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Oestrogel

Important Safety Information regarding Oestrogel Pump-Pack 750 micrograms/actuation Gel

Updated over 2 weeks ago

First of all, thank you for choosing Numan. If your prescription request for Oestrogel Pump-Pack 750 micrograms/actuation Gel has been accepted, or if you considering whether this treatment may be suitable for you, we'd like to help you learn how to use it to its best effect, and give you some important information before you start taking it.

What is it?

Oestrogel is an oestrogen-only HRT in the form of a clear, alcohol-based gel. It contains the body-identical hormone estradiol and is applied to the skin (transdermal route). Each press (actuation) of the pump delivers a measured dose of gel.

What is it used for?

Oestrogel is used for the relief of oestrogen deficiency symptoms in postmenopausal women, such as hot flushes, sleep problems, and vaginal dryness. It is also used for the prevention of osteoporosis in postmenopausal women at high risk of fractures.

Progestogen Requirement: If you have a uterus, you must also take a separate progestogen to protect your womb lining. Speak to your healthcare provider for further advice if you are unsure.

How long does it take to work?

Many women notice an improvement in their symptoms within a few weeks of starting treatment. However, it can sometimes take up to three months for your body to adjust and for you to feel the full benefits.

How do I use it?

Before using a new pump for the first time, you must prime it by pressing the pump once and discarding the first dose:

  • Apply the gel once daily to a large area of clean, dry, intact skin on your outer arms, shoulders, or inner thighs.

  • Do not apply it on or near your breasts or genital area.

  • You should spread the gel thinly, and allow it to dry for at leas 5 minutes before dressing.

  • Do not wash the area or apply other skin products for at least one hour after application.

  • It is important to wash your hands with soap and water after applying the gel to avoid transfer from the hands of any remaining gel to other areas (see Other Important Safety Information for Oestrogel).

Missed dose: If you forget to apply a dose and it is more than 12 hours until the next dose, the missed dose should be applied and normal dosing resumed the next day. If your next dose is less than 12 hours away, it is best just to wait and apply the next dose normally, and you should not apply two doses at the same time. Forgetting a dose may increase the likelihood of break-through bleeding and spotting.

Special dosing requirements

The usual starting dose is two pumps of Oestrogel gel (1.5 mg estradiol) daily. This can be adjusted by your doctor, up to a maximum of four pumps daily, depending on your symptoms. The goal of HRT is always to use the lowest effective dose for the shortest duration necessary to manage your symptoms.

There are no special dosage requirements for elderly patients, though experience in treating women over 65 years is limited. This medicine is not for use in children.

Information on fertility, pregnancy and lactation

Pregnancy: Oestrogel is not a contraceptive and is intended for use only in post-menopausal women. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your healthcare provider for advice on this. If you become pregnant while taking it, you must stop treatment immediately and contact your healthcare provider.

Breastfeeding: Oestrogel is not indicated during breastfeeding.

Other important safety information

It is crucial to understand that if you have not had a hysterectomy (i.e., you still have your womb), you must take a separate progestogen hormone alongside Oestrogel. This is typically prescribed for 12 to 14 days each month. This is a vital safety measure to protect the lining of your womb from the effects of oestrogen, which, when taken alone, can lead to a build-up of the lining (endometrial hyperplasia) and increase the risk of endometrial cancer.

Risk of Transference: The gel can transfer to others via skin contact.

  • You should avoid skin contact with other people, especially men and children, for at least one hour after application.

  • Wait for at least 5 minutes for the gel to dry before covering the application site with clothing.

  • If accidental contact occurs, the other person's skin should be washed with soap and water as soon as possible.

  • Oestrogel should NOT be applied on or near the breasts or on the vulval region, and we recommend frequently changing the area of application.

  • Do not apply to any areas of broken skin, and do not swallow.

Please see the Patient Information Leaflet linked below for illustrations of how to directly apply Oestrogel.

Flammability: The gel is alcohol-based and flammable until dry. Avoid fire, flames, or smoking during and immediately after application.

What are the associated risks with treatment?

Common side effects of using Oestrogel include skin reactions at the application site, headache, breast tenderness, and nausea. These often settle in the first few weeks. As a transdermal form of HRT, Oestrogel bypasses the liver and carries a lower risk of blood clots (venous thromboembolism) compared to other systemic forms of HRT, such as oral tablets or capsules. The other risks associated with systemic HRT, such as a small increased risk of breast cancer and stroke, still apply, although the overall risk remains low for most patients being treated. For a full list of side effects, please see the Patient Information Leaflet provided with your medication and also linked at the bottom of this page.

What monitoring or follow-up is needed to continue taking treatment safely?

Your clinician will review your treatment after three months to check how you’re responding. After that, you should have a check-up at least once a year. These reviews will assess whether HRT is still right for you, make sure your symptoms are under control, ask about any side effects and vaginal bleeding, request a check of your weight and your blood pressure, and decide if you need further tests such as a bone density scan. You should also examine your breasts regularly, and make sure to attend all routine screening appointments such as mammograms and cervical screening, if applicable to you. If you have a premature menopause, the risks of using HRT may be different, which you should discuss with your clinician.

When to stop treatment

You should stop using Oestrogel immediately and consult your doctor if you experience any of the following: signs of a blood clot (e.g. painful swelling in the leg), a swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema, jaundice (yellowing of the skin or eyes), a significant increase in your blood pressure, the new onset of a migraine-type headache, or if you become pregnant. When you and your clinician decide it is time to stop HRT, the dose is often reduced gradually to help prevent your menopausal symptoms from returning suddenly.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, you should be closely supervised, as these conditions may recur or be aggravated during treatment with Oestrogel, in particular:

  • Leiomyoma (uterine fibroids) or endometriosis

  • Risk factors for thromboembolic disorders

  • Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer

  • Hypertension

  • Liver disorders (e.g. liver adenoma)

  • Diabetes mellitus with or without vascular involvement

  • Cholelithiasis

  • Migraine or (severe) headache

  • Systemic lupus erythematosus (SLE)

  • A history of endometrial hyperplasia

  • Epilepsy

  • Asthma

  • Otosclerosis

Storage instructions

This medicinal product does not require any special storage conditions. Keep out of reach of children.

Further information:

If you have questions about your medication, wish to discuss alternative treatment plans, or need reassurance, our clinicians are available to provide expert advice and support. Just email us at [email protected].

Lastly, please read the Patient Information Leaflet linked below and included with your treatment for a full list of side effects, contraindications, and precautions.

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