Oestrogel What is in the tube? Oestrogel containing oestradiol. Oestrogel is a special gel formulation; every 100 grams contains 60 mg of oestradiol as the active ingredient. Oestrogel is the main oestrogen (female sex hormone) produced by the human ovary. The gel also contains carbomer ethanol, triethanolamine and purified water. The dispenser contains 80 grams of gel. Product licence holder: Cox Pharmaceuticals, A.H. Cox & Co Ltd, Whiddon Valley, Barnstaple, Devon EX32 8NS. Manufacturer: Laboratoires Besins Iscovesco, 8 Rue Morel, 92120 Montrouge, France. What is it for? Oestrogel is designed to provide hormone replacement (HRT) for the relief of symptoms of the menopause such as hot flushes and sweats. Oestrogel is not a contraceptive, nor will it restore fertility. If you need advice on Family Planning please consult your doctor. Before using Oestrogel Do not use if: You are pregnant, or you suspect that you might be pregnant. You are receiving treatment or you have been treated for any kind of blood problem, such as blood clots, in the past. You suffer from a serious liver, kidney or heart disease, have high blood pressure, or have a condition known as porphyria. You have had treatment for a breast lump, or any disease of the womb. You have had some bleeding since your last period, or between periods if these are still regular. Consult your doctor before taking this product if: You have not had a complete physical and gynaecological examination. You have not had a hysterectomy and your doctor has not prescribed other medicine to take while using Oestrogel. You have breast pain or a strong family history of breast cancer. You have high blood pressure or a history of high blood pressure. You are due to have an operation in the near future. You suffer from gallstones or have a history of endometriosis (overgrowth of the lining of the womb). Use with other medicines Ask your doctor before using skin cleansers and other skin care products during treatment with Oestrogel. Special warnings DO NOT EXCEED THE PRESCRIBED DOSE. if the prescribed dose does not provide adequate relief of symptoms, consult your doctor. DO NOT APPLY ON OR NEAR THE BREASTS, OR ON THE GENITAL REGION. DO NOT ASK ANYONE ELSE TO APPLY THE GEL. Only you should apply Oestrogel, and you should avoid close skin contact with your partner for one hour after application. DO NOT WASH the skin or apply other skin care products until at least one hour after application. DO NOT USE strong skin cleaners or detergents when washing the area of application. Directions for use Oestrogel should be used as directed by your doctor. For topical use only. If you are still having regular periods you should begin Oestrogel medication within 5 days of the start
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of bleeding. If your periods have stopped, or are irregular, you can start Oestrogel medication at any time. Oestrogel may be applied once daily either in the morning or evening after washing, but preferably about the same time each day. If your doctor has prescribed 2 measures of gel, you will need one measure spread over each arm and shoulder, or each inner thigh. If 4 measures of gel have been prescribed you will need 2 measures on each arm and shoulder or inner thigh. The template You have been provided with a template which when placed on the skin of the shoulder/arm or inner thigh will show you the minimum area of skin over which to spread Oestrogel. The dispenser You have been provided with a dispenser (1); take the plastic cap off the dispenser. Underneath the plastic cap is a plunger which can be pressed down to measure out the correct amount of gel. A safety lock stops the plunger from being pressed down when it is not in use (2). To release this safety lock - turn the plunger until the notch on the transparent band beneath the plunger is in line with the spout (3). The plunger is now free to move downwards and the dispenser is ready to use.
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notch is no longer in line with the spout (7). Do not forget to replace the plastic cap (8). N.B. If on release of pressure the dosing head does not spring up to its initial position, this means that the dispenser is nearly empty and should no longer be used. Do NOT apply on or near the breasts, or on the genital region. Leave to dry for 5 minutes before covering with clothes. Progestogen tablets: Unless you have had a hysterectomy, your doctor will have prescribed a progestogen tablet to be taken while receiving Oestrogel medication . Take the tablets as instructed by your doctor. It is best to take the tablet either just before or just after applying Oestrogel. While you are using both Oestrogel and a progestogen you may have a period towards the end of the treatment with progestogen tablets, this is quite normal. You may find it helpful to tick off each day on the enclosed calendar. This will assist you in keeping a record of your medication and remind you when the next course of tablets is due. Side effects Your doctor will arrange for a complete physical and gynaecological examination before treatment and for regular check-ups while you are using Oestrogel, this is normal practice for patients receiving hormone |
replacement therapy. Oestrogel may cause unwanted effects in some people such as:
If these or any other unwanted effects occur with any severity you should consult your doctor. Use by date Do not use after the expiry date shown on the carton and dispenser. The dispenser will provide at least 64 full measures of 1.25 9. If using 2 measures a day, start a new dispenser at the beginning of each month. If using 4 measures a day you will need to start a new dispenser after 2 weeks. Storage conditions The dispenser should be stored away from heat (at a temperature of less than 25ºC). Like all pressurised containers, the dispenser should neither be pierced nor placed in a fire, even when empty. If you need further information about the use of Oestrogel please ask your doctor or pharmacist. Leaflet last revised November 1994 Distributor: Hoechst Roussel Ltd, Cassenne Division, Broadwater Park, Denham, Uxbridge, Middlesex UB9 5HP. |