Vagifem Vaginal Tablets: Relief from Postmenopausal Symptoms

Quantity	1 x 24 vaginal tablets, 2 x 24 vaginal tablets

What are Vagifem Vaginal tablets?

Vagifem vaginal tablets are a localized form of Hormone Replacement Therapy (HRT) used to treat symptoms of vaginal atrophy in postmenopausal women. These tablets contain estradiol, a form of the female hormone estrogen, which helps to restore the thinning and drying of the vaginal tissues that occur due to decreased estrogen levels after menopause.

Vagifem is specifically designed for vaginal use, providing targeted relief from symptoms such as dryness, itching, burning, and pain during intercourse. Unlike systemic HRT, Vagifem delivers the hormone directly to the vaginal area, minimizing the amount that enters the bloodstream. This makes it an effective option for women who need relief from vaginal symptoms without the need for broader hormone therapy throughout the body.

What is the active ingredient in Vagifem Vaginal tablets?

Each Vagifem vaginal tablet contains the same active ingredient: 10 micrograms of estradiol hemihydrate.

What are Vagifem Vaginal tablets used for?

Vagifem is a type of vaginal Hormone Replacement Therapy (HRT) used to alleviate menopausal symptoms in the vagina, such as dryness and irritation, a condition known as 'vaginal atrophy.' This occurs naturally after menopause due to a decrease in oestrogen levels in the body.

Vagifem works by replenishing the oestrogen that is typically produced by the ovaries. The tablet is inserted directly into the vagina, allowing the hormone to be released exactly where it is needed, which can help relieve vaginal discomfort. The experience of using Vagifem in women over 65 is limited.

How do Vagifem Vaginal tablets work?

Vagifem vaginal tablets work by delivering a small dose of oestrogen directly to the vaginal tissues. During menopause, the body produces less oestrogen, which can lead to thinning, drying, and inflammation of the vaginal walls—a condition known as vaginal atrophy.

When you insert a Vagifem tablet into the vagina, it releases oestrogen locally. This helps to restore the normal thickness and moisture of the vaginal tissue, alleviating symptoms like dryness, irritation, and discomfort. By targeting the affected area directly, Vagifem provides effective relief with minimal systemic absorption of the hormone into the bloodstream.

How do you use Vagifem Vaginal tablets?

Always use this medicine exactly as your doctor has instructed. If you are unsure, check with your doctor or pharmacist.

Using this medicine:

You can start using Vagifem on any day that suits you.
Insert the vaginal tablet using the applicator provided.
Refer to the ‘USER INSTRUCTIONS’ at the end of the leaflet for detailed guidance. Be sure to read these instructions carefully before using Vagifem.

Dosage:

Use one vaginal tablet daily for the first 2 weeks.
After that, use one vaginal tablet twice a week, with 3 or 4 days between each dose.

General information about treating menopausal symptoms:

For OTC products: It’s recommended to use the lowest effective dose for the shortest time necessary.
For prescription-only products: Your doctor will prescribe the lowest dose of Vagifem® to manage your symptoms for the shortest duration needed. If you feel the dose is too strong or too weak, discuss this with your doctor.
Treatment should continue only if the benefits outweigh the risks. Regularly discuss this with your doctor.

If you use more Vagifem than you should:

If you have used more Vagifem than recommended, consult a doctor or pharmacist.
Vagifem is intended for local vaginal treatment, and the dose of estradiol is low. A significant number of tablets would need to be taken to reach a dose similar to that used in oral treatments.

If you forget to use Vagifem:

Use the missed dose as soon as you remember.
Do not use a double dose to make up for a missed one.

If you stop using Vagifem: Do not discontinue Vagifem without consulting your doctor. Your doctor will inform you of the potential effects of stopping the treatment and discuss alternative treatment options with you.

If you need to have surgery: If you are scheduled for surgery, inform the surgeon that you are using Vagifem. You may need to stop using Vagifem about 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, ‘Blood clots in a vein’). Your doctor will advise you on when it is safe to resume using Vagifem.

If you have any additional questions about using this medicine, consult your doctor or pharmacist.

Who should not use Vagifem Vaginal tablets?

