Fematrix
80
transdermal patch
What you should know about Fematrix 80
Please read this leaflet before you take your medicine, and keep it safe because you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.
What is in Fematrix 80?
Fematrix belongs to a group of medicines known as Hormone Replacement Therapy or HRT.
Fematrix 80 is a self-adhesive transdermal patch containing 2.5 mg of estradiol. Each patch delivers approximately 80 micrograms of estradiol in 24 hours. The patch is rectangular in shape with rounded corners and comes in a sachet. Each box contains 8 sachets, each containing one patch.
The estradiol in Fematrix 80 is made from plant materials. The patch also contains: diethyltoluamide, acrylic adhesive (Dow Corning MG-0560) and acrylic thickener (Acrysol 33).
The marketing authorisation holder is
Fematrix 80 patches are manufactured by
What is Fematrix 80 for?
Fematrix is an estrogen only HRT for peri and postmenopausal women, used to treat the symptoms of the menopause (change of life). These symptoms vary from woman to woman, and can include hot flushes, night sweats, sleeping difficulties, dryness of the vagina and urinary problems.
Fematrix 80 may also be used to prevent osteoporosis (thinning of the bones) in women who are at an increased risk of fractures but who are unable to take other medicines for osteoporosis prevention or if these have proved to be ineffective. Your doctor should discuss all the available options with you. Osteoporosis can accelerate after the menopause as estrogen levels fall. If your doctor has prescribed Fematrix for the treatment of menopausal symptoms, you will not need to take another medicine to prevent osteoporosis whilst you are taking Fematrix.
Fematrix is suitable for peri and postmenopausal women who may or may not still be having their periods and women switching from standard (cyclic or sequential) HRT on the advice of their doctor.
Fematrix 80 is not a contraceptive. If you need contraception you should use a non-hormonal method.
How does Fematrix 80 work?
Fematrix contains estradiol. This hormone replaces the estradiol you produce in your ovaries from puberty until the menopause. Your body's natural estrogen is also called estradiol. Fematrix contains estradiol made from plant materials.
Estradiol replaces your body's natural estrogen, controlling your menopausal symptoms and giving protection against osteoporosis. Women who still have a womb should normally take some form of progesterone (a progestagen) because estrogen alone can cause problems due to a build up of the womb lining. When needed, a progestagen such as dydrogesterone 10 mg should normally be added to Fematrix for 12 to 14 days each month. Taking dydrogesterone for part of each monthly cycle (with Fematrix) helps prevent a build up of the womb lining by inducing a regular monthly bleed (see ‘endometrial cancer’).
Before taking Fematrix 80
Before you take your medicine, you should make sure that it is safe for you to do so. If you answer yes to any of the following questions, do not take Fematrix:
- Do you have, have you had, or does your doctor think you might have, breast cancer?
- Have you had or does your doctor think that you might have, a tumour which is made worse by estrogens (e.g., endometrial cancer)?
- Do you have or are you being treated for a blood clot in an artery or in a vein in your leg or anywhere else (a deep vein thrombosis), or a blood clot that has travelled to your lung or other parts of your body (an embolus)? Have you had one of these conditions in the past?
- Do you have angina, or have you ever had a heart attack or stroke?
- Has your doctor told you that you have porphyria (a metabolic disorder)?
- Are you allergic to any of the substances in the patch?
If any of the following apply to you, you should check with your doctor before you start taking Fematrix:
- you have or have had serious liver disease; or
- you have irregular or unusually heavy periods; or
- you have or have had endometrial hyperplasia; or
- you are pregnant.
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.
If you have (or had in the past, or are at risk of getting) any of the following conditions, your doctor may want to see you more often for check-ups:
- fibroids or endometriosis
- blood clots in the legs or lungs
- tumours related to estrogens
- high blood pressure
- liver complaints
- sugar diabetes
- gall stones
- migraine or severe headache
- systemic lupus erythematosus (SLE) (a disease which affects the skin and major organs)
- epilepsy (fits)
- asthma
- otosclerosis (a type of deafness)
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 had heart disease, talk to your doctor to see if you should take HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated estrogen plus the progestagen 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’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestagen HRT is higher than for estrogen-only HRT (but estrogen plus progestagen 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.
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 (an extra 5 cases).
For women who start taking estrogen plus progestagen 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 progestagen 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 progestagen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestagen as well as estrogen. If so, 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 progestagen.
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 progestagen as well as an estrogen.
Your product, Fematrix 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 progestagen 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.
Are you taking any of these other medicines?
If you are taking anticonvulsants (eg. phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir or herbal preparations containing St John’s wort (Hypericum perforatum), talk to your doctor or a pharmacist. These other medicines may stop Fematrix working properly.
How to use Fematrix 80
Generally your doctor will start you on Fematrix 40. Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms. The dose can then be increased, by your doctor, if necessary. One Fematrix patch should be applied twice weekly on a continuous basis. Each patch should be removed after 3 to 4 days and replaced with a new patch applied to a slightly different site. Patches should be applied to clean, dry and intact areas of skin below the waist on the lower back or buttocks. Fematrix should not be applied on or near the breasts.
In women with a uterus, a progestagen such as dydrogesterone 10 mg should normally be added to Fematrix for 12 - 14 days each month.
If you are having regular periods you should apply the first patch within five days of the start of bleeding. If you are not having regular periods and are not taking any other HRT preparations, or you are switching from a combined continuous HRT product, you can apply the patch on any convenient day.
