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GINA is a brand name for Estradiol (also known as Oestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year (see section 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Gina is administered intravaginally as a local oestrogen therapy by use of an applicator.
Initial dose:
One vaginal tablet daily for two weeks.
Maintenance dose:
One vaginal tablet twice a week.
Reinstituting treatment:
For patients still experiencing symptom relief after a break from therapy, it is recommended that treatment is restarted at the maintenance dose. For patients experiencing bothersome symptoms again after a break from therapy, it is recommended to restart treatment at the initial daily dose regimen for 2 weeks, followed by the maintenance twice weekly dose.
Switching from other local vaginal oestrogen preparations:
Patients experiencing symptom relief from vaginal oestrogen preparations that are being used at the recommended dose can be switched to the maintenance dose of Gina provided: • The woman has used her current vaginal oestrogen product for more than 3 months, and; • Her symptoms are adequately controlled, and; • Her health status is unchanged since her last prescription.
Treatment may be started on any convenient day. If a dose is forgotten, it should be used as soon as the patient remembers. A double dose should be avoided. 4) should be used. 4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’).
Gina may be used in women with or without an intact uterus. Method of administration: 1. Open the blister pack at the plunger end. 2. Insert the applicator in the vagina until resistance is met (8-10 cm). 3. Release the tablet by pressing the plunger.
4. Withdraw the applicator and discard.
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 Rare ≥1/10,000 to <1/1,000 Infections and infestations Vulvovaginal mycotic infection Nervous system disorders Headache Gastrointestinal disorders Abdominal pain Nausea Reproductive system and breast disorders Vaginal haemorrhage, vaginal discharge or vaginal discomfort Skin and subcutaneous tissue disorders Rash Investigations Weight increased Vascular disorders Hot flush Hypertension 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.
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.
Treatment initiation or reinstitution and medical examination For the treatment of postmenopausal symptoms, HRT should only be initiated or reinstituted for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at every pharmacy visit for resupply and HRT should only be continued as long as the benefit outweighs the risk.
Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. Women should be referred to their doctor before or at any time during treatment if this or the contraindications and warnings for use indicate a need for a physical (including pelvic and breast) examination by a doctor.
Continued suitability of treatment with Gina should be verified at each supply. Women should be advised to report any unexpected vaginal bleeding to their doctor or nurse. Women should also 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. Conditions requiring a doctor referral before treatment initiation • Women with a history of: • Endometriosis (see below) unless: o She has previously received a prescripiton for vaginal oestrogens and her health status is unchanged since her last prescription, and o she has no recent symptoms of endometriosis ; • Endometrial hyperplasia (see below) unless: o She has previously received a prescripiton for vaginal oestrogens and her health status is unchanged since her last precription, or o She has had a hysterectomy.
Women receiving hormonal therapy, including systemic HRT, unless she has previously received a prescription for a concurrent vaginal oestrogen product and her health status is unchanged since her last prescription. • Women switching to Gina from another vaginal oestrogen product who have: o Used their current vaginal oestrogen product for less than 3 months, or; o Been using their vaginal oestrogen product at the recommended dose and are experiencing bothersome symptoms Follow-up Women with symptoms that do not start to improve or worsen after 3 months of treatment, should be referred to their doctor.
g. g. 4) • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal • Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in United Kingdom.
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4). Class effects associated with systemic HRT The following risks have been associated with systemic HRT and may 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.
The dose of Gina should not be increased. If Gina does not relieve symptoms adequately, advice from a doctor should be sought. The intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.
Symptoms often recur when the treatment is stopped Reasons for immediate withdrawal of therapy Therapy should be discontinued, and advice sought from a doctor in case a contraindication is discovered or if the following situations occur or recur during treatment: • New onset of vaginal bleeding or spotting • New onset of vaginal itching • Vaginal infection not adequately treated by a pharmacy treatment • Symptoms of endometriosis Prompt advice should also be sought from a doctor 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.
Therefore use of vaginal oestrogens in these women should remain under the supervision of a doctor. 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 Gina, it is not recommended to add a progestagen. 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. 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 Gina. 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.
The pharmacokinetic profile of Gina shows that there is very low systemic absorption of estradiol during treatment. A minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once-daily administration.
2). However, being an HRT product, the following need to be considered, especially for long-term or repeated use of this product. Conditions that may be aggravated during exposure to oestrogen The following conditions may recur or be aggravated during oestrogen treatment.
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 advised to […]