Vagifem Tablets

What is Vagifem?

Vagifem® is a local vaginal hormone replacement therapy (HRT) containing estradiol, which is a female sex hormone belonging to the oestrogen group. The estradiol in Vagifem is identical to the natural estradiol produced by women's ovaries, making it a bioidentical hormone treatment.

Mechanism of Action

Vagifem works through a targeted local action in the vaginal tissues. When inserted into the vagina using the provided applicator, the tablet dissolves and releases estradiol directly to the vaginal walls. This local delivery system ensures that the hormone acts primarily where it's needed, with minimal systemic absorption into the bloodstream.

Biological Pathway: Oestrogen receptors in vaginal tissues bind with the estradiol, promoting cellular regeneration and increasing blood flow to the area. This helps restore the natural thickness, elasticity, and moisture-producing capability of vaginal tissues that typically diminishes after menopause due to declining oestrogen levels.

Analogy: Think of Vagifem like a moisturising treatment applied directly to dry skin, rather than drinking water to hydrate your whole body. It delivers the hormone exactly where it's needed most - to the vaginal tissues - without significantly affecting other parts of the body.

What is Vagifem Used For?

Vagifem is specifically approved for the treatment of menopausal symptoms affecting the vagina, medically known as vulvovaginal atrophy or atrophic vaginitis. These symptoms result from the natural decline in oestrogen levels that occurs during and after menopause.

Approved Indications

• Vaginal dryness - Lack of natural lubrication causing discomfort
• Vaginal irritation and itching - Often described as a burning sensation
• Dyspareunia - Pain during sexual intercourse
• Vaginal discomfort - General soreness or feeling of pressure
• Urinary symptoms - Sometimes associated with vaginal atrophy, such as increased frequency or urgency

Target Patient Populations

Vagifem is indicated for postmenopausal women experiencing symptoms of vaginal atrophy. The experience in treating women older than 65 years is limited according to the manufacturer's information.

It may also be considered for women with premature menopause (due to ovarian failure or surgery), though the experience in this population is limited and risks may differ.

Before Using Vagifem

Before starting or restarting Vagifem, a comprehensive medical assessment is essential to ensure the benefits outweigh the risks for your individual situation.

Medical History Assessment Checklist

Your doctor will review:

• Personal and family history of cancer (especially breast, endometrial, ovarian)
• History of blood clots (thrombosis) or clotting disorders
• Liver disease or abnormal liver function tests
• Unexplained vaginal bleeding
• Endometriosis or endometrial hyperplasia
• Cardiovascular conditions (heart disease, stroke, hypertension)
• Diabetes
• Gallbladder disease
• Migraines or severe headaches
• Systemic lupus erythematosus (SLE)
• Porphyria (rare blood disorder)
• Asthma, epilepsy, or other chronic conditions

Required Baseline Tests

• Physical examination including breast examination if indicated
• Blood pressure measurement
• Recent mammogram if appropriate for age/screening schedule
• Liver function tests if there's a history of liver disease
• Endometrial assessment if there's unexplained bleeding or risk factors for endometrial pathology

Pre-treatment Evaluations

Your doctor will:

1. Assess whether your symptoms are truly related to vaginal atrophy
2. Rule out other causes of vaginal symptoms (infections, other pathologies)
3. Determine if local vaginal treatment is more appropriate than systemic HRT
4. Discuss the expected benefits versus potential risks
5. Establish a plan for regular follow-up (at least annually)

Vagifem Contraindications

Absolute Contraindications (DO NOT USE)

Vagifem must not be used if any of the following apply:

• Hypersensitivity to estradiol or any excipients in Vagifem
• Known or suspected breast cancer
• Known or suspected oestrogen-dependent malignancies such as endometrial cancer
• Unexplained vaginal bleeding
• Untreated endometrial hyperplasia
• Active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Active or recent arterial thromboembolic disease (stroke, myocardial infarction)
• Severe liver disease or abnormal liver function tests
• Porphyria (rare inherited blood disorder)
• Pregnancy or suspected pregnancy

Relative Contraindications (Use with Extreme Caution)

Vagifem may be used with careful monitoring if you have:

• History of endometrial hyperplasia (treated)
• Leiomyoma (uterine fibroids)
• Endometriosis
• Gallbladder disease
• Severe hypertension
• Diabetes with vascular complications
• Systemic lupus erythematosus
• History of severe migraine
• Significant risk factors for thromboembolism

Special Population Considerations

Elderly Patients (Over 65 years)

The manufacturer states that experience in treating women older than 65 years with Vagifem is limited. While the local vaginal administration results in minimal systemic absorption, caution is still advised. Regular monitoring is essential, and treatment should be re-evaluated at least annually.

