HARMOGEN 1.5MG
Active substance: ESTROPIPATE
View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET
Harmogen
1.5mg Tablets
Estropipate
1. hat Harmogen is and W what it is used for
Do not take Harmogen if you have the following conditions:
Read all of this leaflet carefully before you start using this medicine. eep this leaflet. You may need to read it K again. f you have any further questions, please I ask your doctor or pharmacist. his medicine has been prescribed for T you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, or I if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Harmogen is a type of hormone treatment that contains the active ingredient Estropipate. Estropipate is a semi-synthetic oestrogen which your body breaks down to form estrone, one of the naturally occurring female sex hormones made by your body. Womens ovaries gradually produce less estrogen as they approach menopausal age (also referred to as the change). Low levels of estrogen can cause symptoms such as hot flushes, sweats, and vaginal dryness which leads to sore or painful sexual intercourse. Harmogen is used as part of hormone replacement therapy (HRT) treatment to maintain adequate levels of estrogen to relieve these symptoms during and after the menopause. It is also used as a treatment to reduce the risk of your bones breaking due to the thinning of the bones (osteoporosis) after the menopause when other treatments are not suitable. Harmogen is not a contraceptive. You should speak to your doctor if you need contraceptive advice.
hypersensitivity (allergy) to estropipate or similar medicines for hormone replacement therapy, or any of the other ingredients in Harmogen (see Section 6 for further information) a hereditary blood disorder (porphyria) abnormal growth in the womb lining have or have had breast cancer or any other cancer have or have had a blood circulation disorder like a blood clot in the veins of the leg or the lungs unexpected vaginal bleeding previous or recent liver disease (where liver function tests are still abnormal) previous or a present case of heart diseases such as angina or heart attack if you are pregnant or breast-feeding.
Effects on Your Heart or Circulation Heart Disease
Blood Clots
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE. You are more likely to get a blood clot: if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if youre off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE.
If any of these things apply to you, talk to your
Effects on Your Risk of Developing Cancer Breast Cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who is still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogenonly HRT (but estrogen plus progestogen HRT is beneficial for the endometrium, see Endometrial cancer below). For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT. Your risk of breast cancer is also higher: if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are overweight. Breast cancer Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65. For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be 33 and 34 in 1000 (i.e. an extra 1-2 cases). If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases). For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases). If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
to your doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
Take special care with Harmogen:
a pain in your chest that spreads to your arm or neck. See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.
2. Before you take Harmogen
BAR CODE AREA
Harmogen may not be suitable for all women. Your doctor will assess your general health and discuss with you the benefits and risks of taking hormone replacement therapy (HRT) before prescribing Harmogen. Your doctor could ask about your own and/or your familys medical history. Depending on your condition, your doctor may need to examine your breasts and/or your abdominal area and may also do an internal examination. These examinations will only be done if necessary for you, based on your medical history or if you have any special concerns.
In this leaflet: 1. What Harmogen is and what it is used for 2. Before you take Harmogen 3. How to take Harmogen 4. Possible side effects 5. How to store Harmogen 6. Further information
Regular Check ups
Whilst taking Harmogen, it is recommended that you see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
It is important that you regularly: go for breast screening and cervical smear tests check your breasts for any lumps or changes
While on HRT, some medical conditions may require your doctor to keep a close watch on you. Tell your doctor if you have or have had in the past any of the following conditions as HRT can make them worse: history of breast cancer or any cancer in your family (especially hormone dependent cancer) heart diseases including blood clots or a history of blood clots in the family high blood pressure diabetes migraine or severe headache epilepsy liver disease gallstones a rare disease called systemic lupus erythematosus (SLE) history of endometrial hyperplasia (overgrowth of the lining of the womb) uterine fibroids and endometriosis (inner lining cells of the womb found in places other than the womb) hearing disorder caused by scarring in the ear (otosclerosis) asthma raised levels of fat in the blood (hypertriglyceridaemia) raised levels of thyroid hormones.
Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include: getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat. If you are warned about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT. Stroke Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke. For women in their 50s who are taking HRT, the figure would be 4 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke. For women in their 60s who are taking HRT, the figure would be 15 in 1000.
doctor to see if you should take HRT. Blood clots
Compare:
Compare:
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot. For women in their 50s who are taking HRT, the figure would be 7 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot. For women in their 60s who are taking HRT, the figure would be 17 in 1000.