Medical History and Regular Check-Ups

Hormone Replacement Therapy (HRT) like Vagifem® comes with certain risks that need to be carefully considered before deciding whether to start or continue treatment. The risks may differ if you experience premature menopause due to ovarian failure or surgery. Please consult your doctor to understand these risks better.

Before beginning (or resuming) HRT, your doctor will ask about your personal and family medical history and may conduct a physical examination, which could include a breast and/or internal examination if necessary. Once you begin using Vagifem®, it's important to have regular check-ups with your doctor at least once a year. During these visits, discuss the benefits and risks of continuing Vagifem®. You should also follow your doctor's recommendations for regular breast screenings.

Do Not Use Vagifem® If:

You are allergic to estradiol or any other ingredients in Vagifem®, please refer to the patient information leaflet.
You have or have ever had breast cancer, or are suspected of having it.
You have or have ever had cancer sensitive to oestrogens, such as cancer of the womb lining (endometrium), or are suspected of having it.
You have any unexplained vaginal bleeding.
You have untreated excessive thickening of the womb lining (endometrial hyperplasia).
You have or have ever had a blood clot in a vein (such as deep venous thrombosis in the legs or pulmonary embolism in the lungs).
You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
You have or recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina.
You have or have ever 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 these conditions appear for the first time while using Vagifem®, stop using it immediately and consult your doctor.

Warnings and Precautions

Before starting Vagifem®, inform your doctor if you have or have had any of the following conditions, as they may return or worsen during treatment:

Asthma
Epilepsy
Diabetes
Gallstones
High blood pressure
Migraines or severe headaches
Liver disorders, such as benign liver tumors
Endometriosis or a history of excessive growth of the womb lining (endometrial hyperplasia)
Otosclerosis (a condition affecting the eardrum and hearing)
Systemic lupus erythematosus (SLE), an autoimmune disease affecting multiple organs
A family history of oestrogen-sensitive cancer (e.g., breast cancer)
An increased risk of developing blood clots (see ‘Blood clots in a vein (thrombosis)’)
Fibroids in the womb
High triglycerides (a type of fat in the blood)
Fluid retention due to heart or kidney problems
Hereditary or acquired angioedema

Stop Using Vagifem® and Seek Immediate Medical Attention If:

You experience migraine-like headaches for the first time
Your skin or the whites of your eyes turn yellow (jaundice), which could indicate liver disease
You have swelling of the face, tongue, and/or throat, difficulty swallowing, or hives, along with difficulty breathing (suggestive of angioedema)
You notice a significant rise in blood pressure (symptoms may include headache, tiredness, dizziness)
Any of the conditions listed in the ‘Do Not Use Vagifem®’ section occur
You become pregnant
You notice signs of a blood clot, such as:
- Painful swelling and redness of the legs
- Sudden chest pain
- Difficulty breathing

For more information, refer to the section on ‘Blood clots in a vein (thrombosis)’.

Note: Vagifem® is not a contraceptive. If it has been less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Consult your doctor for advice.

HRT and Cancer

Endometrial Hyperplasia and Endometrial Cancer Using oestrogen-only HRT tablets for an extended period can increase the risk of developing cancer of the womb lining (endometrial cancer). While it is unclear whether this risk applies to Vagifem® with long-term use (more than one year), the absorption of Vagifem® into the bloodstream is very low. Therefore, adding a progestagen is generally not necessary. If you experience breakthrough bleeding or spotting, it’s typically harmless but should be checked by your doctor to rule out thickening of the womb lining.

Breast Cancer Current evidence suggests that using Vagifem® does not increase the risk of breast cancer in women who have never had the disease. However, it is not known if Vagifem® is safe for use in women with a history of breast cancer. Regularly check your breasts and report any changes, such as dimpling, nipple changes, or lumps, to your doctor. Also, participate in mammography screenings as recommended.

Ovarian Cancer Ovarian cancer is rare but has been slightly associated with the use of oestrogen-only HRT. For example, among women aged 50 to 54 who do not take HRT, about 2 in 2,000 will be diagnosed with ovarian cancer over a five-year period. For those taking HRT for five years, there are about 3 cases per 2,000 users.

