Phenergan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Promethazine hydrochloride 25mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Promethazine hydrochloride 25 mg

Dosage:

25 mg

Pharmaceutical form:

Tablet

Composition:

Active: Promethazine hydrochloride 25mg Excipient: Hypromellose Lactose monohydrate Macrogol 200 Magnesium stearate Maize starch Opaspray blue M-1-4210A Povidone

Units in package:

Blister pack, 25 tablets

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Sanofi Chimie

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 25 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, - 50 tablets - 60 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 250 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

PHENERGAN®
1
PHENERGAN
®
(fen-er-gan)
ACTIVE INGREDIENT: _Promethazine hydrochloride_ (PRO-meth-ar-zine
HIGH-dro (h)-CLOR-ride)
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Phenergan. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING PHENERGAN.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using Phenergan?
2.
What should I know before I use Phenergan?
3.
What if I am taking other medicines?
4.
How do I use Phenergan?
5.
What should I know while using Phenergan?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING PHENERGAN?
PHENERGAN CONTAINS THE ACTIVE INGREDIENT PROMETHAZINE
HYDROCHLORIDE.
PHENERGAN IS AN ANTIHISTAMINE USED TO TREAT A NUMBER OF
CONDITIONS:
•
ALLERGIES - ALLERGIC CONTACT DERMATITIS, HIVES, HAYFEVER,
BITES AND STINGS
•
RESPIRATORY SYMPTOMS DUE TO ALLERGIES - RUNNY NOSE
•
NAUSEA AND VOMITING - MOTION SICKNESS
•
FOR SHORT-TERM USE FOR SEDATION ON THE ADVICE OF A
PHARMACIST OR DOCTOR - DO NOT USE FOR MORE THAN 7-10
DAYS
Antihistamines help reduce allergic symptoms by
preventing the effects of a substance called histamine.
Histamine is produced by the body in response to foreign
substances that the body is allergic to.
Your pharmacist or doctor may have recommended
Phenergan for another reason.
Ask your pharmacist or doctor if you have any questions
about this medicine.
2.
WHAT SHOULD I KNOW BEFORE I USE
PHENERGAN?
WARNINGS
PHENERGAN MUST NOT BE USED IN CHILDREN UNDER 2 YEARS OF
AGE, DUE TO THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
DO NOT USE PHENERGAN IF:
•
you are allergic to promethazine hydrochloride,
medicines of similar properties or belonging to the
specific family of chemicals called phenothiazines,
other phenothiazines, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can
use this medicine.
Some of the symptoms of an allergic reaction may
include:
•
short

Summary of Product characteristics

New Zealand Data Sheet
Phenergan - Promethazine Hydrochloride
phenergan-ccdsv5-dsv11-28jul22
_ _
_Page 1 _
NEW ZEALAND DATA SHEET
1
PHENERGAN TABLETS AND PHENERGAN ELIXIR
Phenergan Tablets 10 mg and 25 mg
Phenergan Elixir 5 mg/5 mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine hydrochloride
Phenergan Elixir contains promethazine hydrochloride 5 mg/5 mL.
Excipients of known effect: maltitol solution, sodium benzoate, sodium
sulfite, sodium
metabisulfite
Phenergan tablets contain 10 mg or 25 mg of promethazine
hydrochloride.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ELIXIR
5 mg/5 mL. Sugar free, alcohol free, orange flavoured.
TABLETS
10 mg: Circular, film-coated biconvex tablets with bevelled edges,
pale blue in colour, one
face impressed 'PN' above '10', the reverse face plain.
25 mg: Circular, film-coated biconvex tablets with bevelled edges,
pale blue in colour, one
face impressed 'PN' above '25', the reverse face plain.
New Zealand Data Sheet
Phenergan - Promethazine Hydrochloride
phenergan-ccdsv5-dsv11-28jul22
_ _
_Page 2 _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Allergies: Treatment of allergic conditions including some allergic
reactions to drugs,
urticaria and allergic contact dermatitis, and allergic reactions to
insect bites and stings.
Upper respiratory tract: Relief of excessive secretion in the upper
respiratory tract as a result
of hayfever and allergic rhinitis.
Nausea and vomiting: Antiemetic for vomiting from various causes,
including postoperative
vomiting, irradiation sickness, drug induced nausea and motion
sickness.
Sedation: For short term use in adults under the advice of a doctor or
pharmacist. Do not use
for more than 7 to 10 consecutive days.
Other: Promethazine can be used as a preanaesthetic medication for the
prevention and
control of post operative vomiting.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
This product should not be used in children under 2 years of age (