Vagifem (Estradiol 10mcg) Vaginal Tablets

Vagifem general information

What is Vagifem used for?

Estrogen is produced by the ovaries and plays a central role in female reproduction, along with other female hormones like progesterone.  Estrogen stimulates the development of female sexual characteristics, including breast development and body shape.  It regulates the menstrual cycle and triggers ovulation.  Estrogen also stimulates the thickening of the endometrium (lining of the uterus) in preparation for pregnancy and maintains, supports vaginal health by promoting the thickening of vaginal tissue, and stimulates vaginal secretions.  It also plays other essential roles, including regulating lipid metabolism and supporting bone density throughout the fertile years of a woman’s life. 

Menopausal changes

As menopause approaches, estrogen production starts to slow down, and eventually, no more is produced by the ovaries.  Menstruation ceases, and this lack of estrogen brings with it a host of menopausal symptoms, some mild and some quite severe.  For some women, although a natural part of life, menopause can cause some severe problems.  Symptoms include hot flashes and night sweats caused by sudden dilation of surface blood vessels, vaginal dryness and discomfort, mood swings, lack of concentration, and reduced energy.  Loss of bone density is a serious problem related to low estrogen, which can lead to osteoporosis.  Vagifem tablets are a topical hormone replacement therapy (HRT) used to treat vaginal symptoms during the early menopausal years. 

Atrophic vaginitis

Atrophic vaginitis, also known as vaginal atrophy, is an unpleasant symptom of menopause experienced by most women when they reach this stage of their lives.  As estrogen levels drop, vaginal tissue begins to thin as cells stop growing.  Changes in the structure of proteins like collagen and elastin that support the stability and flexibility of vaginal tissue are also seen as estrogen diminishes. Usually, vaginal tissue is maintained moist and lubricated by secretion from mucus glands in the cervix, which are also regulated by estrogen, and these secretions dry up in the absence of estrogen.  Changes in vaginal structure and function cause vaginal dryness, itching, burning, and discomfort or pain with sex.  There is also an increased risk of urinary and bladder infections.  Estrogen stimulates vaginal cells to produce glycogen, a type of sugar that is a source of energy for the lactobacilli that live in the vagina without causing any harm.  These lactobacilli keep the pH high and protect against other harmful bacteria.  Without the glycogen-stimulating influence of estrogen, the lactobacilli are replaced by harmful bacteria, which cause infections.  Estrogen also stimulates blood flow, which helps nourish the vaginal tissues.

Vagifem tablets are a topical form of HRT containing estrogen that is absorbed through the skin instead of being taken orally.  Vagifem is used specifically for treating changes that happen in the vaginal tissues after menopause.  It is not a systemic treatment that will help with other menopausal symptoms.

How does Vagifem work?

Vagifem vaginal tablets 10mcg contain estradiol, a naturally occurring estrogen, which is chemically and biologically identical to endogenous (produced by the ovaries) oestradiol.  Estrogen exists in several forms, and estradiol is the primary and most active of the naturally occurring human estrogens.  Vagifem is used as a topical hormone replacement therapy to treat vaginal symptoms of menopausal such as atrophic vaginitis caused by lack of estrogen. 

Oestrogen is a steroid hormone produced by the ovaries that binds to specific receptors inside estrogen-responsive cells.  When the estrogen is locked onto its receptor, it stimulates cells to make proteins involved in developing secondary sexual characteristics, including thickening of the vaginal wall and increasing vaginal secretion.  When Vagifem tablets are inserted into the vagina, estradiol is slowly released and absorbed into the vaginal skin layer, where it reverses changes in the vagina by stimulating thickening of the skin and reducing inflammation.  Vagifem tablets also restore the physiological pH and promote the growth of the “good” bacteria that normally live in the skin.  This increases resistance to infection with other bacteria that cause vaginal or urinary infections.  The restoring effect of Vagifem vaginal tablets reduces symptoms of atrophic vaginitis, which can be maintained with continued use. 

What does Vagifem contain?

Vagifem vaginal tablets contain the active ingredient oestradiol (10 micrograms), used as a topical hormone replacement therapy for atrophic vaginitis.  They also contain hypromellose, lactose monohydrate, maize starch, magnesium stearate, Macrogol 6000.

What are the side effects of Vagifem?

Most medications have some side effects, but they are not experienced by everyone.  Some side effects are commonly experienced when taking Vagifem, but others are not so common, and you should discuss any problems or concerns with your primary care physician. 

Common side effects when taking Vagifem include headache, abdominal pain, vaginal discomfort, discharge and bleeding. 

When should Vagifem not be used?

Have a talk with your primary healthcare physician before taking Vagifem so that you have a full understanding of what this medicine is for and how to use it.  There are some reasons for not taking a medication; these are called contraindications, and for Vagifem you should consider the following before taking Vagifem:

• Have you ever had an unusual reaction or an allergy when taking Vagifem?
• Are you pregnant or breastfeeding?
• Do you have any problems with your liver?
• Have you had an estrogen-dependent cancer such as carcinoma of the breast or endometrial carcinoma?
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with estrogen use
• Have you had any abnormal genital bleeding of unknown cause?
• Do you have porphyria, a condition that affects the skin or nervous system?

How should Vagifem be used and for how long?

Vagifem vaginal tablets 10mcg are intended for topical use only.  Each Vagifem tablet is provided with a disposable applicator.  Insert a single Vagifem tablet into your vagina using the applicator provided.  You should continue to use your Vagifem tablets for as long as recommended by your doctor.  The starting dose is usually one tablet a day, before going to bed, for the first two weeks.  The maintenance dose is one tablet twice a week until your symptoms have improved or as long as your doctor recommends. 

Missed dose of Vagifem

If you miss a dose of Vagifem take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Vagifem be stored?

You should store your Vagifem below 25°C in a cool dry place.