Compare:
If you get:
painful swelling in your leg sudden chest pain difficulty breathing.
See a doctor as soon as possible and do not take any more HRT until your doctor says you
If you notice
If you get:
unexplained migraine-type headaches, with or without disturbed vision. See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.
Safety of Hormone Replacement Therapy (HRT)
in skin or around the nipple.
As well as benefits, HRT has some risks which you need to consider when youre deciding whether to take it, or whether to carry on taking it.
can. These may be signs of a blood clot. If youre going to have surgery, make sure your doctor knows about it. You may need to stop taking 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.
any changes in your breast, such as: dimpling of the skin changes in the nipple. any lumps you can see or feel.
Make an appointment to see your doctor
as soon as possible.
Continued overleaf...
Harmogen v2 pw.indd 1
26/02/2009 13:52:32
Endometrial Cancer (cancer of the lining of the womb)
Risk of Dementia
Taking estrogen-only HRT tablets for a long time can increase the risk of cancer of the lining of the womb (the endometrium). If you still have your womb, your doctor will
HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
usually prescribe a progestogen as well as estrogen. These may be prescribed separately, or as a combined HRT product. If you have had your womb removed (in a procedure referred to as a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen. If youve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.
Harmogen is an estrogen-only product. Endrometrial cancer
Taking other medicines:
Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it. The addition of a progestogen to estrogen-only HRT substantially reduces the risk of endometrial cancer. If you get: breakthrough bleeding or spotting, its usually nothing to worry about especially during the first few months of taking HRT.
But if the bleeding or spotting:
Compare:
Tell your doctor or pharmacist if you are taking any of the following medicines as they may affect how Harmogen works: anticonvulsants for treating epilepsy like phenobarbitol, phenytoin, carbamazepine anti-infective medicines such as rifampicin, rifabutin, nevirapine, and efavirenz herbal preparations containing St. Johns wort (Hypericum perforatum) ritonavir and nelfinavir (drugs used to treat HIV). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is recommended that you swallow the tablets whole, do not chew, crush, or put them in water. If you think that the tablets are too strong or that they are not working, talk to your doctor or pharmacist, as the dose may need to be adjusted. Harmogen is not recommended for use in children.
If you miss a dose
If you miss a dose, take the dose if it is missed within a few hours of when you normally take it, otherwise take the next dose at the scheduled time.
Do not take a double dose to make up for the one you missed.
Minor side effects of Harmogen
Adults and elderly
Treatment of: Menopausal symptoms Prevention of post-menopausal osteoporosis Dosage:
If you take more Harmogen than you should
One or two tablets (1.5mg to 3mg) daily One tablet (1.5mg) daily
It unlikely that taking more than one tablet will do you any harm but you may feel sick or have some vaginal bleeding. Take your usual dose the following day. If you or someone else takes a larger number of tablets by mistake, contact your doctor immediately for advice.
Blood tests
If you are about to have any blood tests, (e.g. to test for presence of high levels of fats (triglycerides) in your blood), you must tell your doctor that you are using Harmogen as these tests can be affected by this medicine.
If you are advised to take two tablets per day, you can either take both at the same time, or you can take one tablet at two different times. It is recommended to get into a routine of taking your tablets at a regular time, e.g. at breakfast, in the early afternoon or at bedtime.
When you finish the tablets in one pack, start your new pack the next day.
Additional medicines you may be given while taking Harmogen
When to take Harmogen
If you have had a hysterectomy (had your womb removed) your HRT will be Harmogen only. If you have not had your womb taken out your doctor will normally also give you a progestogen treatment (another hormone replacement treatment which balances the effect of estropipate on your womb). You will take this for two weeks of each monthly cycle. This is part of your HRT.
While you are using Harmogen and a progestogen treatment you will probably have either a period or some regular bleeding each month. This is quite normal.
