Continuous combined HRT
Please read the whole leaflet carefully before you start to take your Kliofem
What's in your medicine
Kliofem is supplied in a calendar dial pack of 28 yellow tablets, each containing 2 milligrams of oestradiol (an oestrogen) and 1 milligram of norethisterone acetate (a progestogen). So each tablet combines oestrogen and progestogen, and the same tablets are taken continuously.
The tablets also contain lactose, maize starch, gelatin, talc, magnesium stearate, E464, E 171, E 172 and propylene glycol. The tablets do not contain any significant amounts of gluten.
Kliofem is one of a group of hormone replacement therapies called continuous combined H RT.
Product licence holder:Novo Nordisk Pharmaceuticals Limited, Novo Nordisk House, Broadfield Park, Brighton Road, Pease Pottage, Crawley, West Sussex RH11 9RT. Tel: (01293) 613555.
Manufacturer:Novo Nordisk A/S, Novo Alle, DK2880 Bagsvaerd, Denmark.
About Kliofem and Hormone Replacement Therapy
Your doctor has prescribed Kliofem to relieve the unpleasant symptoms (such as hot flushes) which occur in many women around the time of the menopause. Kliofem may also have been prescribed to prevent the bone loss which can occur at this time, and which in some women can lead to fractures of the wrist, spine or hip in later life.
Many women have been put off HRT, because most types cause a return of regular monthly periods. Kliofem does not cause a regular monthly period. After a 3-4 months settling in period, the majority of women have no bleeding or only occasional spotting. Bleeding or spotting does often occur in the first few months until the treatment settles down.
Important questions before taking Kliofem
If you have answered Yes to any of these questions, tell your doctor or pharmacist before starting Kliofem.
Kliofem must be stopped at once if you become pregnant.
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 prolonged periods.
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 increased risk.
Fibroids of the womb may increase in size during treatment. Tell your doctor if you notice any abdominal swelling whilst you are taking Kliofem.
If you suffer from endometriosis, discuss this with your doctor since the symptoms may be worsened by H RT.
There has been concern about the possible risk of breast cancer with oestrogen treatment. Many studies have not shown any increase in breast cancer, but some
have shown a small increase after prolonged treatment (5 years or longer). During treatment with Kliofem 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 clot) is not known to be increased during treatment with Kliofem. However if a blood clot occurs during treatment, Kliofem should be stopped. You should stop taking the tablets and see your doctor if you experience any of the following: unusually severe or frequent headache, sudden visual disturbance, inflamed veins, pain in the chest, swelling in the legs or arms, breathlessness, pain on breathing.
The oestrogens in HRT may increase the risk of gallstones.
You should stop taking Kliofem if you develop jaundice during treatment.
Kliofem has little effect on blood pressure. If you have high blood pressure before starting Kliofem your doctor may want to measure your blood pressure more frequently. If you develop high blood pressure after starting Kliofem, you should stop taking the tablets.
If you have a blood test, remember to tell the doctor that you are taking Kliofem, since it may affect the result.
Kliofem and other diseases
Certain diseases are known to sometimes worsen during HRT, and this can occasionally happen during treatment with Kliofem. If you suffer from otosclerosis (loss of hearing sometimes associated with pregnancy), multiple sclerosis, systemic lupus erythematosus, porphyria, melanoma (skin cancer), epilepsy, migraine, asthma, heart or kidney disease you will require more careful monitoring and your doctor may wish to see you more frequently.
If you have diabetes, your diabetes control may alter when you first start Kliofem - monitor your blood glucose more frequently during this time.
It is important to note that Kliofem is not an oral contraceptive. If you are taking non-hormonal contraceptive precautions when you start Kliofem, 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 Kliofem.
If your doctor has already told you that you no longer need to take contraceptive precautions you need not do so whilst taking Kliofem.
Taking your Kliofem
If you are not currently taking HRT you can start taking Kliofem immediately.
If you are currently taking another HRT, continue taking it until the end of your monthly bleed (if you have one) then start Kliofem.
Take one tablet a day, preferably at about the same time. Swallow it whole.
During the first few months of Kliofem treatment you may experience some bleeding or spotting - this is seen