Product Details

What you need to know before you use Gina

Medical history and Pharmacy Reviews

Before you start using Gina, your pharmacist will ask about your own and your family’s medical history.

They may also ask you about your menopause and what symptoms you have had.

This is to make sure that Gina is suitable for you and that you do not need to see your doctor before using Gina or for any other treatments that may be more suitable.

Once you have started using Gina you should review your treatment regularly with your pharmacist. Let your doctor know that you are using Gina at your next routine appointment. The use of HRT carries some risks, which need to be considered when deciding whether to start using it, or whether to carry on using it. You should go for regular breast and cervical screening as recommended by your doctor. Do not use Gina if any of the following applies to you. If you are not sure about any of the points below, talk to your pharmacist before using Gina. Do not use Gina if: • You are allergic (hypersensitive) to estradiol or any of the other ingredients of Gina (listed in section 6 ‘Contents of the pack and other information’). • You have or have ever had womb or ovarian cancer, or you have symptoms such as vaginal bleeding, or pain, bloating or swelling in your lower abdomen or pelvis that you have not told your doctor about. • You have had any vaginal or genital bleeding since your periods stopped due to the menopause. • You have recent or suspected endometrial hyperplasia (or e.g. if you have been referred for an ultrasound of your womb and are waiting for the results). • You have previously been treated with oestrogen only HRT (without progestogen) and you have not had your womb removed (hysterectomy). • You have any change in the look/feel of the vulval area such as thickening or a lump, or if you have noticed any shrinking or scarring in this area. • You have a current vaginal infection before starting treatment with Gina. • You have a condition called ‘vulval dermatoses’ or you have any genital skin disorders such as severe vaginal itching, or itchy patches or rash. • You have or have ever had breast cancer, or if you are suspected of having it. • 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 or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina. • You have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency). • 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). You may need to see your doctor before using Gina if any of the following apply to you. Tell your pharmacist if: • You have a history of endometriosis. • You have a history of endometrial hyperplasia. • You are receiving a type of HRT (including tablets or patches) that circulates in the blood. • You are switching from another vaginal oestrogen HRT. Warnings and precautions Talk to your doctor or pharmacist if any vaginal infection develops while you are using Gina. Stop using Gina immediately and seek prompt advice from your doctor if you notice any of the following during treatment: • You develop any of the conditions listed in the above section ‘Do not use Gina’. • You develop any new vaginal bleeding, spotting or itching. • If you have endometriosis and your symptoms have come back. • Swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty in breathing which are suggestive of angioedema. You must also seek prompt advice from your doctor if you notice any of the following during treatment: • 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). • Migraine-like headaches which happen for the first time. • You become pregnant. Tell your doctor you are using this medicine if you have or have ever had any of the following, and seek advice from them if any of these conditions return or get worse during treatment: • Uterine fibroids (Leiomyoma); • Increased risk of developing blood clots (e.g. you are unable to walk for a long time because of major surgery/injury/illness, you are overweight with a BMI greater than 30 kg/m², any of your close relatives has ever had a blood clot in the legs or lungs); • Increased risk of getting womb, ovarian or breast cancer (e.g. having a close relative who has had any of these cancers); • High blood pressure; • Liver disorders, such as a benign liver tumour; • Diabetes; • Gallstones; • Migraines or severe headaches; • Systemic lupus erythematosus, (SLE); • Epilepsy; • Asthma; • A disease affecting the eardrum and hearing (otosclerosis); • A very high level of fat in your blood (triglycerides); • Fluid retention due to cardiac or kidney problems; • Hereditary and acquired angioedema. Cancer of the womb lining (endometrial cancer) and excessive thickening of the womb lining (endometrial hyperplasia) Taking oestrogen-only systemic HRT 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 Gina when it is used for repeated or long term (more than one year) treatments. However, Gina has been shown to have very low absorption into the blood, and therefore the addition of a progestogen is not necessary. If you get any vaginal bleeding e.g. breakthrough bleeding or spotting, especially after using the product for some time, it may be nothing to worry about but you should stop using Gina and seek prompt advice from your doctor. It could be a sign that your endometrium has become thicker. General Information – What you should know about HRT Risks associated with HRT Gina is a local vaginal HRT. Other HRT medicines which circulate in the blood and are used to treat hot flushes and other menopausal symptoms are known as systemic HRT. These are known to increase the risk of some conditions occurring, especially when used for a long time. It is thought that the risk of these conditions may not increase by as much with Gina as with systemic HRT, but this is not known for sure: See section 4 for more detail on risk/side effects with systemic HRT. • Breast cancer: Evidence suggests that using Gina does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Gina can be safely used in women who had breast cancer in the past. • Ovarian cancer. • Blood clots in a vein (thrombosis). • Heart disease (heart attack): For women taking oestrogen-only therapy there is no increased risk of developing heart disease. • Stroke. You should speak with your pharmacist or doctor if you are concerned. Children and adolescents Do not give this medicine to children or adolescents. This medicine is only intended for use in postmenopausal women. Other medicines and Gina Please tell your pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. Gina is used for a local treatment in the vagina and is not likely to affect other medicines. However, it may affect other vaginally applied treatments. Ask your pharmacist for advice if you are unsure. Pregnancy and breast-feeding Women who are pregnant or breast-feeding should not use Gina. Driving and using machines No known effect. You may continue to drive or use machines, as long as you feel well enough to do