The following are a list of the less serious but more common side effects: nausea (feeling sick) or vomiting (being sick) unexpected vaginal bleeding, itching, discomfort/pain or unpleasant discharge stomach cramp, bloating tenderness to breasts, or unexpected discharge from breast skin discolouration or rash excessive general itching hair loss, or abnormal distribution of hair growth migraine dizziness mood change (elation/depression) nervous disorders (such as twitching of arms and legs) loss of sex drive visual disturbances intolerance of contact lenses change in body weight, water or salt retention. Other side effects that have been reported while taking Harmogen are: breast cancer (See Section 2 on Risk of developing cancer) increased awareness of, or size, of fibroids (see Section 2 Take special care with Harmogen), or aggravation of endometriosis stroke (See Section 2 on Risk of developing a Stroke) liver tumours and disorders increased blood pressure. Endometrial cancer has been seen in some patients taking HRT (See Section 2 on Risk of developing cancer).
What Harmogen looks like and contents of the pack
Harmogen tablets are flat, bevel-edged, oval, and peach coloured with U/3773 and a line on both sides. It is packaged in blister strips containing 28 tablets in a pack.
Marketing Authorisation Holder Manufacturer
Pharmacia Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Pfizer Service Company BVBA, 10 Hoge Wei, 1930 Zaventem, Belgium.
Company Contact address
For further information on this medicine, please contact Medical Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey. Tel: 01304 616161.
This leaflet was last updated January 2009. Document Reference: HA 5_4
Pregnancy
Harmogen should not be used during pregnancy. You should stop using Harmogen if you become pregnant while being treated. Tell your doctor immediately if you are pregnant.
Breast-feeding
carries on for more than the first few months starts after youve been on HRT for a while carries on even after youve stopped taking HRT.
Make an appointment to see your doctor.
Harmogen should not be taken while breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.
Driving and using machinery
It could be a sign that your endometrium has become thicker.
There are no special precautions, you can drive or operate machinery as long as you feel well and able to do so.
The list below tells you when to start your treatment with Harmogen: if you are having regular periods then you should start taking your Harmogen tablets within 5 days of the start of your bleeding if you are not having regular periods then you can start taking your Harmogen tablets at any time if you are changing from a HRT product that makes you bleed when you stop taking it, then you should finish the treatment cycle and start taking your Harmogen tablets within 5 days of the withdrawal bleeds starting if you are changing from a HRT product that does not give you a withdrawal bleed then you can start using Harmogen on any day.
Remember, when you finish the tablets in one pack of Harmogen, start your new pack the next day. Do not leave a break between packs.
4. Possible side effects
Like all medicines, Harmogen can sometimes cause side effects although not everybody gets them. Whilst using Harmogen, you may experience side effects, but most of these side effects do not stop you continuing your treatment.
5. How to store Harmogen
Please see your doctor straight away if you have the following symptoms as your treatment will be discontinued if it is found that you have these conditions:
Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking estrogenonly HRT for more than 5years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
3. How to take Harmogen
Always take your medicine as directed by your doctor. You should check with your doctor or pharmacist if you are not sure. Your doctor will aim to give you the lowest dose for the shortest time needed to treat your symptoms. Your doctor will tell you how many tablets you should take.
If you stop taking Harmogen
If you want to stop taking Harmogen you should discuss this with your doctor first. When you stop taking Harmogen, you may notice that the symptoms you experienced before taking this medicine return.
you develop any of the symptoms listed in Section 2 - Do not take Harmogen if you have the following conditions blood clot formation, e.g. in the legs or lungs (see Section 4 - Risk of Blood Clots) yellow skin and whites of the eyes (jaundice) rise in blood pressure migraine for the first time or new type of severe headache if you suspect you may be pregnant.
Do not store the tablets above 30C. Keep out of the reach and sight of children. Do not use Harmogen tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
BAR CODE AREA
6. Further Information
What Harmogen contains
Harmogen tablets contain 1.5mg Estropipate (piperazine estrone sulphate), equivalent to 0.93mg estrone. The other ingredients in the tablet include lactose, dibasic potassium phosphate, tromethamine, hydroxypropyl cellulose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hydrogenated vegetable oil wax and sunset yellow (E110), purified water and alcohol 200 proof.
