Oestrogel Pump Pack general information

What is Oestrogel Pump Pack used for?

Oestrogel Pump Pack is a metered-dose pump filled with a clear, colorless transdermal gel containing oestrogen 0.06%.  The transdermal gel is applied to the skin and used for hormone replacement therapy (HRT), to substitute for a lack of oestrogen production by the ovaries that happens during menopause or following surgical removal of the ovaries.  Using Oestrogel helps relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy.  Oestrogel is also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture.  Oestrogel stimulates the development of female sexual characteristics and can be used as part of a transgender hormone therapy for male to female transsexuals.

How does Oestrogel Pump Pack work?

Oestrogel Pump Pack contains a transdermal gel containing 17-beta oestradiol 0.06%, the major and the most active form of the female hormone oestrogen.  When the gel is applied to the skin, oestradiol is absorbed through the skin into the blood.  Oestrogen is a steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in producing secondary sexual characteristics, such as breast development and in regulating the menstrual cycle.  Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism.  Because the oestadiol in Oestrogel Pump Pack enters the blood directly and continuously, it is not metabolised (broken down) by the liver, as happens with oral oestrogen tablets, which means that Oestrogel is effective at a lower dose and provides more even blood levels similar to the natural release of oestrogen by the ovaries. 

What does Oestrogel Pump Pack contain?

Oestrogel Pump Pack contains the active ingredient 17-beta oestradiol 0.06% (w/w), in a clear, colorless transdermal gel, that is used for hormone replacement therapy (HRT), to substitute for a lack of oestrogen.  It also contains ethanol, carbomer triethanolamine, purified water.  One dose delivers 1.25g of gel containing 0.75mg of oestradiol with each actuation (each time the pump is depressed). 

Treating symptoms of menopause with Oestrogel Pump Pack

Oestrogel Pump Pack is a transdermal gel that is applied to the skin and contains oestradiol, an active form of the female hormone oestrogen that alleviates moderate to severe menopausal symptoms.  Oestradiol in Oestrogel Pump Pack substitutes for the loss of oestrogen production by the ovaries that occurs during menopause causing symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, headaches, mood swings, lack of concentration loss of energy and bone loss (osteoporosis). 

Oestrogel Pump Pack for hormone replacement therapy

Oestrogel is a transdermal gel containing oestrogen that is applied to the skin and used for hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries during menopause or following surgical removal of the ovaries.  Oestrogel is used to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy.  Oestrogel is also used to help prevent postmenopausal bone loss (osteoporosis), which is also caused by lack of oestrogen, and reduce risk of fracture.

Oestrogel Pump Pack for transgender treatment

Oestrogel can be used as part of a gender reassignment program for male to female transsexuals, by providing a source of oestradiol, an active form of the female hormone oestrogen.  Oestrogel is a transdermal gel containing oestrogen that is applied to the skin and stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape. 

What are the side effects of Oestrogel Pump Pack?

The most commonly reported side effects when taking Oestrogel Pump Pack include headache, nausea, abdominal pain, breast enlargement, breast swelling/pain, water retention and peripheral oedema, weight change. 

When should Oestrogel Pump Pack not be used?

You should not use Oestrogel Pump Pack if you:

• are allergic to 17-beta oestradiol or any ingredients in Oestrogel Pump Pack
• are pregnant or are breastfeeding
• have liver disease
• have Porphyria, an inherited disorder that can affect the skin and nervous system
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with oestrogen use
• abnormal genital bleeding of unknown cause
• are taking other medications that may interact with Oestrogel Pump Pack, including anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir for HIV, preparations containing St John's Wort. 

What medications interact with Oestrogel Pump Pack?

Several medications interact with Oestrogel Pump Pack and should either not be taken while you are taking Oestrogel Pump Pack or only after discussion and instruction from your doctor:

• Drugs that decrease effectiveness of Oestrogel Pump Pack: anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir for HIV, preparations containing St John's Wort. 

What are the health risks of Oestrogel?

Long-term HRT with Oestrogel does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke and deep vein thrombosis.  For women with an intact uterus adding a progestogen to an oestrogen replacement regimen like Oestrogel is recommended to reduce the risk of endometrial cancer.  There is also an increased risk of developing dementia in postmenopausal women 65 years of age or older.

How should Oestrogel Pump Pack be used?

You should apply your Oestrogel gel once daily morning or evening but at the same time each day.  Avoid using any skin products that may alter the barrier structure or function of your skin while using Oestrogel, such as strong skin cleansers and detergents, skin care products of high alcoholic content (astringents, sunscreens) and keratolytics (e.g. salicylic acid, lactic acid), products containing benzalkonium or benzothonium chloride and sodium lauryl sulphate, as these could make the Oestrogel less effective.

To apply the gel:

1. Press the pump once to dispense one dose (1.25g), or twice to apply two doses (2.5g) of Oestrogel. 
2. Apply to clean, dry, unbroken skin on the outside of your arm, from wrist to shoulder.  You do not need rub the gel in but allow it to dry on your skin for at least 5 minutes.  Do not wash the skin or apply other skin care products until at least one hour after application.  Do not apply to skin that is red or irritated or to the breasts. 
3. Wash your hands after applying Oestrogel gel, to reduce the chance that the gel will spread from your hands to other people. 

The dose you take depends on what you are being treated for and your doctor’s recommendation. You should continue to apply your Oestrogel daily and continuously for as long as recommended by your doctor.

How long should you take Oestrogel Pump Pack?

You should continue to apply your Oestrogel daily and continuously for as long as recommended by your doctor.

Missed dose of Oestrogel Pump Pack

If you miss a dose of Oestrogel Pump Pack:

• and it is more than 12 hours until the next dose, apply your Oestrogel as soon as you remember and apply the next dose on the next day at the usual time.
• and it is less than 12 hours until your next dose, skip the missed dose and apply the next dose on the next day at the usual time

Do not take a double dose.  If you do forget a dose this may increase the likelihood of break-through bleeding and spotting.

How should Oestrogel Pump Pack be stored?

You should store your Oestrogel Pump Pack below 25°C in a cool dry place.