Renal Impairment

No specific dose adjustment is recommended for patients with renal impairment. The local vaginal administration and minimal systemic absorption mean that Vagifem is unlikely to be affected by renal function.

Hepatic Impairment

Vagifem is contraindicated in severe liver disease. For mild to moderate hepatic impairment, caution is advised. Although systemic absorption is low, estradiol is metabolised in the liver. Patients with liver disease should have regular liver function monitoring if Vagifem is considered necessary.

Paediatric and Adolescent Patients

Vagifem is not indicated for use in children or adolescents. It is specifically for postmenopausal women.

Premature Menopause

Women with premature ovarian insufficiency may have different risk-benefit considerations. The experience with Vagifem in this population is limited. A thorough discussion with a specialist is recommended to determine the most appropriate treatment approach.

Vagifem and Other Medicines

Always inform your doctor or pharmacist about all medications you're taking, including prescription, over-the-counter, herbal, and natural products.

Potential Interactions

Due to the very low systemic absorption of Vagifem (local vaginal administration), significant drug interactions are unlikely. However, potential considerations include:

• Other vaginally applied products - Vagifem may affect the absorption or efficacy of other vaginal treatments. Space applications appropriately.
• Enzyme inducers - Medications that induce liver enzymes (e.g., rifampicin, carbamazepine, phenytoin, St John's Wort) could theoretically increase estradiol metabolism, but this is less relevant with local vaginal administration.
• Enzyme inhibitors - Medications that inhibit liver enzymes might theoretically increase estradiol levels, but again, this is less relevant with Vagifem's local action.

Timing Recommendations

If using other vaginal products (creams, pessaries, etc.):

1. Apply Vagifem at a different time of day from other vaginal treatments
2. Allow several hours between applications of different vaginal products
3. Use Vagifem before bedtime to maximise contact time with vaginal tissues
4. If using Vagifem and a vaginal moisturiser, apply the moisturiser at a different time

Pregnancy & Breastfeeding

Pregnancy

Vagifem is for postmenopausal women only. It must not be used during pregnancy as oestrogen exposure during pregnancy can harm the developing fetus. There is no indication for use during pregnancy.

Contraception Requirements

If you are perimenopausal (still having periods or less than 12 months since your last period) or under 50 years old, you may still be fertile. Vagifem is NOT a contraceptive. You should use appropriate contraception to prevent pregnancy if there's any possibility you could conceive.

Timeline guidance:

• If your last menstrual period was less than 12 months ago → Use contraception
• If you're under 50 years old → Use contraception unless confirmed postmenopausal
• If you're over 50 but had a period in the last year → Use contraception

Breastfeeding

Vagifem is not indicated for use in breastfeeding women. Postmenopausal women are, by definition, not breastfeeding. If a premenopausal woman requires treatment for vaginal atrophy while breastfeeding, alternative non-hormonal treatments should be considered first.

Driving & Machine Operation

Vagifem has no known effect on the ability to drive or operate machinery. The local vaginal administration and minimal systemic absorption mean that Vagifem does not cause drowsiness, dizziness, or impaired coordination that could affect these activities.

Impairment Potential Assessment

• Driving: No restrictions or precautions needed
• Operating machinery: No known impairment
• Mental alertness: Not affected by Vagifem
• Coordination: Not impaired by Vagifem

Warning Signs to Watch For

Although Vagifem itself doesn't cause impairment, if you experience any of the following while using Vagifem, you should avoid driving or operating machinery until you've consulted your doctor:

• Severe dizziness or lightheadedness (could indicate other health issues)
• Visual disturbances or migraine with aura
• Significant nausea that affects concentration

These symptoms are uncommon with Vagifem but could occur in individual cases or indicate other medical conditions that need assessment.

