This leaflet contains information on your medication. You should read it before you start to take the tablets. The information given is not designed to replace your doctor's instructions, but to reinforce them. If you have any questions at all about your medication, please ask your doctor or pharmacist.

CLIMAGEST tablets are available in two strengths, CLIMAGEST 1 mg tablets and CLIMAGEST 2mg tablets. Whichever strength you have been prescribed, each pack will contain two types of tablets. One type of tablet contains oestradiol valerate USP, an oestrogen made from plant sources, and the other type contains the oestrogen, oestradiol valerate USP in combination with the progestogen, norethisterone BP.

All of the tablets contain the following inactive ingredients: lactose, maize starch, povidone, talc (sterilised), magnesium stearate, E464, propylene glycol.

In addition the tablets contain the following colouring agents:

CLIMAGEST 1 mg - grey-blue tablets containing oestradiol valerate: E132, E171; white tablets containing oestradiol valerate and norethisterone: E171.

CLIMAGEST 2 mg - blue tablets containing oestradiol valerate: E132 and E171; pale yellow tablets containing oestradiol valerate and norethisterone: E171 and E172.

The difference in the colour of the tablets will help you to know which one of the two tablets contained in your pack you are taking.

CLIMAGEST 1 mg packs contain: 16 grey-blue tablets containing 1 mg oestradiol valerate which are marked E1 on one side and 12 white tablets containing 1 mg oestradiol valerate and 1 mg norethisterone which are marked N1 on one side.

CLIMAGEST 2 mg packs contain: 16 blue tablets containing 2 mg oestradiol valerate which are marked E2 on one side and 12 pale yellow tablets containing 2 mg oestradiol valerate and 1 mg norethisterone marked N2 on one side.

Both strengths are available as one or three month calendar packs, with each calendar pack containing 28 tablets.

CLIMAGEST tablets contain the hormones oestradiol valerate and norethisterone. These hormones are designed to replace the hormones which are lost during the decline in the function of the ovaries after the menopause. Tablets of this kind are often known as Hormone Replacement Therapy or HRT.

The licence for CLIMAGEST is held by Sandoz Pharmaceuticals (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 5SG.

CLIMAGEST tablets are made in the United Kingdom by: Medevale Pharmaservices Ltd. Ashton-Under-Lyne, England.

In middle age, typically between the ages of 45 and 55, a natural process occurs in women, during which the levels of female hormones found in the body decline. These hormones are produced by the ovaries and at the end of this process, which is often called the 'change of life', climacteric or menopause, the ovaries cease to function.

In some women, the drop in hormone levels causes certain symptoms, the best known of which are hot flushes, sweating, tiredness, sleeplessness and depression. Other symptoms include dizziness, head-

ache, palpitations (flutterings in the chest), tingling in the hands and feet and discomfort during sexual intercourse.

Few women will have all of these symptoms and the number, frequency, severity and duration of them varies from one woman to another.

CLIMAGEST is designed to relieve the symptoms associated with the menopause by replacing the hormones lost during the decline in the function of the ovaries. You will still have a regular monthly bleed or period, much like before your menopause.

You should read this section carefully because there are some conditions your doctor should know about before you start your treatment. Ask yourself the following questions before you start to take your tablets. Have you ever suffered or do you currently suffer from:

Liver problems, for example jaundice.

Heart or kidney disease.

Clotting in blood vessels (the medical term for this is thromboembolism) e.g. in the legs or lungs, heart attack or stroke.

Persistent irregular bleeding from the vagina.

Any condition affected by hormones e.g. tumours of the breast or womb

Remember, tell your doctor or pharmacist, if the answer is yes to any of these questions.

You should not take CLIMAGEST if you are pregnant or if you think you are pregnant and you should not breast feed while taking it.

If you are unsure about anything, ask for advice from your doctor or pharmacist.

The hormones in CLIMAGEST supplement your own natural hormones and are unlikely 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.

Your doctor may stop your CLIMAGEST tablets if you are about to have an operation or if you suffer an injury or illness where there may be an increased risk of blood clotting or if your blood pressure rises significantly for the first time.

While you are taking Climagest you should see your doctor regularly, at least every 6 to 12 months. You should have a thorough internal (vaginal) and physical examination before and at regular times during your treatment.

