Oestrogel (estradiol)

• Hormone replacement therapy to relieve symptoms of the menopause.
• As it only contains oestrogen, Oestrogel can be used on its own by women who have had a hysterectomy. Women who have not had a hysterectomy should also be prescribed a progestogen medicine to take with this medicine, for the last 12 to 14 days of each month. 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).
• 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.
• 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 does Oestrogel work?

• Oestrogel contains the active ingredient estradiol, which is a naturally occuring form of the main female sex hormone, oestrogen.
• Womens' 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 (in this case in the form of estradiol) 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.
• Oestrogel is an oestrogen-only form of HRT. The gel is applied to the skin and the estradiol is absorbed through the skin into the bloodstream.

How do I use Oestrogel?

• Follow the instructions provided with your Oestrogel carefully.
• Oestrogel should be applied once each day to a clean, dry, unbroken, non-irritated area of skin on the arms, shoulders or inner thighs. You should apply two measures of the gel to an area of skin twice the size of the template provided with the medicine.
• After applying the gel let it dry for five minutes before dressing and do not wash the area, or apply other skin products (eg creams, lotions, powders) to the area for at least one hour.
• DO NOT apply the gel on or near the breasts, vaginal area or face.
• Avoid getting the gel in contact with your eyes. Wash your hands after applying the gel.
• You should only apply the gel yourself - do not let someone else apply it for you. Avoid skin contact with another person (particularly male) for at least an hour after applying the gel.
• You should avoid using strong skin cleansers and detergents (eg benzalkonium or benzothonium chloride products), skin care products with a high alcoholic content (astringents, sunscreens) and keratolytics (eg salicylic acid, lactic acid) on the areas of skin where you apply Oestrogel.
• You should try and apply the gel at the same time each day. If you forget to apply it at your usual time and it is less than 12 hours late, you should apply the missed application as soon as possible and then carry on as usual. If you forget to apply the gel and it is more than 12 hours late, you should leave out that dose and just apply your next dose as usual at your usual time. Do not apply double the amount of gel to make up for a missed application.

Oestrogel 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 (fibrocystic breast disease).
• 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 or pulmonary embolism).
• 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.

Oestrogel should not be used by

• Women with known, suspected, or a past history of breast cancer.
• Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).
• Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).
• Women with vaginal bleeding where the cause is not known.
• Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C deficiency, protein S deficiency or antithrombin deficiency.
• Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• Women with inflammation of a vein caused by a blood clot (thrombophlebitis).
• Women who have recently had a stroke caused by a blood clot.
• Women who have recently had a heart attack.
• Women with angina pectoris.
• Women with active liver disease, eg hepatitis, liver cancer, or a history of liver disease when liver function has not returned to normal.
• Women who are pregnant or breastfeeding.

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

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• 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 (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

Possible side effects of Oestrogel

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.

• Gut disturbances, such as nausea and vomiting, abdominal pain, bloating, flatulence, indigestion.
• Menstrual bleeding or spotting. 
• Vaginal thrush.
• Increase in the size of uterine fibroids.
• Breast pain, tenderness or enlargement.
• Fluid retention, causing swelling (oedema).
• Headache or migraine.
• Premenstrual-like symptoms.
• Depression, anxiety or mood changes.
• Changes in sex drive.
• Fatigue.
• Dizziness.
• Weight changes.
• Leg cramps.
• Rise in blood pressure.
• Steepening of corneal curvature, which may make contact lenses uncomfortable.
• Skin reactions such as rash and itching.
• Irregular brown patches on the skin, usually of the face (chloasma).
• Disturbance in liver function and jaundice.
• Gallbladder disease.
• Inflammation of the pancreas (pancreatitis).
• Blood clots in the blood vessels.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think is necessary they'll report it for you.

How can Oestrogel affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

You should avoid using strong skin cleansers and detergents (eg benzalkonium or benzothonium chloride products), skin care products with a high alcoholic content (astringents, sunscreens) and keratolytics (eg salicylic acid, lactic acid) on the areas of skin where you apply Oestrogel.

Do not apply other skin products (eg creams, lotions, powders) to the area where you have applied Oestrogel for at least one hour.

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.

References:

https://www.empr.com/drug/estrogel/

https://www.netdoctor.co.uk/medicines/a7261/oestrogel-estradiol/

http://www.estrogel.com

https://www.webmd.com/drugs/2/drug-89430/estrogel-transdermal/details

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

https://www.rxlist.com/estrogel-drug.htm