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Logo VIROBIS tablets

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

VIROBIS tablets

COMPOSITION
Per tablet:
Moroxydine hydrochloride 100 mg
Atropine methonitrate 0,1 mg
Scopolamine methonitrate 0,1 mg

PHARMACOLOGICAL CLASSIFICATION
A 20.2.8 Antiviral agents

PHARMACOLOGICAL ACTION
Moroxydine hydrochloride is a synthetic drug chemically belonging to the series of the heterocyclic biguanidines. It possesses antiviral activity and is of value in the prevention and treatment of influenza. Although its mechanism of action is not fully known the effects seem to be due to an influence on the virus host-cell system. Oral medication has been shown to be effective against influenza, and small doses taken over a period of time have been shown to protect animals against influenza and other viral conditions.
After preliminary trials with intramuscular injections the oral form of medication has been proven to be equally effective: pain usually disappears after two days, temperature reaches normal values and the lesion ceases to spread.
The drug is also reported to reduce the course of influenza by at least one third: most patients recovered within four days while the normal run of the disease is about six days.
In one prophylactic trial an 80 per cent reduction in the number of cases of influenza has been reported.
The drug is readily absorbed from the intestinal mucosa and does not accumulate in the body; it is rapidly excreted as demonstrated by animals which were given half the average lethal dose for several consecutive days, without toxic results.
Moroxydine is completely devoid of antihistaminic, spasmolytic or hypoglycaemic effects, and it may be used alone as well as in combination with other drugs: its therapeutic effectiveness improves greatly in the presence of xerostomia-producing agents, such as atropine methonitrate and scopolamine methonitrate.

INDICATIONS
Treatment and prophylaxis of influenza, mumps, herpes zoster, measles and chicken pox

CONTRA-INDICATIONS
Should not be used in narrow angle glaucoma or in prostatic enlargement, owing to the anticholinergic agents included in the formulation.

DOSAGE AND DIRECTIONS FOR USE
Adults:
Prophylactic
: one tablet three times a day
Therapeutic: two tablets three times a day

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The side-effects which could result from oral medication are dry mouth, headache, disturbed sleep, blurred vision, constipation and tiredness.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The symptoms of overdosage would be those pertaining to atropine and scopolamine, and would be confined to deliberate high overdosage. These would include depression of the central nervous system with circulatory failure and respiratory depression.
Treatment consists of aspiration and lavage and with a saline purgative (30 g Na2SO4 in 250 mL water) to induce peristalsis: cautious use of a short-acting barbiturate; neostigmine methylsulphate 5 mg i.m. or s.c. to relieve peripheral symptoms; assisted respiration; fluids given freely, and catheterisation if urine is not voided.

IDENTIFICATION
Small, white tablet, scored on one side

PRESENTATION
Tablets: 48'

STORAGE INSTRUCTIONS
Store below 25°C, well closed and in a dry place.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER
A367 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
12 June 1968

NORISTAN SELFMED
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA

        D 783/06

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