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Progynova is a Hormone Replacement Therapy (HRT). It contains the female hormone, oestrogen. Your ovaries gradually make less of this hormone as you get older and will no longer produce it after you have been through the menopause.
What Progynova is used for
Progynova is used for the treatment of symptoms of the menopause such as hot flushes, difficulty in sleeping, nervousness, dizziness or vaginal dryness. Progynova is not a contraceptive.
2. BEFORE YOU TAKE PROGYNOVA
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.
Medical history and regular check-ups
Before you start taking HRT, your doctor should ask you 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.
- Gegularly 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 take Progynova if you have:
- Breast cancer, or a history of breast cancer
- Cancer that depends on oestrogen to grow e.g. endometrial cancer (cancer of the lining of the womb)
- Any unexplained vaginal bleeding
- Untreated thickening of the lining of the womb (endometrial hyperplasia)
- Ever had a blood clot in a vein (thrombosis) such as deep vein thrombosis or a pulmonary embolism, now or in the past
- Or recently had a heart attack, stroke or angina
- Had liver disease, and you have been told by your doctor that your liver function tests have not yet returned to normal
- Porphyria (a rare, inherited blood pigment disorder)
- An allergy to oestrogens or to any other ingredient in Progynova
- Been told to avoid lactose, that you have a rare hereditary condition called Lapp lactase deficiency or glucose-galactose malabsorption
- Any reason to believe that you either are, or may be, pregnant, or if you are producing milk (lactating) and breast-feeding. (See also the ´Pregnancy and breast-feeding´ section of this leaflet)
If any of the above conditions appear for the first time while taking Progynova, stop taking it at once and consult your doctor immediately.
When you need to take special care with Progynova
If you have ever had (e.g. during pregnancy or previous hormone treatment) any of the following, you may be closely supervised by your doctor because Progynova may worsen these conditions or cause them to return:
- Fibroids of the womb or any tissue of the lining of the womb at inappropriate places (endometriosis)
- A history of, or risk factors for, blood clotting (see "Progynova and blood clots")
- An increased risk for breast cancer (mother, sister or grandmother who has had breast cancer), or other tumour(s) that depend on oestrogen to grow
- High blood pressure
- Any disorder of the liver
- Migraine or severe headaches
- Systemic lupus erythematosus (SLE; a chronic inflammatory disease which can affect many parts of the body)
- A history of thickening of the lining of the womb (endometrial hyperplasia)
- Deafness due to otosclerosis (excessive growth of the bones in the middle ear)
Effects of Progynova on your heart or circulation
Progynova and 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, sudden 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.
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.
Progynova and 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 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.
Progynova and 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
- Drinking too much alcohol
- An irregular heartbeat
o 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.
Progynova and cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT for 5 years or more slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking 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 extra risk of breast cancer goes up the longer you take HRT, 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 breast cancer is diagnosed in a woman taking HRT, it´s more likely to be found before it has spread beyond the breast.
Looking at women aged 50 who are not taking HRT – on average, 45 in 1000 will be diagnosed with breast cancer by the time they reach the age of 70. For women who start taking HRT at age 50 and take it for 5 years, the figure will be 47 in 1000. If they take HRT for 10 years, the figure will be 51 in 1000. If they take HRT for 15 years, the figure will be 57 in 1000.
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 oestrogen-only HRT for a long time can increase the risk of developing 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 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 your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen. Progynova is an oestrogen-only product.
Looking at women who still have a womb 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 10 to 60 in 1000, depending on the dose and how long you take it. The addition of a progestogen to oestrogen-only HRT greatly lowers the extra 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 (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 the risk in the same way.
Progynova and memory loss
HRT will not prevent memory loss (dementia). A study with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) showed that women who started using this HRT after the age of 65 had a small increase in their risk of developing dementia. It is not known if this applies to other types of HRT, such as Progynova, or to younger women.
- If you have heart or kidney problems, your doctor should examine you carefully as oestrogens may cause fluid retention resulting in swelling
- If you have pre-existing elevated triglycerides (a type of blood fat) your doctor should monitor you closely during oestrogen replacement therapy or HRT. Rare cases of large increases of plasma triglycerides (hypertriglyceridemia) leading to inflammation of the pancreas (pancreatitis) have been reported with oestrogen replacement therapy
- If you have a tendency to develop blotchy brown patches (chloasma) on the face you should avoid exposure to the sun or ultraviolet light whilst using Progynova
- Your doctor will monitor you carefully if you have terminal kidney insufficiency as the blood levels of the active substances in Progynova will probably increase
Progynova and using other medicines
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including ones obtained without prescription. The following may reduce the effects of Progynova:
- Medicines used for the treatment of:
- Epilepsy (e.g. phenobarbital, phenytoin, carbamazepine)
- Infections (e.g. rifampicin, rifabutin)
- HIV infection (e.g. nevirapine, efavirenz, nelfinavir, ritonavir)
- The herbal remedy St. John’s wort (Hypericum perforatum)
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding
Progynova is for use in post-menopausal women. Do not take if you are pregnant or breast-feeding.
