Please read this booklet carefully, it contains important information about Evorel patches and tells you what you should know to be able to use them correctly. This booklet answers some common questions regarding the use of Evorel patches (but does not contain the complete information). If you have any questions about what is written here, or wish for any further information, please ask your doctor or pharmacist.

The book contains general information about the menopause and why Hormone Replacement Therapy (HRT), such as Evorel is useful.

Evorel patches contain a natural oestrogen called oestradiol. The patches come in 4 different sizes: Evorel 25, Evorel 50, Evorel 75 and Evorel 100. The patches contain 1.6 mg, 3.2 mg, 4.8 mg, 6.4 mg of oestradiol and deliver 25, 50, 75 and 100 mcg of oestradiol respectively per 24 hours.

Evorel patches also contain other ingredients as follows: Duro-Tak 280-2287, Guar Gum; Hostaphan MN19.

Evorel patches are square shaped, transparent patches with a self-adhesive backing which can be stuck to the skin.

Evorel 25 is marked CE25 and has a surface area of 8 sq cm.

Evorel 50 is marked CE50 and has a surface area of 16 sq cm.

Evorel 75 is marked CE75 and has a surface area of 24 sq cm.

Evorel 100 is marked CE100 and has a surface area of 32 sq cm.

In each patch the oestradiol is spread evenly in the adhesive and this passes slowly through the skin into the body.

Evorel patches come in a memory pack containing 8 patches.

An Evorel patch is a hormone replacement therapy (HRT).

Product licence holder: Janssen-Cilag Ltd, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ.

Manufactured by: LTS Lohmann GmbH & Co KG Lohmannstrasse 2, D-56626 Andernach, Germany.

Evorel patches are used for hormone replacement therapy in the treatment of symptoms of the menopause. These may be caused by a lack of naturally occurring oestrogens and progestogens.

Women produce oestrogen hormones from their ovaries throughout their adult life. These hormones have many effects, e.g., sexual development and control of the menstrual cycle.

The menopause occurs when a woman's ovaries cease to function and there is a decline in the levels of hormones produced by the ovaries, one of these being oestrogen. This is a gradual process which takes place over a number of years - a time known as the 'change of life'. During this time oestrogen levels fluctuate and decline and it is this which causes symptoms such as hot flushes, night sweats, mood swings and local vaginal symptoms such as dryness and itching and uncomfortable or painful intercourse. Low oestrogen levels also result from surgical removal of the ovaries - this may be done at the same time as a hysterectomy (womb removal). This is described as

a surgical menopause and may cause the same symptoms as given above.

The Evorel patch replaces the natural oestrogen that is normally released by the ovaries. It does this by passing the oestrogen from the patch into the body through the skin. The active levels of oestrogen in the body are reached about 4 hours after the patch is applied to the skin and last for 3 to 4 days after which the patch must be changed.

Do not use Evorel patches if you are pregnant or think that you might be pregnant; if you are breast feeding.

Do not use Evorel patches if you have, or have ever had cancer of the breast or womb, or other cancers known to be sensitive to oestrogens.

Do not use Evorel patches if you have any of the following: severe liver, kidney or heart disease, blood clots (thrombosis); inflammation of veins, undiagnosed vaginal bleeding; endometriosis; hypersensitivity to any of the ingredients in Evorel patches; Rotor Syndrome or Dubin-Johnson Syndrome.

If you have any of the following you may still be able to use Evorel patches but you should discuss this with your doctor first. He/she may need to see you more regularly whilst you are using Evorel. History of: thrombosis, blood clots, stroke, heart attack. Epilepsy diabetes, high blood pressure, certain liver problems which may cause jaundice, any problems with your breasts or a family history of breast cancer, uterine fibroids, gallstones, otosclerosis (bone formation in the ear), multiple sclerosis, systemic lupus erythematosus (SLE; Lupus), porphyria, melanoma, migraine, asthma, as these conditions may be worsened by oestrogen HRT.

If you are not sure about any of the conditions mentioned above please consult your doctor.

It is important that you have a full and thorough physical and gynaecological examination and that your own and family's medical histories are taken before you start any Hormone Replacement Therapy.

There is some evidence that HRT may increase the risk of breast cancer in post menopausal women. If you have taken HRT for 5 years you should discuss with your doctor whether you should receive further HRT treatment.

