SANDOZ FENEZAL promethazine hydrochloride 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

promethazine hydrochloride, Quantity: 25 mg

Available from:

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

INN (International Name):

Promethazine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; maize starch; macrogol 200; lactose monohydrate; hypromellose; povidone; 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 '25', 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:

2007-01-22

Patient Information leaflet

Sandoz Fenezal®
1
Sandoz Fenezal®
Active ingredient: Promethazine hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about taking
Sandoz Fenezal. You should also speak to your doctor or
pharmacist if you would like further information or if you
have any concerns or questions about taking Sandoz
Fenezal.
Where to find information in this leaflet:
1.
Why am I taking Sandoz Fenezal?
2.
What should I know before I take Sandoz Fenezal?
3.
What if I am taking other medicines?
4.
How do I take Sandoz Fenezal?
5.
What should I know while taking Sandoz Fenezal?
6.
Are there any side effects?
7.
Product details
1. Why am I taking Sandoz Fenezal?
Sandoz Fenezal contains the active ingredient
promethazine hydrochloride. Sandoz Fenezal is an
antihistamine used to treat a number of conditions.
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.
Sandoz Fenezal is used to treat allergies (allergic contact
dermatitis, hives, hayfever, bites and stings), respiratory
symptoms due to allergies (runny nose), nausea and
vomiting (motion sickness). It can assist in the
management of the symptoms of chicken pox and
measles by acting as a sedative. It can also be used short-
term for sedation on the advice of a pharmacist or
doctor. Do not use for more than 7-10 days.
2. What should I know before I take Sandoz
Fenezal?
Warnings
Do not take Sandoz Fenezal 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
take this medicine.

you are also taking or have recently taken (within the
last 14 days) monoamine oxidase inhibitors, a type of
medicine used to treat depression.

have jaundice (yellowing of the skin

Summary of Product characteristics

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sandoz-fenezal-ccdsv5-piv7-28jun22
Page 1
AUSTRALIAN PRODUCT INFORMATION – SANDOZ FENEZAL
®
(PROMETHAZINE HYDROCHLORIDE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Promethazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sandoz Fenezal 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
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.
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.
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sandoz-fenezal-ccdsv5-piv7-28jun22
Page 2
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 6 years of age. (see
Section 4.3 Contraindications
and Section 4.4 Special warnings and precautions for use). This
product is not suitable for
children aged 6-12 years unless on pharmacist or medical advice. (see
Section 4.4 Special
warnings and precautions for use).
Dosage