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

Logo TIXYLIX FLU® tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TIXYLIX FLU® tablets

COMPOSITION:
Per Tablet:
Triprolidine hydrochloride         1,25 mg
Pseudoephedrine hydrochloride         30.00 mg

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

PHARMACOLOGICAL ACTION:
TIXYLIX
has sympathomimetic and antihistamine properties.

INDICATIONS:
Symptomatic relief of nasal congestion associated with common cold, hayfever, rhinitis or sinusitis.

CONTRA-INDICATIONS:
TIXYLIX
is contra-indicated :·       
in patients sensitive to any of the active ingredients
during acute attacks of asthma
in patients under treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment
in pregnancy and lactation

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or any other central nervous system depressant agents.
Patients should not operate hazardous machinery or drive motor vehicles when taking TIXYLIX tablets.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years one to two tablets three times a day
Children 6 to 12 years half to one tablet three times a day

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Triprolidine hydrochloride:
Side effects:
The most common side-effect is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness and inco-ordination.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain.
Allergic reactions and cross-sensitivity to related medicines may occur.
It may produce antimuscarinic effects including blurred vision, difficulty in micturition, dysuria, dryness of the mouth and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria and headache.
Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, tachycardia, tremor and convulsions. Epileptic seizures may precipitate in patients with focal lesions of the cerebral cortex. Blood disorders, including agranulocytosis, leucopenia and haemolytic anaemia have been reported.
Special precautions:
It should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. Elderly patients are more susceptible to central nervous system depressant effects, as well as hypotensive effects.
Interactions:
Monoamine oxidase inhibitors may enhance the antimuscarinic effects of triprolidine hydrochloride and has an additive antimuscarinic action with other antimuscarinic medicines such as atropine and tricyclic antidepressants.
It may suppress positive skin test results and should be stopped several days before the test.
Pseudoephedrine hydrochloride:
Side-effects:
Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur.
Stimulation of alpha-adrenergic receptors produces vasoconstriction with resultant hypertension that leads to cerebral haemorrhage and pulmonary oedema. Stimulation of beta-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations, hypotension with dizziness and fainting.
Other side-effects include difficulty in micturition and urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Special precautions:
It should be used with caution in patients who may be hypersusceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular diseases such as ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders including arteriosclerosis; hypertension; or aneurysms.
Anginal pain may precipitate in patients with angina pectoris.
Care is required when given to patients with diabetes mellitus or closed-angle glaucoma.
It should be used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
Drug interactions:
An increased risk of arrhythmias may also occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Reversal of the action of many antihypertensive agents occur in patients given pseudoephedrine hydrochloride.
Special care is advisable in patients receiving antihypertensive therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage in children are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory relapse and death may occur within 18 hours of overdosage.
In adults the usual symptoms are of central nervous system depression with drowsiness, coma and convulsions.
Hypotension may occur.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Tablets:
A white, round, scored tablet.

PRESENTATION:
20’, 100’and 200’in “securitainers”.
20’in blister packs.

STORAGE INSTRUCTIONS:
Store below 25°C in well closed containers and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/5.8/74

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Quatromed Limited
10 Lindley Street
Bethlehem
9701

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 July 1991

                Pro-Print PTI 00628/02-99

Updated on this site: November 2001

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