Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Progynova TS 50 micrograms/24 hours transdermal patch
(estradiol)
Please read all of this booklet carefully before you start taking your medicine
- Keep this booklet as you may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally. It is not suitable for all women, so you should not give it to anyone else as it may harm them.
- This medicine is called ‘Progynova TS 50 micrograms/24 hours transdermal patch’ but will be referred to as ‘Progynova TS 50’ throughout this booklet.
Contents
- What Progynova TS 50 is and what it is used for
- What does Progynova TS 50 contain?
- What kind of medicine is Progynova TS 50?
- What is Progynova TS 50 used for?
- Before you use Progynova TS 50
- Reasons for not using Progynova TS 50
- What you should know before using Progynova TS 50
- Medical check-ups
- Effects on your heart or circulation
- Effects on your risk of developing cancer
- Other important information
- What to do if you are taking other medicines at the same time as Progynova TS 50
- How to use Progynova TS 50
- To apply Progynova TS 50
- What to do if a patch falls off
- What to do if you forget a patch
- What to do if you use too many patches
- Possible side effects
- Reasons for stopping Progynova TS 50
- How to store Progynova TS 50
What Progynova TS 50 is and what it is used for
The name of your treatment is Progynova TS 50.
What does Progynova TS 50 contain?
Progynova patches are oval transparent patches with a self-adhesive backing, which can be stuck to the skin.
Progynova TS 50 is a patch with an area of 12.5 square centimetres containing 3.8 milligrams of estradiol, an oestrogen, (formed from 3.9 milligrams estradiol hemihydrate). Your body will absorb about 50 micrograms of estradiol each day whilst you are wearing a Progynova TS 50 patch.
Inactive ingredients: ethyl oleate, isopropyl myristate and glycerol monolaurate. The adhesive system is an acrylate/acrylamide/vinyl acetate copolymer.
Packs containing either 4 or 12 patches are available. Each sealed pouch contains one Progynova TS 50 patch.
What kind of medicine is Progynova TS 50?
Progynova TS 50 patches are a form of oestrogen replacement therapy.
What is Progynova TS 50 used for?
Progynova TS 50 is used to treat symptoms of the menopause in women who are at least one year past their last menstrual period. The patches contain the hormone oestrogen which is absorbed through your skin and into the blood stream. They can therefore relieve the symptoms caused by the loss of your own oestrogen. Your doctor will aim to prescribe the lowest dose that controls your symptoms.
Thinning of the bones (osteoporosis) can occur after the menopause. In some women this can lead to fractures of the wrist, spine or hip in later life. You may be able to use Progynova TS 50 to prevent this if you are unable to take other treatments or they haven’t worked for you. Your doctor will be able to advise you further.
Because it only contains one of the female sex hormones, Progynova TS 50 is not suitable to be used alone for women who have not previously had a hysterectomy. You will need to take another hormone, progestogen, as well as Progynova TS 50 if this is the case. Your doctor will be able to advise you about this. (See “Effects on your risk of developing cancer” for more information).
The product licence for Progynova TS 50 is held by:
Product Licence number:
PL 00010/0560
Progynova TS 50 is made by:
Batch release in the EU by
Before you use Progynova TS 50
Reasons for not using Progynova TS 50
You must not use Progynova TS 50 if you have any of the following:
- a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis”) or a blood clot that has travelled to your lung or another part of the body (an “embolus”) or have had one of these in the past
- angina (severe chest pain), or if you have recently had a heart attack
- the rare inherited disorder porphyria
- a hormone dependent tumour e.g. cancer of the lining of the womb (endometrial cancer)
- breast cancer, or have had this in the past
- if you have an allergy to any of the ingredients.
- Tell your doctor if:
- you are pregnant or breast feeding
- you have liver disease or have had this in the past
- you have irregular or unusually heavy periods
- you have endometrial hyperplasia (changes to the lining of the womb which may cause heavy vaginal bleeding) or have had this in the past
as these may mean that Progynova TS 50 is not suitable for you.
What you should know before using Progynova TS 50
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 you start taking HRT, your doctor should ask 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.
Make sure you:
- 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.
Certain diseases sometimes get worse when you are taking hormone replacement therapy.
