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Relieving the symptoms of oestrogen deficiency (eg
hot flushes, decreased sex drive, depression) in women who have gone through
the menopause.Prevention of osteoporosis in women who have gone through the
menopause and are at high risk of fractures, but cannot take other medicines
used to prevent osteoporosis.
Women taking any form of HRT should have regular medical and gynaecological
check-ups. Your need for continued HRT should be reviewed with your doctor at
least once a year. It is important to be aware that all women using HRT
have an increased risk of being diagnosed with breast cancer compared with
women who don't use HRT. This risk needs to be weighed against the personal
benefits to you of taking HRT. There is more detailed information about the
risks and benefits associated with HRT in the factsheet about the menopause
linked above. You should discuss these with your doctor before starting HRT.
Women on HRT should have regular breast examinations and mammograms and should
examine their own breasts regularly. Report any changes in your breasts to your
doctor or nurse. It is important to be aware that women using HRT have a
slightly increased risk of stroke and of blood clots forming in the veins (eg
deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT.
The risk is higher if you have existing risk factors (eg personal or family
history, smoking, obesity, certain blood disorders - see cautions below) and
needs to be weighed against the personal benefits to you of taking HRT. There
is more detailed information about the risks and benefits associated with HRT
in the factsheet about the menopause linked above. Discuss these with your
doctor before starting treatment. It is not currently known if tibolone carries
the same risk of blood clots as other forms of HRT. However it is associated
with a slightly increased risk of stroke.The risk of blood clots forming in the
veins (thromboembolism) while taking HRT may be temporarily increased if you
experience major trauma, have surgery, or are immobile for prolonged periods of
time (this includes travelling for over five hours).
For this reason, your
doctor may recommend that you stop taking HRT for a period of time (usually
four to six weeks) prior to any planned surgery, particularly abdominal surgery
or orthopaedic surgery on the lower limbs, or if you are to be immobile for
long periods. The risk of blood clots during long journeys may be reduced by
appropriate exercise during the journey and possibly by wearing elastic
hosiery. Discuss this with your doctor. You may get some breakthrough
bleeding or spotting in the first few months of taking this medicine. Missing a
dose may increase the chance of this.
If you are still experiencing any
bleeding after six months of taking this medicine, or if breakthrough bleeding
or spotting starts after this time, or after you have stopped taking this
medicine, you should consult your doctor so that it can be investigated. This
is because HRT, including tibolone, has been associated with a slightly
increased risk of endometrial cancer. This risk needs to be weighed against the
personal benefits to you of taking HRT and you should discuss this with your
doctor before you start treatment.
Stop taking this medicine and inform your
doctor immediately if you experience any of the following symptoms while taking
this medicine: stabbing pains or swelling in one leg; pain on breathing or
coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness
affecting one side or part of the body; fainting; worsening of epilepsy;
migraine or severe headaches; visual disturbances; severe abdominal complaints;
increased blood pressure; itching of the whole body; yellowing of the skin or
eyes (jaundice); or severe depression.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 a potentially fertile women is taking HRT but also requires
contraception, a non-hormonal method (eg condoms or contraceptive foam) should
be used.
Close family history of breast cancer (eg mother, sister or grandmother has had
the disease)History of benign breast lumps (fibrocystic breast
disease) History of fibroids in the womb History of
endometriosis History of overgrowth of the lining of the womb (endometrial
hyperplasia) Personal or family history of blood clots in the veins
(venous thromboembolism, eg deep vein thrombosis or pulmonary embolism)Blood
disorders that increase the risk of blood clots in the veins, eg
antiphospholipid syndrome,
factor V Leiden Women taking medicines to
prevent blood clots (anticoagulants), eg warfarinLong-term inflammation of skin
and some internal organs (systemic lupus erythematosus) Personal or family
history of recurrent miscarriage Severe obesity Varicose
veins SmokersHistory of high blood pressure (hypertension) Raised levels
of fats called triglycerides in the blood (hypertriglyceridaemia) History
of liver disease, eg liver cancer Decreased kidney functionHeart
failure History of diabetes History of gallstones History of
migraines or severe headaches History of epilepsy History of
asthma History of an ear disorder that may cause hearing loss
(otosclerosis) 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.Not to be used in Pregnancy
Known, suspected or past history of breast cancer Known or suspected
cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of
the lining of the womb (endometrial cancer) Untreated overgrowth of the
lining of the womb (endometrial hyperplasia)Vaginal bleeding of unknown
causeWomen with a blood clot in a vein of the leg (deep vein thrombosis) or in
the lungs (pulmonary embolism), or a past history of these conditions where the
cause is unknown History of angina Women who have had a heart attack Women
who have had a stroke or mini-stroke (transient ischaemic attack or TIA)Active
liver disease History of liver disease when liver function has not
returned to normal Hereditary blood disorders known as porphyriasRare
hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption (Livial 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.
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 get 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 medical advice from your doctor.
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. Because a side effect is stated here,it does not
mean that all people using this medicine will experience that or any side
effect.Vaginal bleeding or spottingVaginal dischargeVaginal thrushVaginal
itchingBreast painDisturbances of the gut such as diarrhoea, constipation,
nausea, vomiting or abdominal painRash or itchingSeborrhoeic dermatitisAbnormal
hair growth (hypertrichosis)DizzinessHeadache/migraineWeight gainVisual
disturbances such as blurred visionExcessive fluid retention in the body
tissues, resulting in swelling (oedema)Pain in the muscles and
jointsDepressionAlteration in results of liver function testsIrregular brown
patches on the skin, usually of the face (chloasma) Blood clots in the
blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings
above) The side effects listed above may not include all of the side
effects reported by the drug'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.
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 ensure that the combination is safe. The following medicines
may potentially reduce the blood levels and effect of this medicine, which
could result in recurrence of symptoms or irregular
bleeding: antiepileptic medicines such as carbamazepine, phenytoin,
phenobarbital and primidone barbiturates such as
amobarbital rifamycin antibiotics such as rifabutin and rifampicin. 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.
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