FemSeven Patches (50, 75, & 100)

FemSeven directions

FemSeven is an oestrogen-only patch that should be applied to the skin once weekly on a continuous basis, i.e. each patch is replaced with a new one after 7 days. Always use FemSeven exactly as your doctor has told you.

Choose a place where there is least wrinkling of the skin and where it will not be rubbed off by clothing, for example on your buttocks, hips or abdomen (avoid the waist).

To remove the FemSeven patch simply lift off one edge and pull. Fold the patch in half (adhesive against adhesive) and throw it away. If the patch starts to come off before 7 days are up, you should take it off completely and apply a new patch.

Replace it when you would normally have done. If you forget to change your patch at the right time, change it as soon as possible, then resume your original schedule. If you still have your womb, breakthrough bleeding is more likely if you forget to change your patch on time.

FemSeven ingedients

The active substance is: estradiol hemihydrate.

The other ingredients are: transparent polyethylene terephthalate foil, styrene-isoprene block copolymer and glycerine esters of completely hydrogenated resins.

Femseven warnings

Do not use FemSeven

• If you have or have ever had breast cancer, or if you are suspected of having it
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• If you have any vaginal bleeding for which the cause is not known
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or in the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries (such as a heart attack, stroke or angina)
• If you have or have ever had a liver disease and your liver function tests have not returned to normal
• If you have an inherited disease (porphyria) characterised by an accumulation of toxic compounds (porphyrins) in the body
• If you are allergic (hypersensitive) to estradiol hemihydrate or any of the other ingredients of FemSeven

If you are not sure of any of the above, consult your doctor before using FemSeven.

If any of the above conditions appear for the first time while using FemSeven, stop using it at once and consult your doctor immediately.

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with FemSeven. If so, you should see your doctor more often for check-ups:

• Benign tumours of the womb (fibroids inside your womb)
• A growth of womb lining outside your womb (endometriosis)
• A history of abnormal growth of the womb lining (endometrial hyperplasia)
• An increased risk of developing blood clots
• An increased risk of getting a cancer which needs oestrogens for its development (such as having a mother, sister or grandmother who has had breast cancer)
• High blood pressure
• A liver disorder, such as a benign liver tumour
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body (systemic lupus erythematosus)
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• A very high level of fat in your blood (triglycerides)
• An increase in the amount of water in your body (fluid retention) due to cardiac or kidney problems

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are using FemSeven. You may need to stop using FemSeven about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Ask your doctor when you can start using FemSeven again.

When to stop using FemSeven

Stop using FemSeven and see a doctor immediately if you notice any of the following when using HRT:

• If you develop any of the conditions mentioned above
• A 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
• If you become pregnant
• If you notice signs of a blood clot, such as:
  • Painful swelling and redness of the legs
  • Sudden chest pain
  • Difficulty in breathing

FemSeven side effects

Like all medicines, FemSeven can cause side effects; although not every body gets them.

The following side effects are reported more often in women using HRT compared to women not using it:

• Breast cancer
• Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• Ovarian cancer
• Blood clots in the veins of the legs or lungs (venous thromboembolism)
• Heart disease
• Stroke
• Probable memory loss if HRT is started over the age of 65

The following side effects may occur very commonly (in more than 1 in 10 people):

Application site reactions:

• Itching (purities)
• Redness (erythema)
• Eczema
• Urticaria
• Swelling (Oedema)
• Changes in skin pigmentation

They were mostly mild skin reactions and usually disappeared 2 or 3 days after patch removal.

The following side effects may occur commonly (up to 1 in 10 people):

• Headache
• Breast discomfort (e.g. mastalgia/ mastopathies, breast enlargement)

The following side effects may occur uncommonly (up to 1 in 100 people):

• Hair changes, sweating increased
• Joint pain (arthralgia), leg cramps
• Dizziness, tingling in fingers or toes (paresthesia), migraine
• Anxiety, appetite increase, depression, difficulty sleeping (insomnia), nervousness
• Nausea, indigestion (dyspepsia), abdominal pain, vomiting
• Blood pressure changes
• Chest pain
• Vein disorders
• Vaginal discharge, breakthrough bleeding
• Swelling (oedema), fatigue, weight changes

The following potential side effects may occur rarely (up to 1 people in 1 000):

• Worsening of uterine fibroids (benign growths of the womb)
• The following side effects have been reported with other HRTs
• gall bladder disease
• various skin disorders:
• discolouration of the skin especially of the face or neck known as "pregnancy patches" (cholasma)
• painful reddish nodules (erythema nodosum)
• rash with target-shaped reddening or sores (erythema multiforme)

If any of the side effects becomes serious, or if you notice any side effects not listed in the patient information leaflet, please tell your doctor or pharmacist.

For a full list of warnings and side effects, please read the patient information leaflet contained within the product packaging.