FYLREVY Film-coated tablet Ref.[116504] Active ingredients: Estetrol

FYLREVY is an oestrogen-only product.

Posology

One tablet should be taken orally once daily at about the same time with or without food, if necessary, with a small amount of water.

Continuous administration is recommended.

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.

Women with a uterus

The treatment should be initiated with FYLREVY 14.2 mg. If there is insufficient response in the form of alleviated symptoms, the dose could be increased to FYLREVY 18.9 mg.

A progestogen approved for addition to oestrogen treatment should be added continuously.

Hysterectomised women

The dose should be FYLREVY 18.9 mg.

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.

Starting or changing treatment

In women who are not taking HRT, or in women who switch from an oestrogen only HRT product or from a continuous combined HRT product, treatment may be started on any convenient day. In women changing from a cyclic or sequential HRT regimen, treatment should begin on the day following completion of the prior regimen.

Management of missed tablets

If a tablet has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet.

Missed tablets may increase the likelihood of breakthrough bleeding or spotting in women with a uterus.

Hepatic impairment

Estetrol is contraindicated in women with severe hepatic impairment as long as liver function values have not returned to normal (see section 4.3).

No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2).

Renal impairment

Estetrol is not recommended in women with moderate or severe renal impairment. No dose adjustment is required in patients with mild renal impairment (see section 5.2).

Paediatric population

There is no relevant use of estetrol in the paediatric population for the indication of HRT for oestrogen deficiency symptoms in postmenopausal women.

Elderly

Estetrol has not been studied for safety and efficacy in women initiating treatment over 65 years of age.

No dose recommendation can be made for this population.

Method of administration

For oral use.

Symptoms of overdose of oestrogen-containing products may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding may occur. Based upon studies conducted with single dose of 94.4 mg and multiple doses of 37.8 mg estetrol, symptoms of nipple tenderness and pelvic pain can also occur.

There is no specific antidote, and treatment should be symptomatic.

3 years.

This medicinal product does not require any special storage conditions.

Transparent PVC/aluminium blister containing 28 film-coated tablets in a carton with an etui storage case.

Pack sizes:

28, 84 or 168 film-coated tablets.

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the environment (see section 5.3).

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