Please consult the Summary of Product Characteristics (SmPC)

Active Ingredient:

Estriol 1mg/g vaginal cream.

Indications:

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least 1 year.

Dosage and Administration:

Intravaginal using supplied applicator. See SmPC for practical instructions. Initial dose: One application (0.5mg estriol in 0.5g of cream) per day for 2 weeks. Maintenance dose: One application twice a week.

Contraindications:

Hypersensitivity to estriol or excipients; Known, past or suspected endometrial cancer; Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Women with an intact uterus who have previously been treated with unopposed systemic oestrogens; Vulval dermatoses or rash; Untreated vaginal infection; Severe vaginal itching; Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast cancer, ovarian cancer); Previous or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism); Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction, ischaemic stroke); Thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency); Acute or historical liver disease with ongoing abnormal liver function tests; Porphyria.

Warnings and Precautions:

HRT should only be initiated if quality of life is adversely affected. Carefully appraise risks, benefits and suitability at each supply. Before and during HRT, complete a personal and family medical history and complete investigations, including mammography, in accordance with screening standards and clinical needs. Treat vaginal infections before starting. Doctor approval required before treatment in women using systemic HRT, or with a history of endometriosis or endometrial hyperplasia (unless she has a stable health status since a previous vaginal oestrogen prescription and has also had no recent endometriosis symptoms or had a hysterectomy for endometrial hyperplasia), and for women experiencing bothersome symptoms following use of another vaginal oestrogen product for less than 3 months. Discontinue immediately and refer to Doctor if a contraindication is discovered or new onset vaginal bleeding/spotting, new onset vaginal itching, inadequately controlled vaginal infection or symptoms of endometriosis. Prompt advice from Doctor required if jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, pregnancy. Advise what breast changes to report. Epidemiological evidence from large meta-analysis suggests risk of breast cancer is not increased in women with no history of breast cancer. Risk of stimulation of recurrence of breast cancer is unknown. Refer to the SmPC for a list of situations requiring close supervision and information regarding potential HRT related concerns. Interactions: Unlikely to be clinically relevant. Consider potential interaction with other vaginal treatments. Pregnancy and Lactation: Not indicated. Withdraw immediately if pregnancy occurs.

Side Effects:

Estriol therapy or overdose may be associated with nausea and vomiting, breast tenderness or pain in the breasts, vaginal bleeding or spotting during or on withdrawal of therapy, excessive cervical mucus, headache. Application site irritation and pruritis, influenza-like illness, breast discomfort and pain reported (usually transient and may indicate high dosage). Refer to the SmPC for further information including details regarding systemic HRT and the risk of ovarian cancer, venous thromboembolism, coronary artery disease, ischaemic stroke, oestrogen dependent neoplasms, gall bladder disease, skin and subcutaneous disorders, dementia.

Supply Classification:

P.

Cost (excl VAT):

15g – £19.95.

Marketing Authorisation Number and Holder:

PL 39699/0118. Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland.

Further information available on request from:

Aspen Pharma Trading Limited, [email protected] or 0800 008 7392.

Date of Revision:

April 2024.
UK-EST-09-23-00011