VAGIRUX

Posology Vaginal infections should be treated before start of the Vagirux therapy. Treatment may be started on any convenient day. Initial dose One vaginal tablet daily for two weeks. Maintenance dose One vaginal tablet twice a week. 4) should be used.

4). If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. Method of administration Vagirux is administered intravaginally as a local oestrogen therapy by use of an applicator. How to administer Vagirux: 1.

Remove the applicator from its sealing foil. 2. While holding the tube, gently pull the plunger out of the applicator until it comes to a stop. Take a vaginal tablet from the separate blister and place it firmly in the holder of the applicator end (wide end).

3. Insert the applicator carefully into the vagina. Stop when you can feel some resistance (8-10 cm). 4. Release the vaginal tablet, by gently pressing the push-button until the end of the plunger. The tablet will stick to the wall of the vagina straight away.

It will not fall out if you stand up or walk. 5. After each use, prior to a subsequent use, clean the applicator according to the following cleaning procedure: - Withdraw the plunger from the applicator. - Clean both the tube and the plunger using mild soap and rinse them with warm tap water thoroughly.

Rinse both the tube’s inner and outer surface. - If necessary, remove larger amounts of remaining water from both the tube and the plunger by shortly shaking them. g. paper towel). - Introduce the plunger again in the applicator-tube for the next use of the applicator.

6. The applicator can be used up to 24 times. Thereafter, throw it away via the household waste. A new applicator should be used with every new pack.

Adverse events from clinical trials:

More than 673 patients have been treated with estradiol 10 micrograms vaginal tablets in clinical trials, including over 497 patients treated up to 52 weeks. Oestrogen-related adverse events such as breast pain, peripheral oedema and postmenopausal bleedings have been reported with estradiol 10 micrograms vaginal tablets at very low rates, similar to placebo, but if they occur, they are most likely present only at the beginning of the treatment.

The adverse events observed with a higher frequency in patients treated with estradiol 10 micrograms vaginal tablets as compared to placebo and which are possibly related to treatment are presented below. System organ class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Infections and infestations Vulvovaginal mycotic infection Nervous system disorders Headache Vascular disorders Hot flush Hypertension Gastrointestinal disorders Abdominal pain Nausea Skin and subcutaneous tissue disorders Rash Reproductive system and breast disorders Vaginal haemorrhage, vaginal discharge or vaginal discomfort Investigations Weight increased Post-marketing experience: In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported for patients being treated with estradiol 10 micrograms vaginal tablets and are considered possibly related to treatment.

The frequencies for the below mentioned adverse drug reactions cannot be interpreted because these reactions are reported voluntarily from a population of uncertain size. g. anaphylactic reaction/shock); - Metabolism and nutrition disorders: fluid retention; - Psychiatric disorders: insomnia; - Nervous system disorders: migraine aggravated; - Vascular disorders: deep vein thrombosis; - Gastrointestinal disorders: diarrhoea; - Skin and subcutaneous tissue disorders: pruritus, rash, urticaria; - Reproductive system and breast disorders: endometrial hyperplasia, vulvovaginal pain1, pruritus genital; - General disorders and administration site conditions: application site reaction2, drug ineffective, injury associated with device3.

1 Including vulvovaginal burning sensation 2 Local allergic reactions including vulvovaginal erythema, genital erythema, vulvovaginal rash, genital rash 3 Minor local trauma caused by intravaginal applicator Other adverse reactions have been reported in association with systemic oestrogen/progestagen treatment.

4). Class effects associated with systemic HRT The following risks have been associated with systemic HRT and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range.

4). 56). For women aged 50 to 54 years who have been taking HRT for 5 years, this results in about 1 extra case per 2,000 users. In women aged 50 to 54 who do not take HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.

e. deep vein thrombosis or pulmonary embolism. 4). 4) 1 (-3 – 10) * Study in women with no uterus. 5-fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during the use of HRT. 4). 6) 3 (1 – 5) * No differentiation was made between ischaemic and haemorrhagic stroke.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and HRT should only be continued as long as the benefit outweighs the risk.

Medical examination/follow-up Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.

During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see “Breast cancer” below).

g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. 2), however, being an HRT product the following need to be considered, especially for long-term or repeated use of this product.

Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. g. g. liver adenoma); - Diabetes mellitus with or without vascular involvement; - Cholelithiasis; - Migraine or (severe) headache; - Systemic lupus erythematosus; - A history of endometrial hyperplasia (see below); - Epilepsy; - Asthma; - Otosclerosis.

2). Due to this, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment. Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered and in the following situations: - Jaundice or deterioration in liver function; - Significant increase in blood pressure; - New onset of migraine-type headache; - Pregnancy.

Endometrial hyperplasia and carcinoma Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with Vagirux.

In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when systemic oestrogens are administered alone for prolonged periods. For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, such as Vagirux, it is not recommended to add a progestagen.

During estradiol 10 micrograms vaginal tablets treatment, a minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once- daily administration. 2). Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.

Therefore, if repeated, treatment should be reviewed at least annually, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma. As a general rule, oestrogen replacement therapy should not be prescribed for longer than one year without another physical, including gynaecological, examination being performed.

If bleeding or spotting appears at any time during therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with Vagirux.

Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

The following risks have been associated with systemic HRT and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range. However, they should be considered in case of long term or repeated use of this product.

Breast cancer Epidemiological evidence from a large meta-analysis suggests no increase in risk of breast cancer in women with no history of breast cancer taking low dose vaginally applied oestrogens. It is unknown if low dose vaginal oestrogens stimulate recurrence of breast cancer.

Ovarian cancer Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

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