Vagifem Ingredients

Active Ingredient

• Estradiol hemihydrate - Equivalent to 10 micrograms estradiol per vaginal tablet

Excipients (Inactive Ingredients)

• Hypromellose - Used as a binder and to control tablet dissolution
• Lactose monohydrate - A filler/bulking agent
• Maize starch - Acts as a disintegrant to help the tablet break down
• Magnesium stearate - A lubricant to aid tablet manufacturing

Film-Coating Ingredients

• Hypromellose - Forms the smooth coating
• Macrogol 6000 - Helps with coating and tablet stability

Allergen Warnings

Vagifem contains lactose. If you have been diagnosed with lactose intolerance or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, you should not use this medicine.

The tablets also contain maize starch. While rare, some individuals may have allergies to corn/maize products.

How to Use Vagifem

Always use Vagifem exactly as prescribed by your doctor. Follow the instructions carefully to ensure proper administration and optimal results.

Step-by-Step Administration

1. Preparation: Wash your hands thoroughly with soap and water.
2. Open blister: Tear off one single blister pack and open the end as shown in the package instructions.
3. Position: You can stand with one foot on a chair, lie on your back with knees bent, or choose any comfortable position that allows access to your vagina.
4. Insert applicator: Carefully insert the applicator into your vagina. Stop when you feel some resistance (approximately 8-10 cm deep).
5. Release tablet: Gently press the push-button until you hear/feel a click. The tablet will adhere to the vaginal wall.
6. Remove applicator: Take out the applicator and dispose of it in household waste.
7. Post-application: Wash your hands again. The tablet will not fall out when you stand up or walk.

Optimal Timing

You can use Vagifem at any time of day that's convenient. Many women prefer to use it at bedtime as this allows the tablet to remain in place undisturbed. You can start treatment on any day that suits you.

Treatment Duration

Vagifem should be used for the shortest duration necessary to relieve your symptoms. Your doctor will regularly review (at least annually) whether you should continue treatment based on the balance of benefits and risks.

Vagifem Dosage Guidelines

Standard Dosage Regimen

Titration Schedule

Vagifem has only one strength (10 micrograms), so titration involves frequency adjustment rather than dose adjustment:

1. Week 1-2: Daily application to build up tissue response
2. Week 3 onward: Reduce to twice weekly maintenance
3. Maintenance: Leave 3-4 days between applications (e.g., Monday and Thursday, or Tuesday and Friday)

Dose Adjustment Considerations

In most cases, the standard regimen is appropriate. However, your doctor might recommend:

• Extended initial treatment: If symptoms are severe, your doctor might recommend continuing daily treatment beyond 2 weeks before reducing to maintenance
• Increased maintenance frequency: If symptoms return on twice-weekly dosing, your doctor might recommend three times weekly
• Treatment breaks: Some women may benefit from periodic breaks (e.g., stop for 1 week every 3 months), but this should only be done under medical supervision

Minimum Effective Dose Principle

As with all HRT, the principle of using the lowest effective dose for the shortest necessary duration applies to Vagifem. Your doctor will aim to prescribe the minimal frequency that controls your symptoms.

Administration Instructions

Detailed Administration Technique

1. Hand hygiene: Wash hands thoroughly before and after administration.
2. Blister opening: Tear off one single blister pack from the strip. Peel back the foil to reveal the applicator.
3. Applicator removal: Remove the applicator from the blister. Do not remove the tablet from the applicator.
4. Positioning: Choose a comfortable position - lying on your back with knees bent, standing with one leg elevated, or squatting.
5. Insertion: Hold the applicator like a pen. Gently insert the rounded end into your vagina. Insert until you feel slight resistance (approximately 8-10 cm or until the applicator is mostly inside).
6. Tablet release: With the applicator in place, push the button at the other end firmly until it clicks. This releases the tablet onto the vaginal wall.
7. Withdrawal: Slowly withdraw the empty applicator.
8. Disposal: Dispose of the used applicator in your household bin. Do not flush.

Tips for Successful Administration

• If the tablet falls out immediately after insertion, you may not have inserted the applicator deeply enough or may not have pressed the button completely
• The tablet may cause slight moisture as it dissolves - this is normal
• If you experience discomfort during insertion, try changing your position or using a water-based lubricant on the applicator tip (not petroleum-based)
• You can use Vagifem during your menstrual period if you still have periods
• The tablet will not interfere with sexual intercourse, but it's generally recommended to apply it afterward or at a different time

Missed Dose Management

General Rule

If you forget a dose of Vagifem, use it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not use a double dose to make up for a missed dose.

