10 microgram vaginal tablets
estradiol
What Vagidonna is and what it is used for
Vagidonna contains estradiol.
- Estradiol is a female sex hormone.
- It belongs to the group of hormones called estrogens.
- It is identical to the estradiol produced in the woman’s ovaries.
Vagidonna belongs to a group of drugs called hormone replacement therapy ( HRT ) and is for vaginal use.
It is used to relieve discomfort in the genital area associated with menopause, such as dryness or irritation. The medical term for this is “vaginal atrophy”. It is caused by declining estrogen levels in the body, which occurs after the last regular menstrual period ( menopause ).
Vagidonna works by replacing the estrogen that is normally produced in the woman’s ovaries. Vagidonna is inserted into the vagina so that the hormone is released where it is needed. This can relieve discomfort in the vagina.
Experience in the treatment of women older than 65 years is limited.
Estrogen deficiency must be diagnosed by a doctor before first use to ensure the correct diagnosis.
What you need to know before using Vagidonna
Medical background and regular medical check-ups
The use of HRT entails risks that must be taken into account when deciding to start treatment or continue an ongoing treatment. Consult a doctor before starting a treatment or discuss whether you should continue treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries stopped working or because of surgery). If your period has stopped prematurely, the risks of using HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your own and your family’s medical history. The doctor may perform a general medical and gynecological examination, which also includes an examination of the breasts.
When you have started treatment with Vagidonna, you must go for regular medical check-ups, at least once a year. During these checks, you must discuss with the doctor the benefits and risks of continued treatment.
Do regular breast examinations as recommended by your doctor.
Do not use Vagidonna
if any of the following apply to you. If you are unsure about any of the points below, talk to your doctor before using Vagidonna.
Do not use Vagidonna if:
- you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6)
- you have or have had breast cancer or there is a suspicion that you may have it
- you have or have had estrogen-dependent cancer, such as cancer of the lining of the womb (endometrium), or if such cancer is suspected
- you have unexpected abdominal bleeding that has not been investigated by a doctor
- you have severe thickening of the lining of the uterus ( endometrial hyperplasia ) and are not being treated for it
- you have or have had blood clots in a vein (venous thromboembolism ), in the legs (deep vein thrombosis ), or the lungs ( pulmonary embolism )
- you have a coagulation disorder (lack of protein C, protein S, or antithrombin)
- you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina pectoris
- you have or have had any liver disease and still have abnormal liver values
- you have porphyria, a rare inherited blood disorder.
If any of the above affects you for the first time while using Vagidonna, stop using Vagidonna and consult a doctor immediately.
Warnings and precautions
Talk to your doctor if you or have had any of the following problems before starting treatment as these may return or get worse during treatment with Vagidonna. Should this occur, you should have more frequent check-ups with a doctor.
- asthma
- epilepsy
- diabetes
- gallstone disease
- Hypertension
- migraine or severe headache
- liver disease, e.g. benign liver tumor
- endometrial tissue that grows outside the uterus ( endometriosis ) or you have previously had heavy growth of the endometrial lining ( endometrial hyperplasia )
- a disease affecting the eardrum and hearing (otosclerosis)
- the disease of the immune system that attacks many organs in the body (systemic lupus erythematosus, SLE )
- increased risk of getting estrogen-dependent cancer (such as a close relative having breast cancer or another estrogen-dependent cancer)
- increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”)
- muscle knots in the uterus (fibroids)
- hypertriglyceridemia (elevated level of blood fats)
- fluid retention due to heart or kidney disease
- hereditary and acquired angioedema.
You should immediately contact a doctor and stop treatment with Vagidonna
If any of the following occurs:
- you get a migraine-like headache for the first time
- skin or whites of the eyes turn yellow (jaundice); it could be a symptom of liver disease
- your blood pressure rises sharply (symptoms may include headache, tiredness, or dizziness)
- swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, along with difficulty breathing which may indicate angioedema
- any of the things mentioned above in the section “Do not use Vagidonna”
- you get pregnant
- you get symptoms of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties.
For further information see below “Blood clots in a vein ( thrombosis )”.
Please note: Vagidonna is not a contraceptive. If it has been less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Strong thickening of the lining of the uterus ( endometrial hyperplasia ) and cancer of the lining of the uterus (endometrial cancer)
Long-term use of estrogen-only HRT tablets can increase the risk of developing cancer in the lining of the uterus (endometrium).
It is unclear whether there is a similar risk with Vagidonna when used for repeated treatment or long-term treatment (more than a year). However, Vagidonna has been shown to have very low absorption into the blood, so the addition of a progestin is not necessary.
If you experience a breakthrough or spotting, it is usually nothing to worry about, but you should contact your doctor. It could be a sign that your endometrium has thickened.
The following described risks refer to treatment with hormone replacement preparations ( HRT ) that circulate in the blood. However, Vagidonna is for local treatment in the vagina, and absorption into the blood is very small. The conditions mentioned below are less likely to worsen or recur during treatment with Vagidonna, but you should see your doctor if you are concerned.
Breast cancer
Data suggest that the use of Vagidonna does not increase the risk of breast cancer in women who have not had breast cancer before. It is unknown whether Vagidonna can be used safely in women who have had breast cancer in the past.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- indentations or pits
- nipple changes
- lumps you can see or feel.
