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There are some small risks with taking HRT and you should discuss this with your doctor before you start taking Cyclo-Progynova (also see Section 2).
2. Before you take Cyclo-Progynova
Do not take Cyclo-Progynova if you have, or have ever had:
An allergic reaction to estradiol or norgestrelAn allergic reaction to any of the other ingredients of Cyclo-Progynova (listed in section 6)Breast or womb cancerBleeding from your vagina and the cause is not knownEndometrial hyperplasia that is not being treated (an overgrowth of the lining of the womb)Blood clots in a vein in your leg (deep vein thrombosis or DVT) or in your lungs (pulmonaryembolus) or any other problems with blood clots forming.Angina, a stroke or other heart diseaseLiver problemsPorphyria (a rare blood disorder).If any of the above applies to you, do not take Cyclo-Progynova and talk to your doctor orpharmacist.
Check with your doctor before taking Cyclo-Progynova if you have, or have ever had any of the following:
Uterine fibroids (lumps of fibrous and muscular tissue in your womb)Endometriosis (where tissue from the womb is found outside the womb)Endometrial hyperplasia (overgrowth of the lining of the womb)Risk factors for cancer, such as history of the disease in your familyRisk factors for blood clotting problemsRisk factors for angina, a stroke or heart diseaseHigh blood pressureDiabetesGallstonesMigraine or severe headacheSystemic lupus erythematosus, (SLE or lupus for short)EpilepsyAsthmaOtosclerosis (hearing loss due to a problem with the bones in the ear).Safety of HRT
As well as benefits, HRT has some risks which you may wish to discuss with your doctor whenyou are deciding whether to start HRT, or whether to carry on taking it.Effects on your heart or circulation,Heart disease,HRT is not recommended for women who have or have recently had heart disease.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 oestrogen 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.
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
Getting olderHigh blood pressureSmokingDrinking too much alcoholAn 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.
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.
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. Thiscondition is called pulmonary embolism, or PE. DVT and PE are examples of a condition calledvenous thromboembolism, or VTE.
You are more likely to get a blood clot if:
You are seriously overweightYou have had a blood clot beforeAny of your close family have had blood clotsYou have had one or more miscarriagesYou have any blood clotting problem that needs treatment with a medicine such as warfarin You’re off your feet for a long time because of major surgery, injury or illnessYou have a rare condition called SLE (see Section 2).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-yearperiod, 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 legSudden chest painDifficulty breathing.You must 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
Surgery (Surgical operations)
If you’re going to have surgery, make sure your doctor knows about it. You may need to stoptaking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Yourdoctor will tell you when you can start taking HRT again.Effects on your risk of developing 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 oestrogen-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. Therisk for a woman who is taking oestrogen plus progestogen HRT is higher than for estrogenonly HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrialcancer’ 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 cancerAre seriously overweight.
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 oestrogen-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 oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).For women who start taking oestrogen 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 oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e.an extra 19 cases).
If you notice any changes in your breast, such as:
Dimpling of the skinChanges in the nippleAny lumps you can see or feelMake an appointment to see your doctor as soon as possible.Endometrial cancer (cancer of the lining of the womb)
Taking oestrogen-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 oestrogen helps to lower the extra risk.
If you still have your womb, your doctor will usually prescribe a progestogen as well as oestrogen. 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 oestrogen without a progestogen.
If you’ve had your womb removed because of endometriosis, any endometrium left in yourbody may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.Your product, Cyclo-Progynova contains a progestogen.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 oestrogen-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 oestrogenonly 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.
If the bleeding or spotting:
Carries on for more than the first few monthsStarts after you’ve been on HRT for a whileCarries on even after you’ve stopped taking HRT.You must make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
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 oestrogen-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 therisk in the same way.
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.
Tell your doctor if you are taking any of the following medicines:
Anticonvulsants such as phenobarbital or phenytoin (to treat epilepsy)Antibiotics such as rifampicin or rifabutin (to treat infections)Herbal medicines containing the herb St. John’s WortInsulin or other medicines to treat diabetesProtease inhibitors (to treat HIV)Transcriptase inhibitors such as nevirapine or efavirenz (to treat HIV)Any other medicine, including medicines obtained without a prescription.Contraception
This medicine will not act as a contraceptive. Ask your doctor for advice if you are already using a contraceptive. This medicine may interfere with it.
Pregnancy and breast-feeding
Do not take Cyclo-Progynova if you are pregnant or breast-feeding.If you become pregnant whilst taking this medicine, you must immediately stop taking this medicine and ask your doctor for advice.
Driving and using machines
Whilst taking Cyclo-Progynova you may feel dizzy. If this happens, do not drive or operate machinery.
Warning about sugar intolerance
This medicine contains sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Cyclo-Progynova
Always take Cyclo-Progynova exactly as your doctor has told you.
