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DONNATAL ELIXIR

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

DONNATAL ELIXIR

COMPOSITION:
Each 5 mL Donnatal Elixir contains:

	Phenobarbital	15,0 mg
	HyoscyamineSulphate	0,1037 mg
	AtropineSulphate	0,0194 mg
	HyoscineHydrobromide	0,0065 mg
	Alcohol (100%)	23,6% v/v

This product contains Tartrazine.

PHARMACOLOGICAL CLASSIFICATION:
A 11.2 Gastro-intestinal: Antispasmodics and cholinolytics (anti-cholinergics).

PHARMACOLOGICAL ACTION:
Donnatal provides natural belladonna alkaloids in a specific fixed ratio combined with phenobarbital to provide both prompt peripheral antispasmodic action and smooth central sedation. Through the synergism of these components, Donnatal achieves greater effectiveness in small doses. It is essentially non-toxic, and has been safely administered over prolonged periods.
Donnatal Elixir provides additional advantages as a vehicle. It is stable, palatable, readily miscible and compatible with a wide variety of drugs indicated in the overall management of visceral spasm and associated disorders.

INDICATIONS:
Donnatal has a wide spectrum of symptomatic usefulness in:

1. Gastro-intestinal Tract:	Esophageal spasm, irritable stomach, nausea, vomiting, gastritis, pylorospasm, duodenal ulcer, gastric ulcer, hyperacidity, nervous indigestion, spastic or irritable colon, spasm of ulcerative colitis, spastic constipation.
2. Biliary Tract:	Symptoms associated with chronic cholecystitis.
3. Genito-urinary Tract:	Frequency of urination, nocturnal enuresis, cystitis, pre-cystoscopy and post-cystoscopy, dysmenorrhea and pre-menstrual tension.
4. Central Nervous System:	Motion sickness.

CONTRA-INDICATIONS:
Donnatal is contra-indicated in patients with glaucoma, advanced renal or hepatic disease, or a hypersensitivity to any one of its ingredients.

WARNING:
This product contains FD and C Yellow No 5 (Tartrazine) which may cause allergic-type reactions (including Bronchial Asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Adults:        5 to 10 mL (one to two medicine measures) of the elixir three to four times daily according to condition and severity of symptoms.
Children:        2,5 to 5 mL (half to one medicine measure) of the elixir three or four times daily as indicated.
The alkaloidal content of each 5 mL is the equivalent of 0,42 mL of fresh belladonna tincture.
Infants:        1 to 2 mL of the elixir thirty minutes prior to or with each feed, increasing if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Blurred vision, dry mouth and difficulty in urination, flushing and dryness of the skin may occur at higher dosage levels, rarely at the usual dose.
Donnatal should be cautiously administered to patients with incipient glaucoma or urinary bladder neck obstruction as in prostatic hypertrophy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Restlessness, confusion, hallucinations, rapid pulse, stertorous breathing and raised body temperature. These symptoms are usually followed by drowsiness, stupor and general depression.
Empty the stomach by aspiration and lavage. The use of charcoal to prevent absorption followed by lavage has been suggested. Treatment of overdosage should be supportive and symptomatic.

CONDITIONS OF REGISTRATION:
To be advertised to the professions only.

IDENTIFICATION:
Green, citrus-flavoured elixir.

PRESENTATION:
Bottles of 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25 °C.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
E975 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
05/08/1972

Updated on this site: December 2006
Source: Community Pharmacy

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