- So tell your doctor if you suffer from:
- fibroids of the womb
- endometriosis (lining of the womb growing in the wrong place causing pain or bleeding)
- risk factors for getting blood clots (see “Effects on your heart or circulation – blood clots” for more information)
- risk factors for hormone dependent tumours (see “Effects on your risk of developing cancer
- high blood pressure
- diabetes
- gall stones
- migraine or severe headaches
- systemic lupus erythematosus – SLE (a disease affecting the skin all over the body)
- epilepsy
- asthma
- inherited deafness (otosclerosis)
- heart or kidney problems
- a blood-fat disorder called hypertriglyceridaemia
- hereditary angioedema (episodes of swelling of body parts)
These may mean that your doctor will need to check you more closely.
- If you are not sure whether any of these apply to you, ask your doctor. If any of these conditions appear during your use of Progynova TS 50, contact your doctor for advice.
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
- 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.
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.
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.
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.
- 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 an operation, 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 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 lining of the womb (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.
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.
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 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 (ie 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 (ie 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.
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. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.
Your product, Progynova TS 50 contains only oestrogen.
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 between 10 and 60 in 1000 depending on the dose and for how long it is taken.
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
- 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.
Other important information
The use of hormone replacement therapy may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using hormone replacement therapy.
Brown patches on your face and body (chloasma) may occasionally occur, especially if you experienced this during a previous pregnancy. You can reduce this by not staying in the sun too long and by not using sunbeds or sunlamps.
HRT will not prevent memory loss. 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 or to younger women.
Progynova TS 50 is not a contraceptive. If there is any possibility that you may become pregnant ask your doctor for contraceptive advice. It is important that you use a reliable form of non-hormonal contraception such as a condom or cap plus spermicide. Oral contraceptives should not be used.
What to do if you are taking other medicines at the same time as Progynova TS 50
Some medicines may stop Progynova TS 50 from working properly and other medicines will be affected by Progynova TS 50.
- Tell your doctor if you have to take any other medicines regularly, especially:
- medicines used to treat epilepsy or other illnesses, such as phenobarbitol, phenytoin, carbamazepine
- medicines used to treat certain infections, such as rifampicin, rifabutin, nevirapine, efavirenz
- medicines used to treat HIV infections, such as ritonavir, nelfinavir
- the herbal remedy commonly known as St John’s wort (Hypericum perforatum).
If in doubt about any medicines you are taking, ask your doctor or pharmacist.
How to use Progynova TS 50
If you are not currently using hormone treatment, or you use a type that does not cause a regular monthly bleed, you can start to use Progynova TS 50 immediately.
If you are changing from another type of hormone replacement therapy that causes a monthly bleed, you may be told to start Progynova TS 50 the day after stopping your treatment or when your doctor has told you to.
If you are changing from a 3-week on, 1-week off, type of hormone replacement therapy you may be told to start Progynova TS 50 the day after the treatment-free period (1-week off).
If you have not had a hysterectomy, your doctor may have prescribed a progestogen separately in addition to Progynova TS 50. Follow your doctor’s instructions.
To apply Progynova TS 50: the patch should be applied to a clean, dry area of skin preferably on the stomach or buttocks. Progynova TS 50 must not be applied on or near the breasts. The area chosen should not be oily, damaged or irritated, and the waistline should be avoided since tight clothing may rub the patch off.
Take the patch out of its packaging. Remove the protective liner. The patch should then immediately be pressed firmly in place with the palm of the hand for about 10 seconds. Make sure there is good contact with the skin; especially around the edges.
The patch should be left in place for 7 days, then removed and replaced with a new patch which should be applied to a different area.
Although the patches should usually be applied continuously, your doctor may tell you to apply the patches on a cyclical basis. In this case, a patch should be applied weekly for 3 weeks followed by a 7 day interval without a patch application before the next course.
You will be able to bath or shower as normal while wearing a patch. However, the patch may fall off in very hot water or in a sauna.
After use, Progynova TS 50 patches still contain large amounts of the active ingredient estradiol. Take care when throwing away used and unused patches. Fold patches in half with the sticky sides together and throw away with your dustbin waste. Patches must not be flushed down the toilet.
What to do if a patch falls off
If a patch falls off before 7 days are up, it may be reapplied. If necessary a new patch may be used if it is not possible to reattach the old patch properly. If a new patch is used it should be kept on for the remainder of the 7 days and then changed on your usual day for applying a new patch.
