Divigel

PRESCRIBING INFORMATION CAN BE FOUND HERE

DIVIGEL GEL OVERVIEW:

Smooth, opalescent transdermal gel: Divigel is an alcohol-based gel containing 1.0mg estradiol, a naturally occurring form of oestrogen derived from plants. Divigel can be used for continuous, cyclic or sequential treatment.

The usual starting dose is 1.0mg estradiol (1.0 g gel) daily but the selection of the initial dose can be based on the severity of the patient's symptoms.

In patients with an intact uterus, it is recommended to be combined with a suitable dose of progestogen for an 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 progestogen in hysterectomised women.

The experience of treating women older than 65 years old is limited.

Divigel is indicated for oestrogen deficiency symptoms in postmenopausal women and provides effective relief of menopausal symptoms.^1,2

ADVANTAGES OF GEL FORMULATION:

• Low incidence of skin irritation³
• Cosmetically appealing and easy to use
• Invisible after application
• Low volume gel absorbs rapidly, is non-greasy and non-smelling

DIVIGEL CAN BE USED FOR POSTMENOPAUSAL WOMEN WHO:

• Do not want to take tablets
• Do not want to wear a patch

SAFETY PROFILE:

Contraindications

• Known, past or suspected breast cancer
• Known or suspected oestrogen-dependent malignant tumours
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism
• Known thrombophilic disorders
• Active or recent arterial thromboembolic disease
• Acute liver disease, or a history of liver disease
• Hypersensitivity to active ingredient or excipients
• Porphyria

SIDE EFFECTS:

During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment.

The common side effects include:

• Oedema, weight increase or decrease
• Depression, nervousness, lethargy
• Headache, dizziness
• Hot flushes
• Nausea, vomiting, stomach cramps, flatulence
• Breast pain / tension
• Unscheduled vaginal bleeding or spotting, vaginal discharge, disorder of vulva / vagina, menstrual disorder
• Skin irritation, application site pruritis, pain, Increased sweating

 

Warning:

Do not allow others, especially children, to come into contact with the exposed area of the skin and to cover the application site with clothing if needed. In case of contact the child's skin should be washed with soap and water as soon as possible.

Contact your healthcare provider if any signs and symptoms (breast development or other sexual changes) in a child that may have been exposed accidentally to estradiol gel.¹

 

See SPC for more information.

September 2023/DIV-41

ADVERSE EFFECTS SHOULD BE REPORTED. YOU CAN REPORT SIDE EFFECTS DIRECTLY VIA THE HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA) WEBSITE: WWW.HPRA.IE OR BY EMAIL ON MEDSAFETY@HPRA.IE. ADVERSE EFFECTS SHOULD ALSO BE REPORTED TO ORION PHARMA VIA IE.MEDICALINFORMATION@ORIONPHARMA.COM