Kliogest tablets are a hormone replacement therapy (HRT) preparation. They are available in two strengths, Kliogest 1mg tablets and Climagest 2mg tablets. Whichever strength you have been prescribed, each pack will contain two types of tablets. One type of tablet contains estradiol and the other type contains estradio in combination with norethisterone. Estradiol and norethisterone are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone.

What is Kliogest used for?

  • Hormone replacement therapy to relieve symptoms of the menopause.

How does Kliogest work?

  • Kliogest tablets are a hormone replacement therapy (HRT) preparation. They are available in two strengths, Kliogest 1mg tablets and Climagest 2mg tablets. Whichever strength you have been prescribed, each pack will contain two types of tablets. One type of tablet contains estradiol and the other type contains estradio in combination with norethisterone. Estradiol and norethisterone are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone.
  • Womens ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result.
The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.
  • Oestrogen (in this case in the form of estradiol valerate) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.
  • A progestogen (in this case in the form of norethisterone) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of cancer, though it does not eliminate this risk entirely. This is known as combined HRT.
  • Kliogest is a sequential form of combined HRT. This means that oestrogen is taken on a continuous basis and the progestogen is added for the last portion of each month. The tablets taken in the first 16 days of each Kliogest cycle contain only estradiol, while the tablets taken in the last 12 days of each cycle contain both estradiol and norethisterone. This type of HRT is more suitable for women who are still having irregular periods, because it usually results in a monthly bleed towards the end of the 28 day cycle.
  • How do I take Kliogest tablets?

    • Kliogest tablets come in a 28 day calendar pack. You should take one tablet every day in the order marked on the pack, starting with tablet one. You should then start the next pack without a break. Your need for continued HRT should be reviewed with your doctor at least once a year.
    • The tablets should be swallowed whole with a drink. They can be taken either with or without food.
    • Your tablet should be taken at around the same time each day; this will help you remember to take it.
    • If you forget to take a dose at your usual time and it is less than 12 hours late when you remember, you should take the missed dose. If it is more than 12 hours late you should just leave out the forgotten dose and take your next dose as usual at your usual time. Don't take a double dose to make up for a missed dose.

    Kliogest should be used with caution by

    • Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.
    • Women with a history of benign breast lumps (fibrocystic breast disease).
    • Women with fibroids in the womb.
    • Women with a history of endometriosis.
    • Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).
    • Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
    • Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.
    • Women who are very overweight or obese.
    • Women with severe varicose veins.
    • Smokers.
    • Women with high blood pressure.
    • Women with heart failure.
    • Women with kidney problems.
    • Women with diabetes.
    • Women with raised levels of fats such as cholesterol or triglycerides in their blood.
    • Women with a history of gallbladder disease.
    • Women with a long-term condition called systemic lupus erythematosus (SLE).
    • Women who suffer from migraines or severe headaches.
    • Women with epilepsy.
    • Women with a history of asthma.
    • Women with a history of depression.
    • Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.

    Kliogest should not be used by

    • Women with known, suspected, or a past history of breast cancer.
    • Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).
    • Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).
    • Women with vaginal bleeding where the cause is not known.
    • Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C deficiency, protein S deficiency or antithrombin deficiency.
    • Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
    • Women with inflammation of a vein caused by a blood clot (thrombophlebitis).
    • Women who have recently had a stroke caused by a blood clot.
    • Women who have recently had a heart attack.
    • Women with angina pectoris.
    • Women with active liver disease, eg hepatitis, liver cancer, or a history of liver disease when liver function has not returned to normal.
    • Women with inherited blood disorders called porphyrias.
    • Women who are pregnant or breastfeeding.
    • Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Kliogest tablets contain lactose).
    • This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

    Pregnancy and breastfeeding

    Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

    • This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you think you could be pregnant during treatment.
    • A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

    Possible side effects of Kliogest

    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.

    • Gut disturbances, such as nausea and vomiting, abdominal pain, bloating, flatulence, indigestion.
    • Menstrual bleeding or spotting. See important information above.
    • Vaginal thrush.
    • Increase in the size of uterine fibroids.
    • Breast pain, tenderness or enlargement.
    • Fluid retention, causing swelling (oedema).
    • Headache or migraine.
    • Premenstrual-like symptoms.
    • Depression, anxiety, irritability or mood changes.
    • Changes in sex drive.
    • Fatigue.
    • Dizziness.
    • Weight changes.
    • Leg cramps.
    • Rise in blood pressure.
    • Steepening of corneal curvature, which may make contact lenses uncomfortable.
    • Skin reactions such as rash and itching.
    • Irregular brown patches on the skin, usually of the face (chloasma).
    • Disturbance in liver function and jaundice.
    • Gallbladder disease.
    • Inflammation of the pancreas (pancreatitis).
    • Blood clots in the blood vessels.

    The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

    How can Kliogest affect other medicines?

    It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

    The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back:

    • aprepitant
    • bosentan
    • barbiturates
    • carbamazepine
    • cobicistat
    • crizotinib
    • dabrafenib
    • efavirenz
    • eslicarbazepine
    • fosaprepitant
    • fosphenytoin
    • modafinil
    • nevirapine
    • oxcarbazepine
    • phenobarbital
    • phenytoin
    • primidone
    • rifabutin
    • rifampicin
    • ritonavir
    • rufinamide
    • telaprevir
    • the herbal remedy St John's wort (Hypericum perforatum)
    • topiramate
    • vemurafenib.

    Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.

    This medicine may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking HRT, but this is particularly important if you are also taking medicines for high blood pressure.

    This medicine may also oppose the fluid-losing effect of diuretic medicines.

    This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.

    This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

    • aminophylline
    • ropinirole
    • selegiline
    • theophylline
    • tizanidine.

    References:

    http://www.netdoctor.co.uk/medicines/a8089/climagest-estradiol-norethisterone/

    http://www.medsafe.govt.nz/Profs/datasheet/k/kliogesttab.pdf

    http://www.myvmc.com/drugs/kliogest/