Resource-medical.co.uk

PACKAGE LEAFLET
• have angina or have recently had a heart
The risk for a woman who is taking oestrogen INFORMATION FOR THE USER
plus progesterone HRT (such as Clinorette • have abnormal vaginal bleeding which
Tablets) is higher than for oestrogen-only Clinorette Film-Coated Tablets
• have endometrial hyperplasia (an increase HRT is beneficial for the endometrium, see
17-β estradiol
in the number of cells in the lining of the 17-β estradiol and
• have liver disease or a history of liver
For all kinds of HRT, the extra risk of breast norethisterone
cancer goes up the longer you take it, but it • are pregnant or think you might
returns to normal within about five years after be pregnant (you should use extra
Read all of this leaflet carefully before you
hormones whilst taking Clinorette Tablets) Your risk of breast cancer is also higher if you: start using this medicine.
• are breast-feeding
• have a close relative (mother, sister or - Keep this leaflet. You may need to read If any of the above statements apply to you, you should not take Clinorette Tablets.
- If you have further questions, please ask Speak to your doctor immediately and stop
2.2 Some women may require special care
taking Clinorette Tablets if you notice any
- This medicine has been prescribed for you personally and you should not pass it on Speak to your doctor before taking
to others. It may harm them, even if their Clinorette Tablets
- If any of the side effects get serious, or if any of the following conditions, or have you notice any side effects not listed in this suffered from any of these conditions in the leaflet, please tell your doctor or pharmacist. past, as these conditions may come back or How likely is breast cancer?
get worse with Clinorette Tablets and so your Looking at women who are not taking
The name of your medicine is Clinorette Film- HRT – on average 32 in 1,000 will be
Coated Tablets. In the rest of this leaflet it is diagnosed with breast cancer between the In this leaflet:
• a risk of cancer which is dependent on For women who start taking oestrogen
1. What Clinorette Tablets are used for
plus progesterone HRT
oestrogen e.g. a family history of breast or and take it for 5
2. Make sure Clinorette Tablets are OK for you
endometrial cancer (cancer of the lining years, the figure will be 38 in 1,000 (i.e.
3. Taking Clinorette Tablets
an extra 6 cases).
of the womb). (see Section 2.4 ‘Clinorette 4. Possible side effects
Tablets and cancer– endometrial cancer’ 5. How to store Clinorette Tablets
If they take oestrogen plus progesterone
6. Further information
for 10 years, the figure will be 51 in
1,000 (i.e. an extra 19 cases).
• endometriosis (the growth of tissue from 1. WHAT CLINORETTE TABLETS ARE
• a history of endometrial hyperplasia (an Ovarian cancer (cancer of the ovaries)
increase in the number of cells in the lining oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is The active ingredients in Clinorette Tablets not yet known whether other kinds of HRT such as Clinorette Tablets increase the risk in norethisterone (a type of progesterone).
• deafness caused by a condition of the • Systemic Lupus Erythematosus (SLE) (a 2.5 Clinorette Tablets and your heart
disease where the body’s immune system or circulation
osteoporosis (bones becoming brittle after the • any condition which makes you at risk of blood clots (see Section 2.5 ‘Clinorette Heart disease
HRT is not recommended for women who
The benefits of Clinorette Tablets
Tablets and your heart or circulation’ – have heart disease, or have recently had heart disease. If you have ever had heart disease, Hormone Replacement Therapy (HRT)
speak to your doctor to see if you should be Clinorette Tablets are used as a hormone • high levels of triglycerides (a type of fat) in who have not had their womb removed (a
Clinorette Tablets will not help to prevent
hysterectomy). Levels of the female hormone 2.3 Reasons to stop taking Clinorette
oestrogen fall during and after the menopause Studies with one type of HRT (containing hot flushes, sweats and vaginal dryness. • jaundice (yellowing of the skin or eyes) or conjugated oestrogen plus the progesterone Clinorette Tablets contain estradiol (a type of MPA) have shown that women may be slightly oestrogen) which relieves these symptoms. • significantly increased blood pressure more likely to get heart disease during the first year of taking the medication. For other Estradiol also stimulates the lining of the • new or unusual migraine-type headaches, types of HRT, the risk is likely to be similar, womb (the endometrium). Clinorette Tablets contain norethisterone (a progesterone) to • painful swelling in your leg, sudden chest Speak to your doctor immediately and stop
thick, and to make sure it is shed during the • pain in your chest that spreads across your taking HRT if you get a pain in your chest
regular vaginal bleeds which go with this type that spreads across your arm or neck as
this pain could be a sign of heart disease.
