Allersoothe
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
05-10-2022
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Active ingredient:
Promethazine hydrochloride 1 mg/mL ((excludes manufacturing overage of 5%)); Promethazine hydrochloride 1 mg/mL ((excludes manufacturing overage of 5%))
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Promethazine hydrochloride 1 mg/mL ((excludes manufacturing overage of 5%))
Dosage:
5 mg/5mL
Pharmaceutical form:
Elixir
Composition:
Active: Promethazine hydrochloride 1 mg/mL ((excludes manufacturing overage of 5%)) Excipient: Citric acid Banana Flavour 103 Sunset Yellow Purified water Sodium benzoate Sucrose Vanillin Active: Promethazine hydrochloride 1 mg/mL ((excludes manufacturing overage of 5%)) Excipient: Citric acid Disodium edetate Glycerol Hyetellose Banana Flavour 103 Propyl gallate Propylene glycol Purified water Quinoline yellow Sodium benzoate Sodium citrate Sunset yellow FCF Vanillin
Units in package:
Bottle, plastic, PET, Amber with white, child-resistant PP cap, 100 mL
Class:
Pharmacy only
Prescription type:
Restricted
Manufactured by:
Dandong Yi-Chuang Pharmaceutical Co. Limited
Therapeutic indications:
1. Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings 2. Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis 3. Anti-emetic for vomiting from various causes including post-operative vomiting, irradiation sickness, drug induced nausea and motion sickness 4. Sedation - for short term use in adults under the advice of a doctor or pharmacist, Do not use for more than 7-10 consecutive days 5. Promethazine has sedative effects and can be used in the symptomatic management of measles and chickenpox. 6. Promethazine can be used as a pre-anaesthetic medication for the prevention and control of post-operative vomiting.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, PET, Amber with white, child-resistant PP cap - 100 mL - 18 months from date of manufacture stored at or below 25°C
Authorization date:
2007-09-21
Summary of Product characteristics
Page 1 of 7
NEW ZEALAND DATA SHEET
1.
ALLERSOOTHE TABLETS
Allersoothe 10 and 25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Allersoothe 10 mg tablets: each tablet contains 10 mg of promethazine
hydrochloride.
Allersoothe 25 mg tablets: each tablet contains 25 mg of promethazine
hydrochloride.
Excipients with known effect:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
Allersoothe 10 mg tablets are light blue, round, biconvex, film-coated
tablets. They contain 10 mg
promethazine hydrochloride.
Allersoothe 25 mg tablets are light blue, round, biconvex, film-coated
tablets. They contain 25 mg
promethazine hydrochloride.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Treatment of allergic conditions including some allergic reactions to
drugs, urticaria and allergic
contact dermatitis, and allergic reactions to insect bites and stings
2.
Relief of excessive secretion in the upper respiratory tract as a
result of hayfever and allergic
rhinitis
3.
Anti-emetic for vomiting from various causes including post-operative
vomiting, irradiation
sickness, drug induced nausea and motion sickness
4.
Sedation - for short term use in adults under the advice of a doctor
or pharmacist. Do not
use for more than 7-10 consecutive days
5.
Promethazine can be used as a pre-anaesthetic medication for the
prevention and control of post-
operative vomiting.
4.2
DOSE AND METHOD OF ADMINISTRATION
Do not break the tablets.
Dose
Allersoothe should not be used in children less than two years of age.
The dosage varies according
to the condition being treated and the patient’s response:
_Allergic disorders_
Children 2-5 years of age: Please use Allersoothe Elixir.
Page 2 of 7
Children 6-12 years of age: 10-25 mg as a single dose at night or 10
mg 2-3 times daily.
Children over 12 years and adults: 25-75 mg as a single dose at night
or 10-20 mg 2-3 times daily.
_ _
_Sedation_
Give as a single dose at night.
Adults: 25-75 mg
_Travel sickness_
To be taken the night before travel and repeated after
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