. In patients with coronary artery disease, this may trigger a decrease in oxygen supply to heart muscle.
Reporting of side effects: If patients get any side effects, they should seek medical advice. This includes any possible side effects not listed previously. By reporting side effects, patients can help provide more information on the safety of this medicine.

Exercise caution in patients who are taking/using, have recently taken/used or might take/use any other medicines, including medicines available without a prescription.
Nitrolingual Spray lowers the blood pressure. This effect is increased when used together with the following medicines: other vasodilators (medicines that widen the blood vessels); medicines for high blood pressure (e.g. beta-receptor blockers, calcium antagonists, water tablets (diuretics), ACE inhibitors); medicines for mental illness such as depression (tricyclic antidepressants) or psychosis (neuroleptics); alcohol; sapropterin, an active substance used to treat hyperphenylalaninaemia; phosphodiesterase-5 inhibitors (e.g. sildenafil, vardenafil or similar products) for the treatment of erection problems (erectile dysfunction) or certain disorders of the blood vessels in the lung (pulmonary arterial hypertension).
Patients treated with phosphodiesterase-5 inhibitors and requiring an acute nitrate (such as Nitrolingual Spray) for an acute angina attack should be promptly hospitalised in advance.
N-acetylcysteine can enhance the vasodilatory effect of Nitrolingual Spray.
In patients who have previously been treated with organic nitrates, e.g. isosorbide dinitrate, isosorbide-5-mononitrate, a higher dosage of glyceryl trinitrate may be required to achieve the desired effect on the blood circulation.
Nitrolingual Spray can, if used at the same time as dihydroergotamine (a medicine used to treat migraine), lead to a rise in the DHE level, thereby enhancing its effect on increasing the blood pressure.
Heparin will become less effective if used at the same time as Nitrolingual Spray. The heparin dose must be adjusted accordingly, together with close monitoring of blood clotting parameters. After discontinuing glyceryl trinitrate, blood clotting may become significantly reduced (massive rise in PTT) and a reduction in the heparin dose may therefore be required.

Do not spray on flames or incandescent bodies.
Dispose of unused medicine with household waste, but not with wastewater, e.g. via the sink or toilet. These measures will help protect the environment.

Do not store above 25°C.

Anti-Anginal Drugs

C01DA02 - glyceryl trinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.

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