What to do if you forget a patch
If you forget to put a patch on, put it on as soon as you remember and keep it on for 7 days before replacing with a new patch. If you are several days late in changing your patch, you may get some light vaginal bleeding (spotting) at unexpected times.
What to do if you use too many patches
If you use too many patches, it is unlikely to cause you any serious problems but you may feel sick, actually be sick or have some vaginal bleeding. If you are worried, talk to your doctor or pharmacist who can tell you what, if anything, you need to do.
Possible side effects
The most frequently reported reactions during the first few months of treatment are breast tenderness or enlargement or vaginal bleeding at unexpected times (breakthrough bleeding or spotting). These are usually temporary and normally disappear with continued treatment.
Below we list other possible side effects by how likely they are to occur:
Common
Between 1 and 10 in every 100 people are likely to get these:
Pain; excessive gas or belching; feeling sick; swelling caused by build up of fluid in arms, legs or other parts of the body; weight gain; depression; dizziness; nervousness; feeling sluggish; headache; increased sweating; hot flushes; itchy rash which may be around the patch; changes to menstrual bleeding; vaginal discharge; vaginal and genital problems.
Uncommon
Less than 1 in every 100 people are likely to get these:
Feeling weak, tired or generally unwell; abnormal laboratory tests; fever, flu-like symptoms; migraine; fast or irregular heartbeats (palpitations); inflamed and itchy veins, usually in the legs (phlebitis); increased blood pressure; increased appetite; constipation; diarrhoea; back passage problems; high level of blood fats (cholesterol); joint problems and muscle cramps; difficulty breathing; runny nose; trouble sleeping; mood changes; problems concentrating; pins and needles; changes to sex drive; shaking or tremor; loss of hair, excessive hair growth; lumpy, enlarged or tender breasts; skin rashes; acne; dry skin or small skin swelling; nail problems; problems with frequency and control of urine; discoloured urine; blood in urine; changes to the lining of the womb which may cause heavier vaginal bleeding; bladder infections (cystitis); dry eyes; eyesight problems.
Rare
Less than 1 in every 1000 people are likely to get these::
Stomach pain or bloating; yellowing of the skin or eyes (jaundice); inflammatory skin rashes; breast pain; fibroids.
Other side effects reported with HRT include:
The risk of breast cancer increases with the number of years of using HRT. Cancer of the lining of the womb (endometrial cancer) has also been reported. See “Effects on your risk of developing cancer” for more information.
Blood clots, heart attacks and stroke (see “Effects on your heart or circulation” for more information); dementia , increased skin pigment especially on the face (chloasma) (see “Other important information” for more information); some rare skin problems and gall bladder disease.
Worsening of hereditary angioedema with swelling of the skin and/or mucous membranes such as swollen face, lips, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.
- Tell your doctor if you have any of the symptoms listed above, or indeed any other new symptoms during treatment. Also tell your doctor if you have any of the symptoms listed under “Reasons for stopping Progynova TS 50”.
Reasons for stopping Progynova TS 50
- Stop treatment (remove the patch) at once and talk to your doctor immediately if you have any of the following:
- your very first attack of migraine (typically a throbbing headache and nausea preceded by visual disturbances);
- if you get a blood clot – see the section “Blood clots” on for warning signs of a blood clot.
- you have difficulty breathing or have worsening of hereditary angioedema.
- Stop treatment (remove the patch) at once and talk to your doctor as soon as you can if you have any of the following:
- if you become pregnant
- if you develop jaundice (get yellowing of the skin or eyes)
- if you develop any of the conditions listed under “Reasons for not using Progynova TS 50” .
- Your doctor may decide that you should stop using Progynova TS 50 if:
- your liver function tests become abnormal
- there is a significant rise in your blood pressure
- you are off your feet for a long time because of major surgery, injury or illness. See also the section “Blood clots” on, especially if you are going to have an operation.
How to store Progynova TS 50
Store your patches in the original packaging in order to protect from moisture.Store below 30ºC.
Keep your patches in a safe place where children cannot see or reach them.
Do not use the patches after the expiry date that is shown on the box.
Date of last revision of this booklet: May 2008
Progynova is a registered trademark of Bayer Schering Pharma AG (formerly Schering AG).
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