HRT and Cardiovascular Health

Blood Clots (Thrombosis) The risk of blood clots in veins is about 1.3 to 3 times higher in HRT users than non-users, especially during the first year. Blood clots can be serious and potentially life-threatening if they travel to the lungs. Your risk of developing a clot increases with age and if you have factors such as prolonged immobility, obesity, blood clotting disorders, a family history of clots, systemic lupus erythematosus (SLE), or cancer. If you notice symptoms of a blood clot, such as leg swelling and redness, chest pain, or difficulty breathing, stop using Vagifem® and seek medical attention immediately.

Heart Disease There is no increased risk of heart disease for women taking oestrogen-only HRT.

Stroke The risk of stroke is about 1.5 times higher in HRT users compared to non-users. The risk increases with age. For example, among women in their 50s who do not take HRT, about 8 in 1,000 might experience a stroke over five years. For those taking HRT, this increases to about 11 cases per 1,000 over five years.

Other Considerations

Memory Loss HRT does not prevent memory loss. Some evidence suggests a higher risk of memory loss in women who start HRT after age 65. Consult your doctor for advice.

Pregnancy and Breastfeeding

Vagifem® is intended for use only in postmenopausal women. If you become pregnant, discontinue use and consult your doctor.

Driving and Using Machines

Vagifem® has no known effects on your ability to drive or operate machinery.

What are the side effects with Vagifem Vaginal tablets?

Like all medicines, Vagifem® can cause side effects, although not everyone will experience them. The following conditions are reported more frequently in women using HRT medicines that circulate in the blood, compared to those not using HRT. However, these risks are less relevant to 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 age 65

Common side effects (may affect up to 1 in 10 people):

Headache
Stomach pain
Vaginal bleeding, discharge, or discomfort

Uncommon side effects (may affect up to 1 in 100 people):

Fungal infection of the genitals
Nausea
Rash
Weight gain
Hot flushes
High blood pressure

Very rare side effects (may affect up to 1 in 10,000 people):

Diarrhoea
Fluid retention
Worsening of migraines
Generalized hypersensitivity reactions (e.g., anaphylactic reaction/shock)

The following side effects have been reported with systemic oestrogen treatments:

Gallbladder disease
Various skin disorders, including:
- Discoloration of the skin, particularly on the face or neck (known as ‘pregnancy patches’ or chloasma)
- Painful reddish skin nodules (erythema nodosum)
- Rash with target-shaped reddening or sores (erythema multiforme)

Reporting of side effects If you experience any side effects, speak to your doctor or pharmacist, including any that are not listed in this leaflet. You can also report side effects directly through the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. Reporting side effects can help provide more information on the safety of this medicine.

Do Vagifem Vaginal tablets interact with other medicines?

Please inform your doctor or pharmacist if you are currently using or have recently used any other medications, including over-the-counter medicines, herbal remedies, or natural products. Since Vagifem® is used locally in the vagina, it is unlikely to interact with other medications, but it may affect other treatments applied vaginally.

Vagifem Vaginal tablets FAQs

What is Vagifem?

Vagifem vaginal tablets are a type of hormone replacement therapy (HRT) used to treat menopausal symptoms, specifically vaginal dryness and discomfort. Vagifem contains estradiol, a form of oestrogen that mimics the natural hormone produced by the ovaries.

During menopause, oestrogen levels drop, leading to symptoms like hot flushes, night sweats, mood swings, and vaginal dryness. Vagifem is inserted directly into the vagina, delivering oestrogen exactly where it is needed, making it an effective treatment for vaginal issues such as dryness, irritation, pain, and urinary problems, without addressing other menopausal symptoms.

What is Vagifem used for?

Vagifem is used to treat changes in and around the vagina during and after menopause, including:

Vaginal dryness
Vaginal irritation
Itching
Urination problems
Pain during urination
Vaginal pain and discomfort during intercourse
Possible bleeding during intercourse

These symptoms are caused by reduced oestrogen levels, and Vagifem helps to replenish oestrogen in the vagina, directly relieving these symptoms, which are known as “vaginal atrophy.”

How does Vagifem work?

