PHARMATEX 1.2 %w/w Vaginal Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
BENZALKONIUM CHLORIDE
Available from:
Innothera Ireland Ltd
INN (International Name):
BENZALKONIUM CHLORIDE
Dosage:
1.2 %w/w
Pharmaceutical form:
Vaginal Cream
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2008-11-29
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pharmatex 1.2% Vaginal Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium Chloride 1.2% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
Unctuous white vaginal cream with an odour of lavender.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(a)
Properties
Cream containing benzalkonium chloride, which is a quaternary ammonium disinfectant and spermicidal agent.
(b)
Indications for use
As an adjunct in the control of conception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravaginal.
UNIDOSE:
The contents of the container should be expelled as deeply as possible into the vagina using the nozzle and exerting
sufficient pressure to the walls of the tube to ensure emptying of the contents. Protection is immediate and lasts for 4
hours.
MULTIDOSE:
The contents of the container should be expelled as deeply as possible into the vagina using the nozzle and crossbar of
the device to ensure adequate distribution. Protection is immediate and lasts for 4 hours.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to benzalkonium chloride.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
If irritation of vagina or penis occurs the use of product should cease.
2.
The product should only be recommended to individuals who understand the appropriate use of the agent.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2006_
_CRN 2030638_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
The spermicide is inactivated by soap and other anionic surfactants even in trace amounts. Bathing or swimming must
be avoided as the efficacy of the product is affected.
4.6
Read the complete document