Osteoporosis
• if you start to have any of the conditions listed earlier in the section 2.1 ‘Some Clinorette Tablets may also be used to prevent women should not take Clinorette Tablets’.
Recent research suggests that one type of bones becoming brittle (osteoporosis) after HRT (containing conjugated oestrogen plus the progesterone MPA) increases the risk of If any of the above statements apply to you having a stroke. For other types of HRT, the
not able to take other treatments for this speak to your doctor immediately and stop risk is likely to be similar, although this is not
taking Clinorette Tablets.
yet certain. Other things that can increase the 2.4 Clinorette Tablets and cancer
2. MAKE SURE CLINORETTE
TABLETS ARE OK FOR YOU
Endometrial cancer (cancer of the lining of • high blood pressure
the womb)
Safety of HRT
Taking oestrogen-only HRT for a long time As well as benefits, HRT has some risks which can increase the risk of cancer of the lining you need to consider when you are deciding whether to take it, or whether to carry on progesterone as well as the oestrogen helps If you are worried about any of the above or Before you start taking Clinorette Tablets
If you still have your womb, your doctor will if you have had a stroke in the past, speak Before you start taking Clinorette Tablets, therefore usually prescribe a progesterone as to your doctor to see if you should take your doctor should ask about your own and well as oestrogen. Clinorette Tablets contain your family’s medical history. Your doctor may decide to examine your breasts and/or Speak to your doctor immediately and
abdomen, and may do an internal examination If you have had your womb removed (a stop taking HRT if you get new or unusual
hysterectomy), your doctor will discuss with migraine-type headaches, with or without
necessary for you, or if you have any special you whether you can safely take oestrogen disturbed vision as these headaches could
without a progesterone. Clinorette Tablets are be an early warning of a stroke.
not recommended for patients who have had • Tell your doctor if you have any medical
How likely is a Stroke?
If you get breakthrough bleeding or spotting, Looking at women in their 50s who are
Regular check-ups
it is usually nothing to worry about, especially not taking HRT – on average, over a 5 year
Once you’ve started on Clinorette Tablets, you during the first few months of taking period; 3 in 1,000 would be expected to
should see your doctor for regular check-ups Clinorette Tablets. Speak to your doctor if
(at least once a year). At these check-ups, your doctor will discuss with you the benefits • carries on for more than the first few For women in their 50s who are taking
and risks of continuing to take HRT.
HRT, the figure would be around 4 in 1,000
• starts after you have been on Clinorette (i.e. an extra 1 case)
Be sure to:
• go for regular breast screening and cervical • carries on even after you have stopped Looking at women in their 60s who are
not taking HRT – on average, over a 5 year
• regularly check your breasts for any period; 11 in 1,000 would be expected to
changes in the nipple, or any lumps you can endometrium has become thicker or you have For women in their 60s who are taking
HRT, the figure would be around 15 in
2.1 Some women should not take
1,000 (i.e. an extra 4 cases).
How likely is Endometrial cancer?
