What are Estradot patches used for?

1. Hormone replacement therapy to relieve symptoms of the menopause.

It is used for the management of menopausal symptoms such as abnormal uterine bleeding, hot flushes, sweating, and chills.

As they only contain oestrogen, Estradot patches are most suitable for women who have had a hysterectomy. Women who have not had a hysterectomy should be prescribed a progestogen medicine to take with this medicine for the last 12 to 14 days of each 28-day cycle. This is because oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of cancer, though it does not eliminate this risk entirely. This is known as combined HRT. If a woman has had her womb surgically removed (a hysterectomy), endometrial cancer is not a risk, and a progestogen is not necessary as part of HRT (unless the woman has a history of endometriosis).

2.    Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis (Estradot 50, 75 and 100 only)

Women considered to be at risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy (eg prednisolone), those with a small thin frame, and smokers.

How do Estradot patches work?

Women's ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching. Oestrogen can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor. HRT is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

Estradot patches are a continuous, oestrogen-only form of HRT. They release estradiol through the skin into the bloodstream at a constant rate and are designed to be changed twice a week.

How do I use Estradot patches?

• Follow the instructions provided with your patches carefully.
• One Estradot patch should be applied twice each week to a clean, dry, unbroken, non-irritated area of skin below the waist, on the lower back or buttocks.
• The patch should be worn continuously for three to four days and then replaced. For instance, you could change your patch every Monday and Thursday. Each fresh patch should be applied to a slightly different area to avoid irritating the skin. Leave at least a week before applying a patch to the same site.
• Don't apply powders, creams, lotions or other oily products before applying a patch as they will stop it sticking.
• Patches should NOT be applied on or near the breasts, or under waistbands. They should not be exposed to sunlight.
• You can shower and bath without removing the patch. If a patch falls off before you are due to change it, for example because you have been doing vigorous exercise, sweating excessively, or wearing clothes that rub the patch, you should replace it with a new one. If a patch falls off in the bath, wait for your skin to cool down before applying a new one. Change the new patch on your normal patch change day.
• If you forget to change your patch on your usual day, change it as soon as you remember. Then carry on as before with your usual patch change days.

Important information about Estradot patches

• This medicine will not usually cause a monthly withdrawal bleed, unless you are also prescribed progestogen tablets to take for the last few days of each month. However, you may experience spotting or breakthrough bleeding during the first few months of treatment. Spotting or breakthrough bleeding is more likely if you forget to change a patch on schedule. If any bleeding continues after a few months of using the medicine, or after stopping treatment, you should consult your doctor.
• Women using any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.
• It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancercompared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.
• It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history of blood clots, smoking, obesity, certain blood disorders) and needs to be weighed against the personal benefits to you of taking HRT.
• The risk of blood clots forming in the veins (thromboembolism) while using HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over three hours). For this reason, your doctor may recommend that you stop using HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery.
• Stop using this medicine and inform your doctor immediately if you experience any of the following symptoms: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.

Estradot patches should be used with caution by

• Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.
• Women with a history of benign breast lumps.
• Women with fibroids in the womb.
• Women with a history of endometriosis.
• Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).
• Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis.
• Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.
• Women who are very overweight or obese.
• Women with severe varicose veins.
• Smokers.
• Women with high blood pressure.
• Women with diabetes.
• Women with raised levels of fats such as cholesterol or triglycerides in their blood.
• Women with a history of gallbladder disease.
• Women with a long-term condition called systemic lupus erythematosus (SLE).
• Women who suffer from migraines or severe headaches.
• Women with inherited blood disorders called porphyrias.
• Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while using HRT.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• This medicine should not be used by women who are pregnant or breastfeeding. You should stop using this medicine and consult your doctor immediately if you think you could be pregnant during treatment.
• A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while using this HRT, you should use a non-hormonal method of contraception. Seek further medical advice from your doctor.

Do not be alarmed by the lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Possible side effects

The following diseases are reported more often in women using HRT compared to women not using HRT:

• 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

Stop using Estradot and tell your doctor immediately if you get any of the effects mentioned below:

• Sudden chest pain
• Pain in your chest that spreads to your arm or neck
• Difficulty in breathing
• Painful swelling and redness of the legs
• Yellowing of the eyes and face, darkening of urine, itchy skin (jaundice)
• Unexpected vaginal bleeding or spotting (breakthrough bleeding) after using Estradot for some time, or
  after you stop treatment
• Breast changes, including dimpling of the breast skin, changes in the nipple, lumps that you can see or
  feel (breast cancer)
• Painful menstrual periods
• Unexplained migraine-like headaches

Other side effects:

• Very common (may affect more than 1 in 10 people): headache, skin reactions at the patch application site (including irritation, burning, rash, dryness, bleeding, bruising, inflammation, swelling, skin pigmentation, hives, and blisters), breast tension and pain, menstrual pains, menstrual disorder.
• Common (may affect up to 1 in 10 people): depression, nervousness, mood changes, sleeplessness, nausea (feeling sick), indigestion, diarrhoea, abdominal pain, bloated feeling, acne, rash, dry skin, itching, breast enlargement, heavy menstrual periods, a white or yellowish discharge from the vagina, irregular vaginal bleeding, severe uterine contractions, inflammation of the vagina, abnormal growth of the womb lining (endometrial hyperplasia), pain (e.g. back pain, arms, legs, wrists, ankles), weakness, fluid retention (oedema) in the extremities (hands and feet), weight changes.

