Cyclo-Progynova 2mg 21 Dragee Bayer

Cyclo-Progynova 2mg 21 Dragee Bayer

Brand:BAYER SCHERING Pharmaceuticals
Product Code:195
Availability:In Stock

Patient Information Leaflet

Cyclo-Progynova® 2 mg

Estradiol valerate and norgestrel

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• In this leaflet, Cyclo-Progynova 2 mg will be called Cyclo-Progynova.

Information in this leaflet can be found by looking under the following sections:

1. What Cyclo-Progynova is for

1.1 Cyclo-Progynova is used for

2. Before you take Cyclo-Progynova

2.1 Do not take Cyclo-Progynova if

2.2 Check with your doctor before taking Cyclo-Progynova if

2.3 Safety of HRT

2.4 Heart disease

2.5 Stroke

2.6 Blood clots

2.7 Surgery (Surgical operations)

2.8 Breast cancer

2.9 Endometrial cancer

2.10 Ovarian cancer

2.11 Dementia

2.12 Tell your doctor if you are taking any of the following medicines

2.13 Contraception

2.14 Pregnancy and breast-feeding

2.15 Driving and using machines

2.16 Warning about sugar intolerance

3. How to take Cyclo-Progynova

3.1 When to start taking your medicine for the first time

3.2 How to use the medicine

3.3 Medical check-ups

3.4 What bleeding pattern to expect with Cyclo-Progynova

3.5 If you take more Cyclo-Progynova than you should

3.6 If you forget to take Cyclo-Progynova

4. Possible side effects

5. How to store Cyclo-Progynova

6. Further information.

6.1 What Cyclo-Progynova contains

6.2 What Cyclo-Progynova looks like

6.3 Marketing Authorisation Holder

6.4 Manufacturer

1. What Cyclo-Progynova is for

Cyclo-Progynova belongs to a group of medicines called hormone replacement therapy (HRT).

Cyclo-Progynova contains two hormones called estradiol (an oestrogen) and norgestrel (a progestogen). These act in different ways in your body.

During the menopause (sometimes called “the change of life”) a woman’s body slowly produces less oestrogen. This may cause hot flushes, night sweats, mood swings and dryness in the vagina.

Over a long time it may also cause a thinning of the bones, which may be more likely to then break (osteoporosis).

Cyclo-Progynova works by replacing the oestrogen you lose during the menopause and therefore improves the unpleasant symptoms you may get.

Oestrogen can also make the lining of your womb grow more than usual, which may lead to cancer developing there. The other hormone in Cyclo-Progynova called a progestogen reduces the chance of getting cancer of the womb.

1.1 Cyclo-Progynova is used for:

• Treating symptoms of the menopause. This includes hot flushes, night sweats, mood swings and  ryness in the vagina

• Preventing thinning of the bones (osteoporosis) in women who are not allowed to take other types of medicines to prevent this from happening 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

2.1 Do not take Cyclo-Progynova if you have, or have ever had:

• An allergic reaction to estradiol or norgestrel

• An allergic reaction to any of the other ingredients of Cyclo-Progynova (listed in section 6)

• Breast or womb cancer • Bleeding from your vagina and the cause is not known

• Endometrial 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 (pulmonary embolus) or any other problems with blood clots forming.

• if you have a high risk of venous or arterial thrombosis (blood clot)

• Angina, a stroke or other heart disease

• Liver problems

• Kidney problems

• Porphyria (a rare blood disorder).

If any of the above applies to you, do not take Cyclo-Progynova and talk to your doctor or pharmacist.

2.2 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 family

• Risk factors for blood clotting problems

• Risk factors for angina, a stroke or heart disease

• You have elevated levels of triglycerides (special type of blood lipids)

• chloasma (patches of discoloration on the skin)

• High blood pressure

• Diabetes

• Gallstones

• Adenoma of the anterior lobe of the pituitary gland (pituitary adenoma)

• Migraine or severe headache

• Systemic lupus erythematosus, (SLE or lupus for short)

• Epilepsy

• Asthma

• Otosclerosis (hearing loss due to a problem with the bones in the ear).

• A condition known as hereditary angioedema (see section 4).

• Chorea minor

• Premature menopause

2.3 Safety of HRT

As well as benefits, HRT has some risks which you may wish to discuss with your doctor when you are deciding whether to start HRT, or whether to carry on taking it.

Effects on your heart or circulation

2.4 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.

2.5 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.

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 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.

2.6 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

• You have had a blood clot before

• Any of your close family have had blood clots

• You have had one or more miscarriages

• You 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 illness

• You 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. Your doctor will discuss with you the benefits and risks of Cyclo-Progynova. She/he will check, e.g. whether you have a higher risk of getting a thrombosis due to a combination of risk factors or perhaps one very strong risk factor. In the case of a combination of factors the risk may be higher than simply adding two individual risks. If the risk is too high, your doctor will not prescribe HRT treatment. 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-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.

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

2.7 Surgery (Surgical operations)

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  hen you can start taking HRT again.

Effects on your risk of developing cancer

2.8 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, alcohol intake  nd adiposity. The risk for a postmenopausal 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. 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

• are seriously overweight.

Compare:

- 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 skin

• changes in the nipple

• any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

2.9 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 your body 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 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.

2.10 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.

2.11 Dementia

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.

2.12 Liver tumor

During or after the use of hormones such as those that are contained in Cyclo-Progynova, benign liver tumors have rarely occurred, and malignant liver tumors even more rarely. In isolated cases, bleeding from such tumors into the abdominal cavity has endangered life. Although such events are extremely improbable you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.

2.13 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 Wort

• Insulin or other medicines to treat diabetes

• Protease inhibitors (to treat HIV)

• Transcriptase inhibitors such as nevirapine or efavirenz (to treat HIV)

• Any other medicine, including medicines obtained without a prescription.

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