Vagifem 10 micrograms coated vaginal tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Vagifem 10 micrograms vaginal coated tablets
estradiol
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4, “Possible adverse effects.”
Contents of the leaflet
- What Vagifem is and what it is used for
- What you need to know before using Vagifem
- How to use Vagifem
- Possible adverse effects
- How to store Vagifem
- Contents of the pack and other information
1. 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 called estrogens.
- It is identical to the estradiol naturally produced in women's ovaries.
Vagifem belongs to a group of medicines called vaginal Hormone Replacement Therapy (HRT).
It is used to relieve menopausal vaginal symptoms such as dryness or irritation. Medically, this is known as "vaginal atrophy." It is caused by a decrease in estrogen levels in your body, which occurs naturally during menopause.
Vagifem works by replacing the estrogen normally produced in women's ovaries. It is inserted into the vagina so that the hormone is released where it is needed. This can relieve vaginal discomfort.
Experience with treatment in women over 65 years of age is limited.
2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE VAGIFEM
Medical history and regular check-ups
The use of HRT carries risks that must be considered when deciding whether to start or continue treatment.
Experience with treating women with premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of using HRT may differ.
Before starting (or restarting) Vagifem, your doctor will ask about your medical history and that of your family. Your doctor may decide to carry out a physical examination, which may include a breast and/or internal examination, if necessary.
Once you have started taking Vagifem, you should visit your doctor for regular check-ups at least once a year. During these visits, discuss with your doctor the benefits and risks of continuing Vagifem.
Attend regular breast examinations as recommended by your doctor.
Do not use Vagifem:
If any of the following apply to you. If you are unsure about any of these points, consult your doctor before taking Vagifem.
Do not use Vagifem if:
- you are allergic (hypersensitive) to estradiol or to any of the other ingredients of Vagifem (listed in section 6 “Contents of the pack and other information”)
- you have or have had breast cancer, or suspect you may have it
- you have or have had estrogen-dependent cancer, such as cancer of the lining of the uterus (endometrium), or suspect you may have it
- you have abnormal vaginal bleeding
- you have excessive growth of the cells lining the uterus (endometrial hyperplasia) that is not being treated
- you have or have had blood clots in a vein (venous thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)
- you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
- you have or have previously had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina pectoris
- you have or have had liver disease and your liver function tests have not returned to normal
- you have a rare inherited blood disorder called “porphyria”
If any of the above conditions occur for the first time while you are using Vagifem, stop treatment immediately and consult your doctor without delay.
Warnings and precautions
Consult your doctor if you have or have previously had any of the following conditions, as they may return or worsen during treatment with Vagifem. If so, you should see your doctor more frequently for medical examinations.
- Asthma
- Epilepsy
- Diabetes
- Gallstones (gallbladder stones)
- High blood pressure
- Migraine or severe headaches
- Liver disorders, including benign liver tumours
- Thickening of the cells lining the uterus (endometriosis) or history of excessive thickening of the uterine lining (endometrial hyperplasia)
- A disease affecting the eardrum and middle ear (otosclerosis)
- A systemic autoimmune disease affecting multiple organs (systemic lupus erythematosus, SLE)
- High risk of developing estrogen-dependent cancer (e.g., having a mother, sister, or grandmother who had breast cancer)
- High risk of developing blood clots (see “Blood clots in veins (thrombosis)”)
- Uterine fibroids
- High levels of fat in the blood (triglycerides)
- Fluid retention due to heart or kidney problems
- Hereditary or acquired angioedema
Stop treatment with Vagifem and see your doctor immediately
If you experience any of the following while using HRT:
- first occurrence of migraine-type headache
- yellowing of the skin or whites of the eyes (jaundice), which may be a sign of liver disease
- swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives together with difficulty breathing, which are symptoms of angioedema
- a large increase in your blood pressure (symptoms may include headache, fatigue, and dizziness)
- any of the conditions listed in the section “Do not use Vagifem” above
- if you become pregnant
- if you notice signs of a blood clot, such as:
- swelling, pain, and redness in the legs
- sudden chest pain
- difficulty breathing
For more information, see “Blood clots in veins (thrombosis)”.