If you have mild chronic liver disease, your liver function will be checked every 8-12 weeks. Your doctor will also keep a closer eye on you if you suffer from gallstones or some diseases, including multiple sclerosis, epilepsy, migraine, diabetes, high blood pressure, hearing impairment due to bone deposits in the ear, tetany, uterine fibroids, and porphyria.

You will also be monitored and receive regular checks from your doctor if you have any significant kidney or heart impairment.

If you have had or currently suffer from breast nodules or fibrocystic disease your doctor may want to keep a careful check on you.

It is recommended that all women regularly check their breasts. HRT may increase the risk of breast cancer very slightly if it is used for longer than five years, so it is especially important to check your breasts regularly. If you do not know how to do this yourself, your doctor or practice nurse can show you how. They may also check your breasts for you at your regular appointments and in addition, you may also have a breast scan (a 'mammography') at your doctor's surgery or at hospital.

CLIMAGEST is not intended to be used as an oral contraceptive.

If you are using an oral or other hormonal contraceptive, e.g. the 'pill' or depot injection, you must

change to a non-hormonal contraceptive, for example a diaphragm or condom, BEFORE starting CLIMAGEST.

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 CLIMAGEST even if you experience monthly bleeding.

Whether you are taking CLIMAGEST 1 mg or CLIMAGEST 2 mg tablets, you should take one tablet each day.

If you are still having periods (monthly bleeds) it is advisable to take the first tablet on the first day of your period unless your doctor tells you otherwise. If however your periods are infrequent, or have stopped, your doctor may suggest you start immediately.

The pack has been designed specifically to help you take the tablets correctly.

Remove the tablets from the foil as shown in the picture.

You should take one tablet each day by following the sequence of numbers and arrows below each tablet.

Swallow your tablets whole with a glass of water.

The tablets are best taken at the same time every day, try to get into a routine.

You should start your next pack of CLIMAGEST IMMEDIATELY after you have finished this one, whether you have any bleeding or not.

You should follow your doctor's instructions as to how and when you should take CLIMAGEST tablets and never change the dose yourself, however well you feel. If you are unsure about how much medicine to take or when to take it ask your doctor or pharmacist.

Your doctor will advise you how long to carry on with your treatment. Many women use Hormone Replacement Therapy for several years.

If you accidentally take too much of your medicine try not to worry but you should seek advice from a doctor as soon as possible.

If you forget to take a tablet at your usual time try to take it within 12 hours. If this is not possible leave the forgotten tablet and continue to take the remaining tablets at the usual time.

Most people who are prescribed CLIMAGEST will benefit from taking it but some people can be upset

Other effects of taking CLIMAGEST can be: breast tenderness; nausea; headaches; indigestion; wind; vomiting; abdominal or stomach cramps; bloating; weight gain; palpitations or flutterings in the chest; changes in sexual desire, dizziness; vertigo; nose bleeds; biliary stasis which is a decrease or stoppage in the flow of bile; high blood pressure; general itchiness or rash; inflammation of a vein associated with blood clots; vaginal discharge.

If any side effects worry you or do not go away, talk to your doctor. If you notice any other unexpected symptoms, even if they are not listed hear tell your doctor.

Whether you are still having periods or not CLIMAGEST will usually cause you to bleed during the week after you have completed each pack, i.e. the first week of your new pack. This may not always be the case, but you should have a bleed at the same time each monthly cycle.

When treatment with CLIMAGEST is first started you may have some irregular bleeding. This is common during the first few months. It is usually temporary and wears off with time, however if it persists you should tell your doctor.

As with normal periods the amount of bleeding will vary from one woman to another but is not usually heavy.

Keep the tablets in their pack and only take them out when it is time to take your medicine.

There is an expire or 'use by' date printed on the pack and carton of your tablets. Do not take the tablets after this date.

You should always keep your tablets in a safe place out of reach of children. Store below 25ºC in a dry place protected from light.

If your doctor decides to stop treatment you should return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to.

This leaflet was last revised in November 1995.

REMEMBER: This medicine is only for you. You should never give it to anyone else even if they have the same symptoms as you. This can be dangerous.

This leaflet does not contain complete information about your medicine. If you have any questions or you are unsure about anything, ask your doctor or pharmacist.

The product licence numbers for CLIMAGEST are:

CLIMAGEST 1 mg tablets: PL 0101/0328

CLIMAGEST 2 mg tablets: PL 0101/0366

CLIMAGEST is a registered Trade Mark.