Femseven

FemSeven is a Hormone Replacement Therapy (HRT) containing an oestrogen, estradiol hemihydrate, which is a sexual female hormone. FemSeven is used in postmenopausal women more than one year after menopause. FemSeven comes in three strengths 50, 75 and 100.

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. In women with an intact uterus, the addition of a progestogen for at least 12 to 14 days every month/28 day cycle is essential to help prevent any endometrial hyperplasia induced by the oestrogen.Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. Therefore, therapy should normally be started with one FemSeven patch (delivering 50 micrograms of estradiol in 24 hours). If the prescribed dose does not eliminate the menopausal symptoms, the dose should be adjusted stepwise after the first few months by using a transdermal patch delivering 75 or 100 micrograms estradiol per day. A maximum of 100 micrograms estradiol per day should not be exceeded. If there are persistent signs of overdose, such as breast tenderness, the dose should be reduced accordingly.

Hysterectomised women not taking HRT or transferring from another HRT product may start treatment with FemSeven on any convenient day. The same holds true for non-hysterectomised women not taking HRT or transferring from a continuous combined HRT product. In non-hysterectomised women switching from sequential HRT regimens, treatment with FemSeven should start after the previous treatment regimen has ended.

Consecutive new patches should be applied to different sites. It is recommended that sites are chosen below the waist where little wrinkling of the skin occurs e.g., buttocks, hip or abdomen. FemSeven must not be applied on or near the breasts. The patch should be applied to clean, dry, healthy and intact skin. The patch should be applied to the skin as soon as it is removed from its wrapping. The patch is applied by removing both parts of the protective liner and then holding it in contact with the skin for at least 30 seconds (warmth is essential to ensure maximal adhesive strength).

Should part or all of a patch detach prematurely (before 7 days) it should be removed and a new patch applied. To aid compliance it is recommended the patient then continues to change the patch on the usual day. This advice also applies if a patient forgets to change the patch on schedule. Forgetting a patch may increase the likelihood of break-through bleeding or spotting.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been associated with Femseven:

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 list above isn’t exhaustive. If you experience serious side effects or side effects lasting longer than 3 months, then you should consult your doctor immediately. Make sure you read the patient information leaflet for a full list of side effects, cautions and contraindications. You should only take HRT once you have understood all the warnings and precautions as HRT may increase your chances of getting certain cancers or cardiovascular disease. If you are concerned discuss this with your doctor or The Family Chemist clinician.

Do not use FemSeven

If any of following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Femseven.

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 (prophyrins) in the body.
• If you are allergic (hypersensitive) to estradiol hemihydrate or any of the other ingredients of 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.

FemSeven is not a contraceptive. As a consequence for women who still have their womb, a treatment with progestogen hormone will be added for the last twelve days of treatment with FemSeven at least. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

Before you start the treatment:

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 tumors 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 (see “Blood clots in a vein (thrombosis)”);
• an increased risk of getting a cancer which needs estrogens 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 tumor;
• 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.

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 in the “Do not use FemSeven” section
• 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 a signs of a blood clot, such as:
  • painful swelling and redness of the legs;
  • sudden chest pain;
  • difficulty in breathing

• https://www.medicines.org.uk/emc/files/pil.12937.pdf
• https://www.womens-health-concern.org/
• https://patient.info/medicine/oestrogen-and-progestogen-for-hrt
• https://www.nhs.uk/conditions/menopause/
• https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/