Vaginal atrophy is the name given to the deterioration of vaginal tissues due to loss of oestrogen which happens at the menopause. This occurs in approximately 50% of postmenopausal women. This deterioration of vaginal tissue may cause a dry and uncomfortable feeling which unlike other symptoms of menopause such as hot flushes will not improve on its own and can get worse with time.1,2
Vaginal Atrophy
This reduction in oestrogen can cause Vaginal dryness, pain/burning sensation, or severe itching.3
These symptoms can lead to discomfort during sex, urgency with urination and recurrent urinary tract infections.4,5
The lining of the vagina before menopause
The lining of the vagina after menopause
This diagram is an example of the lining of the vagina before menopause (left side of diagram) and after menopause (right side of diagram).
Vaginal Atrophy
Vaginal atrophy is the name given to the deterioration of vaginal tissues due to loss of oestrogen which happens at the menopause. This occurs in approximately 50% of postmenopausal women. This deterioration of vaginal tissue may cause a dry and uncomfortable feeling which unlike other symptoms of menopause such as hot flushes will not improve on its own and can get worse with time.1,2
This reduction in oestrogen can cause Vaginal dryness, pain/burning sensation, or severe itching.3
These symptoms can lead to discomfort during sex, urgency with urination and recurrent urinary tract infections.4,5
The lining of the vagina before menopause
The lining of the vagina after menopause
This diagram is an example of the lining of the vagina before menopause (left side of diagram) and after menopause (right side of diagram).
How can Vaginal Atrophy affect my life?
Vaginal atrophy can cause a lot of discomfort which can make it uncomfortable to sit, stand and exercise. Some women find it painful to urinate as well as causing pain during sex. This discomfort can make it difficult to go about daily life and some people find it can even affect their work. These symptoms can have a significant impact on a person’s quality of life and can lead to loss in self-confidence and sexual-confidence which may lead to sexual dysfunction disorders.2,6,7
Some signs of sexual dysfunction may include; difficulty in becoming aroused, reduced vaginal lubrication, issues climaxing or achieving orgasm, reduced ability to relax the vaginal muscles leading to sex becoming more difficult.8 As regular sexual activity increases blood flow which can help to maintain healthy vaginal tissues, less frequent sexual activity may lead to poor urinary tract health.6,9
How is vaginal atrophy treated?
Treatments range from over the counter vaginal moisturisers or lubricants which can help improve some symptoms to prescription only medications in the form of a pessary, cream, tablet, ring or gel. One such medication is Imvaggis (estriol) 0.03mg, a low-dose estriol (oestrogen) pessary.1,10,11
Understanding my Imvaggis Treatment
What is Imvaggis?
Imvaggis (estriol) 0.03mg pessary for vaginal atrophy
A low dose, smooth, easy-to-use pessary containing 0.03mg estriol.10
What is Imvaggis used for?
It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause.10
How to use Imvaggis?10
Imvaggis works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina. Always use this medicine exactly as your healthcare professional has told you, if you are not sure you can check with your pharmacist or doctor.
It is best to use Imvaggis in the evening before going to bed. With clean hands simply remove the smooth pessary from the foil packaging and holding the pessary between your index finger and thumb, insert the pessary into the vagina. Once inserted, push the pessary as far as possible into the vagina using your finger.
Recommended dosing schedule
During the first 3 weeks of treatment, one pessary is administered daily (in the evening).
Thereafter, a maintenance dose of one pessary twice a week is recommended.
Possible side effects10, 11
Like all medicines, Imvaggis (estriol) 0.03mg may cause side effects, although not everybody gets them.
If you experience any of the following, stop using Imvaggis and see your doctor immediately:
- Yellowing of your skin or whites of your eyes
- A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
- Migraine-like headaches for the first time
- If you become pregnant
- If you notice signs of a blood clot
- painful swelling and redness of the legs;
- sudden chest pain;
- difficulty in breathing.
Common side effects may include
- Vulvovaginal burning, itching or pain sensation
- Discomfort when urinating
These are often transient and of mild intensity.11
For full information about Imvaggis and possible side effects, please refer to the Patient Information Leaflet
When not to use Imvaggis10
Do not use Imvaggis if any of the following applies to you, if you are not sure about any of the points below, talk to your healthcare professional before using Imvaggis.
