Please read the whole leaflet carefully before you start to take your Trisequens.

Cartons containing 3 calendar packs are available.

The blue tablets each contain 2 milligrams of Estradiol (as hemihydrate) and 1 milligram of Estriol. These ingredients are both oestrogens.

The white tablets each contain 2 milligrams of Estradiol (as hemihydrate) and 1 milligram of Estriol plus 1 milligram of norethisterone acetate (a progestogen).

The red tablets each contain 1 milligram of Estradiol (as hemihydrate) and 0.5 milligram of Estriol.

The tablets also contain lactose, maize starch gelatin, talc, magnesium stearate, triacetin, E464 E171, E172, E132 and propylene glycol. The tablets do not contain any significant amounts of gluten. Trisequens is one of a group of hormone replacement therapies called cyclically-opposed HRT.

Product licence holder and manufacturer: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark.

• Have you had cancer of the breast or endometrium (lining of the womb)?
• Have you had any other cancer which may have been sensitive to oestrogens?
• Do you have or are you being treated for phlebitis (inflamed veins), DVT (deep vein thrombosis), blood clots in the lung, or stroke?
• Have you recently had any vaginal bleeding, other than during a period?
• Do you suffer from liver problems, for example jaundice?
• Do you suffer from heart or kidney disease?
• Are you being treated with any lipid lowering drugs?
• In any previous pregnancy did you suffer from severe itching, herpes, otosclerosis (loss of hearing) or jaundice?
• Are you pregnant?
• Are you allergic to any of the constituents? (These are listed above)

If you have answered Yes to any of these questions tell your doctor or pharmacist before starting Trisequens.

Ask your doctor for advice on whether you should stop taking the tablets if you need an operation or if you are confined to bed for a long time.

Your doctor will measure your blood pressure and carry out gynaecological and breast examinations at regular intervals, as appropriate for you.

It has been established that taking oestrogens alone increases the risk of endometrial cancer (cancer of the lining of the womb). Taking a progestogen in addition to the oestrogen lowers the additional risk.

Fibroids of the womb may increase in size during treatment. Tell your doctor if you notice any abdominal swelling whilst you are taking Trisequens.

treatment (5 years or longer). During treatment with Trisequens you should regularly self-examine your breasts. Your doctor will advise you if you need regular mammography; this may be necessary if you have, or have had, breast nodules or fibrocystic disease.

The risk of thrombosis (blood clots) is not known to be increased during treatment with Trisequens. However if a blood clot occurs during treatment, Trisequens should be stopped. You should stop taking the tablets and see your doctor if you experience any of the following: unusually severe or frequent headaches sudden visual disturbance, inflamed veins pain in the chest, swelling in the legs or arms breathlessness, pain on breathing.

You should stop taking Trisequens if you develop jaundice during treatment.

Trisequens has little effect on blood pressure. If you have had blood pressure before starting Trisequens you r doctor may want to measure your blood pressure more frequently. If you develop high blood pressure after starting taking Trisequens you should stop taking the tablets.

If you have a blood test remember to tell the doctor that you are taking Trisequens, since it may affect the result.

Certain diseases are known to sometimes worsen during HRT and this can occasionally happen during treatment with Trisequens. If you suffer from heart or kidney disease, you will need more careful monitoring and your doctor will wish to see you more frequently.

If you have diabetes, your diabetic control may alter when you first start Trisequens - monitor your blood glucose more frequently during this time.

It is important to note that Trisequens is not an oral contraceptive. If you are taking non-hormonal contraceptive precautions when you start Trisequens, you should continue to do so until your doctor tells you that contraceptive precautions are no longer required. If you have been taking a hormonal contraceptive (i.e. the pill or depot injections) you must change to a non-hormonal form of contraception before starting Trisequens.

If your doctor has already told you that you no longer need to take contraceptive precautions you need not do so whilst taking Trisequens.

If required other medicines can be taken together with Trisequens. However other oestrogen products should not be used unless prescribed by the same doctor specifically to be used with Trisequens. Remind your doctor if you are taking or start to take antidepressant drugs, or drugs for the treatment of epilepsy, since additional precautions may be necessary.

Taking mineral oil (liquid paraffin) with Trisequens may reduce its effect.

If you are still having periods take the first tablet on the fifth day of your period, whether your period has stopped or not. If your periods have stopped or become infrequent, the tablets can be started straight away; your doctor will let you know if this is the case.

Take one tablet a day, preferably at about the same time. Swallow the tablet with a glass of water. Begin by taking the blue tablets for 12 days followed by the white tablets for 10 days and finally the red tablets for 6 days.

The signs of overdosage are nausea and vomiting. Apart from treating these symptoms no other action

Whether you are still having periods or not, taking Trisequens will probably cause you to have regular bleeding during the red tablet phase or at the end of the white tablet phase. The amount of bleeding varies from woman to woman, but is not usually unduly heavy.

When treatment is first started, spotting or breakthrough bleeding can occur at other times in the tablet sequence. This normally disappears after continued treatment. However if it does occur you should let your doctor know, but it is not necessary to stop taking the tablets unless told to do so.

During the first few months of treatment you may experience some breast tenderness or enlargement, and spotting or breakthrough bleeding can also occur. These side effects are usually temporary and normally disappear after continued treatment. Other side effects such as headache, oedema (water retention) or nausea seldom occur. Tell your doctor or pharmacist if you notice any other unwanted side effect not mentioned above.

The expiry date is printed on the calendar pack and outer carton: do not use the tablets after this date. Store the tablets at room temperature (below 25 C, but do not refrigerate) and keep them away from moisture. Protect them from light by keeping the calendar pack inside the box. Keep your tablets away from children.

If your doctor decides to stop the treatment, return any left over tablets to the pharmacist. Only keep your tablets if your doctor tells you to.

Date of leaflet preparation: August 1995

1. The first tablet to be taken (blue) is under the sealed opening in the transparent outer rim of the calendar dial pack. Use your thumb nail to break the clear plastic tab, tip out your first tablet and swallow it whole.

2. Now use a coin on the centre to set the right day of the week against the empty space. You only need to do this once. If, at any time, you think you might have missed a days treatment, the calendar pack will show you on what day you took your last tablet.

3. Every day simply move the transparent outer rim one space in the direction of the arrow, and tip out the next tablet. The transparent dial can only be turned after the tablet under the opening has been removed. After four weeks it time to start a new pack.