Estradot Patch

ESTRADOT is used to relieve symptoms you may experience at the time of the menopause (the time when your menstrual periods stop), whether occurring naturally or as a result of a surgery. It can also be used to prevent osteoporosis (thinning of the bones, which causes fractures), the risk of which may be increased after the menopause. You and your doctor should discuss the benefits and risks of ESTRADOT and other alternative therapies. Relief of the symptoms of the menopause: ESTRADOT is used to help relieve the discomfort that you may experience during and after the menopause. Menopause occurs naturally in all women, usually between the ages of 45 and 55. It also occurs in younger women who have their ovaries removed by surgery. After the menopause, your body produces estrogens in much smaller amounts than it did before.

This can cause unpleasant symptoms such as hot face, neck and chest, "hot flushes" (sudden waves of heat and sweating in the whole body), sleep problems, irritability and depression. Estrogens can be given to reduce or eliminate these symptoms. Prevention of osteoporosis: After the age of 40, and especially after the menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break. It affects the bones of the spine, hip and wrist in particular. The risk of osteoporosis is increased by a lack of estrogens. Taking estrogens after the menopause slows down bone loss and can help to prevent osteoporosis. You and your doctor should discuss the benefits and risks of ESTRADOT and other alternative therapies. ESTRADOT should not be used to prevent heart disease. ESTRADOT is not a contraceptive, nor will it restore fertility. Ask your doctor if you have any questions about how ESTRADOT works or why this medicine has been prescribed for you.

Follow all instructions given to you by your doctor or pharmacist carefully. Read the following information before you use ESTRADOT. Do not use ESTRADOT:

• If you have ever had any unusual or allergic reaction to estrogens or any of the other components of the patch.
• If you currently have or have ever had a cancer of the breast, endometrium (lining of the womb) or any other cancer which is sensitive to estrogens.
• If you have abnormal vaginal bleeding.
• If you currently have a severe liver disease.
• If you currently have a problem with blood clot forming in your blood vessels or have ever had such a problem in the past. This may cause a painful inflammation of the veins (thrombophlebitis) or blockade of a blood vessel in the leg (deep vein thrombosis), the lungs (pulmonary embolism), or other organs.
• If you have ever had a heart attack or stroke.
• If you have had several miscarriages.
• If you are pregnant or think you may be pregnant.
• If you are breast feeding.
• If you have depression, which is not well controlled with treatment.
• If you have had depression with previous use of estrogen and/or progesterone/progestogen containing medicines.

Talk to your doctor if you have any further questions or if you think that any of the above may apply to you. Further safety measures: Before you start using ESTRADOT you will discuss with your doctor your personal medical history and that of your family. You will also be given a complete physical and gynaecological examination. Tell your doctor if you currently have, or have ever had, any of the following conditions:

• Breast cancer in your immediate family.
• Lumps in your breast.
• Fibroids or other benign tumours of the womb.
• Endometriosis (disorder of the pelvis causing painful menstrual periods).
• Jaundice or itching related to estrogen use or during pregnancy.
• Heart, kidney, or liver problems.

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. 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 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 patch firmly in place with the palm of your hand for about 10 seconds. Make sure that the patch is properly adhered to your skin and go over the edges with your finger to ensure good contact around the patch. Apply the patch immediately after opening the pouch and removing the protective backing. ESTRADOT should be worn continuously until it is time to replace it with a new patch. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.

Other useful information:

• Bathing, swimming, showering or exercising should not affect the patch if it has been applied correctly. If the patch does come off, e.g. in the bath or shower, just shake it to remove any water, dry the skin thoroughly, reapply it and continue with your regular schedule.
• Sunbathing: always make sure your patch is covered by clothing.
• Swimming: you can wear the patch under your swimming costume.
• Never apply a patch to sweaty skin or straight after a hot bath or shower. Wait until the skin is completely cool and dry.
• If a patch falls off, the same patch may be put on a different area of your abdomen. Make sure you choose a clean, dry, lotion-free area of skin. If the patch does not stick completely to your skin, use a new patch. No matter what day this happens, go back to changing the patch on the same days as the initial schedule.

Do not share medicines prescribed for you with others. If you use more ESTRADOT than you should: Because of the way it is administered, it is unlikely that you will use more ESTRADOT than you should. If this does happen, contact your doctor immediately. If you forget to use ESTRADOT: If you miss applying a patch, reapply another patch as soon as you remember. No matter what day that happens, go back to changing the patch on the same days as your initial schedule. While you are using ESTRADOT: See your doctor regularly and at least once a year for check-up. Some women will need to go more often. You should discuss with your doctor the need for adjusting or continuing therapy. Your doctor will check your breasts and your pelvis. It is important to learn how to examine your own breasts and do this regularly. This helps to prevent unwanted effects of HRT. Tell your doctor if you suspect any abnormality. Tell your doctor well in advance of any expected hospitalisation or surgery. If you have to go into hospital unexpectedly, tell the doctor who admits you that you are using ESTRADOT. The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injuries or having to stay in bed for a prolonged period. ESTRADOT should not be restarted until you are fully mobile. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using ESTRADOT. Ask your doctor or pharmacist to answer any questions you may have.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Tell your doctor immediately and remove the patch if any of the following occur:

• Signs of an allergic reaction: sudden troubled breathing, tightness of the chest, general rash, swelling or itching.
• Signs of jaundice: yellowing of the eyes or the skin.
• Signs that blood clots may have formed in your body: pains in the calves, thighs or chest, sudden shortness of breath, coughing blood or dizziness.
• Signs of heart attack: chest pain, dizziness, nausea, shortness of breath, irregular pulse.
• Signs of stroke: collapse, numbness or weakness of the arms and the legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech.

The above side effects are serious and require urgent medical attention. Most of these side effects are rare. Tell your doctor if you notice any of the following:

• Mood changes, including depression, headache, migraine, dizziness, uncontrollable jerky movements (chorea).
• Nausea, vomiting, cramps in the abdomen, bloated feeling.
• Spotty darkening of the skin, particularly on the face (chloasma).
• Redness, rash, or itching of the skin after the patch has been removed, hair loss, excessive hairiness.
• Vaginal bleeding or spotting.
• Enlargement in size of fibroids.
• Vaginal thrush (vaginal fungal infection with severe itching, vaginal discharge).
• Changes in vaginal discharge.
• Tender or enlarged breasts.
• Change in weight.
• Swelling of the lower legs, ankles, fingers or abdomen due to fluid retention (oedema).
• Changes in your sex drive.
• Contact lens discomfort.
• Worsening of porphyria (a condition affecting the liver).
• Gall bladder disease (tendency to form gall stones).

The following side effect is reported from post-marketing experience: Suicidal thoughts/behavior and suicide. If you notice any side effects not mentioned in this leaflet, tell your doctor. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

• Store at or below 25 °C.

• STORE ALL MEDICINES OUT OF THE 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 ESTRADOT after the expiry date shown on the box.

• Do not use any ESTRADOT pack that is damaged or shows signs of tampering.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).