If you become pregnant, stop taking Progynova immediately and tell your doctor.
Driving or using machines
There is nothing to suggest that the use of Progynova affects driving or use of machines.
Important information about some of the ingredients of Progynova
Progynova contains lactose (a type of sugar). If you have an intolerance to some sugars, check with your doctor before taking Progynova.
3. HOW TO TAKE PROGYNOVA
Progynova is not for use in adolescents or children.
About the pack
This pack is designed to help you remember to take your medicine. Each tablet is placed in a section marked with the day of the week on which it should be taken. The arrows between tablets show the order in which they must be taken. Your doctor may tell you when to start (see "when to start" for further information). On the day you start, take your first tablet from the blue section of the pack (top row of tablets) marked with the correct day. For instance, if you start on a Tuesday, press out the tablet from the blister marked ´TUE´. Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the memo strip. When you have finished each memo strip, start the next memo strip on the following day. Do not leave a break between memo strips. It is best to take your tablet at the same time each day. You can take Progynova with or without food. The tablet should be swallowed whole with a glass of water or milk. Your doctor may prescribe the hormone progestogen in addition to Progynova for at least 12-14 days each month:
- If you still have your womb
- If you have a history of endometriosis
When to start
If you have been taking other HRT preparations:
carry on until you have finished your current pack and have taken all the tablets for that month. Take your first Progynova tablet the next day. Do not leave a break between your old tablets and the Progynova tablets.
If this is your first HRT treatment and you are still having regular periods:
start your Progynova tablets on the first day of bleeding
If this is your first HRT treatment and your periods have become very infrequent or have stopped completely:
you can start your Progynova tablets at any time if you sure you are not pregnant.
If you take more Progynova than you should
If you have taken too many Progynova tablets by mistake, you may feel sick, vomit or have some menstruation-like bleeding. No specific treatment is necessary but you should consult your doctor or pharmacist if you are worried.
If you forget to take Progynova
If you forget to take a tablet at your usual time and you are less than 12 hours late, take it as soon as possible. Take the next tablet at the usual time.
If you are more than 12 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time every day. You may experience breakthrough bleeding.
If you stop taking Progynova
You may begin to feel the usual symptoms of menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist if you want to stop taking Progynova tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Progynova can cause side effects, although not everybody gets them.
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.
Serious side effects associated with Hormone Replacement Therapy:
- Blood clots in the veins
- Cancer of the lining of the womb (9/0) Page 8 of 10
- Breast cancer
- Heart disease
For more information about these side effects see Section 2.
Other side effects that have been linked to the use of Progynova and other oral hormone replacement therapies:
- During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These symptoms normally lessen with continued treatment. If they don’t, contact your doctor (see section 2 ‘Progynova and cancer/Endometrial cancer (cancer of the lining of the womb)’ for more information)
- Breast pain, tenderness or enlargement, breast discharge
- Painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb
- Indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease
- Skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the face (chloasma – see section 2 ‘other conditions’ for more information), some rare skin problems
- Headache, migraine, dizziness, anxiety or depressive symptoms, fatigue
- Fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs
- Fluid retention leading to swelling of parts of the body
- Changes in body weight and sex drive, increased appetite
- Muscle cramps, leg pains
- Nose bleeds, visual disturbances (such as blurred vision), discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).
5. HOW TO STORE PROGYNOVA
Keep out of the reach and sight of children. Do not use Progynova after the expiry date which is printed on the label after "EXP". The expiry date refers to the last day of the month stated. Do not dispose of medicines down the drain or in the household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Progynova contains
The active substance is estradiol valerate.
The other ingredients are lactose monohydrate, maize starch, povidone 25,000, talc, magnesium stearate (E572), sucrose, povidone 700,000, macrogol 6,000, calcium carbonate (E170), titanium dioxide (E171), glycerol 85% (E422), montan glycol wax, ferric oxide pigment (E172) and purified water. What Progynova looks like and contents of the pack Progynova 1mg tablets are pale yellow sugar-coated tablets. They are supplied in a blister pack (memo strip) containing 28 tablets with the days of the week printed on the blister. Boxes containing three blister packs are available.