Oestrogel Gel 80 gm

What Is Oestrogel Gel 80 g?

Oestrogel Gel 80 g is a transdermal hormone replacement therapy (HRT) containing estradiol 0.06% w/w. Estradiol is an oestrogen hormone used to replace oestrogen that decreases after menopause.

Oestrogel is supplied as an 80 g bottle with a metered-dose pump. Each pump actuation delivers 1.25 g of gel containing 0.75 mg (750 micrograms) of estradiol. The gel is applied to the skin, where estradiol is absorbed into the bloodstream.

What Is Oestrogel Used For?

Oestrogel is used as hormone replacement therapy for oestrogen-deficiency symptoms in postmenopausal women.

The product is also indicated for the prevention of osteoporosis in postmenopausal women who are at high risk of future fractures and who cannot use, or have a contraindication to, other medicines approved for osteoporosis prevention.

Oestrogel is not intended to treat every symptom associated with menopause. The decision to use HRT depends on the individual’s symptoms, medical history, risk factors, and treatment needs.

How Does Oestrogel Work?

Oestrogel contains estradiol, a form of oestrogen. After application to the skin, estradiol passes through the skin and enters the systemic circulation.

Estradiol binds to oestrogen receptors in responsive tissues and provides the oestrogen component of hormone replacement therapy. This helps replace the oestrogen deficiency that occurs after menopause.

Oestrogel Dose

Oestrogel is applied once daily on a continuous basis.

For initiation and continuation of treatment for postmenopausal symptoms, the usual starting dose is two pump actuations once daily, providing a total of 1.5 mg of estradiol.

Depending on the clinical response, the dose may be adjusted. The product information allows a maximum of four pump actuations daily. The lowest effective dose should be used for the shortest duration appropriate for treatment.

The dose should not be increased or reduced without guidance from a healthcare professional.

How to Apply Oestrogel

Apply Oestrogel to clean, dry, intact skin.

The recommended application areas include the arms and shoulders or the inner thighs. Do not apply Oestrogel to or near the breasts or the vulval area.

Application steps

1. Apply the prescribed number of pump actuations to clean, dry, intact skin.
2. Spread the gel evenly over a sufficiently large area of skin.
3. Allow the gel to dry for approximately 5 minutes before covering the area with clothing.
4. Wash your hands with soap and water after application.
5. Do not wash the application area or apply other skin products to it for at least one hour after application.

Oestrogel should be applied by the patient herself because estradiol can be transferred through skin-to-skin contact.

Preventing Transfer of Oestrogel

Estradiol from the gel can transfer to another person through direct contact with the application site.

After applying Oestrogel:

• Allow the gel to dry before covering the area with clothing.
• Avoid skin-to-skin contact between the application area and another person for at least one hour.
• Prevent children from coming into contact with the area where the gel has been applied.
• Wash the application area with soap and water before prolonged skin contact with another person if required by the product instructions.

Oestrogel and the Uterus

Oestrogel is an oestrogen-only HRT.

For women who have an intact uterus, systemic oestrogen treatment can stimulate the endometrium and increase the risk of endometrial hyperplasia and endometrial cancer. The product information recommends considering an appropriate progestogen for women with a uterus to reduce this risk.

Women without a uterus may use oestrogen-only HRT when clinically appropriate. The appropriate HRT regimen should be determined by a healthcare professional.

Any unexplained or unexpected vaginal bleeding during treatment should be assessed by a healthcare professional.

Possible Side Effects

Oestrogel may cause side effects in some people. Reported effects associated with estradiol HRT can include:

• Breast tenderness or breast pain
• Headache
• Nausea
• Abdominal discomfort or bloating
• Vaginal bleeding or spotting
• Skin reactions at the application site
• Fluid retention
• Mood changes

The type and frequency of side effects vary between individuals.

Seek Medical Attention for Serious Symptoms

Contact a healthcare professional promptly if you develop unusual vaginal bleeding or other concerning symptoms.

Seek urgent medical attention for symptoms that may indicate a blood clot or another serious complication, including:

• Painful swelling or redness of a leg
• Sudden chest pain
• Difficulty breathing
• Sudden severe headache
• Sudden changes in vision or other neurological symptoms

Who Should Not Use Oestrogel?

Oestrogel should not be used in certain circumstances, including:

• Known, past, or suspected breast cancer
• Known or suspected oestrogen-dependent cancer
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Current or previous venous thromboembolism, such as deep vein thrombosis or pulmonary embolism
• Known thrombophilic disorders
• Active or recent arterial thromboembolic disease
• Acute liver disease or a history of liver disease where liver function has not returned to normal
• Known allergy or hypersensitivity to estradiol or any component of the product
• Porphyria

These contraindications are based on the current product information for Oestrogel.

Important Safety Information

Before starting or restarting HRT, the individual’s medical history, family history, and relevant risk factors should be reviewed by a healthcare professional.

Conditions such as endometriosis, uterine fibroids, hypertension, diabetes, migraine, liver disorders, gallstones, epilepsy, asthma, or a history of blood clots may require additional consideration before or during HRT.

HRT should be reviewed periodically to ensure that continued treatment remains appropriate.

Breast Cancer

Systemic HRT has risks that vary according to the type of HRT, duration of treatment, and individual risk factors.

Oestrogel should not be used by women with known, past, or suspected breast cancer. Any new or unusual breast changes should be assessed by a healthcare professional.

Blood Clots

Systemic oestrogen therapy can be associated with an increased risk of venous thromboembolism.

Tell your healthcare professional if you have a personal or family history of blood clots or a known thrombophilic condition. Oestrogel is contraindicated in women with current or previous venous thromboembolism or known thrombophilic disorders.

Pregnancy

Oestrogel is intended for postmenopausal HRT and should not be used during pregnancy.

If pregnancy occurs while using Oestrogel, discontinue treatment and contact a healthcare professional.

Missed Dose

If a dose is missed and there are more than 12 hours before the next scheduled dose, the missed dose may be applied and the normal schedule continued the following day.

If the next dose is due within 12 hours, skip the missed dose and apply the next dose at the usual time.

Do not apply two doses together to make up for a missed dose.

Storage

Oestrogel does not require special storage conditions according to the current product information.

Keep the medicine out of the sight and reach of children.

Do not use Oestrogel after the expiry date stated on the packaging.

FAQs – Frequently Asked Questions