Prochlorperazine 3 mg Buccal Tablets

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Prochlorperazine maleate 3mg equivalent to 1.851 mg prochlorperazine

Available from:

Max Health Limited

INN (International Name):

Prochlorperazine maleate 3 mg

Dosage:

3 mg

Pharmaceutical form:

Buccal tablet

Composition:

Active: Prochlorperazine maleate 3mg equivalent to 1.851 mg prochlorperazine Excipient: Ceratonia Magnesium stearate Povidone Purified talc Riboflavin sodium phosphate Sucrose Xanthan gum

Units in package:

Blister pack, sample, 3 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Trifarma SpA

Therapeutic indications:

Buccastem is indicated: · for the symptomatic treatment of vertigo due to Meniere's disease, labyrinthitis and other causes · for nausea and vomiting from whatever cause · in the treatment of migraine.

Product summary:

Package - Contents - Shelf Life: Blister pack, sample - 3 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1988-05-12

Summary of Product characteristics

Page 1 of 7
New Zealand Data sheet
1.
PRODUCT NAME
Prochlorperazine 3mg Buccal Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Prochlorperazine maleate 3 mg
Each buccal tablet contains 3.0 mg prochlorperazine maleate BP.
Excipient(s) with known effect
Compressible sugar (contains sucrose) 49.493 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Buccal tablet.
Presentation
Circular, biconvex, pale-yellow, glossy tablets. Imprinted “JI” on
one side and plain on the
other. 7/32 inches.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Symptomatic treatment of vertigo due to Meniere's Disease,
Labyrinthitis and other
causes.
For nausea and vomiting from whatever cause.
In the treatment of migraine.
4.2.
Dose and method of administration
To be placed in the buccal cavity high up along the top gum under the
upper lip, until
dissolved. Do not chew or swallow the tablet.
Adults and children aged 12 years and over: One or two
Prochlorperazine 3 mg Buccal
Tablets twice a day.
Children under 12 years: Not recommended.
Elderly patients: There is no evidence that dosage need be modified
for the elderly.
4.3.
Contraindications
•
Hypersensitivity to the active substance or to any of the excipients
listed in section
‘List of Excipients’
•
Impaired liver function
•
Existing blood dyscrasias
Page 2 of 7
•
Epilepsy
•
Parkinson’s Disease
•
Prostatic hypertrophy
•
Narrow angle glaucoma.
4.4.
Special warnings and precautions for use
Prochlorperazine 3 mg Buccal Tablets should be avoided in patients
with stroke risk
factors and myasthenia gravis.
Agranulocytosis has been reported with phenothiazines. The occurrence
of unexplained
infections or fever may be evidence of blood dyscrasia (see section
‘Undesirable effects’),
and requires immediate haematological investigation.
It has been reported that patients with AIDS may be particularly
susceptible to
antipsychotic-induced extrapyramidal effects.
Because of the risk of photosensitisati