Important:Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
When to start taking your medicine for the first timeDepending on your situation you should start to take this medicine at the following times of the month:
If you are having regular periods, start taking the medicine on the fifth day of your period.If you are not having regular periods, you can start at any time.If you are changing from another HRT medicine that gives you a period complete the treatmentcourse of the other medicine. Then on the next day start to take this medicine.If you are changing from another HRT medicine that does not give you a period, you can start at any time. How to use the medicine
Your pack contains 1 foil memo-strip and 7 blue stickers showing days of the week. Each blue sticker starts with a different day of the week.Peel off a strip that starts with your starting day. Stick this sticker along the top of the foilmemostrip where it states ‘fix the blue sticker here’ so that the first day is above the pill marked ‘start’.You can now see on which days you have to take each tablet. Take one tablet each day, following the direction of the arrows, until you have finished all 21 tablets.Swallow the tablets whole with water. Do not chew the tablets.Take the tablets at the same time every day.After day 21 you will have a 7 day tablet free break. During this week, bleeding similar to a period may occur. This is normal.Start the next strip immediately after the 7 day break. You will start your new strip of tablets on the same day of each month. Take the tablets even if your bleeding has not finished.If you are not sure how to use the sticker and the memo-pack then please ask your pharmacist for advice.
Once you are taking this medicine:
Regularly check your breasts for any changes. If you notice dimpling of the skin, changes in the nipple, or any lumps you must see your doctor as soon as possible.Go for regular breast screeningGo for regular cervical smear testsSee your doctor for regular check-ups (at least once a year). At these check-ups, your doctor will discuss with you the benefits and risks of continuing to take HRT.What bleeding pattern to expect with Cyclo-ProgynovaAs with normal periods, the amount of blood loss will vary from woman to woman.Your bleeding pattern may change when you are taking this medicine. You may have:
Bleeding in the first three weeks of starting the tablets. If so, ask your doctor for advice.Heavier bleeding. You may notice this more if your periods have become short or lighter before you started treatment. This is normal.Bleeding in the break where you take no tablets.This is normal.If after several months you are still getting spotting or breakthrough bleeding, or you are worried about your bleeding you must see your doctor.
If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.
If you forget to take Cyclo-Progynova- If your tablet is less than 12 hours late, take the tablet as soon as possible, then take your nexttablet at the normal time.If your tablet is more than 12 hours late, leave the forgotten tablet in the pack, and take your next tablet at the normal time.You may get some vaginal bleeding (breakthrough bleeding) if you have missed a tablet. This is normal.If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines Cyclo-Progynova can cause side effects, although not everybody gets them.If you have any of the following symptoms:
Chest pain that spreads to your arm or neckSudden numbness or confusionDifficulty breathingSevere rash that might blisterSudden pain and swelling in your legYou notice yellowing of your skin or eyesSevere or prolonged headache, possibly with disturbed vision for the first time. Seek immediate medical help and stop taking Cyclo-Progynova. If you get any of the following symptoms:
If you notice any changes in your breast such as a lump, dimpling in the skin or the nipple changingIf bleeding or spotting carries on for more than the first few months, or starts after you have been taking the tablets for a whileIf bleeding or spotting carries on even after you’ve stopped taking HRT. See your doctor as soon as possible. Important: All the symptoms in the boxes above are signs that you may be developing a serious problem. If you ignore these symptoms they may become worse.
Other possible side effectsReproductive system problems:
Bleeding at unexpected times (breakthrough bleeding and spotting). This is more likely during the first few months of treatmentSwollen or tender breasts. This is more likely during the first few months of treatment.Stomach problems:
Feeling or being sickBloating of your stomachIncreased appetiteIndigestion.Nervous system problems:
HeadacheDizzinessAnxiety or depressive moodsLoss or change in sex drive.Skin problems:
Changes in your weightSwollen anklesLeg crampsHeart palpitations.Other side effects reported with similar HRT treatment include the following:
Breast cancerWomb or ovary cancer (endometrial or ovarian cancer)Blood clots, usually in a leg or lungHeart attackStrokeGall bladder diseaseSerious skin disease, where the skin may get darker, bleed underneath or develop a severe rashDementia (loss of memory and other mental powers).If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Cyclo-Progynova
Keep out of the reach and sight of children. Do not use Cyclo-Progynova after the expiry date on the carton. The expiry date refers to the last day of that month.Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
What Cyclo-Progynova contains
There are two active substances in this medicine. the white tablets contain 2mg of estradiol valerate. The pale-brown tablets contain 2 mg of estradiol valerate and 0.5 mg of norgestrel.The other ingredients are lactose, maize starch, povidone, talc, magnesium stearate (E572), sucrose, calcium carbonate (E170), polyethylene glycol 6000.The white tablets also contain titanium dioxide (E171), yellow ferric oxide (E172) and red brownferric oxide (E172)The pale-brown tablets also contain glycerin and montan glycol wax.
What Cyclo-Progynova looks like
Cyclo-Progynova is made up of white and pale brown tablets. Each carton contains 1 or 3 memo-packs. Each memo-pack contains 21 tablets, which include 11 white tablets and 10 pale brown tablets.Not all pack sizes may be marketed