Evorel conti patches are a hormone replacement therapy (HRT) preparation. Each patch contains two active ingredients, estradiol (previously spelt oestradiol in the UK) and norethisterone
What are Evorel conti patches used for?
- Hormone replacement therapy to relieve symptoms of the menopause.
- 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
- In December 2003, a review of the available evidence on the risks and benefits of HRT by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) in the UK, concluded that the risks of using HRT long-term to prevent osteoporosis in women aged over 50 years exceed the benefits. As a result this medicine should not be used as a first-line option for preventing postmenopausal osteoporosis in women over 50.
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.
You can read more about the risks and benefits of HRT and other medicines for preventing osteoporosis in the factsheets about menopause and osteoporosis linked above.
How do Evorel conti patches work?
- Evorel conti patches are a hormone replacement therapy (HRT) preparation. Each patch contains two active ingredients, estradiol (previously spelt oestradiol in the UK) and norethisterone. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone.
- 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 (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.
- A progestogen (in this case in the form of norethisterone) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, 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.
- Evorel conti patches are a continuous form of combined HRT. One patch is worn at all times without a break. Each Evorel conti patch contains both estradiol and norethisterone, so that both hormones are received each day. The patches release the hormones through the skin into the bloodstream at a constant rate and are designed to be changed twice a week, ie a patch is worn for three to four days and then replaced with a new one. This type of HRT does not produce a monthly bleed. It is suitable for women whose natural periods have already stopped, eg for postmenopausal women who have not had a period for at least 18 months.
- The declining level of oestrogen at menopause can also affect the bones, causing them to become thinner and more prone to breaking; a condition known as osteoporosis. Oestrogen can therefore also be supplemented to help prevent bone loss and fractures that may occur in women in the years after menopause.
How do I use Evorel conti patches?
- Follow the instructions provided with your patches carefully. There is general information about how to use your skin patches here.
- One Evorel conti patch should be applied twice each week to a clean, dry, unbroken, non-irritated area of skin below the waist, preferably on the buttock or hip.
- The patch should be worn continuously for three or 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 Evorel conti patches
- This medicine will not usually cause a monthly menstrual bleed. 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 cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting 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 (eg deep vein thrombosis/pulmonary embolism) 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 - see cautions below) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment.
- 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. Discuss this with your doctor.
- 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.
- 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 a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.
Evorel conti 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 (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.
- Women with high blood pressure.
- Women with heart failure.
- Women with kidney problems.
- 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 epilepsy.
- Women with a history of asthma.
- Women with a history of depression.
- 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 taking HRT.
Evorel conti patches 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 with inherited blood disorders called porphyrias.
- 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 Evorel conti patches
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.
- Redness or itching at patch application site.
- Gut disturbances, such as nausea and vomiting, abdominal pain, bloating, flatulence, indigestion.
- Menstrual bleeding or spotting. See important information above.
- 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.
- 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 (eg, DVT, pulmonary embolism, stroke, heart attack).
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 Evorel conti patches 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.
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:
- the herbal remedy St John's wort (Hypericum perforatum)
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: