Cyclo-Progynova 2mg

What is your medicine?

The name of your medicine is Cyclo-Progynova 2 mg.

Each strip of Cyclo-Progynova 2 mg has 11 white tablets containing 2 mg estradiol valerate and 10 pale brown tablets each containing 2 mg estradiol valerate and 500 micrograms of norgestrel.

The active ingredient in this medicine is estradiol. This is the new name for oestradiol. The ingredient itself has not changed.

Cyclo-Progynova 2 mg also contains the following inactive ingredients: lactose, maize starch, povidone, magnesium stearate (E 572), sucrose, polyethylene glycol 6000, calcium carbonate (E 170), glycerin (E 422), talc, montan glycol wax, titanium dioxide (E 171), yellow and red/brown ferric oxide pigments (E 172).

Each pack of Cyclo-Progynova 2 mg contains 1 or 3 memo-packs (strips) of 21 tablets.

The product licence is held by:

This product is manufactured by:

You must not take Cyclo-Progynova 2 mg

• If you have, or have had, cancer of the breast
• If you have, or have had, cancer of the or womb
• If you currently have any problems with your liver
• If you have vaginal bleeding and the cause is not known
• If you have a condition called endometrial hyperplasia (where the lining of the womb grows more than normal) and if you are not having treatment for it
• If you have a blood clot in a vein in your leg or anywhere else (a "deep vein thrombosis") or if you have had one of these in the past
• If you have a blood clot that has travelled to your lung or another part of the body (an "embolus") or if you have had one of these in the past
• If you have, or have had, a disease related to blood clots such as angina, or a heart attack
• If you are allergic to any of the ingredients in Cyclo-Progynova
• If you have the condition known as porphyria.
• If you are pregnant, suspect that you are pregnant or if you are breast feeding

What you should know before using Cyclo-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 Check-ups

Before starting to take hormone replacement therapy you should discuss your personal and family medical history with your doctor.

Your doctor may decide to perform a physical examination of the breasts and/or a pelvic examination before starting this medication - 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.

Before starting to take your medicine you must tell your doctor if you have, or have had any of the following as he may decide to alter your treatment or he may ask to see you more often:-

• fibroids in your uterus
• endometriosis (when the lining of the womb grows outside the womb)
• a family history of cancer of the breast or womb
• liver disease
• diabetes
• gall stones
• migraine or severe headaches
• a condition known as systemic lupus erythematosus
• a condition called endometrial hyperplasia (where the lining of the womb grows more than normal)
• epilepsy
• asthma
• deafness (otosclerosis)
• hypertension
• risk factors that indicate you may experience blood clots. These include being seriously overweight, having blood clotting problems or having a blood clot previously. The full list of these risk factors is provided in the section on Blood clotting below.

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.

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 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 you must see a doctor as soon as possible. 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.

Consider the following:

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) you must see a doctor as soon as possible. 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.

Consider the following:

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 any of the following:

• painful swelling in your leg
• sudden chest pain
• difficulty breathing

you must see a doctor as soon as possible. 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 oestrogen-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 oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen 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 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

Consider the following:

Looking at women aged 50 who are not taking HRT – on average 32 in 1000 will have breast cancer diagnosed by 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 between 33 and 34 in 1000 (ie 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 (ie 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 skin
• changes in the nipple
• any lumps you can see or feel

you must 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 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 may prescribe a progestogen as well as oestrogen. 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 oestrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. If so, your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.

Your product, Cyclo-Progynova 2 mg contains a progestogen.

Consider the following:

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 oestrogen-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

you must 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 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.

What about other medicines that you may be taking?

Some medicines affect the way that drugs are handled by the liver and may reduce the effectiveness of Cyclo-Progynova 2 mg. These include some epilepsy medicines (for example phenytoin, phenobarbital and carbamazepine), and some antibiotics/anti-infectives (for example rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir) and the herbal preparation, St John’s Wort.

If you are taking oral contraceptives, these should be stopped and other, non-hormonal methods of contraception should be used.

If you are a diabetic on insulin or tablets, your daily dose might need to be changed, your doctor will advise you.

What about food and drink?

Cyclo-Progynova 2 mg is not known to react with any types of food and drink.