If you still have your womb (i.e., have not had a hysterectomy) taking oestrogen alone may increase the risk of overgrowth of the womb lining. You should discuss this with your doctor who may prescribe another hormone progestogen to take with the oestrogen.

You should receive regular full medical examinations whilst taking Evorel.

If you have had a blood clot in the leg or lung, a stroke or a heart attack or are immobile for any reason, such as after an operation, you may still be able to use Evorel patches but your doctor should decide this and check you regularly if you do use it. If this occurs while using Evorel, treatment should be stopped and your doctor contacted immediately.

Evorel patches should not be used by children.

Evorel patches should not be used for contraception .

Some medicines can alter the way Evorel works, such as barbiturates, hydantoins, carbamazepine, meprobamate, phenylbutazone and rifampicin. If you are taking any of these medicines consult your doctor.

Evorel patches are available in 4 different sizes: Evorel 25, Evorel 50, Evorel 75 and Evorel 100. These contain different amounts of the oestrogen hormone oestradiol. Your doctor will choose which size is suitable for you to use.

The following instructions apply to all 4 sizes of Evorel patches:

1. When to use the patch

There is enough hormone in each patch to last for several days but to ensure a steady supply to the body, the patches must be changed at 3 or 4 day intervals. To make it easy to remember when this should be done, keep to the same two days every week. This will mean that one patch is on for three and the other for four days. For example, if you use your first patch on a Monday, it should be changed on Thursday and again on the following Monday.

You can work out your two days from the following table, starting from the first day of use:

To help you remember your "two patch change" days, mark them as shown:

2. How to put the patch on

The patch should be applied to clean, dry skin but not on top of cuts, spots or other skin blemishes OR on an area where you have just applied cream, moisturiser or talc.

The Evorel Patch should be applied to the skin as soon as it is removed from the wrapper and applied as described below.

1. Tear open the wrapper, first between the 'V's along one edge and then along the other edge. Take out the patch.
2. With the silver foil facing you, bend the patch and peel off one half of the foil. Do not touch the sticky side of the patch otherwise it may not stick properly.
3. Apply the open half of the patch to your skin, remove the other half of the foil and press down the rest of the patch.
4. Press the patch with the palm of your hand to ensure it is firmly stuck to the skin.
5. To remove, peel away an edge of the patch and pull smoothly away from the skin.
6. You may use baby oil to help remove any gum/glue which may remain on your skin after patch removal.

Most women prefer to wear the patch on the thigh or bottom. It should NEVER be worn on or near the breasts. Although it can be worn underneath clothing, it should not be placed under elasticated waistbands.

The patch should not be placed on the same area of skin twice in a row.

Just apply a new patch and keep to your original 'patch change' days. If you have just had a bath or

shower, wait until your skin cools before applying a new patch.

Just change it as soon as possible and then keep to your original 'patch change' days.

Overdosage with a patch is unlikely. Effects of too much oestrogen can be reversed simply by removal of the patch. Your doctor may decide to change you to a different size of Evorel patch. The most common symptoms of oestrogen overdose are breast tenderness, nausea and irregular bleeding.

As with any other medicines, in a few women, Evorel patches may cause some unwanted effects. Most are usually minor and will disappear within a couple of months, for example:

• Headaches
• Local skin irritation
• Nausea
• Tender breasts
• Irregular vaginal bleeding

Rarely, dizziness, bloating, fluid retention, weight gain and leg cramps may occur.

If such side effects are prolonged, or if you react to the patch itself with skin rashes or irritation, remove the patch and ask your doctor for advice. If you notice any other symptoms not listed above whilst using the patch, please tell your doctor about them.

Evorel patches should be stored at room temperature (not exceeding 25ºC). Keep out of reach of children.

Do not use this medicine:

• After the expiry date shown on the label.
• If the pouch is open.

YES, but do not scrub too hard in case you loosen the edges of the patch.

YES, the patch will not be affected.

YES, try to avoid wearing it under tight clothing or waistband.

YES, but keep the patch covered to avoid direct sunlight.

As with normal sticking plaster, allergic reactions to the patch are unlikely. However, should you have such a reaction, please consult your doctor.

NO, the levels of hormone supplied by the Evorel patch are too low for it to do this. Although menopausal women face an ever-decreasing risk of pregnancy, normal precautions should be taken during sexual intercourse. If in doubt, consult your doctor.

Date of preparation: July 1995.