This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Trisequens®
film-coated tablets
Estradiol and norethisterone acetate
1. What Trisequens® is and what it is used for 2. Before you take Trisequens® 3. How to take Trisequens® 4. Possible side effects 5. How to store Trisequens® 6. Further information
Trisequens® is a sequential combined Hormone Replacement Therapy (HRT) which is taken every day without interuption. It contains two types of female hormones, an oestrogen and a progestogen. Trisequens® is used in post-menopausal women with at least 6 months since their last natural period.
Trisequens® is used for:
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”). Trisequens® alleviates these symptoms after menopause. You will only be prescribed Trisequens® if your symptoms seriously hinder your daily life.
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 Trisequens® to prevent osteoporosis after menopause.
The experience of treating women older than 65 years is limited.
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 Trisequens® 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 Trisequens®.
Go for regular breast screening, as recommended by your doctor.
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 Trisequens®,
Do not take Trisequens®
If any of the above conditions appear for the first time while taking Trisequens®, stop taking it at once and consult your doctor immediately.
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Trisequens®. If so, you should see your doctor more often for check-ups:
If you notice any of the following when taking HRT:
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Trisequens® 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.
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 Trisequens® protects you from this extra risk.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking Trisequens®. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
see your doctor as soon as possible
Breast cancer
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.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 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 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
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 Trisequens® 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 for 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.
Stroke
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 conditions
Some medicines may interfere with the effect of Trisequens®. This might lead to irregular bleeding. This applies to the following medicines:
Other medicines may increase the effects of Trisequens®:
Concomitant administration of cyclosporine may cause increased blood levels of cyclosporine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
The tablets can be taken with or without food and drink.
If you need a blood test, tell your doctor or the laboratory staff that you are taking Trisequens®, because this medicine can affect the results of some tests.
Trisequens® is for use in post-menopausal women only. If you become pregnant, stop taking Trisequens® and contact your doctor. You should not use Trisequens® if you are breast-feeding.
Trisequens® has no known effect on the ability to drive or use machines.
Trisequens® contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Trisequens®.
Always take Trisequens® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.
If you are not switching from another hormone replacement therapy you can start treatment with Trisequens® on any convenient day. If you are switching from another hormone replacement therapy ask your doctor when you should start treatment with Trisequens®.
Take one tablet once a day, at about the same time each day.
Each pack contains 28 tablets
Days 1 - 12 Take one blue tablet everyday for 12 days
Days 13 - 22 Take one white tablet everyday for 10 days
Days 23 - 28 Take one red tablet everyday for 6 days
Take the tablets with a glass of water.
Once you have finished the pack, start a new pack continuing the treatment without interruption. A menstruation-like bleeding usually occurs at the beginning of a new pack.
For further information on the use of the calendar pack, see USER INSTRUCTIONS at the end of the package leaflet.
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. Talk to your doctor if you do not experience symptom relief after 3 months of treatment. You should only continue treatment as long as the benefit outweighs the risk.
If you have taken more Trisequens® tablets than you should, talk to a doctor or pharmacist.
An overdose of Trisequens® could make you feel sick or vomit.
Do not take a double dose to make up for a forgotten individual dose. If you forget to take your tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone by, start again as normal the next day. Do not take a double dose to make up for a forgotten tablet.
Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
If you would like to stop your treatment with Trisequens® for any reason, please discuss your decision with your doctor, who will explain the effects of stopping treatment and discuss other possibilities with you. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you are going to have surgery, tell the surgeon that you are taking Trisequens®. You may need to stop taking Trisequens® 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 Trisequens® again.
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.
Hypersensitivity/allergy
(uncommon side effects - Affects 1 in 10 users in 1,000)
Though it is an uncommon event, hypersensitivity/allergy may occur. Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing, low blood pressure (paleness and coldness of skin, rapid heart beat), feeling dizzy, sweating, which could be signs of anaphylactic reaction/shock. If one of the mentioned symptoms appears, stop taking Trisequens® and seek immediate medical help.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)
Very common side effects
Common side effects
Uncommon side effects
Rare side effects
Very rare side effects
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The following side effects have been reported with other HRTs:
Keep out of the reach and sight of children.
Do not use Trisequens® after the expiry date which is stated on the label and outer carton after ‘EXP’.
The expiry date refers to the last day of that month.
Store below 25°C. Do not refrigerate.
Keep the container in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The film-coated tablets are round with a diameter of 6 mm. The blue tablets are engraved with NOVO 280. The white tablets are engraved with NOVO 281. The red tablets are engraved with NOVO 282.
Each pack of 28 tablets contains 12 blue tablets, 10 white tablets and 6 red tablets.
Pack sizes available:
This leaflet was last approved in: 12/2011
1. Set the day reminder
Turn the inner disc to set the day of the week opposite the little plastic tab.
2. Take the first day’s tablet
Break the plastic tab and tip out the first tablet.
3. Move the dial every day
On the next day simply move the transparent dial clockwise 1 space as indicated by the arrow. Tip out the next tablet. Remember to take only 1 tablet once a day.
You can only turn the transparent dial after the tablet in the opening has been removed.
Trisequens® is a trademark owned by Novo Nordisk FemCare AG, Switzerland
© 2011
Novo Nordisk A/S
8-2801-11-042-5
Link to this document from your website:http://www.medicines.ie/medicine/14529/XPIL/Trisequens/