SANDRENA Gel Ref.[27748] Active ingredients: Estradiol

Posology

Sandrena is a gel for transdermal use. Sandrena can be used for continuous or cyclical treatment.

The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the selection of the initial dose can be based on the severity of the patient’s symptoms. Depending on the clinical response, the dosage can be readjusted after 2-3 cycles individually from 0.5 g to 1.5 g per day, corresponding to 0.5 to 1.5 mg estradiol per day. 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.

In patients with an intact uterus, it is recommended to combine Sandrena with an adequate dose of progestagen, for adequate duration for at least 12-14 consecutive days per month/28 day cycle or to oppose oestrogen-stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.

In women who are not using hormone replacement therapy (HRT), or women transferring from continuous combined HRT product, treatment with Sandrena may be started on any convenient day. In women transferring from a continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen.

If the patient has forgotten to apply one dose, the forgotten dose is to be applied as soon as possible if the dose is not more than 12 hours late. If the dose is more than 12 hours late, the dose should be forgotten and continue as normal. Forgetting a dose may increase the likelihood of break-through bleeding and spotting.

There is no relevant indication for use of Sandrena in children.

Method of administration

Apply on dry and clean skin.

The Sandrena dose is applied once daily on the skin of the lower trunk of the right or left thigh, on alternate days. The application surface should be 1-2 times the size of a hand. Sandrena should not be applied on the breasts, on the face or irritated skin. After application the gel should be allowed to dry for a few minutes and the application site should not be washed within 1 hour. Contact of the gel with eyes should be avoided. Hands should be washed after application.

Generally, oestrogens are well tolerated even in massive doses. Acute toxicity studies did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. Nausea, vomiting and withdrawal bleeding may occur in some women.

Overdose effects generally lead to breast tenderness, abdominal or pelvis swelling, anxiety, irritability. These symptoms disappear when the treatment is stopped or when the dose is reduced.

Overdosage is unlikely with transdermal application. There is no specific antidote and treatment should be symptomatic. The gel should be washed.

3 years.

Do not store above 25°C.

Single-dose aluminium foil container (PET/Aluminium/PE) supplied in packages containing 28 or 91 single-dose containers. Not all pack sizes may be marketed.

No special requirements.