INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NITECALL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

NITECALL
Syrup

COMPOSITION:
Each 30 mL of syrup contains:
Paracetamol                        600 mg
Dextromethorphan hydrobromide         15 mg
Chlorpheniramine maleate         4 mg
Phenylpropanolamine hydrochloride         25 mg
Alcohol (96,5%) 10% v/v
Sodium benzoate (as preservative) 0,1% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
NITECALL
syrup has analgesic, antipyretic, antihistaminic, sympathomimetic and antitussive properties.

INDICATIONS:
NITECALL
syrup may be taken at bedtime for symptomatic relief of major symptoms associated with colds and influenza, such as nasal congestion, sniffing, headache, minor aches and pains, and coughing.

CONTRA-INDICATIONS:
NITECALL syrup should not be taken by asthmatic patients or by patients with a known hypersensitivity to any of the active ingredients, or children less than 6 months of age. Do not administer concurrently with monoamine oxidase inhibitors or within 14 days of stopping such treatment (eg. Tranylcypromine).
Contra-indicated in most type of cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma and closed-angle glaucoma.
Safety in pregnancy and lactation has not been established.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol, or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Dosages in excess of those recommended may cause severe liver damage, nervousness, dizziness, sleeplessness, tremulousness or cadiac arrythmias. This may also occur in sensitive individuals at small doses.
Use with caution in patients with pheochromocytoma or occlusive vascular disease including arteriosclerosis and aneurysms. Patients suffering from liver or kidney disease should take NITECALL syrup only under medical supervision.
Severe hypertensive episodes leading to intracranial haemorrhage have followed phenylpropanolamine ingestion. Patients should be informed of the dangers of exceeding the recommended dose; in particular the increased risk of serious adverse effects such as hypertensive crisis and haemorrhagic stroke. In addition, NITECALL may aggravate conditions such as diabetes, glaucoma or prostatic enlargement.
Do not use continuously for more than seven days without consulting a doctor. After 5-7 days, tachyphylaxis may occur and the product may lose effect. Consult a doctor if symptoms do not improve or are accompanied by fever.

DOSAGE AND DIRECTIONS FOR USE:
Take at bedtime.
Adults 12 years and over: 30 mL (6 medicine measuresful) just before bedtime.
If symptoms persist after five days, consult your doctor.
Do not give this medicine to children under the age of 12 years, unless directed by a doctor.
Do not exceed the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS :
Paracetamol:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
1. Consult your doctor if no relief is obtained with the recommended dosage.
2. Do not use continuously for longer than 10 days without consulting your doctor.
3. Patients suffering from kidney or liver disease should take paracetamol under medical supervision.
Dextromethorphan hydrobromide:
May cause drowsiness, dizziness, excitation, mental confusion and gastro-intestinal disturbances. Should be administered with caution to patients with liver disease.
Chlorpheniramine maleate:
Is an antihistamine which can cause sedation varying from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic and epigastric pain, headache, blurred vision, tinnitus, excitation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, tingling, heaviness, and weakness of the hands. Symptoms of cerebral stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Allergy, anaphylaxis, and dermatological reactions may occur. Blood dyscrasias, including agranulocytosis and haemolytic anaemia have been reported. Chlorpheniramine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquillisers.
The effects of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of Chlorpheniramine. Chlorpheniramine may affect the metabolism of drugs in the liver.
Phenylpropanolamide hydrochloride:
Haemorrhagic stroke may occur, particularly at high doses and in high risk patients (see Warnings).
May give rise to side-effects such as dizziness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness, tremors, anxiety, restlessness, insomnia, fear, confusion, irritability, psychotic states, reduced appetite, vasoconstriction, hypertension, cerebral haemorrhage, pulmonary oedema, bradycardia, cardiac arrythmias, anginal pain, cardiac arrest, hypotension with dizziness and fainting, flushing, urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation.
In patients with prostatic enlargement, it may increase difficulty with micturition.
Severe hypertensive episodes have followed phenylpropanolamine ingestion.
Should be used with caution in patients with: hyperthyroidism; cardiovascular diseases such as ischaemic heart desease, arrythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms, diabetes mellitus and closed angle glaucoma.
Anginal pain may be precipitated in patients with angina pectoris.

INTERACTIONS :
Reversal of the action of antihypertensive agents may occur and therefore care is advisable in patients receiving antihypertensive therapy. Interaction with alpha- and beta- blocking drugs may be complex and can produce hypertensive crisis.
Interactions are possible with guanethidine, reserpine, tricyclic antidepressants, digoxin and alpha-methyldopa.
NITECALL syrup should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
An increased risk of arrhythmias may occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See also 'Side-effects and special precautions'.
Paracetamol:
Symptoms of overdosage include nausea and vomiting.
Liver damage which may be fatal may only appear after a few days.
Kidney failure has been described following acute intoxication.
Dextromethorphan hydrobromide:
Respiratory depression.
Chlorpheniramine maleate:
Symptoms of overdosage may include convulsions and hyperpyrexia.
Phenylpropanolamine hydrochloride:
Paranoid psychosis, delusions, hallucinations.
In the event of overdosage consult a doctor or take the patients to the nearest hospital immediately.
Specialised treatment is essential as soon as possible.
Toxic effects are treated symptomatically as required.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
NITECALL
syrupis a clear green liquid with a distinctive honey, menthol and lemon odour and flavour.

PRESENTATION:
Amber glass bottles containing 180 mL.
Amber PVC bottles containing 180 mL.

STORAGE INSTRUCTIONS:
Store below 30°C in tightly closed containers, protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
U/5.8/90

NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77, 2152
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 March 1987

New addition to this site: May 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004