DIVIGEL GEL 0.5MG/DOSE [SIN11644P]

Product Info

DIVIGEL GEL 0.5MG/DOSE

[SIN11644P]

4.1 Therapeutic Indications

Treatment of the climacteric syndrome associated with natural or artificial menopause (estrogenic deficiency, e.g. hot flushes, night sweatings, urogenital atrophy and prevention of postmenopausal (type 1) osteoporosis).

4.2 Posology and method of administration

Posology
Divigel 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.

In patients with an intact uterus, it is necessary to combine Divigel with an adequate dose of progestin for adequate duration, at least 12–14 consecutive days per month/28 day cycle or to oppose estrogen-stimulated hyperplasia of the endometrium.

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

Estrogen with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual women.

Method of administration
Apply on dry and clean skin.

The Divigel dose is applied once daily, on the skin of the lower trunk or the right or left thighs, on alternate days. The application surface should be 1–2 times the size of the hand. Divigel 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 one hour. Accidental contact of the gel with the eyes should be avoided.

• Hands should be washed with soap and water after application

• As soon as the gel has dried after application, application site should be covered with clothing

• Application site should be showered before situations where skin contact with others is expected

• If another person (e.g. child or spouse) or pet accidentally touches the application site, that area of their skin should be washed with soap and water right away.

If no precautionary measures are taken, the estradiol gel can be accidentally transferred through close skin contact to others (e.g. child, spouse, pets), which may cause adverse effects to them. In case of any signs of symptoms of adverse effects, physician or veterinarian should be contacted.

Patients should be informed that children should not come in contact with the area of the body where estradiol gel was applied on (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In women who are not using hormone replacement therapy (HRT), or women transferring from continuous combined HRT-product, treatment with Divigel may be started on any convenient day. In women transferring from a sequential or cyclic HRT regimen, treatment should begin the day following completion of the prior 28 days regimen.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be used.

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.

Route of Administration
For topical use only

4.3 Contraindications

• Known, past or suspected breast cancer

• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease or a history of liver disease as long as liver functions have failed to return to normal

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Porphyria