When to start treatment

• If you are currently not using any form of HRT (patches or tablets), or if you have been using a continuous combined HRT product (where oestrogen and the progestogen are given every day without interruption), you can start to use Estradot on any convenient day.
• If you are changing from a cyclic or sequential HRT treatment (where the progestogen is added for 12-14 days of the cycle), you should start to use Estradot on the day after you complete your previous cycle.

How long to use Estradot

It is important that you use the lowest possible effective dose and only as long as needed. If you want to continue using HRT for longer than a few months, discuss the possible risks and benefits with your doctor. From time to time, you should discuss with your doctor whether you still need the treatment.

How can Estradot patches affect other medicines?

•           The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back: aprepitant, bosentan, barbiturates, carbamazepine, cobicistat, crizotinib, dabrafenib, efavirenz, eslicarbazepine, fosaprepitant, fosphenytoin, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, ritonavir, rufinamide, telaprevir, the herbal remedy St John's wort (Hypericum perforatum), topiramate, vemurafenib.
•           Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while using this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.
•             This medicine may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are using HRT, but this is particularly important if you are also taking medicines for high blood pressure.
•           This medicine may also oppose the fluid-losing effect of diuretic medicines.
•           This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.
•         This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects: aminophylline, ropinirole, selegiline, theophylline, tizanidine.

How to apply Estradot

• Each patch is individually sealed in a protective pouch. Tear open this pouch at the indentation and remove the patch (do not use scissors to open the pouch as this could damage the patch).
• A stiff protective backing covers the sticky side of the patch. This backing must be removed before the patch is stuck to the skin. Apply the patch immediately after opening the pouch and removing the protective backing.
• Hold the patch with the protective backing facing you. Peel off one side of the protective backing and discard it. Try to avoid touching the sticky side of the patch with your fingers.
• Holding the other half of the backing, apply the sticky side of the patch to a dry area of your lower abdomen. Press the sticky side to the skin and smooth down. Fold back the remaining side of the patch.
• Grasp the straight edge of the protective backing and pull it off the patch.
• Press the sticky remaining side of the patch to the skin and smooth down. Press the patch firmly in place with the palm of your hand for about 10 seconds.
• Make sure that the patch sticks properly to your skin and go over the edges with your finger to ensure good contact between the patch and skin.
• When changing the patch, peel it off, fold it in half with the sticky side inwards. Do not flush used patches down the toilet.

Further useful information

Bathing, swimming, showering or exercising should not affect the patch if it has been correctly applied. If a patch falls off, e.g. during bathing or showering, shake it to remove the water. After careful drying and cooling down of the skin, reapply the same patch on a different area of the lower abdomen.

If the patch does not stick completely to your skin, use a new patch. No matter what day this happens, go back to changing this patch on the same days as your original schedule.

When sunbathing or using a solarium, the patch should be covered. When swimming, the patch can be worn under your bathing suit.

If you use more Estradot than you should

Remove the patch if you have used too much Estradot. Symptoms of overdose are usually tenderness of the breasts and/or vaginal bleeding. Acute overdose is unlikely due to the way Estradot is used (patch). If symptoms persist contact your doctor.

If you forget to use Estradot

If you forget to change the patch, change the patch as soon as you remember. No matter what day this happens, go back to changing the newly applied patch on the same days as your original schedule.

Do not use a double dose to make up for the forgotten patch.

If you stop using Estradot

Stopping use of Estradot may increase the risk of breakthrough bleeding or spotting. Talk to your doctor if this occurs. After a long break in treatment, consult your doctor before starting to use the patch again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

How to store Estradot

• Keep this medicine out of the sight and reach of children.
• Store Estradot in the original package in a cool, dry place. Once opened or once the protective pouch has
  been removed, the patch should be applied to the skin immediately.
• Do not refrigerate or freeze Estradot.
• Do not use this medicine after the expiry date which is stated on the carton and patch after ‘EXP’. The
  expiry date refers to the last day of that month.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
• After removing a patch, fold it in half with the sticky side inwards and dispose of it safely out of the
  reach of children. Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy, preferably in the original packaging. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

References:

https://www.netdoctor.co.uk/medicines/a8395/estradot-patches-estradiol/

https://www.medicines.ie/medicines/estradot-transdermal-patches-32070/patient-info

https://www.medsafe.govt.nz/Consumers/cmi/e/estradot.pdf

https://www.drugs.com/sfx/estradot-50-side-effects.html

https://chealth.canoe.com/drug/getdrug/estradot

https://www.medicines.org.uk/emc/product/3869/smpc