This booklet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The reason why you can only get this medicine with a doctor's prescription is that its use needs medical supervision.

Please tell your doctor if you have any doubts or worries about taking this medicine, either before you start or while you are taking it.

'The change of life' (a/so known as 'the climacteric') is a gradual process, which usually takes place between the ages of about 45 and 55. The periods usually become irregular, both in timing and amount of bleeding, before they stop altogether, but the time at which the periods finally stop - 'the menopause' is not the end of the change of life, which always continues for some time afterwards.

Although the change of life is natural, it often causes distressing symptoms. These symptoms are due to the gradual loss of the female sex hormones produced by the ovaries.

In addition the loss of these hormones may, in some women, lead to thinning of the bones (osteoporosis) in later life.

Each pack of Nuvelle has 16 white tablets each containing 2 mg oestradiol (estradiol) valerate and 12 pink tablets each containing 2 mg oestradiol (estradiol) valerate and 75 micrograms levonorgestrel.

Nuvelle also contains the inactive ingredients: lactose, maize starch, povidone 25,000, povidone 700,000, magnesium stearate (E572) sucrose, macrogol 6000 (polyethylene glycol 6000) calcium carbonate (E170), glycerol (E422), talc, montan glycol wax, titanium dioxide (E171), yellow and red ferric oxide pigments (E172).

Each pack of Nuvelle contains 3 memo packs (strips) of 28 tablets. Packs containing 1 memo strip of 28 tablets are also available to doctors.

Nuvelle is a hormone replacement therapy.

The product licence is held by Schering Health Care Ltd, The Brow, Burgess Hill, West Sussex RH15 9NE.

Nuvelle is manufactured by Schering AG, Berlin, Germany.

Nuvelle contains both types of hormone that are lost during the change of life: oestrogen and progestogen. Therefore, it replaces the hormones that the body no longer makes, and prevents or relieves the troublesome symptoms. Nuvelle is also designed to control heavy or irregular periods, and is likely to produce regular monthly bleeding even if you have already passed the menopause. Nuvelle will not make you able to have children, but, on the other hand, if you are still fertile, Nuvelle will not prevent pregnancy.

Diseases that are known to get worse during pregnancy might behave similarly during treatment, and require careful observation while you are taking Nuvelle (e.g. the disease of the nervous system called multiple sclerosis, fits(epilepsy),diabetes, high blood pressure (hypertension), lumpy or painful breasts (benign breast disease), certain types of heart or kidney disease, asthma, tetany and inherited deafness (otosclerosis) and the inherited disease called porphyria).

Substances such as those contained in Nuvelle (steroids) may cause jaundice in people who have an inherited abnormality of bile excretion.

Your doctor will carry out gynaecological, blood pressure and other examinations as appropriate, e.g. if you are known to have any liver disease, your doctor will arrange for your liver function to be checked periodically.

Your doctor will examine your breasts periodically during treatment, particularly if there is a history of breast cancer in your family.

During or after the use of hormones such as are contained in Nuvelle, benign liver tumours have rarely occurred, and even more rarely malignant liver tumours. In isolated cases, bleeding from such tumours into the abdominal cavity has endangered life.

Although such events are extremely improbable with Nuvelle, you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

It is important to note that Nuvelle is not an oral contraceptive. If you still have the ability to become pregnant, Nuvelle is unlikely to alter it. If you are taking contraceptive precautions other than oral (or other hormonal) contraceptives when you start Nuvelle, continue to do so until your doctor tells you that you no longer require contraceptive protection. If you have been taking an oral (or other hormonal) contraceptive, you must change to an alternative (non-hormonal) form of contraception before starting Nuvelle. On the other hand, if your doctor has already advised you that you need no longer use any contraceptive you need not do so while taking Nuvelle, despite the fact that you again have regular monthly bleeding.

and nausea, preceded by visual disturbances) that you have ever experienced; worsening of pre-existing migraine; any unusually frequent or unusually severe headaches- sudden disturbance of vision or hearing inflamed veins (phlebitis), pains in the chest o; abdomen- swelling in the limbs; pain, tingling or numbness in any part of the body; unexplained cough; breathlessness; pain on breathing.

