ELANTAN LA Prolonged release capsule Ref.[49650] Active ingredients: Isosorbide mononitrate

The capsules should be used with caution in patients who have a recent history of myocardial infarction or low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure). Reducing systolic blood-pressure below 90 mmHg must be avoided. Also in patients who are suffering from hypothyroidism, hypothermia, malnutrition, severe liver or renal disease.

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

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.

Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.

Elantan LA capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Due to the presence of sucrose, 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 Elantan LA capsules.

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

Treatment of Elantan LA, 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 Elantan should be informed that they must not use phosphodiesterase inhibitor-containing products (e.g. sildenafil, tadalafil, vardenafil).

Elantan 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).

Concurrent administration of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonists etc and/or alcohol may potentiate the hypotensive effect of Elantan LA. This may also occur with neuroleptics and tricyclic antidepressants.

Any blood pressure lowering effect of Elantan LA will be increased if used together with phosphodiesterase type-5 inhibitors which are used for erectile dysfunction (seesections 4.3 and 4.4). This might lead to life threatening cardiovascular complications. Patients who are on Elantan LA therapy therefore must not use phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).

Reports suggest that concomitant administration of Elantan LA may increase the blood level of dihydroergotamine and its hypertensive effect.

Sapropterine (Tetrahydrobiopterine, BH4) is a cofactor for nitric oxide sythetase. Caution is recommended during concomitant use of saproterine-containing medicine with all agents that cause vasodilation by affecting nitric oxide (NO) metabolism or action, including classical NO donors (e.g. glyceryl trinitrate (GTN)), isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (5-ISMN) and others).

The use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see section 4.3) since concomitant use can cause hypotension.

Pregnancy

No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy. Safety in pregnancy, however, has not been established.

Isosorbide mononitrate should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits outweigh the possible hazards.

Breast-feeding

It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women.

Fertility

There is no data available on the effect of isosorbide mononitrate on fertility in humans.

Dizziness, tiredness or blurred vision may occur at the start of treatment. The patient should therefore be advised that if affected, they should not drive or operate machinery. This effect may be increased by alcohol.

Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100 <1/10), uncommon (≥1/1,000 <1/100), rare (≥1/10,000 <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

During administration of Elantan LA the following undesirable effects may be observed:

Nervous system disorders

very common: headache

common: dizziness (including dizziness postural), somnolence

Cardiac disorders

common: tachycardia

uncommon: angina pectoris aggravated

Vascular disorders

common: orthostatic hypotension

uncommon: circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope)

not known: hypotension

Gastrointestinal disorders

uncommon: nausea, vomiting

very rare: heartburn

Skin and subcutaneous tissue disorders

uncommon: allergic skin reactions (e.g. rash), flushing

not known: dermatitis exfoliative

Immune system disorders

not known: angioedema

General disorders and administration site conditions

common: asthenia

Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.

During treatment with Elantan LA, a temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.