The usual dose is to insert one Vagifem tablet into the vagina once daily for two weeks. This is then reduced to one dose twice a week. Leave 3-4 days between each dose.You should only insert Vagifem tablets into the vagina. You should not take this medication orally.

Each tablet is pre-inserted into a single-use applicator. You will need to open a new applicator for every dose of Vagifem.

The full instructions for how to insert Vagifem can be found in the Patient Information Leaflet that comes with the tablets.

Follow the instructions below to ensure appropriate use of this medication:

• Wash your hands and dry them thoroughly before and after use
• Open one applicator from the end, and take it out of the packet without touching the insertion end
• Insert the end of the applicator containing the tablet inside the vagina until you reach some resistance (this will be approximately 8-10cm)
• Release the tablet by pushing down on the plunger end of the applicator until you feel it click
• Take out the applicator and throw it away in the bin

Always use this medication exactly as your clinician has told you. Check with our clinical team or your GP or pharmacist if you are not sure.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Unlike other hormone replacement therapy, using estradiol vaginal inserts like Vagifem tends to result in fewer, milder side effects. On the whole, these symptoms are less common and less severe than in women who take oral HRT.

Most commonly women who use Vagifem report the following side effects:

• Headaches
• Stomach pain and nausea
• Vaginal bleeding, discharge or discomfort
• Vaginal thrush
• Rash
• Weight gain or fluid retention
• Hot flush
• High blood pressure

If you are concerned about any side effects or you do not feel that they are improving over the first few months you should discuss this with a doctor or pharmacist.

If you experience a severe side effect or have an allergic reaction you must seek medical support from your nearest emergency department as soon as possible.

For full information on side effects and correct use, see the patient information leaflet. If any side effects concern you, or you are experiencing any of the side effects mentioned in the patient information leaflet whilst taking this medication, please contact our clinical team or speak to your GP.

HRT can be very beneficial for women who suffer from menopause symptoms. However, there are risks associated with HRT. You shouldn’t use oestrogen creams or pessaries if:

• You have a higher than normal risk of clots e.g. angina or heart attack, deep vein thrombosis or pulmonary embolism.
• You have thrombophlebitis, which is inflammation and blood clotting in your blood vessels
• You’ve ever had breast cancer, endometrial (womb) cancer or ovarian cancer
• You have any other health conditions which affects how your blood clots
• You’ve had bleeding from your vagina which has not been diagnosed yet
• You have a condition called endometrial hyperplasia

The above risks are associated with HRT products in general. It is likely that the risks are lower with Vagifem because it is for local treatment in the vagina and very little is absorbed into the bloodstream.

It is important to tell us about any medication you currently take. Vagifem is a local treatment in the vagina which means very little is absorbed into the bloodstream. This means it is unlikely to interact with other medicines. It may affect other treatments applied into the vagina.

The following people are at an even higher risk of developing a blood clot and you should inform our clinical team before using Vagifem if any of them apply to you:

• You are immobile for an extended amount of time due to surgery, injury or illness
• Your BMI is over 30
• Your close relatives have ever had a blood clot
• You have systemic lupus erythematosus (SLE)

Developing blood clots can be dangerous and life-threatening, and can lead to heart attacks and strokes.If you think you are experiencing symptoms of a blood clot, you must either call 111 or see a doctor straight away.

Vagifem should only be used by postmenopausal women and is not a contraceptive. If you are under 50 years old or have had a menstrual period in the last 12 months, you may still need to use additional contraception to prevent pregnancy.If you become pregnant while using Vagifem, you should stop using this medication and speak to a doctor for advice.

Vagifem is for use in postmenopausal women only. You should not use Vagifem if you are breastfeeding.

Get emergency medical help if you have signs of an allergic reaction to this medication. These include:

• Hives
• Dizziness
• Fast or pounding heartbeats
• Wheezing
• Difficult breathing
• Swelling of your face, lips, tongue, or throat.

It is important that you let us know which prescription, over-the-counter medicines and recreational drugs you are currently taking. You must also tell us about any other medical conditions that you currently have (or had in the past). This will help us ensure the prescribed medication is safe and appropriate for you to take.

For full information on warnings, medication interactions and contraindications, refer to the Patient Information Leaflet. Please read all packaging and the Patient Information Leaflet before taking any new medicine and inform our clinical team or your GP of medicines you are taking or intend to take.