If you would like any more information about your tablets, the menopause or Hormone Replacement Therapy (HRT), after you have read this leaflet, speak to your doctor or pharmacist (chemist).

The active ingredients in your tablets are oestradiol valerate (a type of oestrogen) and norethisterone (a type of progestogen). Oestrogens and progestogens are similar to the natural female sex hormones.

Each tablet contains 2 mg of oestradiol valerate USP and 0.7 mg of norethisterone BP.

The inactive ingredients in your tablets are lactose, maize starch, povidone, talc, magnesium stearate, hydroxypropylmethylcellulose and propylene glycol. The colouring in the tablets is E171 and E172.

CLIMESSE is available as packs of one or three calendar packs. Each calendar pack contains 28 tablets and is marked with the days of the week. This helps you to remember to take your tablets.

CLIMESSE is a Hormone Replacement Therapy (HRT). Your own level of the hormones oestrogen and progestogen fall during the menopause. The active ingredients in CLIMESSE supplement your natural hormones. This help to bring your level of oestrogen and progestogen back to their level before your menopause.

CLIMESSE is made by CP Pharmaceuticals Ltd. Wrexham, Wales.

The company licenced to sell it in the UK is Sandoz Pharmaceuticals (UK) Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 5SG.

Women usually reach the menopause between 45 and 55. There is a natural fall in the level of female sex hormones at this time. The fall in the levels of oestrogen and progestogen can cause unpleasant symptoms.

The menopause affects different women in different ways. Some have no symptoms, or very few, while others have many unpleasant symptoms. These can include: irregular, heavy or light periods; hot flushes, sweats, palpitations, and tingling in the hands and feet; discomfort or soreness during sexual intercourse (this is often due to vaginal dryness); pain when passing water and problems with bladder control; dizziness and headaches; tiredness, sleeplessness, depression and loss of interest in sex.

CLIMESSE helps to relieve these symptoms by supplementing the hormones which are lost at the menopause.

In later life, after the menopause some women develop a condition called osteoporosis, in which the bones lose calcium and become more likely to break. Your doctor may prescribe CLIMESSE to help prevent this condition.

Read this section carefully to make sure that CLIMESSE is right for you. CLIMESSE is only meant for women who are past the menopause. It is not a contraceptive pill. It should not be used in children.

You should not take these tablets if:

• you are pregnant, or think you might be, or you are breast feeding.
• you have ever had breast cancer or any lumps in your breasts (unless your doctor has checked and found them to be harmless). Make sure that your doctor knows if any of your relations have had breast cancer.

Remember, if any of these apply to you, do not take CLIMESSE. Tell your doctor.

Your doctor also needs to know if you have any of these illnesses or problems:

• gallstones, mild liver disease or a tendency to get jaundice, Dubin-Johnson syndrome or Rotor syndrome
• porphyria (your urine turns dark red when it has been standing, and you get skin blisters and/or pains in your abdomen and muscles)
• hearing loss due to 'otosclerosis' (a problem with the bones in your ear)
• migraine (or other very bad headaches) or epilepsy
• cysts or nodules in your breasts, or womb problems such as endometriosis or fibroids
• multiple sclerosis
• diabetes
• systemic lupus erythematosus
• high blood pressure (also known as hypertension)

HRT could make these problems worse. Make sure your doctor knows if you have any of them. You may need extra check-ups before and during your treatment.

The hormones in CLIMESSE are to supplement your own natural hormones and are not likely to react with other medicines. However, you should always tell your doctor about any other medicines you are taking, including ones you have bought yourself.

Contraception CLIMESSE is not a contraceptive pill. It may still be possible for you to become pregnant. If you are using an oral or other hormonal contraceptive, for example the 'pill' or depot injection, you must change to a non-hormonal method, for example, a diaphragm or condom, BEFORE you start your CLIMESSE tablets. However, women who take CLIMESSE should be past the age when they can have children, so if your doctor has already told you that you no longer need to use any form of contraception, you do not need to do so whilst taking CLIMESSE.

