Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or internal examination, if necessary.

Once you have started on Vagifem® you should see your doctor for check-ups at least once a year. At these check-ups, discuss with your doctor the benefits and risks of continuing with Vagifem®.

Go for regular breast screening as recommended by your doctor.

Do not use Vagifem®:

If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before using Vagifem®.

Do not use Vagifem® if:

• You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem® (listed in section 6 ‘Contents of the pack and other information’).
• You have or have ever had breast cancer, or you are suspected of having it.
• You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• You have or have 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 a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called ‘porphyria’, which is passed down in families (inherited).

If any of the above conditions appear for the first time while using Vagifem®, stop using it at once and consult your doctor immediately.

Warnings and precautions

Tell your doctor if you have or have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Vagifem®. If so, you should see your doctor more often for check-ups.

• Asthma
• Epilepsy
• Diabetes
• Gallstones
• High blood pressure
• Migraines or severe headaches
• A liver disorder, such as a benign liver tumour
• Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• A disease affecting the eardrum and hearing (otosclerosis)
• A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• Increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• Increased risk of developing blood clots (see ‘Blood clots in a vein (thrombosis)’)
• Fibroids inside your womb
• A very high level of fat in your blood (triglycerides)
• Fluid retention due to cardiac or kidney problems.

Stop using Vagifem® and see a doctor immediately

If you notice any of the following when using HRT:

• Migraine-like headaches which happen for the first time
• Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• Any of the conditions mentioned in the ‘Do not use Vagifem®’ section above
• If you become pregnant
• If you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing.

  For more information, see ‘Blood clots in a vein (thrombosis)’.

Note: Vagifem® is not a contraceptive. If it is 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. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).

It is uncertain whether there is a similar risk with Vagifem® when it is used for repeated or long term (more than one year) treatments. However, Vagifem® has shown to have very low absorption into the blood, and therefore the addition of a progestagen is not necessary.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

The following risks apply to hormone replacement therapy (HRT) medicines which circulate in the blood. However, Vagifem® is for local treatment in the vagina, and the absorption into the blood is very low. It is less likely that the conditions mentioned below will get worse or come back during treatment with Vagifem®, but you should see your doctor if you are concerned.

Breast cancer

Evidence suggests that using Vagifem® does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Vagifem® can be safely used in women who had breast cancer in the past.

Regularly check your breasts. See your doctor if you notice any changes such as:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Additionally, you are advised to join mammography screening programs when offered to you.

Ovarian cancer

Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.

Compare

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who do not take HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there are about 3 cases per 2,000 users (i.e. about 1 extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3- to 3-times higher in HRT users than in non-users, especially during the first year of taking it.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:

• you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, ‘If you need to have surgery’)
• you are seriously overweight (BMI >30 kg/m²)
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.

For signs of a blood clot, see ‘Stop using Vagifem® and see a doctor immediately’.

Compare

Looking at women in their 50s who do not take HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case).

Heart disease (heart attack)

For women taking oestrogen-only therapy there is no increased risk of developing a heart disease.

Stroke

The risk of getting stroke is about 1.5-times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT increases with age.

Compare

Looking at women in their 50s who do not take HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who take HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).

Other conditions

HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

Other medicines and Vagifem®

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. However, Vagifem® is used for a local treatment in the vagina and is not likely to affect other medicines. Vagifem® may affect other vaginally applied treatments.

Pregnancy and breast-feeding

Vagifem® is for use in postmenopausal women only. If you become pregnant, stop using Vagifem® and contact your doctor.

Driving and using machines

No known effect.