10 microgram vaginal
tablet estradiol
What Vagifem is and what it is used for
Vagifem contains estradiol
- Estradiol is a female sex hormone.
- It belongs to the group of hormones known as estrogens.
- It is identical to the estradiol produced in the woman’s ovaries.
Vagifem belongs to a group of drugs called hormone replacement therapy ( HRT ) and is for vaginal use.
Vagifem is used for the local treatment of complaints such as dryness or irritation caused by a lack of estrogen in the vagina in women after the last regular menstrual period ( menopause ).
The estrogen deficiency must first be diagnosed by a doctor to ensure the correct diagnosis.
The medical term for this is vaginal atrophy. It is caused by falling estrogen levels in the body, which occurs after menopause.
Vagifem works by replacing the estrogen that is normally produced in the woman’s ovaries. Vagifem 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. Women over the age of 65 can use Vagifem if this is followed up carefully through medical checks.
What you need to know before using Vagifem
Do not use Vagifem
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.
Once you have started treatment with Vagifem, 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 Vagifem:
if any of the following apply to you. Talk to your doctor before using Vagifem.
Do not use Vagifem if:
- 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
- you are allergic (hypersensitive) to estradiol or any other ingredient in Vagifem (specified in section 6 “Contents of the package and other information”).
If any of the above affects you the first time you use Vagifem, stop using Vagifem and contact your 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 Vagifem. Should this occur, you should have more frequent check-ups with a doctor.
- Asthma.
- Epilepsy.
- Diabetes.
- Gallstone disease.
- High blood pressure.
- Migraine or severe headache.
- Liver disease eg benign 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 hearing (otosclerosis).
- The disease of the immune system 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 other estrogen-dependent cancer).
- Increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”).
- Muscle knots in the uterus.
- 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 Vagifem
if any of the following occurs:
- If you get a migraine-like headache for the first time
- If the skin or whites of the eyes turn yellow (jaundice); it could be a symptom of liver disease
- If you develop swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, along with breathing difficulties which may indicate angioedema
- If your blood pressure rises sharply (symptoms may include headache, tiredness, or dizziness)
- Any of the things mentioned above in the section “Do not use Vagifem”
- If you become pregnant
- If 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: Vagifem 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 Vagifem when used for repeated treatment or long-term treatment (more than a year). However, Vagifem has been shown to have very low absorption into the blood, so the addition of a progestin is not necessary.
If you experience breakthrough bleeding 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, Vagifem 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 Vagifem, but you should see your doctor if you are concerned.
Breast cancer
Data suggest that the use of Vagifem does not increase the risk of breast cancer in women who have not had breast cancer before. It is unknown whether Vagifem 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.
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.
- 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 must immediately contact a doctor and stop treatment with Vagifem 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 Vagifem
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including over-the-counter medicines and herbal medicines. Since Vagifem is used for local treatment in the vagina, however, it is unlikely that Vagifem will affect the effectiveness of other medicines. Vagifem can affect the effectiveness of other treatments given vaginally.
Pregnancy and breastfeeding
Vagifem is intended for women whose menstruation has stopped. Do not use Vagifem if you are pregnant. If you become pregnant, stop using Vagifem and contact your doctor. Do not use Vagifem during breastfeeding.
Driving ability and use of machinery
How to use Vagifem
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
- Treatment with Vagifem can start on any day.
- For vaginal use only. The 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 Vagifem should be used. 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 Vagifem
- 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.
- Vagifem 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 Vagifem
- 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 Vagifem
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 Vagifem. You may need to stop using Vagifem 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 Vagifem 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 Vagifem:
- Ovarian cancer ( ovarian cancer )
- Blood clots in veins in 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 you use Vagifem” for more information about these side effects.
Common: may affect up to 1 in 10 people
- Headache
- Stomach pain
- Vaginal bleeding, discharge, or discomfort.
Uncommon: may affect up to 1 in 100 people
- Fungal infection in the vagina
- Nausea
- Rash
- Weight gain
- Heatwave
- High blood pressure.
Very rare: may affect up to 1 in 10,000 people
- Diarrhea
- Fluid retention
- Worsening of migraines
- General hypersensitivity (eg anaphylactic reaction/shock).
The following side effects have been reported with systemic treatment with estrogen:
- Gallbladder disease
- 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 Vagifem
Keep this medicine out of the sight and reach of children.
Store protected from cold.
Use before the expiry date which is stated on the carton and blister after Ex. Date. 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 10 micrograms (as estradiol hemihydrate). 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 6000.
Appearance and package sizes of the medicine
Each vaginal tablet is in a disposable applicator.
Vagifem is marked NOVO 278 on one side.
Package sizes
18 vaginal tablets with applicator.
Novo Nordisk A/S
Novo Allé
DK-2880 Bag Sword
Denmark