PHENERGAN promethazine hydrochloride 10mg tablet blister pack (reformulation)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

promethazine hydrochloride, Quantity: 10 mg

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; macrogol 200; maize starch; lactose monohydrate; hypromellose; titanium dioxide; indigo carmine; purified water; industrial methylated spirit

Administration route:

Oral

Units in package:

50's

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

ALLERGIES: Treatment of allergic conditions including some allergic reactions to drugs, urticaria, contact dermatitis, and allergic reactions to insect bites and stings. UPPER RESPIRATORY TRACT: Relief of excesive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis. NAUSEA AND VOMITING: Antiemetic in vomiting of various causes, including post-operative vomiting, irradiation sickness, drug induced nausea, and motion sickness. SEDATION: For short term use on the advice of a doctor or pharmacist.

Product summary:

Visual Identification: Circular, film-coated biconvex tablets with bevelled edges, pale blue in colour, one face impressed 'PN' above '10', the reverse face plain.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-09-17

Patient Information leaflet

PHENERGAN
®
(fen-er-gan)
P
H
E
N
E
R
G
A
N
®
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
•
ASSISTS IN THE MANAGEMENT OF THE SYMPTOMS OF
CHICKEN POX AND MEASLES BY ACTING AS A SEDATIVE
•
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

Summary of Product characteristics

phenergan-ccdsv5-piv10-27may22
Page 1
AUSTRALIAN PRODUCT INFORMATION – PHENERGAN
®
(PROMETHAZINE HYDROCHLORIDE) TABLET AND ELIXIR
1
NAME OF THE MEDICINE
Promethazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenergan Elixir contains promethazine hydrochloride 5 mg / 5 mL.
Excipients with 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, clear, bright, golden
syrupy liquid.
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.
phenergan-ccdsv5-piv10-27may22
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 under the advice of a doctor or pharmacist. Do not
use for more than
7 to 10 consecutive days.
_Other: _
Promethazine has sedative effects and can be used in the symptomatic
management of
measles and chicken pox.
Promethazine can be used as a preanaesthetic medication for the
prevention and control of post
operative vomiting.
4.2
DOSE AND METHOD OF ADMINISTRATION
This product must not be used in children under 2 years of a