- medroxyprogesterone acetate
- estradiol valerate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 27925/0014.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Estradiol valerate and Medroxyprogesterone acetate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
In this leaflet:
1. What Tridestra is and what it is used for
2. What you need to know before you take Tridestra
3. How to take Tridestra
4. Possible side effects
5. How to store Tridestra
6. Contents of the pack and other information
1. WHAT TRIDESTRA IS AND WHAT IT IS USED FOR
Tridestra is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen.
Tridestra is used for:
Relief of menopausal symptoms
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Tridestra alleviates these symptoms. You will only be prescribed Tridestra if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Tridestra to prevent osteoporosis after menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIDESTRA
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.
Once you have started on Tridestra you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Tridestra.
Regularly check your breasts for any changes (see section 2, Breast cancer). Go for regular breast screening, as recommended by your doctor.
Do not take Tridestra
if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Tridestra.
Do not take Tridestra
If any of the above conditions appear for the first time while taking Tridestra, stop taking it at once and consult your doctor immediately.
Warnings and Precautions
Talk to your doctor before starting the treatment if you have ever had any of the following problems, as these may return or become worse during treatment with Tridestra. If so, you should see your doctor more often for check-ups:
Stop taking Tridestra and see a doctor immediately
If you notice any of the following when taking HRT:
Note: Tridestra is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
The progestogen in Tridestra protects you from this extra risk.
You will have a bleed once every three months (so-called withdrawal bleed) while taking Tridestra. But, if you have unexpected bleeding or drops of blood (spotting) besides your three monthly bleed, which:
see your doctor as soon as possible.
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 (i.e. an extra 4 to 6 cases).
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:
For signs of a blood clot, see “Stop taking Tridestra and see a doctor immediately”.
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
Other medicines and Tridestra
Some medicines may interfere with the effect of Tridestra. This might lead to irregular bleeding.
This applies to the following medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
If you need a blood test, tell your doctor or the laboratory staff that you are taking Tridestra, because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
Tridestra is for use in postmenopausal women only.
Tridestra with food and drink
Tridestra can be swallowed with a glass of water at the same time each day.
Driving and using machines
Tridestra should not affect your ability to drive or operate machinery.
Tridestra 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.
3. HOW TO TAKE TRIDESTRA
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
If you are still having periods you should start to take the tablets on the fifth day of bleeding.
If you are not having periods or you are switching from a continuous combined HRT product you can start taking your tablets on any day.
If you are switching from a cyclic HRT product you should start taking Tridestra one week after you stop taking the other HRT product. Tridestra Tablets come in a calendar pack of 91 days.
There are three blister strips numbered 1 to 3.
The pack is designed to help you to take your tablets correctly.
The white tablets are taken on days 1 - 70
The blue tablets are taken on days 71 - 84.
The yellow tablets are taken on days 85 - 91.
Whilst taking this medicine
You should expect a regular menstrual type bleed every 3 months. This is quite normal even if your periods had stopped before. When you first start to take the tablets you may get some bleeding at odd times for a few months (see section 2, sub-heading ‘Unexpected bleeding’).
However, if this is still happening after a few months or if you experience heavy bleeding tell your doctor.
If you take more Tridestra than you should
If you or somebody else has taken too many Tridestra Tablets, tell your doctor or pharmacist.
If you forget to take Tridestra
It is best to take your tablet at the same time each day. If you forget, take it within 12 hours. If you do not remember and you are more than 12 hours late, leave the forgotten tablet. You should then continue by taking the next tablet at your usual time. Missing a tablet or irregular use of Tridestra tablets may cause unscheduled or breakthrough bleeding or spotting.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Tridestra. You may need to stop taking Tridestra about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Tridestra again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, particularly early on (in the first few months of treatment). However, not everybody gets them. These often disappear with continued treatment.
There are a number of situations in which you may have to stop taking Tridestra. Tell your doctor immediately if you develop any of the following conditions:
The following diseases are reported more often in women using HRT compared to women not using HRT:
For more information about these side effects, see Section 2.
The following is a list of side effects that have been linked to the use of HRT:
Common: (may affect up to 1 in 10 people)
Uncommon: (may affect up to 1 in 100 people)
Rare: (may affect up to 1 in 1,000 people)
Other side effects reported (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE TRIDESTRA
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store this medicine at room temperature not exceeding 25°C in a dry place.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tridestra contains
The active substances are:
white tablet: 2 mg estradiol valerate
blue tablet: 2 mg estradiol valerate and 20 mg medroxyprogesterone acetate
yellow tablets do not contain any active ingredients.
The other ingredients are:
white tablet: lactose, maize starch, gelatin, talc and magnesium stearate
blue tablet: lactose, maize starch, magnesium stearate, gelatin and indigo carmine (E132)
yellow tablet: lactose, maize starch, gelatine, magnesium stearate and yellow iron oxide (E172).
Tridestra tablets are gluten free.
What Tridestra looks like and contents of the pack
Each pack contains 91 tablets, 70 white ones, 14 blue ones and 7 yellow ones.
Marketing Authorisation Holder:
Distributed in the UK by:
Tridestra is a registered trademark. ©1999 Orion Pharma (UK) Ltd.
Date of last revision of leaflet: March 2016
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