If any of the following side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Harmogen v2 pw.indd 2
26/02/2009 13:52:32
Harmogen
1.5mg Tablets
Estropipate
1. hat Harmogen is and W what it is used for
Do not take Harmogen if you have the following conditions:
Read all of this leaflet carefully before you start using this medicine. eep this leaflet. You may need to read it K again. f you have any further questions, please I ask your doctor or pharmacist. his medicine has been prescribed for T you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, or I if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Harmogen is a type of hormone treatment that contains the active ingredient Estropipate. Estropipate is a semi-synthetic oestrogen which your body breaks down to form estrone, one of the naturally occurring female sex hormones made by your body. Womens ovaries gradually produce less estrogen as they approach menopausal age (also referred to as the change). Low levels of estrogen can cause symptoms such as hot flushes, sweats, and vaginal dryness which leads to sore or painful sexual intercourse. Harmogen is used as part of hormone replacement therapy (HRT) treatment to maintain adequate levels of estrogen to relieve these symptoms during and after the menopause. It is also used as a treatment to reduce the risk of your bones breaking due to the thinning of the bones (osteoporosis) after the menopause when other treatments are not suitable. Harmogen is not a contraceptive. You should speak to your doctor if you need contraceptive advice.
hypersensitivity (allergy) to estropipate or similar medicines for hormone replacement therapy, or any of the other ingredients in Harmogen (see Section 6 for further information) a hereditary blood disorder (porphyria) abnormal growth in the womb lining have or have had breast cancer or any other cancer have or have had a blood circulation disorder like a blood clot in the veins of the leg or the lungs unexpected vaginal bleeding previous or recent liver disease (where liver function tests are still abnormal) previous or a present case of heart diseases such as angina or heart attack if you are pregnant or breast-feeding.
Effects on Your Heart or Circulation Heart Disease
Blood Clots
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE. You are more likely to get a blood clot: if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if youre off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE.
If any of these things apply to you, talk to your
Effects on Your Risk of Developing Cancer Breast Cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who is still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogenonly HRT (but estrogen plus progestogen HRT is beneficial for the endometrium, see Endometrial cancer below). For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT. Your risk of breast cancer is also higher: if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are overweight. Breast cancer Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65. For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be 33 and 34 in 1000 (i.e. an extra 1-2 cases). If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases). For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases). If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
to your doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease Studies with one type of HRT (containing conjugated estrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
Take special care with Harmogen:
a pain in your chest that spreads to your arm or neck. See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.
2. Before you take Harmogen
BAR CODE AREA
Harmogen may not be suitable for all women. Your doctor will assess your general health and discuss with you the benefits and risks of taking hormone replacement therapy (HRT) before prescribing Harmogen. Your doctor could ask about your own and/or your familys medical history. Depending on your condition, your doctor may need to examine your breasts and/or your abdominal area and may also do an internal examination. These examinations will only be done if necessary for you, based on your medical history or if you have any special concerns.
In this leaflet: 1. What Harmogen is and what it is used for 2. Before you take Harmogen 3. How to take Harmogen 4. Possible side effects 5. How to store Harmogen 6. Further information
Regular Check ups
Whilst taking Harmogen, it is recommended that you see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
It is important that you regularly: go for breast screening and cervical smear tests check your breasts for any lumps or changes
While on HRT, some medical conditions may require your doctor to keep a close watch on you. Tell your doctor if you have or have had in the past any of the following conditions as HRT can make them worse: history of breast cancer or any cancer in your family (especially hormone dependent cancer) heart diseases including blood clots or a history of blood clots in the family high blood pressure diabetes migraine or severe headache epilepsy liver disease gallstones a rare disease called systemic lupus erythematosus (SLE) history of endometrial hyperplasia (overgrowth of the lining of the womb) uterine fibroids and endometriosis (inner lining cells of the womb found in places other than the womb) hearing disorder caused by scarring in the ear (otosclerosis) asthma raised levels of fat in the blood (hypertriglyceridaemia) raised levels of thyroid hormones.
Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include: getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat. If you are warned about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT. Stroke Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke. For women in their 50s who are taking HRT, the figure would be 4 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke. For women in their 60s who are taking HRT, the figure would be 15 in 1000.
doctor to see if you should take HRT. Blood clots
Compare:
Compare:
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot. For women in their 50s who are taking HRT, the figure would be 7 in 1000. Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot. For women in their 60s who are taking HRT, the figure would be 17 in 1000.