If you have any of the symptoms listed above you should stop taking the tablets and contact your doctor at once.

Nuvelle must also be stopped at once if you become pregnant, or if you develop jaundice, or your doctor finds your blood-pressure to be significantly raised or if you notice an increase in epileptic seizures.

If you have fibroids of the womb these may grow during treatment. You should stop taking Nuvelle if your doctor finds this has happened.

Ask your doctor for advice on whether you should stop taking the tablets if you are confined to bed, or have an accident or illness, or you need an operation.

• Some drugs e.g. antibiotics and antiepileptics may reduce the effectiveness of Nuvelle.
• If you have to take other medicines regularly, you should inform your doctor.
• If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.
• Oral contraceptives should not be used. Consult your doctor for contraceptive advice.
• If in doubt about any medicines you are taking, ask your doctor.

The pack of Nuvelle is designed to help you remember to take your medicine. To use it you must first know the day of the week on which you will take the first tablet. If you are still having periods, take the first tablet on the fifth day of your period, whether the period has finished or not. If your periods have become infrequent or have stopped altogether, your

Figure 1

Figure 2

doctor may have advised you to start immediately. In addition to the memo-pack (which contains the tablets), the outer carton contains seven self-adhesive strips showing the days of the week. Each strip starts with a different day of the week. Peel the strip that ;tarts with your starting day off the backing.

For instance, if you start the tablets on a Wednesday, se the strip that starts with 'Wed' (see Figure 1).

Stick the strip along the top of the memo-pack on he clear side, where the tablets are visible, so that the first day is above the white tablet to which the arrow marked 'Start' is pointing (see Figure 2)

You can now see on which day you have to take each tablet (Figure 3). Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the pack. This means that you will be taking one white tablet daily for the first 16 lays and then one pink tablet daily for the following 12 days. If, at any time, you are in doubt whether you lave taken your tablet, a glance at the appropriate lay on the memo-pack will tell you.

Figure 2

It is best to take your tablet at the same time each day, preferably after a meal. The tablet should be swallowed whole, with a glass of water or milk.

When you have finished each pack, start the next pack on the following day. Never leave a break between packs. Tablet-taking should be continuous. Bleeding may occur 2-3 days after the end of each pack.

• If you are less than 12 hours late, take it as soon as possible, and take the next one at your normal time.
• But if you are more than twelve hours late, leave the forgotten tablet in the pack. Continue to take the remaining tablets at the usual time on the right days.

• There have been no reports of ill-effects from overdosage. You should consult your doctor who will be able to advise you what action, if any, is necessary.

• If you are still menstruating, you will probably have bleeding regularly, 2-3 days after finishing each pack of Nuvelle. If you miss a period, the possibility of pregnancy should be ruled out. Ask your doctor what to do.
• If you have finished your periods, Nuvelle will probably cause you to bleed again after the end of each pack, but may not always do so.
• If bleeding starts at any time except the week after you have finished a pack, let your doctor know. It is not necessary to stop tablet-taking unless your doctor says so.

Just as with normal periods, the amount of bleeding with Nuvelle varies from woman to woman. Usually the bleeding is not unduly heavy, and it may even be rather scanty, but this is not important as far as the

treatment is concerned. If you have recently had very light, short periods, you may have rather heavier bleedings with Nuvelle.

During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting) and some breast tenderness or enlargement. These are usually temporary and normally disappear with continued treatment. If they don't, contact your doctor.

The following symptoms, which may or may not have been caused by Nuvelle, and which in some cases were probably symptoms of the change of life have been reported: indigestion, nausea, vomiting bloated stomach, increased appetite, increased o; reduced weight, leg pains, fluid retention, palpitations, dizziness, anxiety, headaches, migraine, depressive moods, rashes, altered sexual interest, yellow brown patches on the skin (chloasma).

Expiry date: The expiry date for this pack of medicine is printed on the label. Do not use the pills after this date.

Storage: Keep out of the reach of children.

Date of last revision of this booklet: 17 January 1996.

Product Licence number: 0053/0219.

Nuvelle™ is a trademark of Schering AG.

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