ANGI-SPRAY : Spray
(and dosage form):
ANGI-SPRAY : Spray
Each 0,09 mL spray contains 1,25 mg of isosorbide dinitrate:
Contains 83,5% m/m alcohol.
Category A, 7.1.4 Vasodilators - coronary and other medicines used in angina pectoris.
Isosorbide dinitrate is absorbed from the oral mucosa and exerts the actions of organic nitrates on the cardiovascular system.
For the treatment or prevention of angina pectoris attacks; as a temporary aid in left ventricular failure and acute myocardial infarction prior to hospitalization.
Patients with marked anaemia or with head trauma or cerebral haemorrhage. Glaucoma, acute coronary thrombosis or patients with increased intracranial pressure.
Should not be used in children. Should not be used during pregnancy except in the event of cardiac emergency. In this case the lowest possible dose should be administered.
DOSAGE AND DIRECTIONS FOR USE:
Remove the protective cap. Before administration press the spray valve firmly a few times until a uniform vapour forms. When spraying, hold the container upright. For subsequent administration, the spray can be used immediately. Sometimes, if the spray has not been used for a few days, a second priming of the valve may be necessary to obtain full spraying power. Replace the cap after use.
Unless otherwise prescribed, at the start of an angina pectoris attack, or directly before effort known to precipitate an attack, 2 to 3 doses of ANGI-SPRAY should be sprayed into the buccal cavity at 30 second intervals while holding the breath.
Do not inhale.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Severe headaches, flushing of the face, throbbing in the head, fainting, dizziness, gastric discomfort, tachycardia and blood pressure reduction may appear but generally subside after a few days. Severe hypotension, especially after myocardial infarction may occur. Patients may have no untoward effects while recumbent but may develop postural hypotension with faintness upon rising suddenly. If methaemoglobinaemia occurs, withdraw treatment. There is a theoretical hazard of rapid withdrawal following chronic exposure which might be expected to produce non-exertional ischaemic cardiac pain or peripheral ischaemia.
Special precautions: Isosorbide dinitrate should be used with caution in patients who are predisposed to closed-angle glaucoma.
The simultaneous intake of alcohol can impair reactions, e.g.:- when driving or operating machinery.
The possibility of drug interaction exists when ANGI-SPRAY is used concomitantly with other drugs which effect the cardiovascular system.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Large doses of isosorbide dinitrate cause vomiting, restlessness, hypotension, syncope, cyanosis and methaemoglobinaemia, coldness of the skin, impairment of respiration and bradycardia may ensue.
Treatment is symptomatic and supportive.
Colourless, clear solution with an odour of ethanol.
Presented in brown glass bottles containing 20 mL (17 g) of solution.
Store below 30°C. Protect from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Akromed Products (Pty) Ltd.
Co. reg. No. 05/13586/07
20 Spanner Road, Clayville 1666, Olifantsfontein.
Imported, packed and distributed under licence from
Heinrich Mack Nachf, GERMANY.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 6th, 1987.
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