Clinorette Tablets
Looking at women who still have a uterus and who are not taking HRT – on aver-
Do not take Clinorette Tablets if you:
age 5 in 1,000 will be diagnosed with
• are allergic to estradiol, norethisterone
or any of the other ingredients contained
in Clinorette Tablets (see list under heading ‘What Clinorette Tablets contain’ in section the number will be 2-12 times higher,
• currently have or have previously had breast cancer
• have cancer which is dependent on
oestrogen e.g. endometrial cancer (cancer
oestrogen-only HRT substantially reduces • currently have or have previously suffered from clots forming in the veins or
travelling to other parts of the body, such Breast cancer
Women who have or are suspected of
• have porphyria (an inherited blood
having breast cancer, or have had breast
cancer in the past, should not take HRT.
Taking HRT increases the risk of breast cancer.
Blood clots
3. TAKING CLINORETTE TABLETS
In the skin
HRT may increase the risk of blood clots in • blotchy brownish marks on your face which the veins (also called deep vein thrombosis, or Your doctor will decide the dose which is may persist when the drug is discontinued DVT), especially during the first year of taking best for you. Always follow your doctor’s it. These blood clots are not always serious, instructions completely and also follow any but if one travels up to the lungs it can cause special instructions or warnings which appear • loss of scalp hair chest pain, breathlessness, collapse or even on the label which the pharmacist has put on death. This condition is called pulmonary the package. If you do not understand, or are embolism or PE. DVT and PE are examples of in any doubt, ask your doctor or pharmacist.
In the eyes
a condition called venous thromboembolism 3.1 When to take the tablets
• difficulties with contact lenses.
• Clinorette Tablets are provided in a calendar You are more likely to get a blood clot if: In the nervous system and brain
• One tablet is taken each day; a treatment • any of your close family have had blood • Bleeding usually occurs after the last pink • you have had one or more miscarriages • you have any blood clotting problem that • 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 In other parts of the body
• you are off your feet for a long time because • The next pack is usually taken without a • you have a rare condition called SLE.
break in therapy. However your doctor will • fluid retention and swelling of your body If any of the above statements apply to you, (particularly if you have heart or kidney speak to your doctor to see if you should take If you have not been taking another type
of HRT
• In addition Clinorette Tablets may affect the Speak to your doctor immediately and stop • If you are still having regular periods, you
results of certain laboratory tests.
taking HRT if you get any of the following
should take your first white tablet on the as these may be signs of a blood clot:
If any of the side effects get serious, or if you • If you are not having regular periods you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist How likely is a blood clot?
4.3 Vaginal bleeding
Looking at women in their 50s who are
You will usually experience a vaginal bleed not taking HRT – on average, over a 5 year
If you are changing from another type
(similar to your usual period) after taking the period; 3 in 1000 would be expected to get
last pink Clinorette Tablet in each pack. This • If you are having periods, you should might continue as you start the next pack. The complete your current course of tablets and bleed will tend to become less and less as For women in their 50s who are taking
then take your first Clinorette Tablet the next you continue with the treatment and in some HRT, the figure would be around 7 in 1,000
patients it may disappear altogether.
(i.e. an extra 4 cases).
• If you are not having periods, then you may start taking Clinorette Tablets at any time If you get breakthrough bleeding or spotting, according to any instructions given to you it is usually nothing to worry about, especially not taking HRT – on average, over a 5 year
period; 8 in 1,000 would be expected to
speak to your doctor if you notice vaginal
bleeding at an unusual time during the cycle For women in their 60s who are taking
of tablets (see section ‘Endometrial cancer’ 3.2 If you take more Clinorette Tablets than above).
17 in 1,000 (i.e. an extra 9 cases).
you should
If you accidentally take too many tablets, you 4.4 Dementia
2.6 Having an operation
may experience nausea or vomiting. If you are HRT will not prevent memory loss. In one If you are going to have an operation make worried or have any unusual symptoms you study of women who started using one type sure your doctor knows about it. You may should contact your doctor. You should take need to stop taking Clinorette Tablets about your usual tablet the following day or follow plus the progesterone MPA) after the age of four to six weeks before the operation to the advice given to you by your doctor.
65, an increase in the risk of dementia was reduce the risk of a blood clot. Your doctor will observed. It is uncertain if this finding applies tell you when to start taking Clinorette Tablets 3.3 If you forget to take Clinorette Tablets
also to patients on Clinorette Tablets.