Note: Vagifem is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need to use additional contraceptive methods to prevent pregnancy. Consult your doctor for advice.
HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Long-term use of oral HRT containing estrogens alone may increase the risk of developing cancer of the uterine lining (endometrium).
It is unclear whether a similar risk exists with Vagifem when used repeatedly or long-term (more than one year). However, Vagifem has been shown to have very low systemic absorption, and therefore, the addition of a progestogen is not necessary.
It is not usually a cause for concern if you experience bleeding or spotting, but you should consult your doctor. It could be a sign of endometrial thickening.
The following risks apply to systemic hormone replacement therapy (HRT) that circulates in the blood. However, Vagifem is used for local vaginal treatment and systemic absorption is very low. It is less likely that the conditions mentioned below will worsen or reappear during treatment with Vagifem, but you should consult your doctor if you are concerned.
Breast cancer
Available data indicate that using Vagifem does not increase the risk of breast cancer in women who have not previously had breast cancer. It is not known whether Vagifem can be used safely in women who have had breast cancer in the past.
Examine your breasts regularly. See your doctor if you notice any changes such as:
- indentations or dimpling of the skin
- changes in the nipple
- any lump that you can see or feel
In addition, it is advisable to participate in breast screening programs when offered.
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, in women aged 50 to 54 who do not take HRT, about 2 out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. In women who have been taking HRT for 5 years, there will be approximately 3 cases per 2,000 users (i.e., about 1 additional case).
Effect of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of venous blood clots is approximately 1.3 to 3 times higher in women using HRT compared to non-users, especially during the first year of treatment.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.
Your risk of developing blood clots increases with age and if any of the following apply to you. Inform your doctor if you have any of the following:
- you are unable to walk for long periods due to major surgery, injury, or illness (see also section 3 if you are undergoing surgery)
- you are significantly overweight (BMI >30 kg/m²)
- you have a blood clotting disorder requiring long-term treatment with anticoagulant medication
- a close family member has ever had a blood clot in the legs, lungs, or other organs
- you have systemic lupus erythematosus (SLE)
- you have cancer
If you suspect signs of blood clots, see “Stop treatment with Vagifem and see your doctor immediately”.
Comparison
In women in their fifties who are not taking HRT, an average of 4 to 7 out of 1,000 will experience a venous blood clot over a 5-year period.
In women in their fifties who have been taking estrogen-only HRT for more than 5 years, the number will be 5 to 8 out of 1,000 users (i.e., one additional case).
Heart disease (heart attack)
There is no increased risk of heart disease in women taking estrogen-only HRT.
Stroke
The risk of stroke is approximately 1.5 times higher in women using HRT compared to non-users. The number of additional stroke cases due to HRT use increases with age.
Comparison
In women in their fifties who do not take HRT, an average of 8 out of 1,000 will have a stroke over a 5-year period.
In women in their fifties who take HRT, there will be 11 cases per 1,000 users over 5 years (up to 3 additional cases).
Other conditions
HRT does not prevent memory loss. The risk of possible memory impairment may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Use of Vagifem with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including over-the-counter, herbal, or natural products. However, Vagifem is used for local vaginal treatment and is unlikely to affect other medicines. Vagifem may affect other treatments applied vaginally.
Fertility, pregnancy, and lactation
Vagifem is intended for use in postmenopausal women. If you become pregnant, stop using Vagifem and contact your doctor immediately.
Driving and using machines
Not known.
3. HOW TO USE VAGIFEM
Follow exactly the instructions for administering the medicine as given by your doctor.
Consult your doctor or pharmacist if you have any doubts.
Use of the medicine
- You may start using Vagifem on whichever day is most convenient for you.
- Insert the vaginal tablet into your vagina using the applicator.
Instructions on how to do this are provided in the section “DIRECTIONS FOR USE” at the end of this leaflet. Read the instructions carefully before using Vagifem.
Frequency of use
- Apply one vaginal tablet daily for the first two weeks.
- Afterwards, apply one vaginal tablet twice a week. There should be an interval of 3 or 4 days between each application.
