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PHARMATEX OVULE

Main information

  • Trade name:
  • PHARMATEX OVULE
  • Available from:
  • Innothera Ireland Ltd
  • Dosage:
  • 18.9 Milligram
  • Pharmaceutical form:
  • Pessary
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • PHARMATEX OVULE
    Ireland
  • Language:
  • English

Other information

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Status

  • Source:
  • IMB
  • Authorization date:
  • 06-12-1983
  • Last update:
  • 09-08-2016

Summary of Product characteristics

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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

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 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not applicable.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hydroxypropylcellulose

Witepsol S51 (semi-syntheytic glycerides)

6.2 Incompatibilities

Soap and other anionic surfactants even in trace amounts inactivate this spermicide. Bathing or swimming must be

avoided as the efficiency of the product is affected.

6.3 Shelf Life

3 years.

6.4 Special precautions for storage

Do not store above 25ºC.

6.5 Nature and contents of container

10 or 20 Pharmatex ovules in 2 or 4 strips of 5 ovules in a thermoformed blister (PVC / low density Polyethylene) in a

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/11/2006 CRN 2030648 page number: 2

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

If the ovules have melted because of the heat, place them in a fridge or under cold water, pointed downwards. They will

recover their initial form without any alteration of the product.

7 MARKETING AUTHORISATION HOLDER

Innothera Ireland Ltd

Donaghcumper

Celbridge

Co. Kildare

8 MARKETING AUTHORISATION NUMBER

PA 334/1/1

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06 December 1983

Date of last renewal: 06 December 2003

10 DATE OF REVISION OF THE TEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/11/2006 CRN 2030648 page number: 3

There are no safety alerts related to this product.

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Updated Date: Aug 25, 2016 EST

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