Oestrogel Pump

What is Oestrogel Pump?

Oestrogel Pump-Pack is a hormone replacement therapy (HRT) medication presented as a clear, colourless transdermal gel. Its active ingredient is estradiol, a manufactured form of the primary female sex hormone, oestrogen. It belongs to a class of medicines called oestrogens.

Mechanism of Action

During menopause, a woman's natural oestrogen levels decline significantly. Oestrogel works by topically replacing this oestrogen. The estradiol in the gel is absorbed through the skin and enters the bloodstream, supplementing the body's levels. This helps to restore a hormonal balance more similar to the pre-menopausal state, thereby alleviating symptoms caused by the deficiency.

Analogy: Think of it like refilling a vital fuel tank. Menopause causes the body's "oestrogen tank" to run low, triggering various symptoms. Oestrogel provides a measured, daily top-up of this fuel through the skin to help the body's systems run more smoothly again.

What is Oestrogel Pump Used For?

Oestrogel Pump is prescribed for postmenopausal women to address specific health concerns related to oestrogen loss.

Approved Indications:

Target Patient Population: Postmenopausal women, including those with premature menopause due to ovarian failure or surgery (although experience is more limited in this group).

Before Using Oestrogel Pump

Initiating HRT requires a thorough individual risk-benefit assessment by a doctor.

Medical History Assessment Checklist:

Your doctor will ask about your personal and family history of:

• Breast, ovarian, or endometrial cancer.
• Blood clots (thrombosis, pulmonary embolism), stroke, or heart attack.
• Liver disease, gallstones, or porphyria.
• High blood pressure, diabetes, migraine, asthma, epilepsy, lupus.
• Unexplained vaginal bleeding or endometrial hyperplasia.

Required Baseline Tests & Evaluations:

1. Physical Examination: May include breast examination and, if necessary, an internal (pelvic) examination.
2. Blood Pressure Measurement.
3. Breast Screening (Mammography): As per national guidelines and prior to starting treatment if indicated.

Regular Check-ups: Once on Oestrogel, you should see your doctor for at least annual reviews to re-evaluate the need for treatment and monitor risks.

Oestrogel Pump Contraindications

Do NOT use Oestrogel Pump if any of the following apply to you:

Absolute Contraindications (Must Not Use)

• Known allergy to estradiol or any ingredient (e.g., carbomer, trolamine, ethanol).
• Known or suspected breast cancer, or a history of it.
• Known or suspected oestrogen-dependent cancer (e.g., cancer of the womb lining/endometrium).
• Unexplained vaginal bleeding.
• Untreated excessive thickening of the womb lining (endometrial hyperplasia).
• Active, recent, or history of blood clots in veins (e.g., deep vein thrombosis, pulmonary embolism).
• Active or recent arterial thromboembolic disease (e.g., angina, heart attack, stroke).
• Active liver disease, or liver function tests not yet returned to normal.
• Porphyria (a rare inherited blood disorder).

Risk Stratification (Conditions Requiring Extra Caution):

• High Risk: Strong family history of breast cancer, personal history of blood clots, severe liver disease.
• Moderate Risk: Controlled high blood pressure, migraine, diabetes, gallstones, history of endometrial hyperplasia.

Special Population Considerations

Elderly:

Women over 65 starting HRT have a higher risk of developing dementia. The risk of stroke and blood clots also increases with age. The lowest effective dose for the shortest duration should be used.

Renal/Hepatic Impairment:

• Contraindicated in active liver disease.
• Use with caution in mild liver impairment.
• No specific dose adjustment is needed for renal impairment, but caution is advised in patients with fluid retention related to kidney problems.

Paediatric/Adolescent:

Not indicated. This medicine is for postmenopausal women only. Accidental transfer to children can cause premature puberty.

Oestrogel Pump and Other Medicines

Some medicines can affect how Oestrogel works, or Oestrogel can affect them.

High-Risk Medication Combinations:

• Enzyme Inducers: Medicines that increase liver metabolism can reduce Oestrogel's effectiveness, leading to breakthrough bleeding. These include:
  • Antiepileptics (phenobarbital, phenytoin, carbamazepine).
  • Antibiotics for tuberculosis (rifampicin, rifabutin).
  • Some HIV medicines (e.g., nevirapine, efavirenz).
  • Herbal remedy St. John's Wort.
• Medicines affected by HRT: Oestrogel may increase the frequency of seizures when taken with lamotrigine. It may also interfere with certain Hepatitis C treatment regimens.

