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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pharmatex 18.9 mg Ovule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ovule contains 18.9 mg of benzalkonium chloride.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Pessary
White odourless cylindrical pessary, with conical head.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(a)
Properties
Ovule 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.
One ovule should be inserted intravaginally at least 10 minutes prior to each coitus.
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.
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 PREGNANCY AND LACTATION
As benzalkonium chloride is not absorbed, and as diffusion does not occur into the blood or milk of nursing mothers,
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/11/2006_
_CRN 2030648_
_page number: 1_
nor into the uterine cavity of animals, the use of Pharmatex Ovule in pregnancy or lactation is not contra-indicated.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRABLE EFFECTS
Possibility of allergy.
4.9
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