50 mcg oestradiol (meprobamate) patches

1 mg norethisterone tablets

Please read this booklet carefully, it contains important information about Evorel Pak and tells you what you should know to be able to use it correctly. This booklet does not contain the complete information regarding the use of Evorel Pak. If your have any questions about what is written here, or need any further information, please ask your doctor or pharmacist.

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

Evorel Pak contains Evorel 50 patches and norethisterone tablets.

Evorel 50 patches contain a natural oestrogen called oestradiol (estradiol). Each patch contains 3.2 mg of oestradiol and delivers 50 mcg of oestradiol per 24 hours.

Evorel 50 patches also contain other ingredients as follows: Duro-Tak 280-2287, Guar Gum- Hostaphan MN19.

Evorel 50 patches are square shaped, transparent patches with a self-adhesive backing which can be stuck to the skin. Each patch is marked with CE50 and has a surface area of 16 sq. cm.

Norethisterone tablets contain a progestogen hormone called norethisterone. Each tablet contains 1 mg norethisterone.

Other ingredients: Anhydrous lactose, pregelatinised starch, magnesium stearate.

A slim cardboard box containing 8 patches and 12 tablets in silver foil in the inside of the box lid.

Norethisterone tablets are round white tablets engraved with C over 1 on both sides.

Evorel Pak belongs to the group of medicines known as Hormone Replacement Therapy (HRT).

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

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

Tablets: Cilag AG, Hochstrasse 201/209, CH-8201 Schaffhausen, Switzerland.

Evorel Pak is 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.

applied to the skin and last for 3 to 4 days after which the patch must be changed.

In women who still have a uterus(womb), taking oestrogen regularly may cause the lining of the womb to build up and thicken. It is necessary to shed this lining regularly to prevent any problems occurring. Adding a progestogen hormone to the oestrogen treatment for approximately 12 days of the 28 day cycle, will cause the lining to be shed to protect the womb. This produces a few days of withdrawal bleeding at the end of each cycle, rather like a period.

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

Do not used Evorel Pak 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 Pak 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 or the tablets; Rotor Syndrome or Dubin-Johnson Syndrome or if you had jaundice, severe itching or a skin condition called pemphigoid gestationis during pregnancy.

If you have any of the conditions listed below you may still be able to use Evorel Pak but you should discuss this with your doctor first. It may be necessary for you to be seen more regularly whilst you are taking this treatment.

History of: thrombosis/blood clots, stroke, heart attack, epilepsy or diabetes, high blood pressure, certain liver problems which may cause jaundice, breast disease, family history of breast cancer, fibroids, gallstones, otosclerosis (bone formation in the ear),multiple sclerosis, systemic lupus erythematosus (SLE; Lupus), porphyria, melanoma, 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. Thus it is very important that you use the norethisterone tablets as instructed together with the Evorel patches from this pack.

You should receive regular full medical examinations whilst using Evorel Pak.

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 Pak but your doctor should decide this and check you regularly if you do use it. If this occurs while taking Evorel Pak, treatment should be stopped and your doctor contacted immediately.

Evorel Pak should not be used by children.

Evorel Pak should not be used for contraception.

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

There is enough oestrogen 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 days 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:

Monday Thursday Monday

Tuesday Friday Tuesday

Wednesday Saturday Wednesday

Thursday Sunday Thursday

Friday Monday Friday

Saturday Tuesday Saturday

Sunday Wednesday Sunday

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

Mon Tues Wed Thur Fri Sat Sun

Thur Fri Sat Sun Mon Tues Wed

Also, write your start date in the box provided on the lid. This date will be your day 1 of therapy.

2. When to use the tablets:

You should take one tablet a day for 12 days towards the end of each 28 day cycle i.e. days 15 to 26 (day 15 will be the day you apply your 5th patch).

Further illustration of when to take your patches and tablets is shown inside Evorel Pak.

If you have problems with the bleed at the end of taking the tablets, please discuss this with your doctor.

3. 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.
1. With the silver release liner 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.
1. 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.
1. Press the patch with the palm of your hand to ensure it is firmly stuck to the skin.
1. To remove, peel away an edge of the patch and pull smoothly away from the skin.
1. 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.

There have been no reports of serious ill effects from overdose of norethisterone tablets. If nausea and vomiting or any other problems occur please contact your doctor or nearest hospital casualty department for advice.

As with any other medicines, in a few women, treatment with Evorel Pak may cause some unwanted effects. Most are usually minor and will disappear within a couple of months and should not need you to stop treatment. They are: headaches, migraines, dizziness, local skin irritation or rash (if so please remove patch and consult doctor), nausea, vomiting, abdominal pains, bloating, jaundice, irregular vaginal bleeding, pre-menstrual tension-type symptoms, breast tenderness, increase in breast size nipple secretions, increase in size of fibroids, vaginal thrush, change in genital secretions, cystitis-like symptoms, patches of darkened skin, small red marks on skin, red lumpy swellings on the legs, bruise-like marks on the skin. The patches of darkened skin may not disappear even when you stop using Evorel Pak. Hair loss, excessive hair growth, problems with contact lenses, depression, changes in body weight, water retention (you may notice swollen ankles), leg cramps, change in libido (interest in sex), involuntary limb movements, aggravation of porphyria, raised blood sugar may also occur.

If such effects occur and become troublesome, frequent and/or more severe please consult your doctor for advice.

If you notice any other symptoms not listed above whilst using Evorel Pak, please tell your doctor about them.

Keep away from direct sunlight. Store at room temperature (at or below 25ºC).

Other important points: Keep out of reach of children.

After the expiry date shown on the label. If the tablets or patches are not as described above. If the patch 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.