General information about the treatment of menopausal symptoms
- Your doctor should prescribe the lowest effective dose of Vagifem needed to treat your symptoms for the necessary duration. Consult your doctor if you think this dose is too strong or not strong enough.
- Treatment should only be continued if the benefit outweighs the risk. Discuss this with your doctor.
If you use more Vagifem than you should
- If you have used more Vagifem than you should have, consult your doctor or pharmacist.
- Vagifem is used for local treatment inside the vagina. The dose of estradiol is so low that a considerable number of tablets would need to be used to reach the dose normally used for oral treatment.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount used.
If you forget to use Vagifem
- If you forget a dose, use the medicine as soon as you remember.
- Do not use a double dose to make up for forgotten doses.
If you stop using Vagifem
Do not stop treatment with Vagifem without consulting your doctor. Your doctor will explain the effects of stopping treatment and will discuss other treatment options with you.
If you are scheduled for surgery
If you are due to undergo surgery, inform the surgeon that you are taking Vagifem. You may need to stop taking Vagifem 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, “Blood clots in a vein”). Ask your doctor when you can start taking Vagifem again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following conditions are observed more frequently in women using systemic hormone replacement therapy (HRT) that circulates in the blood, compared to women who do not use HRT. These risks are less associated with treatments administered vaginally, such as Vagifem:
- Ovarian cancer;
- Blood clots in the veins of the legs or lungs (venous thromboembolism);
- Stroke;
- Possible memory loss if HRT is started after the age of 65.
For further information on these side effects, see section 2, “What you need to know before you start using Vagifem”.
Common: may affect up to 1 in 10 people
- Headache
- Stomach pain
- Vaginal bleeding, discharge, or vaginal discomfort
Uncommon: may affect up to 1 in 100 people
- Fungal genital infection
- Dizziness (nausea)
- Skin rash
- Weight gain
- Hot flushes
- Hypertension
Frequency not known (cannot be estimated from available data) · Diarrhea
- Fluid retention
- Worsening of migraine
- Generalized hypersensitivity (e.g., allergic reaction or anaphylactic shock)
- Difficulty sleeping
- Vaginal and genital itching
- Itching
- Urticaria
- Allergic reaction at the application site, such as genital rash
- Injury related to the applicator
- Medication does not work
- Breast cancer
- Endometrial cancer
- Deep vein thrombosis
- Endometrial hyperplasia
- Vulvovaginal pain
- Reaction at the application site
The following adverse effects have been reported with systemic estrogen therapy:
- Gallbladder disease
- Various skin disorders
- Skin discolouration, especially on the face or neck, known as
“pregnancy mask” (chloasma)
- Painful red nodules on the skin (erythema nodosum)
- Skin rashes with red inflamed areas or sores (erythema multiforme).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.
You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VAGIFEM
Keep this medicine out of the sight and reach of children.
Do not refrigerate.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated after EXP.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vagifem
The active substance is estradiol 10 micrograms (as estradiol hemihydrate). Each vaginal tablet contains 10 micrograms of estradiol (as estradiol hemihydrate).
The other components are: hypromellose, lactose monohydrate, corn starch, and magnesium stearate.
The coating contains: hypromellose and macrogol 6000.
Appearance of the medicine and contents of the pack
Each white vaginal tablet comes in a single-use applicator.
Vagifem is marked with NOVO 278 on one side.
Pack sizes:
18 vaginal tablets with applicator
24 vaginal tablets with applicator
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Isdin S.A.
Provençals 33
Barcelona 08019
Spain
Manufacturer:
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd
Denmark
Date of the most recent revision of this leaflet: March 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/
DIRECTIONS FOR USE
How to use Vagifem
- Separate one individual blister from the pack.
Open it at the end as shown in the illustration.
- Carefully insert the applicator into the vagina.
Stop when you feel slight resistance (8-10 cm).
- To release the tablet, gently press the plunger until you hear a "click".
The tablet is immediately attached to the vaginal wall.
The tablet will not fall out even if you stand up or walk.
- Remove the applicator and discard it.