Harmogen 1.5mg Tablets
estropipate
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What is this leaflet about?
This leaflet is a summary of the information about your Harmogen tablets. Please read this leaflet before you start taking your tablets. If there is anything you do not understand or if you want to know more, ask your own doctor or pharmacist (chemist).
This medicine has been prescribed for you personally. You should not give it to others as it may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Harmogen 1.5 mg Tablets are and what they are used for.
2. Before you use Harmogen 1.5 mg.
3. When to use Harmogen 1.5 mg.
4. Using Harmogen 1.5 mg.
5. Possible side-effects.
6. Reasons to stop using Harmogen 1.5 mg.
7. Storing Harmogen 1.5 mg.
8. Further information.
The name of your medicine is Harmogen 1.5 mg Tablets (Harmogen).
Your Harmogen tablets contain 1.5 mg Estropipate USP (piperazine estrone sulphate), equivalent to 0.93 mg estrone. The estropipate is the active ingredient.
There are also inactive ingredients in the tablet. These are: lactose, dibasic potassium phosphate, tromethamine, hydroxypropyl cellulose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hydrogenated vegetable oil wax and sunset yellow, a yellow food dye colouring (E110).
Harmogen comes in a blister pack of 28 tablets.
Marketing Authorisation Holder and Manufacturer.
The Marketing Authorisation holder for Harmogen is
The manufacturer of Harmogen is
What Harmogen 1.5 mg Tablets are and what they are used for.
Harmogen is an estrogen hormone treatment.
Harmogen contains estropipate, which is a semi-synthetic estrogen. Your body breaks down estropipate to form estrone, which is one of the female hormones called estrogens made naturally by your body.
After the menopause, (sometimes called "the change"), a woman may produce less estrogen, and this may lead to symptoms such as hot flushes, night sweats and discomfort during sexual intercourse.
Harmogen is used to treat these symptoms of the menopause.
Other changes in your bones may take place over a longer time following the menopause. These changes can lead to an increased risk of your bones breaking or cracking. If you are at an increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatments or if other therapies prove to be ineffective, Harmogen may also be used for this purpose. Your doctor should discuss all the available options with you
Harmogen is not a contraceptive, if you need contraceptive advice you should speak to your doctor.
Before you use Harmogen 1.5 mg
Harmogen may not be suitable for all women. Please read the following information.
Do not use Harmogen if:
- You have or have had blocked arteries possibly leading to angina or heart disease;
- You have had any vaginal bleeding that your doctor cannot find the cause of;
- You suffer from the hereditary blood condition, porphyria;
- You have, or have had, or are being treated for a blood clot in a vein in your leg or anywhere else (a "deep vein thrombosis");
- You have, or have had, or are being treated for a blood clot that has travelled to your lung or another part of the body (an "embolus"), please see "Blood clots" below;
- You have endometrial hyperplasia (an increase in the number of cells of the inner lining of the womb), which has not been treated;
- You have any cancer that is sensitive to estrogen, (e.g. womb cancer);
- You have, or ever have had breast cancer;
- You have, or have had, any acute liver disease, such that your liver still does not work properly;
- You are pregnant, or are breast feeding;
- You are allergic to estropipate or any other of the ingredients in this medicine;
Medical check-ups
Before you start taking HRT, your doctor should ask about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination — but only if these examinations are necessary for you, or if you have any special concerns.
Once you’ve started on HRT, you should 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.
Be sure to:
go for regular breast screening and cervical smear tests
regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel
Also, some of the following conditions may get worse, while you are using Harmogen. Your should discuss these with your doctor, and he/she may want to monitor them, and you, more closely if you have, or have had:
- Family history of cancer, particularly breast cancer
- High blood pressure
- Diabetes
- Migraine or severe headache
- Uterine fibroids
- Epilepsy
- History of Liver disease
- Gallstones
- History of, or are predisposed to, having blood clots e.g. in your legs or lungs, please see "Blood clots", below
- Systemic lupus erythematosus, (SLE)
- History of endometrial hyperplasia (an increase in the number of cells of the inner lining of the womb),
- Endometriosis (a condition where cells of the inner lining of the womb are found in places other than the womb)
- Problems with your hearing
- Asthma
Safety of HRT
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Effects on your heart or circulation
Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk 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:
- 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.
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 worried 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.
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 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.
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.
Blood clots
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 you’re 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 doctor to see if you should take HRT.
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.
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 can. These may be signs of a blood clot.
If you’re 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.
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 estrogen-only 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 seriously overweight
Compare
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 (ie 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 (ie an extra 6 cases).
If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19 cases).
If you notice
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.