Compare:
If you get:
painful swelling in your leg sudden chest pain difficulty breathing.
See a doctor as soon as possible and do not take any more HRT until your doctor says you
If you notice
If you get:
unexplained migraine-type headaches, with or without disturbed vision. See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.
Safety of Hormone Replacement Therapy (HRT)
in skin or around the nipple.
As well as benefits, HRT has some risks which you need to consider when youre deciding whether to take it, or whether to carry on taking it.
can. These may be signs of a blood clot. If youre going to have surgery, make sure your doctor knows about it. You may need to stop taking 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.
any changes in your breast, such as: dimpling of the skin changes in the nipple. any lumps you can see or feel.
Make an appointment to see your doctor
as soon as possible.
Continued overleaf...
Harmogen v2 pw.indd 1
26/02/2009 13:52:32
Endometrial Cancer (cancer of the lining of the womb)
Risk of Dementia
Taking estrogen-only HRT tablets for a long time can increase the risk of cancer of the lining of the womb (the endometrium). If you still have your womb, your doctor will
HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
usually prescribe a progestogen as well as estrogen. These may be prescribed separately, or as a combined HRT product. If you have had your womb removed (in a procedure referred to as a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen. If youve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.
Harmogen is an estrogen-only product. Endrometrial cancer
Taking other medicines:
Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it. The addition of a progestogen to estrogen-only HRT substantially reduces the risk of endometrial cancer. If you get: breakthrough bleeding or spotting, its usually nothing to worry about especially during the first few months of taking HRT.
But if the bleeding or spotting:
Compare:
Tell your doctor or pharmacist if you are taking any of the following medicines as they may affect how Harmogen works: anticonvulsants for treating epilepsy like phenobarbitol, phenytoin, carbamazepine anti-infective medicines such as rifampicin, rifabutin, nevirapine, and efavirenz herbal preparations containing St. Johns wort (Hypericum perforatum) ritonavir and nelfinavir (drugs used to treat HIV). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is recommended that you swallow the tablets whole, do not chew, crush, or put them in water. If you think that the tablets are too strong or that they are not working, talk to your doctor or pharmacist, as the dose may need to be adjusted. Harmogen is not recommended for use in children.
If you miss a dose
If you miss a dose, take the dose if it is missed within a few hours of when you normally take it, otherwise take the next dose at the scheduled time.
Do not take a double dose to make up for the one you missed.
Minor side effects of Harmogen
Adults and elderly
Treatment of: Menopausal symptoms Prevention of post-menopausal osteoporosis Dosage:
If you take more Harmogen than you should
One or two tablets (1.5mg to 3mg) daily One tablet (1.5mg) daily
It unlikely that taking more than one tablet will do you any harm but you may feel sick or have some vaginal bleeding. Take your usual dose the following day. If you or someone else takes a larger number of tablets by mistake, contact your doctor immediately for advice.
Blood tests
If you are about to have any blood tests, (e.g. to test for presence of high levels of fats (triglycerides) in your blood), you must tell your doctor that you are using Harmogen as these tests can be affected by this medicine.
If you are advised to take two tablets per day, you can either take both at the same time, or you can take one tablet at two different times. It is recommended to get into a routine of taking your tablets at a regular time, e.g. at breakfast, in the early afternoon or at bedtime.
When you finish the tablets in one pack, start your new pack the next day.
Additional medicines you may be given while taking Harmogen
When to take Harmogen
If you have had a hysterectomy (had your womb removed) your HRT will be Harmogen only. If you have not had your womb taken out your doctor will normally also give you a progestogen treatment (another hormone replacement treatment which balances the effect of estropipate on your womb). You will take this for two weeks of each monthly cycle. This is part of your HRT.
While you are using Harmogen and a progestogen treatment you will probably have either a period or some regular bleeding each month. This is quite normal.