- if you have or have had breast cancer, or if you are suspected of having it
- if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (Endometrium), or if you are suspected of having it
- if you have any unexplained vaginal bleeding
- if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
- if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
- if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
- if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
- if you have or have ever had a liver disease and your liver function tests have not returned to normal
- if you have a rare blood problem called “porphyria” which is passed down in families
- if you are allergic to estriol or any of the other ingredients of this product
If any of the above conditions appear for the first time while using Imvaggis, stop using it at once and consult your doctor immediately.
Reporting of side effects10
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this site. You can also report side effects directly via reporting forms and information that can be found at www.hpra.ie or by posting the form to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517 or E-mailing medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.
Reporting Side Effect10
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this site. You can also report side effects directly via reporting forms and information that can be found at www.hpra.ie or by posting the form to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517 or E-mailing medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.
Patient Resources
What is vaginal atrophy?
Vaginal atrophy is the name given to the deterioration of vaginal tissues due to loss of oestrogen which affects approximately 50% of women after the menopause. This may cause a dry and uncomfortable feeling which unlike other symptoms such as hot flushes is unlikely to go away on its own.1,2,7
What are the symptoms of vaginal atrophy?
The most common symptoms of vaginal atrophy include3,4
- Vaginal dryness
- Pain/burning sensation
- Pruritus or severe itching
- Discharge
- Light bleeding after intercourse
- Discomfort with intercourse
- Decreased vaginal lubrication during sexual activity
- Urgency with urination
- Frequent urination
- Recurrent urinary tract infections
- Urinary incontinence
- Shortening and tightening of the vaginal canal
What causes vaginal atrophy?1,7
Vaginal atrophy is caused by the reduction of oestrogen in the body and is a common issue for postmenopausal women.
What is Imvaggis?
Imvaggis is a soft vaginal pessary used in the treatment of vaginal symptoms due to an oestrogen deficiency in postmenopausal women. It contains a low dose of semi-synthetic estriol as the active ingredient. It is the same as the estriol that is produced naturally in the body.10,11
How does Imvaggis work?
Imvaggis is an ultra-low dose oestrogen, it works by replacing the oestrogen which is produced naturally in the body. It is placed into the vagina where it works locally where it is needed.10
How is Imvaggis supplied?
Imvaggis is supplied in a pack with 24 vaginal pessaries. Each pessary is individually wrapped and comes in an aluminium strip of pessaries with tear-off perforations for ease of use. At a maintenance dose of one pessary twice a week, this equates to 12 weeks of use.11
What does 0.03mg mean?
The 0.03mg refers to the amount of estriol in each pessary. Estriol is the active ingredient in Imvaggis that replaces the natural oestrogen produced in the body.10
What is the recommended dose of Imvaggis?
For the treatment of vaginal atrophy, it is recommended to use one pessary daily for the first three weeks and thereafter one pessary twice a week for as long as needed to alleviate symptoms. Your doctor may assess your treatment on an annual basis.10,11
What do I do if I miss a dose of Imvaggis?10
During daily use within the first 3 weeks of treatment:
If you do not realise the missed dose before the next day, you should skip the missed dose. In that case you should continue with the usual dosing schedule.
During twice-weekly use:
If you have forgotten to administer Imvaggis at a scheduled date, please make up for the missed dose as soon as possible.
Why doesn’t Imvaggis have an applicator?
Imvaggis is designed to be inserted into the vagina using a finger.10,11
Is there a discharge after using Imvaggis?
Experiencing vaginal discharge is uncommon. If you do experience some discharge we recommend wearing a panty liner after inserting Imvaggis into the vagina.
What is the source of estriol in Imvaggis?
The active pharmaceutical ingredient estriol is a semi-synthetic substance. For manufacture we use, amongst others, plant-based raw materials (phytosterols), extracted from yam roots (diosgenin) and soy beans (stigmasterol).
How quickly will Imvaggis take to work?
Allow three months for effective symptom control. If you don’t feel your symptoms are improving, please speak to your doctor.3
What is the shelf life of Imvaggis?
Imvaggis has a shelf life of three years.11
How should I store my Imvaggis?
Imvaggis should be stored below 25⁰C.11
How often should treatment with Imvaggis be reviewed?
Once you have started on Imvaggis you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Imvaggis.11
Imvaggis Patient Information Leaflet
References:
Besins Healthcare (UK) Ltd. Imvaggis Patient Information Leaflet. Available from: www.medicines.ie