What to do if you see a different doctor or have to go to hospital for treatment.

If you see any other doctor or go to hospital for treatment, tell your doctor about all your medicines, including Cyclo-Progynova 2 mg.

Special warnings

Lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

You should stop taking your tablets and tell your doctor if you:

• develop any of the conditions listed in this leaflet under "You must not take Cyclo-Progynova".
• start developing headaches or migraines
• develop jaundice or problems with your liver
• become pregnant
• experience pain, tingling or numbness in any part of the body
• experience sudden chest pain

Cyclo-Progynova 2 mg must also be stopped at once if your doctor finds your blood pressure to be significantly raised.

How to take your Cyclo-Progynova 2 mg

It is usually recommended that Cyclo-Progynova is taken at the lowest dose which is effective and for the shortest time possible.

About the pack:

The pack of Cyclo-Progynova 2 mg is designed to help you take your tablets. To use it you must first know the day of the week on which you will take the first tablet. If you are still having your periods, take the first tablet on the fifth day of your period, whether the period has finished or not. If your periods have become infrequent or have stopped altogether, your doctor may have advised you to start Cyclo-Progynova 2 mg immediately. If you have been taking a continuous HRT product (i.e. you take the same dose each day) you may change to Cyclo-Progynova 2 mg on any day. If you have been taking an HRT product which is followed by a withdrawal bleed, you should complete the cycle of treatment before changing to Cyclo-Progynova 2 mg.

In addition to the memo-pack (which contains the tablets), the outer carton contains a self adhesive blue sticker showing the days of the week. Peel the circular sticker off its backing and stick it in the centre of the memo-pack so that the day on which you start taking the tablets is directly underneath the red segment marked 'Start'.

For instance, if you are to start the tablets on a Wednesday, then stick a 'Wed' directly underneath the red segment marked 'Start'. You can now see on which day you have to take each tablet. Simply take one tablet each day, following the direction of the arrows on the foil, until the pack is empty. This means that you will be taking one white tablet for the first 11 days and then one pale brown tablet daily for the following 10 days. If, at any time, you are in doubt whether you have taken your tablet, a glance at the appropriate day on the memo-pack will tell you.

When you have finished taking your pack, you must leave a tablet free interval of seven days (unless your doctor decides otherwise). During this week, bleeding similar to a period may occur. This is normal.

Start your next pack of Cyclo-Progynova 2 mg immediately after this seven day break, whether the bleeding has stopped or not. You will in fact start on the same day of the week that you started your previous pack and the same will be true for each successive pack.

It is best to take your tablet at the same time each day, preferably after a meal. The tablet should not be chewed or sucked, but swallowed whole with a glass of water.

What to do if you forget to take a tablet

Take it as soon as possible, and take the next one at your normal time. If you are more than twelve hours late, leave the forgotten tablet in the pack. Continue to take the remaining tablets at the usual time on the right days.

You may experience some vaginal bleeding (breakthrough bleeding) if you have missed a tablet. This is normal.

What to do if you take too many tablets at once

There have been no reports of ill effects from taking too many tablets.

You should consult your doctor who will be able to advise you what action, if any, is necessary.

What bleeding to expect (what to do if your bleeding pattern seems different)

Just as with normal periods, the amount of bleeding with Cyclo-Progynova 2 mg varies from woman to woman. Usually the blood loss is not unduly heavy and it may even be rather scanty, but this is not important as far as the treatment is concerned. If you have recently had very light, short periods, you may have rather heavier blood loss with Cyclo-Progynova 2 mg.

If you are still menstruating, you will probably have regular blood loss 2 – 3 days after finishing each pack of Cyclo-Progynova 2 mg. If you miss a period, the possibility of pregnancy should be investigated.

Ask your doctor for advice.

If you have stopped having periods, Cyclo-Progynova 2 mg will probably cause you to experience blood loss again after the end of each pack, but may not always do so.

If blood loss occurs during the three weeks in which you are taking the tablets, let your doctor know. This may be a sign that your endometrium is getting thicker (see section on Endometrial Cancer in this leaflet). It is not necessary to stop taking your tablets unless your doctor tells you to.