It is also recommended that you participate in mammography screening when you are called to do so.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Comparison
The risk of ovarian cancer varies with age. For example, the diagnosis of ovarian cancer will be given to around 2 women out of 2,000 aged 50 to 54 who do not take HRT for 5 years. For women who have taken HRT for 5 years, it is about 3 cases per 2000 users (ie about 1 extra case).
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is 1.3-3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
You are more likely to get a blood clot in a vein if you are older and if any of the following apply to you. Tell your doctor if any of these situations apply to you:
- you have not been able to walk for a long time due to a major operation, injury or illness (see also section 3, “If you need an operation”)
- you are severely overweight ( BMI over 30 kg/m 2 )
- you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- if a close relative has had a blood clot in a leg, lung, or another organ
- you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of blood clots are described in the section “You should immediately contact a doctor and stop treatment with Vagidonna if any of the following occur:”.
Comparison
For women in their 50s, who do not take HRT, over a 5-year period an average of 4–7 in 1,000 are expected to have a blood clot in a vein.
For women in their 50s taking estrogen alone for more than 5 years, 5–8 in 1,000 users are expected to develop a blood clot in a vein (ie 1 extra case).
Heart disease (heart attack)
For women taking estrogen alone, there is no increased risk of developing heart disease.
Stroke _
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age dependent, therefore the number of cases of stroke due to the use of HRT increases with increasing age.
Comparison
For women in their 50s who do not take HRT, for over 5 years an average of 8 in 1,000 are expected to have a stroke. For women in their 50s taking HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).
Other conditions
HRT use does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Other medicines and Vagidonna
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines and herbal remedies.
Since Vagidonna is used for local treatment in the vagina, however, it is unlikely that Vagidonna will affect the effect of other drugs. Vagidonna can affect the effectiveness of other treatments given vaginally.
Pregnancy and breastfeeding
Vagidonna is intended for women whose menstruation has stopped. Do not use Vagidonna if you are pregnant. If you become pregnant, stop using Vagidonna and contact your doctor. Do not use Vagidonna during breastfeeding.
Driving ability and use of machinery
How to use Vagidonna
Always use this medicine exactly as described in this leaflet or as directed by your doctor, nurse, or pharmacist. Consult a doctor, nurse, or pharmacist if you are unsure.
Use of this medication
- The treatment with Vagidonna can start on any day.
- For vaginal use only. The vaginal tablet must not be taken by mouth!
- The vaginal tablet is inserted into the vagina with the applicator.
“DIRECTIONS FOR USE” at the end of this leaflet shows how to use Vagidonna. Read the instructions carefully before use.
How much to use
- Use 1 vaginal tablet daily for the first 2 weeks.
- Then use 1 vaginal tablet 2 times a week with 3 or 4 days between each dose.
You must talk to your doctor if you do not feel better or if you feel worse after 2-4 weeks or if other symptoms appear.
General information about the treatment of menopausal symptoms
- When using medicines for menopausal symptoms, it is recommended to use the lowest dose that works and to use the medicine for the shortest possible time.
- Treatment should only be continued if the benefits outweigh the risks. Talk to your doctor about this.
If you have used too much Vagidonna
- If you have used too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
- Vagidonna is intended for local treatment in the vagina. The dose of estradiol is so low that a large number of tablets must be taken to reach the dose normally used in oral treatment.
If you forget to use Vagidonna
- If you forget a dose, take it as soon as you remember.
- Do not take a double dose to make up for a missed dose.
If you stop using Vagidonna
Talk to your doctor if you have questions about how long treatment should last or discuss other treatment options.
If you need surgery
If you are going to have surgery, you must inform the operating doctor that you are using Vagidonna. You may need to stop using Vagidonna for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis ) ” ). Ask the doctor when it is appropriate to start using Vagidonna again.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are more common in women who take HRT drugs that circulate in the blood compared to women who do not take HRT. These risks are less for vaginally administered treatments such as Vagidonna:
- ovarian cancer ( ovarian cancer )
- blood clots in the veins of the legs or lungs (venous thromboembolism)
- stroke
- probable memory loss, if treatment with HRT is started after the age of 65.
See section 2, “What you need to know before using Vagidonna” for more information about these side effects.
Common: may affect up to 1 in 10 users
- headache
- stomach pain
- vaginal bleeding, discharge, or discomfort.
Uncommon: may affect up to 1 in 100 users
- vaginal yeast infection
- nausea
- rash
- weight gain
- hot flush
- Hypertension.
Very rare: may affect up to 1 in 10,000 users
- diarrhea
- fluid accumulation
- worsening of migraines
- general hypersensitivity (eg anaphylactic reaction/shock).
The following side effects have been reported with systemic treatment with estrogen:
- the disease of the gallbladder
- various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful red-purple bumps on the skin (erythema nodosum)
- ring-shaped reddening or ulcerated rash (erythema multiforme).
How to store Vagidonna
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
This medicine may be a risk to the aquatic environment.
Contents of the packaging and other information
Contents declaration
- The active substance is estradiol. Each vaginal tablet contains 10 micrograms of estradiol (as estradiol hemihydrate).
- Other ingredients are hypromellose, lactose monohydrate, corn starch, and magnesium stearate.
- The film coating contains hypromellose and macrogol.
Appearance and packaging size of the medicine
White, round, film-coated vaginal tablets, marked with “E” on one side and plain on the other side.
Package size:
18 vaginal tablets and 1 applicator for multiple uses
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany