Patient leaflet - Trisequens film-coated tablets
1. What Trisequens® is and what it is used for
Trisequens® is a sequential combined Hormone Replacement Therapy (HRT) which is taken every day without interruption. Trisequens® is used in postmenopausal women with at least 6 months since their last natural period.
Trisequens® contains two hormones, an oestrogen (estradiol) and a progestagen (norethisterone acetate). The estradiol in Trisequens® is identical to the estradiol produced in the ovaries of women, and is classified as a natural oestrogen. Norethisterone acetate is a synthetic progestagen, which acts in a similar manner as progesterone, another important female sex hormone.
Trisequens® is used for:
Relief of symptoms occurring after menopause
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.
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 Trisequens® to prevent osteoporosis after menopause.
The experience of treating women older than 65 years is limited.
2. What you need to know before you take Trisequens®
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
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In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.
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Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 who start taking oestrogen-only HRT for 5 years, there will be 16-17 cases in 1,000 users (i.e. an extra 0 to 3 cases).
For women aged 50 who start taking oestrogen-progestagen
HRT for 5 years, there will be 21 cases in 1,000 users (i.e. an extra 4 to 8 cases).
Women aged 50 to 59 who are not taking HRT, on average, 27 in 1,000 will be diagnosed with breast cancer over a 10-year period.
For women aged 50 who start taking oestrogen-only HRT for 10 years, there will be 34 cases in 1,000 users (i.e. an extra 7 cases).
For women aged 50 who start taking oestrogen-progestagen HRT for 10 years, there will be 48 cases in 1,000 users (i.e. an extra 21 cases).
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Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. an extra 5 cases).
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Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 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 1,000 users over 5 years (i.e. an extra 3 cases).
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Pregnancy and breast-feeding
Pregnancy: Trisequens® is for use in postmenopausal women only. If you become pregnant, stop taking Trisequens® and contact your doctor.
Breast-feeding: You should not take Trisequens® if you are breast-feeding.
Driving and using machines Trisequens® has no known effect on the ability to drive or use machines.
Important information about some of the ingredients in Trisequens®
Trisequens® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking Trisequens®.
Trisequens® contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially `sodium-free’.
Once you have finished the pack, start a new pack continuing the treatment without interruption. A menstruation-like bleeding (period) 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 take more Trisequens® than you should
If you have taken more Trisequens® than you should, talk to a doctor or pharmacist. An overdose of
3. How to take Trisequens®
Always take this medicine exactly as your doctor has told you. 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 every day
for 12 days
Days 13 – 22
Take one white
tablet every day
for 10 days
Days 23 – 28
Take one red
tablet every day
for 6 days.
Take the tablets with a glass of water.
Trisequens® could make you feel sick or vomit.
If you forget to take Trisequens®
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 stop taking Trisequens®
If you would like to stop taking Trisequens®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
If you have any further questions on the use of this medicine, 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 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 (venous thromboembolism)). Ask your doctor when you can start taking Trisequens® again.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:
•
breast cancer
•
abnormal growth or cancer of
the lining of the womb (endometrial hyperplasia or cancer)
•
ovarian cancer
•
blood clots in the veins of the
legs or lungs (venous thromboembolism)
•
heart disease
•
stroke
•
probable memory loss if HRT is
started over the age of 65.
For more information about these side effects, see section 2 What you need to know before you take Trisequens®.
Hypersensitivity/allergy (uncommon side effect – affects 1 to 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 heartbeat), 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.
Very common side effects
•
Breast pain or breast tenderness
Uncommon side effects
•
Bloating or flatulence
•
Acne
•
Hair loss (alopecia)
•
Abnormal (male pattern) hair
growth
•
Itching or hives (urticaria)
•
Inflammation of a vein
(superficial thrombophlebitis)
•
Drug ineffective
•
Allergic reaction
•
Endometrial hyperplasia
(excessive growth of the lining of the womb)
•
Painful periods
•
Nervousness.
Rare side effects
•
Pulmonary embolism (blood clot)
(see Blood clots in a vein in section 2 What you need to know before you take Trisequens®)
•
Deep inflammation of a vein
associated with thrombosis (blood clot).
Very rare side effects
•
Cancer of the lining of the womb
(endometrial cancer)
•
Increase in blood pressure or
worsening of high blood pressure
•
Gall bladder disease, gallstones
occurrence/recurrence or aggravated
•
Excessive secretion of sebum,
skin eruption
•
Acute or recurring attack of
oedema (angioneurotic oedema)
•
Insomnia, dizziness, anxiety
•
Change in sexual desire
•
Visual disturbances
•
Weight decreased
•
Vomiting
•
Heartburn
•
Vaginal and genital itching
•
Heart attack and stroke.
The frequency of possible side effects listed above 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).
Other side effects of combined HRT
The following side effects have been reported with other HRTs:
•
various skin disorders:
discolouration of the skin,
especially of the face or neck,
known as ‘pregnancy patches’
(chloasma)
painful reddish skin nodules
(erythema nodosum)
rash with target-shaped
reddening or sores (erythema
multiforme).
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 Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trisequens®
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 label and carton.
Do not refrigerate.
Keep the container in the outer carton in order to protect it from light.
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 Trisequens® contains
-
The active substances are estradiol and norethisterone acetate.
The blue film-coated tablet contains: estradiol 2 mg (as estradiol hemihydrate).
The white film-coated tablet contains: estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.
The red film-coated tablet contains: estradiol 1 mg (as estradiol hemihydrate).
-
The other ingredients are: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate.
Film-coating (blue tablets)
contains: hypromellose, talc, titanium dioxide (E171), indigo carmine (E132) and macrogol 400.
Film-coating (white tablets)
contains: hypromellose, triacetin and talc.
Film-coating (red tablets)
contains: hypromellose, talc, titanium dioxide (E171), red iron oxide (E172) and propylene glycol.
What Trisequens® looks like and contents of the pack
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:
•
1×28 film-coated tablets
•
3×28 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novo Nordisk Limited
3 City Place, Beehive Ring Road
Gatwick, West Sussex, RH6 0PA
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
This leaflet was last revised: 04/2025
•
Irregular periods or excessive
bleeding during your periods.
Common side effects
•
Headache
•
Weight gain caused by fluid
retention
•
Vaginal inflammation
•
Vaginal infection with a fungus
•
Migraine, new or worse than
before
•
Depression, new or worse than
before
•
Nausea
•
Abdominal pain, swelling or
discomfort
•
Enlargement or swelling of the
breasts (breast oedema)
•
Back pain
•
Leg cramps
•
Uterine fibroid (benign tumour),
aggravation, occurrence or recurrence
•
Swelling of arms and legs
(peripheral oedema)
•
Weight increase.
Trisequens® is a trademark owned by Novo Nordisk Health Care AG, Switzerland
© 2025
Novo Nordisk A/S
Other medicines may increase the effect of Trisequens®:
•
Medicines containing
ketoconazole (a fungicide).
Trisequens® may have an impact on a concomitant treatment with 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. Your doctor will advise you.
Laboratory tests
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.
Taking Trisequens® with food and drink
The tablets can be taken with or without food and drink.
USER INSTRUCTIONS
How to use the calendar pack
- 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.
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