Like all medicines, Gina may cause side effects, which are usually of mild to moderate intensity and only last a short time. However, there are some uncommon situations when women will need to seek immediate medical help.
Women must STOP USING Gina and seek IMMEDIATE medical help if they experience:
A serious allergic reaction, which may occur very rarely (<1/10,000 patient years).
Signs may include:
⁃ suddenly feeling unwell with sweating
⁃ vomiting
⁃ difficulty breathing
⁃ rapid heartbeat or feeling dizzy
Signs of a blood clot in the leg or lungs, which may occur very rarely (<1/10,000 patient years).
Signs may include:
⁃ painful swelling and redness of legs
⁃ sudden chest pain
⁃ difficulty breathing
If women experience any of the following while taking Gina, they should STOP USING Gina immediately and seek prompt medical advice from their doctor:
- It is found that they have a contraindication to the use of Gina
- Any new vaginal bleeding or spotting, which can be a sign of endometrial cancer[NHS 2018a]
- New vaginal itching (this could be a symptom of a vulval dermatoses or a vaginal infection)[Vaginal Yeast Infection: overview; Ringel 2020]
- Current vaginal infections not adequately treated by a pharmacy treatment (infections can indicate underlying health conditions or misdiagnosis, such as diabetes[Vaginal Yeast Infection: overview])
- Symptoms of endometriosis (recurrence of endometriosis can be caused by unopposed oestrogen stimulation, which can lead to premalignant or malignant transformation in the residual foci of endometriosis)[SPC]
Women should also seek prompt medical advice if they experience any of the following while taking Gina:
- Yellowing of the skin or whites of the eyes (these can be caused by oestrogens, and may be signs of jaundice or deterioration in liver function)
- Significant increase in blood pressure which can be caused by oestrogens. Symptoms may be: headache, tiredness, dizziness
- New migraine-type headache which happens for the first time (may indicate hypertension, therefore requires further investigation by GP)
- Pregnancy, which Gina is contraindicated for
A full list of side effects experienced with Gina can be found in the Patient Information Leaflet. The most commonly reported side effects associated with the use of Gina reported in ≥1/100 to <1/10 patient years are:
- headache
- abdominal pain
- vaginal haemorrhage
- vaginal discharge
- vaginal discomfort
Oestrogen-related adverse events such as breast pain, peripheral oedema and postmenopausal bleeding have been reported at very low rates. If they occur, they are most likely at the beginning of treatment. Sexual partners are not at risk. There are other side effects that have been reported in association with systemic HRT. The risks have been estimated for systemic exposure, so it is not known how they apply to a local oestrogen therapy like Gina, where blood oestrogen levels remain within the normal postmenopausal range.
These include:
- gall bladder disease
- some skin and subcutaneous disorders
- an increased risk of probable dementia if women start using HRT over the age of 65 years
Reporting side effects
Women should be encouraged to report any side effects to their pharmacist or another healthcare professional. They can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
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