Vagifem Pessaries

Generic Name: Oestradiol
Product Name: Vagifem Pessaries

Indication: What Vagifem is used for

Vagifem is used to treat atrophic vaginitis due to oestrogen deficiency in women after menopause. Symptoms include dryness, itchiness and pain during sexual intercourse.

Action: How Vagifem works

Vagifem is a form of hormone replacement therapy. After a woman experiences menopause, it is quite common for her hormone levels to decrease significantly. One important hormone is oestrogen. A reduction in the levels of oestrogen after menopause can cause some vaginal changes, which may cause symptoms such as dryness, itchiness and pain during sexual intercourse.

Vagifem works by releasing a hormone called oestradiol, which is a special form of oestrogen. It therefore acts to restore the levels of oestrogen in the vagina, enhancing the moisture of the vagina and relieving the discomfort of vaginal symptoms experienced after menopause.

Dose advice: How to use Vagifem

This medication can only be obtained with a prescription from the doctor.

Contraindications

Vagifem should not be used by women with certain medical conditions. Tell your doctor if you have:

• Past history of, suspected or known breast cancer, or other oestrogen-dependent cancer (e.g. endometrial cancer);
• Unexplained and abnormal genital bleeding;
• Pregnancy or suspected pregnancy;
• Current or past thromboembolic disorder;
• Current or recent arterial thromboembolic disease (e.g. angina, heart attack);
• Current or past liver disease;
• Abnormal LFTs;
• Porphyria;
• Known hypersensitivity to the ingredients.

Precautions

Certain conditions require special consideration before and while taking this medication. Tell your doctor if you are taking any other medications or have any medical conditions, especially the following:

• Strong family history of breast cancer;
• Breast nodules;
• Uterine fibroids;
• Endometriosis;
• Cholelithiasis;
• Thrombophlebitis;
• Current or past cerebral vascular accident;
• Sickle cell anaemia;
• Epilepsy;
• Migraine or severe headaches;
• Diabetes mellitus;
• Asthma;
• Heart, kidney, liver or blood problems;
• High blood pressure;
• Systemic lupus erythematosus (SLE);
• History of endometrial hyperplasia;
• Otosclerosis.

Pregnancy

Vagifem is a Pregnancy Category B3 medication. It is contraindicated during pregnancy. If pregnancy occurs during use, treatment should be stopped immediately.

Breastfeeding

Women who are breastfeeding should not use this medication.

Dose information

Your doctor will prescribe an appropriate dose for you. The usual dose of Vagifem is:

• Initial dose: One pessary daily for two weeks.
• Maintenance dose: One pessary twice a week.

Treatment can be started anytime. Your doctor will tell you how long to use this medication and will monitor your condition with regular check-ups.

What to do if you miss a dose

In the case of a missed dose:

• Insert Vagifem as soon as you remember.
• Do not double the dose to make up for the missed dose.

How to use it

Vagifem is intended for intravaginal use only. The correct method on how to use it is as follows:

1. Wash and clean your hands, then remove the applicator from its individual casing.
2. Position yourself in a comfortable way. Insert the applicator with the pessary end first into your vagina as far as it can go.
3. Firmly press the end of the applicator. There will be a click sound as the pessary is released.
4. Withdraw the applicator and dispose of it.

If you have any questions about the correct way to use the pessary, please ask your healthcare professional. It may take up to two weeks for treatment results to show.

Storage

Vagifem should be stored in the original box in a dark, dry place, below 25°C. Do not refrigerate Vagifem.

Schedule of Vagifem

Vagifem is a Schedule 4 medication.

Side effects of Vagifem

Common side effects

All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on this medication.

Common side effects are those that occur in 1–10% of people using Vagifem. These include:

• Vaginal discharge, discomfort or bleeding;
• Genital candidiasis or vaginitis;
• Headache;
• Nausea and vomiting;
• Abdominal pain, distension or discomfort;
• Dyspepsia;
• Flatulence;
• Breast oedema, enlargement, pain or tenderness;
• Peripheral oedema.

Uncommon side effects

Side effects that occur in less than 1% of people given Vagifem are considered uncommon. People do not necessarily experience any of these side effects, so do not become alarmed by this list:

• Vaginal discharge, discomfort or bleeding;
• Genital candidiasis or vaginitis;
• Headache;
• Nausea and vomiting;
• Abdominal pain, distension or discomfort;
• Indigestion;
• Flatulence;
• Breast swelling, enlargement, pain or tenderness;
• Peripheral oedema.

If you experience any of the listed side effects, or any other symptoms that appear abnormal or unusual, please tell your doctor.

References

1. Australian Medicines Handbook. Adelaide: Pharmaceutical Society of Australia; 2007.
2. MIMS Online. Product Information: Vagifem pessaries [online]. UBM Medica; 17 September 2009 [cited 29 June 2010]. Available from: [URL Link]

For further information talk to your doctor.