oestradiol

oestradiol

Information for patients

What you need to know about Estraderm MX

Please read this leaflet carefully before you start to use your patches. It contains important information about your patches.

What’s in your medicine

Estraderm MX patches contain a substance called oestradiol. Oestradiol is a form of oestrogen and belongs to a group of medicines known as Hormone Replacement therapy (HRT).

The patches come in three sizes:

Estraderm MX 25 contains 0 75mg oestradiol. Your body will absorb about 25 micrograms of oestradiol each day whilst you are wearing an Estraderm MX 25 patch.
Estraderm MX 50 contains 1.49 mg oestradiol. Your body will absorb about 50 micrograms of oestradiol each day whilst you are wearing on Estraderm MX 50 patch.
Estraderm MX 100 contains 2.99mg oestradiol. Your body will absorb about 100 micrograms of oestradiol each day whilst you are wearing an Estraderm MX 100 patch.

The patches also contain acrylate esters and isopropyl palmitate. The oestradiol is plant-derived and synthetically produced. A one month calendar pack contains 8 patches; a three month pack contains 24 patches of one size.

Made by: Lohmann LTS, Lohmannstr. 2, P.O. Box 1525, 56605 Andernach, Germany.

Supplied by: Ciba Pharmaceuticals,

Horsham, West Sussex. RH12 4AB

Product Licence Holder: Cibo-Geigy plc, Hulley Road, Macclesfield, Cheshire.

SK10 2NX

What this medicine is used for

Estraderm MX is used to relieve symptoms of the menopause (change of life), such as hot flushes and night sweats. Your doctor may also prescribe this product for the prevention of osteoporosis (thinning of the bones).

Before taking your medicine

Have you ever had treatment for a breast lump or any serious disease of your womb?
Do you have any liver, kidney or heart disease?
Are you being treated for a thrombosis (blood clot) of any kind?

Have you had any bleeding between periods or since your last period, if your periods have stopped?

Is there any chance that you may be pregnant?

Are you allergic to any components of this patch (see "What’s in your Medicine")

If the answer to any of these questions is YES, do not use the patches without talking to your doctor again.

Do you have lumpy or painful breasts?

Do you have fibroids?

Do you suffer from epilepsy (fits) or migraine?

Do you have diabetes?

Have you ever suffered from hearing loss during pregnancy or when taking oestrogens, for example, oral contraceptives?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Are you taking any of the following:

Barbiturates or meprobamate?
Hydantoins or anticonvulsants?
Phenylbutazone?
Antibiotics?
Activated charcoal?
Any other medicines which your doctor does not know about?

If the answer to any of these questions is YES, tell your doctor or pharmacist.
Other special warnings

Whilst you are receiving Estraderm MX you should have regular check-ups with your doctor. He or she will tell you how often this should be

You should not use Estraderm MX if you are pregnant or breast feeding.

Taking your medicine
Using your patches:

Always use your patches as directed by your doctor

Most women using Estraderm MX will have had a hysterectomy (an operation to remove the womb).

If you have not had a hysterectomy you will need to take another hormone called progestogen for 12 days each month. You will probably have a ‘period’ each month towards the end of the course of progestogen. This is quite normal.

The patches should be changed twice each week, always on the same two days. You may find it helpful to tick the box on the inside cover of the wallet for the day of the week when you apply your first Estraderm MX patch. This then shows the two days each week when you should change your patch. When you finish on Estraderm MX pack, start the next pack straight away. There is no need to have a break between packs.

Putting on a patch:

Remove one sachet from the box and tear it open at the notch. Use your fingers because cutting with scissors might damage the patch inside.

Take out the patch and remove the backing by removing the (smaller) backing strip. Then peel off the larger piece. Try to avoid touching the adhesive Now apply the patch at once.

Stick the patch on to a hairless area of skin below the waist. Most patients find that the buttock is the best place. You could also try the lower back, hip, abdomen or upper thigh. Never put a patch on or near the breasts Choose a clean, dry area of skin. Avoid skin which is red or irritated. Never powder or oil your skin before putting on a patch as it may not stick properly

Place the sticky patch on the area of skin you have chosen and press it firm into position with the palm of your hand. Pressing for 10-20 seconds or so will make it stick securely. Run your finger around the edge of the patch to make sure that the edges stick. Provided that you have applied the patch correctly, you can bathe, shower or swim with little risk of the patch coming off.

When the time comes to change your patch, take off the old one, fold it in half with the sticky side inwards and throw it away carefully out of the reach of children. Remember, it will still contain some medication.

Always place your new patch an a fresh area of skin.

If you forget to change the patch at the right time, you should change it as soon as possible. Then continue to change your patches on the usual days as normal.

After taking your medicine

These patches may sometimes cause unwanted effects in some people. These include:

Headaches, nausea or breast tenderness

Cramping pains in calf

Feeling slightly bloated

Dizziness

Unusual weight changes or fluid retention

Trouble with your veins

Increase in blood pressure

Slight redness and itching of the skin where a patch has been. This usually disappears within 3-4 days of taking off the patch

Breakthrough bleeding ("spotting:) between periods (if you have not had a hysterectomy)

These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor. Also if your patches upset you in any other way tell your doctor.

Storing your medicine

The expiry date for these patches is given on the carton. Do not use the patches after this date.
Store your medicine in a cool place (below 25°C) out of reach of children. Return any unused patches to your pharmacist.

Other useful information

Sunbathing – always make sure your patch is covered by clothing.

Using a sunbed – cover up your patch as above.

Swimming – you can wear your patch beneath your swimming costume during swimming.

Never stick on a patch straight after a hot bath or shower. Wait a while for the skin to become completely cool and dry.

If a patch comes off, apply a new patch in the usual way. Remember to apply your next patch at the normal time. If you have run out of patches, contact your doctor straight away.

REMEMBER: this medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you.

The information in this leaflet applies only to Estraderm MX This leaflet does not contain the complete information about your patches. If you have any questions or are not sure about anything ask your doctor or pharmacist

Ciba Laboratories

Wimblehurst Road, Horsham

West Sussex RH12 4AB

Date: January 1996