Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

This product may give rise to symptoms of postural hypotension and syncope in some patients. Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.

Monolong should be used with caution in patients who have a recent history of myocardial infarction low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure), or orthostatic dysfunction.

Reducing systolic blood-pressure below 90 mmHg must be avoided.

It should also be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.

Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation.

Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.
Monolong capsules contain lactose and therefore should not be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

Monolong capsules also contain sucrose and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

In the event of an acute angina attack, a sublingual treatment such as a GTN spray or tablet should be used instead of Monolong capsules. The onset of action of Monolong is not sufficiently rapid to be useful to treat an acute anginal attack.

If the capsules are not taken as indicated (see section 4.2) tolerance to the medication could develop. In some patients being treated with slow release preparations, attenuation of effect is observed. In such patients, intermittent therapy may be more appropriate. The lowest effective dose should be used.

Treatment with Monolong, as with any other nitrate, should not be stopped suddenly.

Both the dosage and frequency should be tapered gradually (see section 4.2).
In patients with decreased gastrointestinal transit time, a decrease in release of the active ingredient may occur.

Patients who undergo a maintenance treatment with Monolong should be informed that they must not use phosphodiesterase inhibitor-containing products (e.g. sildenafil, tadalafil, vardenafil).

Monolong therapy should not be interrupted to take phosphodiesterase inhibitor containing products (e.g. sildenafil, tadalafil, vardenafil), because the risk of inducing an attack of angina pectoris could increase by doing so (see section 4.3 and 4.5).

Hypoxaemia Caution should be exercised in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart failure. As a potent vasodilator, isosorbide mononitrate could result in increased perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.

During treatment with isosorbide mononitrate alcohol should be avoided as it may potentiate the hypotensive effect of isosorbide mononitrate (see section 4.5).

Effects on Driving

4.7 Effects on ability to drive and use machines
Dizziness, tiredness or blurred vision might occur at the start of treatment. If affected, do not drive or operate machinery. This effect may be increased by alcohol.