VAGIRUX Vaginal tablet Ref.[28008] Active ingredients: Estradiol

Posology

Vaginal infections should be treated before start of the Vagirux therapy.

Treatment may be started on any convenient day.

Initial dose

One vaginal tablet daily for two weeks.

Maintenance dose

One vaginal tablet twice a week.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as Vagirux, it is not recommended to add a progestagen (see section 4.4).

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

Method of administration

Vagirux is administered intravaginally as a local oestrogen therapy by use of an applicator.

How to administer Vagirux:

1. Remove the applicator from its sealing foil.

2. While holding the tube, gently pull the plunger out of the applicator until it comes to a stop.

Take a vaginal tablet from the separate blister and place it firmly in the holder of the applicator end (wide end).

3. Insert the applicator carefully into the vagina.

Stop when you can feel some resistance (8-10 cm).

4. Release the vaginal tablet, by gently pressing the push-button until the end of the plunger.

The tablet will stick to the wall of the vagina straight away. It will not fall out if you stand up or walk.

5. After each use, prior to a subsequent use, clean the applicator according to the following cleaning procedure:

• Withdraw the plunger from the applicator.
• Clean both the tube and the plunger using mild soap and rinse them with warm tap water thoroughly. Rinse both the tube’s inner and outer surface.
• If necessary, remove larger amounts of remaining water from both the tube and the plunger by shortly shaking them.
• Air dry both the tube and the plunger on a clean surface (e.g. paper towel).
• Introduce the plunger again in the applicator-tube for the next use of the applicator.

6. The applicator can be used up to 24 times. Thereafter, throw it away via the household waste. A new applicator should be used with every new pack.

Vagirux is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.

2 years.

This medicinal product does not require any special storage conditions.

Vagirux tablets are packed in PVC/PVDC/aluminium blister packs.

The blisters are packed into cardboard boxes accompanied by a multiple-use applicator sealed separately in foil.

Pack sizes: 18 × or 24 × vaginal tablets with one applicator in each box.

Not all pack sizes may be marketed.

17-beta-estradiol is expected to pose a risk to the aquatic environment, especially to fish populations.

See section 4.2 for instructions on cleaning and disposal of applicator device.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.