oestradiol and norethisterone acetate

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

Estracombi TTS patches contain oestradiol and norethisterone acetate. Oestradiol is a form of oestrogen; norethisterone acetate is a progestogen. They belong to a group of medicines known as Hormone Replacement Therapy (HRT).

A one month calendar pack of Estracombi TTS contains:

• 4 Estragest TTS patches each containing 10 mg of oestradiol and 30mg of norethisterone acetate. Your body will absorb about 50 micrograms of oestradiol and 250 micrograms of norethisterone acetate each day whilst you are wearing an Estragest TTS patch.

The patches also contain ethanol, hydroxypropylcellulose, liquid paraffin and polyisobutylene. The oestradiol and norethisterone acetate are plant derived and synthetically produced.

A three month calendar pack contains 12 Estraderm TTS 50 and 12 Estragest TTS patches.

Made by: CIBA-GEIGY Ltd, Stein, Switzerland.

Supplied by: Ciba Pharmaceuticals, Horsham, West Sussex. RH12 4AB

Product Licence Holder: Ciba-Geigy plc, Hulley Road, Macclesfield, Cheshire. SK10 2NX

Estracombi TTS 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).

• 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 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 this medicine without talking to your doctor again.

• Do you have a family history of breast cancer?
• Do you have lumpy or painful breasts?
• Do you have fibroids?
• Do you suffer from epilepsy (fits) or migraine?
• Do you have diabetes?
• Do you suffer from high blood pressure (hypertension)?
• Do you suffer from gallstones?
• 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.

• 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.

• You should not use Estracombi TTS if you are pregnant or breast feeding.
• Whilst you are receiving Estracombi TTS you should have regular check-ups with your doctor. He or she will tell you how often this should be done.
• There is some evidence that HRT used for long periods (over 5 years) may slightly increase the risk of breast cancer. If you have taken HRT for 5 years you should discuss the continuation of HRT with your doctor.

• Always use all your patches in the correct order as directed by your doctor.
• If your periods have stopped or become very irregular, you can start using Estracombi TTS at any time. Otherwise, start using Estracombi TTS within 5 days of the start of your next period.
• The patches should be changed every 3 to 4 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 patch. This then shows the two days each week when you should change your patch.

• For weeks 1 and 2 you should use the Estraderm TTS 50 patches.
• For weeks 3 and 4 you should use the Estragest TTS patches.
• It is important that you use all the Estraderm TTS 50 patches followed by all the Estragest TTS patches in the correct order each month. If, for any reason, a patch becomes unusable or you lose it, use a fresh patch of the same sort, preferably taken from a spare pack. You should then keep this pack as a spare pack until its expiry date. If this is not possible or leaves you without adequate supplies, contact your doctor.
• You may find that you have some irregular bleeding or spotting during the first month or so of treatment. Once your treatment has become settled, you will probably have a period' each month starting during Week 4, shortly before you finish an Estracombi TTS pack. This is quite normal. If, however, you continue to have irregular bleeding or spotting, tell your doctor.
• When you finish an Estracombi TTS pack, start the next pack straightaway. There is no need to have a break between packs.

• 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. You must never cut or tear your patches in any way.
• Take out the transparent patch and loosen the backing by rubbing the edge of the patch between your thumb and forefinger. The stiff protective liner will peel away from the flexible, sticky patch.
• Stick the patch onto a hairless area of skin below the waist. Most patients find that the buttock is the best place and that skin irritation is less likely to occur at this site. 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 firmly 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 bath, shower or swim with little risk of the patch coming off.
• If the patch does come off in the bath or shower, just shake it to remove any water, dry the skin thoroughly and put it on again in the usual way.
• 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 on 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 change to your next patch on the normal day.

These patches may sometimes cause unwanted effects in some people. You are unlikely to get any of the following but, if you do, tell your doctor at once.

• difficulty in breathing
• general swelling or itching occurring outside the site of patch application
• tender or painful veins or calves
• yellowing of your skin or eyes

Other effects which may occur include:

• Headaches, nausea or breast tenderness
• Cramping pains in calf
• Feeling slightly bloated
• Slight redness and itching of the skin where a patch has been. This usually disappears within
• 3-4 days of taking off the patch
• Irregular or unusual vaginal bleeding
• Dizziness
• Unusual weight changes or fluid retention
• Increase in blood pressure

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 medicine upsets you in any other way, tell your doctor.

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

• Sunbathing - always make sure your patch is covered by clothing.
• Using a sunbed - either cover up your patch as above or take it off and put it back on after your shower when your skin is completely cool and dry.
• 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 and will not stick back on, 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 straightaway.

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 Estracombi TTS. if you have any questions or are not sure about anything, ask your doctor or pharmacist.

Date: January 1996 Copyright Ciba-Geigy plc