Product Details

What you need to know before you use Ovestin cream

Medical history and regular check-ups: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor. Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary. Once you have started on Ovestin you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Ovestin. Go for regular breast screening, as recommended by your doctor. Do not use Ovestin: If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before using Ovestin, Do not use Ovestin: • If you have or have ever had breast cancer, or if you are suspected of having it • If you have cancer which is sensitive to estrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it • If you have any unexplained vaginal bleeding • If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated • If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina • If you have or ever have had a liver disease and your liver function tests have not returned to normal • If you have a rare blood problem called “porphyria” which is passed down in families (inherited) • If you are allergic (hypersensitive) to estriol or any of the other ingredients of Ovestin (listed in section 6 Contents of the pack and further information) If any of the above conditions appear for the first time while using Ovestin, stop taking it at once and consult your doctor immediately. Warnings and precautions Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Ovestin. If so, you should see your doctor more often for check-ups: • fibroids inside your womb • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”) • increased risk of getting an estrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer) • high blood pressure • a liver disorder, such as a benign liver tumor • diabetes • gallstones • migraine or severe headaches • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) • epilepsy • asthma • a disease affecting the eardrum and hearing (otosclerosis) • fluid retention due to cardiac or kidney problems Tell your doctor if you have Hepatitis C and you are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Taking the combination of these drugs with some oestrogen-containing products may cause increases in liver function blood test results (increase in ALT liver enzyme); the risk of this happening with Ovestin is currently unknown. Ovestin contains cetyl alcohol and stearyl alcohol. This may cause local skin reactions (e.g.contact dermatitis). Stop using Ovestin and see a doctor immediately If you notice any of the following when taking HRT: • any of the conditions mentioned in the ‘DO NOT take Ovestin’ section • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) • migraine-like headaches which happen for the first time • if you become pregnant • if you notice signs of a blood clot, such as: – painful swelling and redness of the legs – sudden chest pain – difficulty in breathing For more information, see ‘Blood clots in a vein (thrombosis)’. Note: Ovestin is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice. HRT and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium). It is uncertain whether there is a similar risk with Ovestin if used for repeated or long term (more than one year) treatments. However, Ovestin has been shown to have very low absorption into the blood, therefore the addition of a progestagen is not necessary. If you get bleeding or spotting, it’s usually nothing to worry about, but you should make an appointment to see your doctor. It could be a sign that your endometrium has become thicker. The following risks apply to hormone replacement therapy (HRT) medicines which circulate in the blood. However Ovestin is for local treatment in the vagina and the absorption into the blood is very low. It is less likely that the conditions mentioned below will get worse or come back during treatment with Ovestin, but you should see your doctor if you are concerned. Breast cancer Evidence suggests that using Ovestin does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Ovestin can be safely used in women who had breast cancer in the past. Regularly check your breasts. See your doctor if you notice any changes such as: • dimpling of the skin • changes in the nipple • any lumps you can see or feel Additionally, you are advised to join mammography screening programs when offered to you. Ovarian cancer Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case). Effect of HRT on your heart or circulation Blood clots in a vein (thrombosis) The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death. You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you: • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery) • you are seriously overweight (BMI >30 kg/m2 ) • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots • if any of your close relatives has ever had a blood clot in the leg, lung or another organ • you have systemic lupus erythematosus (SLE) • you have cancer. For signs of a blood clot, see “Stop taking Ovestin and see a doctor immediately”. Compare Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein. For women in their 50s who have been taking estrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case). Heart disease (heart attack) For women taking estrogen-only therapy there is no increased risk of developing a heart disease. Stroke The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age. Compare Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases). Other conditions HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, herbal medicines or other natural products. This is because Ovestin can affect the way some other medicines work. Also some other medicines can affect the way Ovestin works. →Tell your doctor or pharmacist if you are taking any of the following: • medicines for epilepsy – such as barbiturates, hydantoins and carbamezapine. • medicines for infections – such as griseofulvin and rifamycins. • medicines for viral infections – such as nevirapine, efavirenz, ritonavir or nelfinavir. • herbal preparations containing St John’s wort (Hypericum perforatum) – a herbal medicine used for depression. • one of the following medicines: corticosteroids, succinylcholine,theophyllines or troleandomycin. Tell your doctor if you have Hepatitis C and you are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Taking the combination of these drugs with some oestrogen-containing products may cause increases in liver function blood test results (increase in ALT liver enzyme); the risk of this happening with Ovestin is currently unknown. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Ovestin. If you have a vaginal infection, your doctor may also prescribe a medicine to treat the infection. Operations →Tell your doctor you are using Ovestin if you are going to have surgery. You may need to stop using HRT about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again. Pregnancy and breast-feeding Ovestin is for use in postmenopausal women only. If you become pregnant, stop taking Ovestin and contact your doctor. • Do not use Ovestin if you are pregnant or might become pregnant. This is because it may affect the baby. • Do not breast-feed if you are using this medicine. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines Ovestin has no or little effect on the ability to drive or use machines