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 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.

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).

For more information please see the enclosed leaflet

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®.
  • Skin rash or peeling or mouth ulcers, itching or sweating

How much to use:

• Initial Dose: Use one vaginal tablet each day for the first 2 weeks of treatment
• Maintenance Dose: Use one vaginal tablet twice a week. Leave 3 or 4 days between each dose You can use it at any time of the day, but you should try and use it at the same time for each application.

What Gina contains

• The active substance is estradiol 10 micrograms (as estradiol hemihydrate).
• Each vaginal tablet contains 10 micrograms estradiol (as estradiol hemihydrate).
• Other ingredients are: hypromellose, lactose monohydrate, maize starch and magnesium stearate.
• The film-coating contains: hypromellose and macrogol 6000.