Sandrena

PRESCRIBING INFORMATION CAN BE FOUND HERE 
Adverse event reporting can be found at the bottom of this page

SANDRENA GEL OVERVIEW:

Smooth, opalescent transdermal gel: Sandrena is an alcohol-based gel containing either 0.5mg or 1.0mg estradiol, a naturally occurring form of oestrogen derived from plants. Sandrena can be used for continuous or cyclical treatment.

The usual starting does 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 it not recommended to add a progestogen in hysterectomised women.

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

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

ADVANTAGES OF GEL FORMULATION:

• Cosmetically appealing and easy to use
• Invisible after application
• Low volume gel is non-greasy and non-smelling

SANDRENA 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:

• Weight increase or decrease
• Depression, nervousness and lethargy
• Headache, dizziness
• Hot flushes
• Nausea, vomiting, stomach cramps, flatulence, abdominal pain, rash, pruritis
• Unscheduled vaginal bleeding or spotting, vaginal discharge, disorder of vulva/vagina, menstrual disorder, breast pain/tension
• Skin irritation, application site pain, increased sweating, edema

 

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. Your doctor will advise you.

See SPC for more information.

February 2024/HRT-2bab(3)

ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.MHRA.GOV.UK/YELLOWCARD. ADVERSE EVENTS SHOULD ALSO BE REPORTED TO ORION PHARMA (UK) LTD ON 01635 520300.