Timing Recommendations: Always inform your doctor or pharmacist about all medicines you take, including over-the-counter and herbal products, before starting Oestrogel. There is no specific timing required between applying the gel and taking other oral medications.

Avoid on Application Site: Do not use strong skin cleansers, detergents, astringents, sunscreen, or other topical medications (e.g., for acne, warts) on the same skin area where you apply the gel, as they may interfere with absorption.

Pregnancy & Breastfeeding

Pregnancy:

• Contraindicated.
• Oestrogel is for postmenopausal women only.
• If you become pregnant while using it, stop immediately and consult your doctor.

Breastfeeding:

• Contraindicated.
• Not intended for use in breastfeeding women.

Contraception Requirements:

Oestrogel is NOT a contraceptive. If you are perimenopausal (under 50 or within 12 months of your last period), you may still need to use non-hormonal or progestogen-based contraception to prevent pregnancy. Discuss with your doctor.

Driving & Machine Operation

• Oestrogel has no or negligible influence on the ability to drive and use machines.
• The gel is applied topically and systemic side effects like dizziness are uncommon.
• However, if you experience unusual headaches, migraines, or dizziness after starting treatment, avoid these activities until you feel well.

Oestrogel Pump Ingredients

Active Ingredient:

• Estradiol (as hemihydrate) - 750 micrograms per 1.25g gel dose.

Excipients (Other Ingredients):

Allergen Warnings:

• If you are allergic to any of the above ingredients, do not use this medicine.
• The alcohol content may cause a burning sensation on damaged skin.

How to Use Oestrogel Pump

Oestrogel is for external use only. Do not swallow. Apply once daily to clean, dry, unbroken skin.

Starting Treatment:

• If new to HRT or switching from a continuous (period-free) HRT: Start on any convenient day.
• If switching from a cyclic HRT (where you have periods): Finish your current pack first.

Oestrogel Pump Dosage Guidelines

The aim is to use the lowest effective dose for the shortest necessary time.

Standard Dosage Schedule

Your doctor will advise on the appropriate dose based on your symptoms and response. For detailed dosing information, refer to the official Oestrogel SMPC.

Administration Instructions

Step-by-Step Guide

1. Prepare the Pump: For a new pack, remove cap, detach stopper, press plunger a few times until gel appears (discard this first dose).
2. Clean & Dry: Wash and dry your hands and the application site.
3. Dispense Gel: Hold pump, place hand under spout, press plunger firmly once for one measured dose.
4. Apply: Spread the gel immediately over a large area of skin on:
   • Both outer arms and shoulders, OR
   • Both inner thighs.
5. Avoid: Do not apply on/near breasts, genital area, or on broken skin.
6. Let Dry: Allow to dry for 5 minutes before dressing. The gel is flammable until dry.
7. Wash Hands: Thoroughly wash hands with soap and water after application.
8. Prevent Transfer: Avoid skin-to-skin contact with others (especially children) for at least one hour. Cover the area with clothing once dry.

Missed Dose Management

Time-Based Guidance

Do NOT apply a double dose to make up for a forgotten one. Missing a dose may cause breakthrough bleeding or spotting.

Overdose Information

Symptoms

• Accidental application of excessive gel is unlikely to cause acute harm due to the metered pump.
• Effects of prolonged overuse may include breast tenderness, nausea, and vaginal bleeding.

Management

1. If you suspect overdose, stop treatment immediately.
2. Contact your doctor or pharmacist.
3. Symptoms typically resolve upon stopping or reducing the dose.

Oestrogel Pump Side Effects

Like all medicines, Oestrogel can cause side effects, although not everyone gets them. Serious risks are discussed in Section 2.

Frequency-Based Categorisation:

Reporting: You can report side effects via the Yellow Card Scheme.

How to Store Oestrogel Pump

Storage Guidelines

• Keep out of sight and reach of children.
• Do not use after the expiry date (printed on carton and pump as "Exp").
• No special storage conditions required.
• Do not dispose of via wastewater or household waste.

Disposal

• Return unused medicine to a pharmacy for safe disposal.
• Do not throw away in household rubbish.

Oestrogel Pump Pack Information

Pack Details

• Pack Size: 80g translucent bottle with a metered-dose pump.
• Appearance: Colourless, non-greasy, non-staining gel with an alcohol odour.
• Doses per Pack: 64 metered doses (1.25g gel per dose).
• Manufacturer: Besins Manufacturing Belgium / Laboratoires Besins International.
• Marketing Authorisation Holder: Besins Healthcare, Belgium.

Where Can I Buy Oestrogel Online in the UK