If you are currently using a 'cyclic’ or ‘sequential' HRT preparation (which involves taking an estrogen tablet or patch for part of the month, followed by both estrogen and progestagen tablet or patch for up to 14 days) you should apply the first Fematrix patch the day after you finish the pack i.e. at the end of the progestagen phase.
If you forget to change your patch at the right time you should change it as soon as possible. But remember to follow your normal schedule for sticking on the next one. If you normally change your patch on a Monday and Thursday and you forget to change your Monday patch until Tuesday or Wednesday, then you must still change your next patch on Thursday. If a patch is missed or applied late, it is more likely that you will have irregular bleeds.
If your patch comes off before the day when you regularly change it and you cannot stick it back on, put a new patch on. You should then change this patch on your normal change day and carry on as usual.
How to put on a patch
You should stick the patch on dry, unbroken areas of your skin below the waistline such as your lower back or buttocks. Do not put the patch on or near the breasts.
When you have chosen the area where you want to put the patch, make sure the area is not red or irritated. Before you apply the patch, wash and dry the area where you are going to put it. Do not put any powder, oil or cream on your skin before you stick the patch on as this might prevent it from sticking properly.
Take one sachet out of the box and carefully tear it open. Take out the patch, take off the smaller piece of shiny backing covering the sticky side (see Figure 1) and put the patch on the area of skin you have chosen.
Gently peel off the rest of the backing and flatten the surface of the patch with your other hand as you pull (Figure 2). This should give a smooth and wrinkle-free surface. Pressing it for a few seconds will make it stick firmly (Figure 3). As long as you have stuck the patch on correctly, you can bathe or shower with little risk of it coming off.
When the time comes to change the patch, take off the old one. Place your new patch on a fresh area of skin.
After use, fold the Fematrix patch in two with the adhesive surface to the inside and dispose with the normal household waste. Do not flush the patch down the toilet.
Overdose
It is almost impossible to get an overdose of estradiol from Fematrix 80, but if you think you have, take off the patch(es) and tell a doctor.
Possible side effects
Some women may have side effects when taking Fematrix, but they usually disappear after the first few months. In the list of possible side effects given below, we give an indication of how likely it is that you will get these side effects: ‘common’ means less than one in ten patients may experience this side effect; ‘uncommon’ means less than one in a hundred; ‘rarely’ means less than one in a thousand; and ‘very rarely’ means less than one in ten thousand patients.
Some patients may experience a mild and brief local rash at the site of application with or without itching; this usually disappears rapidly on removal of the patch.
- Infections:
- symptoms of cystitis; thrush; (uncommon)
- Tumours:
- breast cancer; fibroids get bigger; (uncommon)
- Blood changes:
- anaemia (iron deficiency); (very rare)
- Mental problems:
- depression; change in sex drive; nervousness; (uncommon)
- Nervous system:
- headache; migraine; (common)
- dizziness; (uncommon)
- chorea (muscle twitches); (very rare)
- Eye changes:
- intolerance to contact lenses; change in the surface of the eye; (rare)
- Heart:
- heart attack; (very rare)
- Blood vessels:
- high blood pressure; peripheral vascular disease; varicose veins; venous thromboembolism (blood clots in the legs, pelvis or lungs); (uncommon)
- stroke; (very rare)
- Gut complaints:
- nausea; abdominal pain; flatulence (wind); (common)
- indigestion; (uncommon)
- vomiting; (very rare)
- Liver complaints:
- gall bladder disease; (uncommon)
- liver function changes (e.g. jaundice); (rare)
- Skin complaints:
- allergic skin reactions (including rash or itching); (uncommon)
- skin discolouration; swelling or red patches on the skin; (very rare)
- Muscle and bone:
- leg cramps; (common)
- back pain; (uncommon)
- Reproductive system:
- tender breasts; irregular bleeds and spotting; pelvic pain; (common)
- vaginal discharge; painful periods; heavy or irregular periods; (uncommon)
- swollen breasts; pre-menstrual tension (PMT); (rare)
- Inherited conditions:
- porphyria (a metabolic disorder) gets worse; (very rare)
- General complaints:
- asthenia (feeling weak); (common)
- fluid retention; (uncommon)
- Investigations:
- weight changes (up or down); (common)
Tumours related to estrogens (both benign and malignant) have been associated with HRT (see ‘Effect on your risk of developing cancer’ above).
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.
Usually, side effects are not common and do not usually last long. If any of these side effects do last for a long time or you notice any other side effects and you are worried about them, please contact your doctor or a pharmacist for advice.
You should stop taking Fematrix 80 and contact your doctor if:
- you develop any of the conditions listed in the ‘Before taking Fematrix 80’ section; or
- you develop a blood clot (see ‘Blood clot’); or
- you get sudden problems with your vision, severe headaches or migraines (see ‘Stroke’); or
- you develop jaundice (yellowing of the skin); or
- you become pregnant; or
- your blood pressure increases.
How to store your medicine
Do not store above 25°C. Store in the original package. Do not use the patches after the expiry date shown on the pack. Store all medicines where children cannot see or reach them.
Take any unused patches back to a pharmacy (chemist).
This leaflet was revised in January 2006.
Remember
This medicine is for you. Please do not offer it to your family and friends, even if they have the same symptoms as you.
For more advice on osteoporosis contact the following organisation:
(Monday to Friday, 10am to 3pm)
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