Climedette
Climedette contains 17-β estradiol and medroxyprogesterone
acetate. 16 white tablets contain 2mg of 17-β estradiol and 12 blue
tablets contain 2mg 17-β estradiol and 5mg medroxyprogesterone acetate.
Climedette is one of a group of medicines known as Hormone Replacement
Therapy (HRT) and is used to treat symptoms and conditions associated
with the menopause.
Typically between the ages of 45 and 55, a natural process occurs in
women, during which the levels of female hormones found in the body
decline. These hormones are produced by the ovaries and at the end of
this process, which is often called (the change of life, climacteric
or menopause.), the ovaries cease to function.
In some women, the drop in hormone levels causes certain symptoms. The
best known of which are hot flushes, sweating, tiredness, sleeplessness
and depression.
Climedette contain the hormone estradiol and medroxyprogesterone. These
hormones are designed to replace the hormones, which are lost during
the decline in the function of the ovaries during and after the menopause.
Tablets of this type are often known as Hormone Replacement Therapy
or HRT.
The body natural estrogen is called 17-beta estradiol. Climedette contains
17-beta estradiol made from plant. Medroxyprogesterone in Climedette
is similar to a woman's own progesterone. Estradiol controls menopausal
symptoms, while medroxyprogesterone protects the lining of the womb
by causing period -like bleeding every month. It also makes irregular
period more regular.
In the long run, lack of estrogen can cause bone to thin, and bone loss
occurs in some women during and after the menopause. This increases the
risk of bone fractures, hence, HRT such as Climedette may also be
used to help prevent bone loss. A condition known as thinning of the
bones (osteoporosis).
As well as benefits, HRT has some risks, which you need to consider
when you are deciding whether to carry on taking it.
Medical check ups
Once you have started on HRT, you should see your doctor for regular
check-ups. At these check-ups, your doctor may discuss with you the
benefits and risks of continuing to take HRT.
You are advised to:
- Go for regular breast screening and cervical smear tests
- Regular check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
Do not start taking Climedette if you:
- Have or have had breast cancer.
- Have or have had other tumours such as endometrial cancer (cancer of the lining of the womb [uterus]), which is sensitive to estrogen.
- Have recently had unusual vaginal bleeding (e.g. unexpected or unusually heavy periods) which has not been checked by a doctor.
- Have endometrial hyperplasia (abnormal growth of the lining of the womb) which has not been treated.
- Have had a recent blood clot of a vein in your leg (deep vein thrombosis or in any where else such as the lung (pulmonary embolus) Have had a recent blood clot of an artery (e.g. stroke or heart attack) Have or have had liver disease where you have been told the liver function is not yet normal.
- Have porphyria (a metabolic disorders).
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.
Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently.
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.
Stroke
Recent research suggests that HRT slightly increase 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.
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.
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 any of these things apply to you, talk to your doctor to see if you should take HRT.
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.
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.
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
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. 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 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.
CLIMEDETTE contains a progestogen.
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.
How to use Climedette
What is the usual dose?
The usual dose of Climedette is one tablet a day. Your doctor will aim to give you the lowest dose for the shortest duration to treat your symptoms.
When should I take the tablets?
The tablets are provided in a calendar pack. It is important that you take the correct tablet each day. You should take the tablets at a regular time each day, either in the morning or the evening. The next pack of Climedette is usually taken without a break in therapy.
If
you have not been taking another type of HRT:
If you are still having regular periods, you should take your first
white tablet on the fifth day of bleeding. If you are not having regular
periods you can start straight away.
If
you are changing from another type of HRT:
If you are having periods, you should complete your current course of
tablets for the month and then take your first Climedette tablet the
next day. If you are not having periods, then you may start Climedette
at any time or according to any instructions given to you by your doctor.
What should you do if you forget a tablet?
If you do forget to take a Climedette tablet at the usual time of day, take it as soon as you remember. If a whole day has passed do not take two Climedette tablets at the same time. Carry on taking one tablet a day until you have finished the 28 tablets in the pack and then carry on taking the tablets as usual. You might notice some bleeding or spotting if you miss a tablet.
Will I need to take other contraceptive precautions?
Climedette is not a contraceptive and so additional contraceptive measures will be needed. Climedette should not be taken during pregnancy or during lactation.
If you have a blood test whilst you are taking Climedette
Climedette may affect the results of certain laboratory tests, so you should tell the person taking the sample that you are on Climedette.
What
might happen while you are using Climedette (side effects)
The most commonly occurring side effects of Climedette are usually mild.
Irregular bleeding, breast tenderness and swelling may occur particularly
during the first few months of treatment. These problems are temporal
and disappear eventually. Other symptoms are feeling sick, tummy pain,
tummy swelling, dizziness, high blood pressure, headaches, weight changes,
and changes in sexual desire. Anxiety or mood changes may occur. Pigmentation
on the skin of the face and eyelids. Gall bladder problems such as gall
bladder stones have been observed. Climedette may cause enlargement
of an already exist fibroid inside the womb. It may also affect the
vaginal secretion.
Other adverse reactions have been reported in association with Climedette
or similar tablets contain estrogen/progesterone are estrogen sensitive
tumours (i.e. cancer of the lining of the womb), breast cancer, heart
attack and stroke.
Storing your medicine
You
will see that an expiry date is embossed on the pack. You should not
use the product after this date.
Always store the Climedette tablets below 25°C in a dry, dark place
out of the reach of children.
Patient Information Leaflet
Climedette PIL
“The abridged safety information and not a complete reflection of safety information, the complete PIL is available on request by contacting Resource medical [see contact us] “
“CLIMEDTTDE is not authorised for sale in the UK”
