ISOSORBIDE DINITRATE Tablet Ref.[7872] Active ingredients: Isosorbide dinitrate

Tolerance and cross-tolerance to other nitrates may occur. Use with caution in patients with closed-angle glaucoma (increased intra-ocular pressure).

Alcohol should be avoided during treatment as reduction capacity may be reduced. Isosorbide dinitrate may act as a physiological antagonist to acetylcholine, histamine and noradrenaline (norepinephrine).

There is a possibility of precipitating haemolysis in patients with G6PD deficiency (Favism).

There is a risk of precipitating intra-cardiac abnormalities when isosorbide dinitrate is used in patients with seriously damaged myocardia.

Severe hepatic or renal impairment, hypothyroidism, malnutrition or hypothermia, head trauma, cerebral haemorrhage.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Isosorbide dinitrate can act as a physiological antagonist to noradrenaline (norepinephrine), acetylcholine, histamine and other agents. The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiesterase inhibitors (eg sildenafil, tadalafil and vardenafil).

Othostatic hypotension may occur with the combined use of calcium channel blockers, anti-hypertensive agents, phenothiazines and tricyclic anti-depressants. Use of alcohol may produce severe hypotension and collapse.

There are no data reported indicating the possibility of adverse effects during the human pregnancy, however, the tablets should not be administered during pregnancy or lactation unless considered to be essential.

None known.

The following frequencies are used:

Very common: ≥ 10 %
Common: ≥ 1 % - < 10 %
Uncommon: ≥ 0,1 % - < 1 %
Rare: ≥ 0,01 % - < 0,1 %
Very rare: < 0,01 %, including isolated cases

Very common: ≥ 10 %

• Headache (“Nitrate headache”) at the beginning of treatment, which in most cases improve/resolve after some days of continued treatment.
• Cutaneous vasodilation including flushing.

Common: ≥ 1 % - < 10 %

• Decrease in blood pressure and/or orthostatic hypotension with reflex tachycardia and symptoms/signs of cerebral ischaemia (including drowsiness and dizziness and weakness) with first time use and when the dose is increased.
• Peripheral oedema in patients treated for left ventricular failure.

Uncommon: ≥ 0,1 % - < 1 %

• Nausea and vomiting.
• Allergic skin reactions.
• Marked decreases in blood pressure with an aggravation of symptomatic angina pectoris.
• Collapse associated with bradycardia and cardiac rhythm disturbances.

Very rare: < 0,01 %, including isolated cases

• Exfoliative dermatitis/Stevens-Johnson Syndrome or angioedema.
• Alveolar hypoventilation with consequent hypoxaemia and the risk of developing a myocardial infarction in patients with coronary heart disease.
• Angle closure glaucoma.
• Pituitary apoplexy in patients with undiagnosed pituitary tumours.

Development of tolerance and also with cross tolerance against other nitrates have been described. In order to avoid weakening or even loss of effect high continuous doses should be avoided.

Enhancement of the dose and/or change in the dose interval may lead to reduction or even loss of effect.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product 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; website: www.mhra.gov.uk/yellowcard.

None known.