If You Miss Several Doses

If you haven't used Vagifem for an extended period (more than a week):

1. Resume your twice-weekly schedule
2. You don't need to restart with daily dosing unless your symptoms have completely returned
3. If symptoms have worsened significantly, consult your doctor about whether a short course of daily treatment might be helpful

Overdose Information

Accidental Overdose Risk

The risk of systemic overdose with Vagifem is extremely low due to:

• Very low dose (only 10 micrograms per tablet)
• Local vaginal administration with minimal systemic absorption
• Physical limitation of how many tablets can practically be inserted

However, if you accidentally use more Vagifem than prescribed:

1. Do not panic - serious effects are unlikely
2. Do not try to remove inserted tablets - they will dissolve naturally
3. Contact your doctor or pharmacist for advice
4. Resume your normal schedule at the next scheduled dose time

Theoretical Overdose Symptoms

Given the local action and low dose, significant overdose symptoms are improbable. However, theoretically, excessive oestrogen exposure could cause:

• Nausea
• Breast tenderness
• Fluid retention
• Headache
• Irregular vaginal bleeding

Management of Suspected Overdose

If you're concerned about potential overdose:

1. Stop using Vagifem temporarily
2. Contact your doctor or NHS 111 for advice
3. Monitor for any unusual symptoms
4. Seek emergency care if you experience severe symptoms like chest pain, difficulty breathing, or severe headache

Vagifem Side Effects

Like all medicines, Vagifem can cause side effects, although not everyone experiences them. The frequency and severity of side effects are generally lower with vaginal administration compared to systemic HRT.

Frequency-Based Side Effect Categorisation

Very Common (may affect more than 1 in 10 people)

No side effects are classified as very common with Vagifem.

Common (may affect up to 1 in 10 people)

• Headache
• Stomach (abdominal) pain
• Vaginal bleeding, discharge or discomfort

Uncommon (may affect up to 1 in 100 people)

• Genital fungal infection (such as thrush)
• Nausea
• Rash
• Weight increase
• Hot flushes
• Hypertension (high blood pressure)

Rare (may affect up to 1 in 1,000 people)

No side effects are specifically classified as rare for Vagifem in the PIL.

Very Rare (may affect up to 1 in 10,000 people)

• Diarrhoea
• Fluid retention
• Worsening of migraine
• Generalised hypersensitivity reactions (including anaphylactic reaction/shock)

Managing Common Side Effects

• Vaginal discharge/spotting: Usually temporary. Use panty liners if needed. If persistent or heavy, consult your doctor.
• Headache: Usually mild and temporary. Ensure adequate hydration. If persistent or severe, consult your doctor.
• Breast tenderness: Uncommon with Vagifem. Usually resolves within a few weeks. Wear a supportive bra.

Reporting Side Effects

If you experience any side effects, report them to your doctor or pharmacist. You can also report directly via the UK Yellow Card Scheme:

• Website: www.mhra.gov.uk/yellowcard
• Search for "MHRA Yellow Card" in the Google Play or Apple App Store

By reporting side effects, you help provide more information on medicine safety.

How to Store Vagifem

Storage Conditions

• Temperature: Store below 25°C. Do not refrigerate.
• Moisture: Keep the blister packs in the outer carton to protect from moisture.
• Light: No special light protection needed beyond the original packaging.
• Children: Keep out of sight and reach of children.

Expiry Date

Do not use Vagifem after the expiry date printed on the carton and blister pack after "EXP". The expiry date refers to the last day of that month.

Disposal Protocol

Do not dispose of medicines via wastewater or household waste. Take unused or expired medicines to your local pharmacy for proper disposal. This helps protect the environment.

Vagifem Pack Information

What Vagifem Looks Like

• Tablet: Small, white, film-coated vaginal tablet
• Engraving: "NOVO 278" on one side
• Applicator: Single-use, disposable plastic applicator
• Packaging: Blister packs in a carton

Available Pack Sizes

Not all pack sizes may be available at all pharmacies.

Marketing Authorisation Holder

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

UK Office

Novo Nordisk Limited
3 City Place
Beehive Ring Road
Gatwick
West Sussex
RH6 0PA
Tel: (01293) 613555

Product Licence Number

PL 0061/0345

Leaflet Information

This leaflet was last revised in: 01/2022

Vagifem® is a registered trademark owned by Novo Nordisk Health Care AG, Switzerland.

Where to Buy Vagifem in the UK