Endometrial cancer (cancer of the lining of the womb)
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor will 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 (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.
If you’ve 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.
Your product, Harmogen, is an estrogen-only product.
Compare
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
, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
- carries on for more than the first few months
- starts after you’ve been on HRT for a while
- carries on even after you’ve stopped taking HRT
Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
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 estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Dementia:
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.
Other Information:
If you are about to have any blood tests, you must tell your doctor that you are using Harmogen, as these tests can be affected by Harmogen.
If you are taking any anti-seizure medication (such as phenobarbitol, phenytoin or carbamezapine), or anti-infective medication (such as rifampicin, rifabutin, nevirapine or efavirenz) or herbal medicines containing St John’s Wort, you must tell your doctor you are using Harmogen. These medicines can affect how Harmogen works.
When to use Harmogen 1.5 mg.
If you are having regular periods then you should start your Harmogen treatment within 5 days of the start of your bleeding.
If you are not having regular periods then you can start Harmogen treatment at any time.
If you are changing from a HRT product that gives you a withdrawal bleed (eg a sequential or cyclic product) then you should finish the treatment cycle and start using Harmogen within 5 days of the withdrawal bleed 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.
Using Harmogen 1.5 mg.
Your doctor will aim to give you the lowest dose for the shortest duration that will treat your symptoms.
Most people take either one or two tablets every day. Your doctor will tell you how many tablets you should take. If you forget, check the label on the carton - it will tell you. Follow the instructions carefully
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.
Always follow any instructions your doctor gives you. Check with your doctor or pharmacist if you are unsure.
Keep using Harmogen as part of your HRT until your doctor tells you to stop.
How do you take Harmogen Tablets?
Always:
- swallow the tablets whole - do not chew them, crush them or put them in water.
If you take two tablets, you can either take them both at the same time of the day, or you can take them at different times in the day. Whichever way you choose, it will help you to remember to take your tablets if you can get into a routine of taking them 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.
What if you forget to take your Harmogen Tablets?
Take the tablet as soon as you remember, and take the next one at the normal time.
If you have missed your tablet, but it is nearly time for the next tablet, dispose of this missed tablet safely and take the next one at the normal time. You may experience some breakthrough bleeding or spotting.
What if you take too many Harmogen Tablets?
Tell your doctor straight away. The extra tablets are unlikely to cause you any harm, although you may feel sick or have a withdrawal bleed. Take the usual tablet the following day.
Do you need to take anything else while using Harmogen?
If you have had a hysterectomy (your womb taken out) 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 estradiol on your womb). You will take this for two weeks of each monthly cycle. This is part of your HRT, see "Endometrial cancer (cancer of the lining of the womb".
While you are using Harmogen and a progestogen you will probably have either a "period" or some regular bleeding each month. This is quite normal.
Possible side-effects.
All medicines can sometimes cause problems. Whilst using Harmogen, you may experience side effects, but most of these do not prevent continued treatment. The following are a list of the most common side effects observed while using estrogen therapy:
- Tenderness to breasts, or unexpected secretions;
- Unexpected vaginal bleeding, itching, discomfort/pain or unpleasant discharge;
- Increased awareness of, or size, of fibroids, aggravation of endometriosis;
- Breast cancer, (See section on "Effects on your risk of developing cancer");
- Increased blood pressure;
- Stroke, (See section on "Stroke");
- Blood clot formation, e.g. in the legs or lungs (See section on "Blood Clots");
- Liver tumours;
- Liver disorders;
- Nausea or vomiting;
- Stomach cramp, bloating;
- Skin discolouration or rash;
- Excessive general itching;
- Hair loss, or abnormal distribution of hair growth;
- Migraine, serious headache, 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 sodium retention;
If any of these bothers you, or you notice any other side effects, tell your doctor or pharmacist straight away.
Reasons to stop using Harmogen 1.5 mg
You should stop using Harmogen and see your Doctor, if any of the following occur:
- If you think you may be pregnant
- Jaundice, (yellowing of the skin or eyes)
- New migraine or severe headache
- Any of the conditions listed in "Do not use Harmogen if"
Also, your doctor may advise you to stop taking your HRT if your blood pressure increases.
Storing Harmogen 1.5 mg.
Keep your tablets in their pack.
Keep your tablets in a safe place out of the sight and reach of children.
If you stop taking Harmogen before you have finished all the tablets, take any that are left back to the pharmacist.
There is a 'use-by' date on the pack. Do not take any tablets after this date.
Further Information
If you need any more information, please contact:
This leaflet was last revised May 2007
Ref: HA 4_0
© Pharmacia Limited.
Harmogen is a Registered Trademark
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