Accidents, illnesses and operations If you have an accident, an illness or an operation which will keep you in bed or sitting still for a few days or more, remind your doctor that you are taking CLIMESSE. You may need to stop taking the tablets until you are mobile again. This is because your circulation can be affected. Tell your doctor about your accident, illness or operation as soon as you can.

Check-ups Regular check-ups are important for women, not just women on HRT. Several illnesses do become more common as you get older. A check up before you start taking CLIMESSE and regularly while you are taking it mean that you and your doctor should notice any warning signs as early as possible. This gives you the best chance of tackling any problems successfully and keeping in good health.

Some checks are even more important for women before and during HRT. HRT may increase the risk of breast cancer very slightly if it is used for longer than five or ten years so it is especially important to check your breasts regularly. Your doctor or practice nurse can show you how to do this yourself each month. They may also check your breasts for you at your regular appointments. You may also have a breast

scan (a 'mammography') at your doctor's surgery or in hospital.

You may have an internal (vaginal) examination, your womb checked and regular cervical smear tests as well.

If you have mild liver disease, you will have your liver function checked regularly every 8 to 12 weeks. Likewise, if you have high blood pressure, your doctor will want to keep a special check on you.

When should you take your first tablets? You should not start taking CLIMESSE until at least twelve months after your last natural period.

You should take one tablet each day.

If you have been taking other Hormone Replacement Therapy tablets, carry on until you have taken all the combined (oestrogen plus progestogen) tablets for the month. Usually this will be at the end of your calendar pack. Take your first CLIMESSE tablet the next day. Do not leave a break between your old tablets and the CLIMESSE tablets.

If you have not been taking other HRT preparations, start the tablets on any day. Try taking the tablets at the same time every day to help you remember.

How should you continue with CLIMESSE? swallow one tablet each day. Start your next calendar pack of tablets the day after you finish your previous pack. Do not take a break between packs.

Your doctor will advise you about how long to carry on with HRT. Many women use it for several years. If your doctor has prescribed CLIMESSE to prevent osteoporosis then it's likely that you will carry on taking it for several years for any real benefit. Short term use may be sufficient for controlling the unpleasant symptoms associated with the menopause.

Don't worry. It is unlikely to do you any harm. If you do have any unpleasant effects afterwards, tell your doctor.

Don't worry. Just leave out the forgotten tablet or tablets. Take your next tablet at the right time.

What will happen to your periods while you are taking CLIMESSE? Most women taking CLIMESSE do not have periods. This is quite normal and not a cause for concern. If you want to know more about this your doctor or pharmacist will be able to explain.

You may have some bleeding at odd times during the first few months. This can be a nuisance, but itusually stops after a few months. If you have any heavy bleeding or if bleeding occurs after the first few months when your periods have already stopped, tell your doctor. You may need a test to find out why you are having irregular bleeding.

As with any medicine, CLIMESSE can sometimes have side-effects. Some find that their breasts feel tender or are enlarged whilst some women put on weight – this can be because of fluid retention.

HRT may cause wind, period or stomach pains, or a bloated feeling. It may also cause sickness or a feeling of sickness. Some women feel dizzy or irritable. Some get skin rashes or more vaginal fluid. Some women get high blood pressure or palpitations, and some get headaches or muscle cramps. Some women may experience a change in their sexual desire.

Tell your doctor and stop taking the tablets if you get repeated severe headaches or if you notice any symptoms of jaundice for example, yellowing of the whites of the eyes or skin.

Some women get spots and some may also feel tired or depressed.

If any side-effects worry you or do not go away, talk to your doctor.

If you notice any other changes while you are taking CLIMESSE, even if they are not listed here, tell your doctor.

Keep your tablets in the pack they came in. Do not take any tablets after the 'use-by' date on the pack.

Keep your tablets in a safe dry place where children cannot reach them. Keep them away from heat.

Only a doctor can prescribe CLIMESSE. Do not give your tablets to anyone else, even if they seem to have the same symptoms as you. This can be dangerous.

If you stop taking CLIMESSE before you have finished all the tablets, take any that are left back to the chemist.

PL: 0101/0396

This leaflet was last revised in September 1995.