ESTRING Vaginal delivery system Ref.[7706] Active ingredients: Estradiol

ESTRING vaginal delivery system is an oestrogen-only product for vaginal use.

Adults including elderly people (≥65 years old)

One ring to be inserted into the upper third of the vagina. Once inserted it is left in the vagina continuously for 90 days and replaced by a new ring as appropriate. 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. The maximum recommended duration of continuous therapy is two years.

Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. Patients changing from a cyclical or continuous sequential preparation should complete the cycle, after a withdrawal bleed, and then change to ESTRING vaginal delivery system. Patients changing from a continuous combined preparation may start therapy at any time.

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

To put ESTRING into the vagina:

• Choose a comfortable position
• With one hand, the folds of skin around the vagina are opened.
• With the other hand, press the ring into an oval shape.
• The ring is pushed into the vagina as far as it will go, upwards and backwards towards the small of the back.

To take out ESTRING:

• Choose a comfortable position.
• Place a finger into the vagina and hook around the ring.
• The ring is gently pulled out – downwards and forwards.

Comprehensive advice for removal and reinsertion of the ring are provided in the Patient Information Leaflet, which is included in every pack.

Paediatric Population

Estring vaginal delivery system is not recommended for use in the paediatric population.

ESTRING 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.

Do not store above 25°C.

Each ring is individually packed in a heat-sealed rectangular pouch consisting of, from outside to inside: Polyester/Aluminium foil/Low density Poly-ethylene. Each pouch is provided with a tear-off notch on one side and is packed into a cardboard carton.

After use the ring still contains some of the active hormonal ingredient, which may be harmful to the environment. Therefore, the used ring should be placed within the original pouch or a plastic bag, then sealed and discarded safely. Used rings should not be flushed down the toilet nor placed in liquid waste disposal systems. Any used or unused medicinal product or waste material should be disposed of according to local requirements.