Gina 10 Micrograms Vaginal Tablets

• Gina is for postmenopausal women aged 50 years and older who have not had a period for at least 1 year and suffer from vaginal symptoms due to estrogen deficiency. Gina is a form of hormone replacement therapy (HRT).

Do NOT use Gina if:
• You are allergic (hypersensitive) to estradiol.
• 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).

• Gina is a tablet for vaginal use only. Each vaginal tablet comes preloaded in a single-use applicator.
• Using intravaginal applicators can sometimes cause minor injury in your vagina, especially if inserted or removed without care or if your vaginal atrophy (thinning) is severe.
• Speak to your doctor or pharmacist if you experience any difficulties with using the vaginal applicator, as your doctor may be able to prescribe another vaginal oestrogen preparation that is more suitable for you.
• You can start using Gina on any day which is best for you.
• Always use this medicine exactly as described in this leaflet or as the pharmacist has told you. Check with the pharmacist if you are not sure.

Like all medicines, Gina can cause side effects, although not everybody gets them.
Stop using this medicine and seek urgent medical attention if you have a serious allergic reaction to Gina:

A serious allergic reaction may occur only very rarely. Signs may include:
• Suddenly feeling unwell with sweating;
• Vomiting;
• Difficulty in breathing;
• Rapid heartbeat or feeling dizzy.

Stop using Gina and seek prompt advice from your doctor if:
• You develop any new vaginal bleeding, spotting or itching.
• You have endometriosis and your symptoms have come back.
• A vaginal infection develops while you are using Gina.

Other side effects reported are listed below. Speak to your doctor or pharmacist if these continue or become troublesome.

Common: may affect up to 1 in 10 people
• Headache;
• Stomach pain;
• Vaginal bleeding, discharge or discomfort.

Uncommon: may affect up to 1 in 100 people
• An infection of the genitals caused by a fungus;
• Nausea (Feeling sick);
• Rash;
• Weight increase;
• Hot flush;
• High blood pressure.

Very rare: may affect up to 1 in 10,000 people
• Diarrhoea;
• Water retention;
• Worsened migraines;
• Generalised hypersensitivity (e.g. anaphylactic reaction/shock).