Ovestin tablets

- 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.
- 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.
- 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.
- This medicine will not usually cause a monthly withdrawal bleed, unless you are also prescribed progestogen tablets to take for the last few days of each month.

Use with caution in

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- Close family history of breast cancer (eg mother, sister or grandmother has had the disease)
- History of benign breast lumps
- 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 warfarin
- Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)
- Personal or family history of recurrent miscarriage
- Severe obesity
- Varicose veins
- Smokers
- History of high blood pressure
- Raised levels of fats called triglycerides in the blood
- History of liver disease, eg liver cancer
- Decreased kidney function
- Heart 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

- 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
- Untreated overgrowth of the lining of the womb (endometrial hyperplasia)
- Vaginal bleeding of unknown cause
- Women 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
- Women who have recently had a stroke caused by a blood clot
- Women who have recently had a heart attack
- Angina pectoris
- Active liver disease
- History of liver disease when liver function has not returned to normal
- Hereditary blood disorders known as porphyrias
- Pregnancy
- Breastfeeding
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Ovestin 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 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.

Label warnings

- This medication is to be swallowed whole, not chewed.