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).

• Menopause is when your periods stop due to lower hormone levels.
• This usually happens between the ages of 45 and 55.
• Perimenopause is when you have symptoms before your periods have stopped. You reach menopause when you have not had a period for 12 months.
• Menopause and perimenopause can cause symptoms like anxiety, mood swings, brain fog, hot flushes and irregular periods. These symptoms can start years before your periods stop and carry on afterwards.
• Menopause and perimenopause symptoms can have a big impact on your life, including relationships and work.
• There are things you can do to help with symptoms. There are also medicines that can replace the missing hormones and help relieve your symptoms.

(NHS, 2022)

• It happens naturally between the age of 45 and 55 due to declining reproductive hormones.
• Sometimes, it may happen earlier due to a surgery to remove the ovaries (oophorectomy) or the uterus (hysterectomy), cancer treatments like chemotherapy, or a genetic reason.

HRT medicines which circulate in the blood and used to treat hot flushes and other menopausal symptoms are known as ‘systemic HRT’. These medicines include oral tablets and patches (transdermal patches) or gels which go on the skin. Systemic HRT increases the risk of some conditions occurring, especially when used for a long time (see below).

Gina contains a low dose of oestrogen which works locally in the vagina. Gina is classed as a local vaginal HRT, not a systemic HRT. It is thought that the risks associated with local HRT's such as Gina are lower than those associated with systemic HRT's, although it is not known for sure. You should speak with your doctor or pharmacist if you are concerned.

1) 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.
Check your breasts regularly and see your doctor if you notice any changes such as:
• dimpling or soreness of the skin (sometimes looking like an orange peel);
• changes in the nipple (such as discharge or the nipple turns inwards);
• unusual swelling in all or part of the breast, or any lumps or thickening you can see or feel.
You should also join mammography screening programmes when offered to you.

2) Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only systemic HRT has been associated with a slightly increased risk of ovarian cancer.

Compare
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who do not take HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there are about 3 cases per 2,000 users (i.e. about 1 extra case).

3) Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher in systemic HRT users than in nonusers, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older. Tell your doctor if any of these situations applies to you:
• You are unable to walk for a long time because of major surgery, injury or illness (see also section 3, ‘If you need to have surgery’).
• You are seriously overweight (BMI greater than 30 kg/m²).
• You have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots.
• If any of your close relatives has ever had a blood clot in the leg, lung or another organ.
• You have systemic lupus erythematosus (SLE).
• You have cancer.

Signs of a blood clot to look out for include:
• painful swelling and redness of the legs;
• sudden chest pain;
• difficulty in breathing.
If you observe any signs of a blood clot, stop using Gina and see your doctor immediately.

Compare
Looking at women in their 50s who do not take HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein. For women in their 50s who have been taking oestrogen-only HRT for over 5 years, there will be 5 to
8 cases in 1,000 users (i.e. 1 extra case).

4) Heart disease (heart attack)
For women taking oestrogen-only therapy there is no increased risk of developing heart disease.

5) Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT increases with age.

Compare
Looking at women in their 50s who do not take HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who take HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).

6) Other conditions
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.

The following side effects have also been reported with systemic HRT treatments:
• Gall bladder disease;
• Various skin problems such as:
- discolouration of the skin especially of the face or neck known as ‘pregnancy patches’;
- painful reddish skin nodules;
- rash with target-shaped reddening or sores.