The following are a list of the less serious but more common side effects: nausea (feeling sick) or vomiting (being sick) unexpected vaginal bleeding, itching, discomfort/pain or unpleasant discharge stomach cramp, bloating tenderness to breasts, or unexpected discharge from breast skin discolouration or rash excessive general itching hair loss, or abnormal distribution of hair growth migraine dizziness mood change (elation/depression) nervous disorders (such as twitching of arms and legs) loss of sex drive visual disturbances intolerance of contact lenses change in body weight, water or salt retention. Other side effects that have been reported while taking Harmogen are: breast cancer (See Section 2 on Risk of developing cancer) increased awareness of, or size, of fibroids (see Section 2 Take special care with Harmogen), or aggravation of endometriosis stroke (See Section 2 on Risk of developing a Stroke) liver tumours and disorders increased blood pressure. Endometrial cancer has been seen in some patients taking HRT (See Section 2 on Risk of developing cancer).
What Harmogen looks like and contents of the pack
Harmogen tablets are flat, bevel-edged, oval, and peach coloured with U/3773 and a line on both sides. It is packaged in blister strips containing 28 tablets in a pack.
Marketing Authorisation Holder Manufacturer
Pharmacia Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Pfizer Service Company BVBA, 10 Hoge Wei, 1930 Zaventem, Belgium.
Company Contact address
For further information on this medicine, please contact Medical Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey. Tel: 01304 616161.
This leaflet was last updated January 2009. Document Reference: HA 5_4
Pregnancy
Harmogen should not be used during pregnancy. You should stop using Harmogen if you become pregnant while being treated. Tell your doctor immediately if you are pregnant.
Breast-feeding
carries on for more than the first few months starts after youve been on HRT for a while carries on even after youve stopped taking HRT.
Make an appointment to see your doctor.
Harmogen should not be taken while breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.
Driving and using machinery
It could be a sign that your endometrium has become thicker.
There are no special precautions, you can drive or operate machinery as long as you feel well and able to do so.
The list below tells you when to start your treatment with Harmogen: if you are having regular periods then you should start taking your Harmogen tablets within 5 days of the start of your bleeding if you are not having regular periods then you can start taking your Harmogen tablets at any time if you are changing from a HRT product that makes you bleed when you stop taking it, then you should finish the treatment cycle and start taking your Harmogen tablets within 5 days of the withdrawal bleeds starting if you are changing from a HRT product that does not give you a withdrawal bleed then you can start using Harmogen on any day.
Remember, when you finish the tablets in one pack of Harmogen, start your new pack the next day. Do not leave a break between packs.
4. Possible side effects
Like all medicines, Harmogen can sometimes cause side effects although not everybody gets them. Whilst using Harmogen, you may experience side effects, but most of these side effects do not stop you continuing your treatment.
5. How to store Harmogen
Please see your doctor straight away if you have the following symptoms as your treatment will be discontinued if it is found that you have these conditions:
Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking estrogenonly HRT for more than 5years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
3. How to take Harmogen
Always take your medicine as directed by your doctor. You should check with your doctor or pharmacist if you are not sure. Your doctor will aim to give you the lowest dose for the shortest time needed to treat your symptoms. Your doctor will tell you how many tablets you should take.
If you stop taking Harmogen
If you want to stop taking Harmogen you should discuss this with your doctor first. When you stop taking Harmogen, you may notice that the symptoms you experienced before taking this medicine return.
you develop any of the symptoms listed in Section 2 - Do not take Harmogen if you have the following conditions blood clot formation, e.g. in the legs or lungs (see Section 4 - Risk of Blood Clots) yellow skin and whites of the eyes (jaundice) rise in blood pressure migraine for the first time or new type of severe headache if you suspect you may be pregnant.
Do not store the tablets above 30C. Keep out of the reach and sight of children. Do not use Harmogen tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
BAR CODE AREA
6. Further Information
What Harmogen contains
Harmogen tablets contain 1.5mg Estropipate (piperazine estrone sulphate), equivalent to 0.93mg estrone. The other ingredients in the tablet include lactose, dibasic potassium phosphate, tromethamine, hydroxypropyl cellulose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hydrogenated vegetable oil wax and sunset yellow (E110), purified water and alcohol 200 proof.
If any of the following side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Harmogen v2 pw.indd 2
26/02/2009 13:52:32
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