If you forget to take a dose, take a tablet as soon as you remember. If a whole day has 2.7 Taking other medicines
passed, do not take two Clinorette Tablets at 5. HOW TO STORE CLINORETTE
Taking another medicine while you are taking the same time. Carry on taking one tablet a Clinorette Tablets can affect how it or the day until you have finished the 28 tablets in other medicine works. Please inform your the pack and then carry on taking the next Keep out of the reach and sight of children.
doctor or pharmacist if you are taking or have pack of tablets as usual. You might notice recently taken any other medicines, including some bleeding or spotting if you miss a tablet.
those you may have bought yourself without a Do not take this medicine if the expiry date on prescription (including herbal medicines such the pack has passed. The expiry date refers to 4. POSSIBLE SIDE EFFECTS
Please check with your doctor if you are Clinorette Tablets should not be taken if Like many medicines Clinorette Tablets may taking any of the following (or any other they show signs of deterioration such as cause side effects in some patients, although not everybody gets them. Tell your doctor • anticonvulsants, used to prevent fits (e.g. or pharmacist if you are worried about any side effects which you think may be due to • anti-infectives, to treat infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz, Store in the original container or package in order to protect from light and moisture. 4.1 Serious side effects – see your doctor
immediately
If you have any doubts about whether you should take Clinorette Tablets then discuss matters with your doctor before taking it.
You should speak to your doctor immedi-
ately and stop taking Clinorette Tablets if
pharmacist how to dispose of medicines no 2.8 Taking Clinorette Tablets with food
you experience any of the following:
longer required. These measures will help to and drink
• jaundice (yellowing of the skin or eyes) or You can eat and drink normally while you are • significantly increased blood pressure 2.9 Pregnancy and breast-feeding
• signs of a blood clot in your leg or lungs e.g. 6. FURTHER INFORMATION
You should not take Clinorette Tablets if you
painful swelling in your leg, sudden chest are pregnant or trying to become pregnant. If 6.1 What Clinorette Tablets contain
you become pregnant whilst taking Clinorette • signs of heart disease e.g. pain in your The active ingredients in Clinorette Tablets are Tablets, you should stop taking the tablets
17-β estradiol and norethisterone. The white and contact your doctor immediately.
tablets contain 2mg of 17-β estradiol and the • new or unusual migraine-type headaches, pink tablets contain 2mg 17-β estradiol and contraceptive; nor will they restore fertility. Other ingredients are lactose, crospovidone, contraception without hormones whilst you dimpling of the skin, changes in the nipple Opandry white Y-I-7000 HSE (methocel E5, titanium dioxide E171, propylene glycol) and Clinorette Tablets are not recommended if
• endometrial cancer (cancer of the lining of 6.2 What Clinorette Tablets look like and
2.10 Driving and using machines
4.2 Other side effects
contents of the pack
Clinorette Tablets do not affect the ability to In the reproductive and urinary system
There are 16 round, white biconvex (curved on both sides) film coated tablets and 12 round, pink biconvex film coated tablets 2.11 Clinorette Tablets contain lactose
arranged in a specific order in each calendar If you have been told by your doctor that you have an intolerance to some sugars, contact • symptoms similar to those felt just before your doctor before taking this medicinal 6.3 Marketing Authorisation Holder:
• increase in the size of fibroids (growths in ReSource Medical UK Ltd, 2 Carlton Avenue, If you are worried about anything in this Manufacturer: Pharbil Waltrop GmbH, Im
section, talk to your doctor about the risks and • changes in the neck of the womb (cervix) Wirringen 25, 45731 Waltrop, ie. Germany.
• symptoms like those of an infection of the bladder e.g. burning or itching on passing In the breasts
In the stomach
• pancreatitis (inflammation of the pancreas).

Source: http://www.resource-medical.co.uk/Clinorettetablets.pdf