Vagifem works by restoring oestrogen levels in the body. During menopause, oestrogen production naturally decreases, leading to various symptoms. Since Vagifem is inserted into the vagina, the oestrogen is absorbed directly where it’s needed, effectively relieving vaginal discomfort, dryness, and other related symptoms.

What are the benefits of Vagifem?

Vagifem offers similar benefits to other topical vaginal treatments like creams or vaginal rings for menopause. These treatments quickly and effectively reduce vaginal and urinary symptoms to the same extent as oral HRT but without the same increased risks. Because Vagifem is applied directly in the vagina, a smaller dose of oestrogen is needed, reducing the likelihood of side effects.

Is Vagifem safe?

Vagifem has been used worldwide since 1999 to treat millions of women with menopausal symptoms. Its safety and effectiveness have been widely researched. However, like all HRTs, Vagifem may cause side effects and may not be suitable for everyone. It’s important to discuss potential risks and side effects with your doctor.

Does Vagifem cause weight loss or weight gain?

There is no strong evidence linking Vagifem to weight loss or weight gain. However, some women have reported weight gain while using it. This could be due to fluid retention, which often resolves within the first three months of use. Weight changes during menopause are common, regardless of HRT use, due to lower oestrogen levels and natural ageing processes. Regular exercise and a healthy diet are recommended to manage weight.

What are alternatives to Vagifem?

Alternatives to Vagifem include other forms of localised oestrogen treatments like creams, gels, or vaginal rings. Vagirux pessaries are another option with the same active ingredient as Vagifem. Vaginal lubricants like Sylk or Replens MD can also be used alongside Vagifem to reduce discomfort during daily activities and sex.

How should Vagifem be used?

Vagifem should be used as follows:

Insert 1 vaginal tablet daily for the first 2 weeks.
After the initial 2 weeks, use 1 tablet twice a week, with 3-4 days between each dose.

Vagifem is for vaginal use only and should not be taken orally. Each tablet is pre-inserted into a single-use applicator. Detailed instructions on how to insert Vagifem can be found in the Patient Information Leaflet.

Can you use Vagifem more than twice a week?

No, Vagifem should only be used as directed. After the first 2 weeks of daily use, you should only insert 1 tablet twice a week. If you don’t find Vagifem effective, consult your doctor rather than increasing the dosage on your own.

How do I stop taking Vagifem?

If you wish to stop using Vagifem, consult your doctor first. They will explain the effects of stopping the treatment and discuss other possible treatment options.

What are the ingredients in Vagifem?

Each Vagifem vaginal tablet contains 10 micrograms of estradiol hemihydrate. Inactive ingredients include hypromellose, lactose monohydrate, maize starch, magnesium stearate, and the film coating contains hypromellose and macrogol 6000.

What are the possible side effects of Vagifem?

Common side effects of Vagifem include:

Headaches
Stomach pain
Vaginal bleeding, discharge, or discomfort
Vaginal thrush
Rash
Weight gain or fluid retention
Hot flushes
High blood pressure

If you experience severe side effects or allergic reactions, seek medical help immediately. For more details, refer to the Patient Information Leaflet.

Are there any warnings I should be aware of before using Vagifem?

You should not use Vagifem if you have unexplained vaginal bleeding, endometrial hyperplasia, liver disease, breast cancer, or other oestrogen-sensitive cancers, or if you have ever had blood clots. Discuss any health conditions or concerns with your doctor before starting Vagifem, and have regular check-ups to monitor your health while using this treatment.

Does Vagifem increase the risk of cancer?

While oral oestrogen-only HRT can increase the risk of certain cancers, the low absorption rate of Vagifem makes it less likely to cause cancer. However, you should consult your doctor immediately if you experience unusual vaginal bleeding or other concerning symptoms.

Can Vagifem cause blood clots?

Like other HRTs, Vagifem may slightly increase the risk of blood clots. Speak to your doctor if you are at a higher risk for blood clots due to factors like immobility, high BMI, or family history.

Can I use Vagifem if I am pregnant or breastfeeding?

Vagifem is intended for postmenopausal women and is not a contraceptive. If you become pregnant while using Vagifem, stop using it and consult your doctor. Vagifem should not be used while breastfeeding

Download patient leaflet

https://www.medicines.org.uk/emc/files/pil.5719.pdf