TRISEQUENS FILM-COATED TABLETS - patient leaflet, side effects, dosage | Patient info (2024)

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 6months since their last natural period.

Trisequens® contains 2hormones, 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’sbody 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 dailylife.

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 65years 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’smedical 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 checkups, discuss with your doctor the benefits and risks of continuing with Trisequens®.

Go for regular breast screening, as recommended by your doctor.

Do not take Trisequens®

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 you have, have had or suspect having breast cancer
  • if you have, have had or suspect having cancer of the womb lining (endometrial cancer) or any other oestrogen dependentcancer
  • if you have any unexplained vaginal bleeding
  • if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
  • if you have or have ever had

a blood clot in a vein (venous thromboembolism), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)

  • if you have a blood clotting disorder (such as protein C, protein Sor antithrombin deficiency)
  • if you have or previously have had a disease caused by blood clots in the arteries, suchas

a heart attack, stroke or angina

  • if you have or have ever had a liver disease and your liver function tests have not returned tonormal
  • if you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Trisequens® (listed in section 6Contents of the pack and other information)
  • if you have a rare blood problem called ‘porphyria’ which is passed down in families (inherited).

If any of the above conditions appear for the first time while taking Trisequens®, stop taking it at once and consult your doctor immediately.

Warnings and precautions

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:

  • fibroids inside your womb
  • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
  • increased risk of developing blood clots (see Blood clots in a vein (venous thromboembolism))
  • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
  • high blood pressure
  • a liver disorder, such as a benign liver tumour
  • diabetes
  • gallstones
  • migraine or severe headaches
  • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus,SLE)
  • epilepsy
  • asthma
  • a disease affecting the eardrum and hearing (otosclerosis)
  • a very high level of fat in your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems
  • hereditary and acquired angioedema
  • lactose intolerance.

Stop taking Trisequens® and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the Do not take Trisequens® section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema

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  • a large rise in your blood pressure (symptoms may be headache, tiredness and dizziness)
  • migraine-like headaches which happen for the firsttime
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
  • – painful swelling and redness of the legs

  • – sudden chest pain

  • – difficulty in breathing.

For more information, see Blood clots in a vein (venous thromboembolism).

Note: Trisequens® is not a contraceptive. If it is less than 12months since your last menstrual period or you are under 50years 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 progestagen in Trisequens® protects you from this extrarisk.

Compare

In women who still have a womb and who are not taking HRT, on average, 5in 1,000will be diagnosed with endometrial cancer between the ages of 50and65.

For women aged 50to 65who still have a womb and whotake

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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 bleedingwhich:

  • carries on for more than the first 6months
  • starts after you have been taking Trisequens® more than 6months
  • carries on after you have stopped taking Trisequens®

see your doctor as soon as possible.

Breast cancer

Evidence shows that taking combined oestrogen-progestagen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10years or more if you have used HRT for more than 5years.

Compare

Women aged 50to 54who are not taking HRT, on average, 13to 17in 1,000will be diagnosed with breast cancer over a 5-year period.

For women aged 50who start taking oestrogen-only HRT for 5years, there will be 16–17 cases in 1,000users (i.e. an extra 0to 3cases).

For women aged 50who start taking oestrogen-progestagen HRT for 5years, there will be 21cases in 1,000users (i.e. an extra 4to 8cases).

Women aged 50to 59who are not taking HRT, on average, 27in 1,000will be diagnosed with breast cancer over a 10-year period.

For women aged 50who start taking oestrogen-only HRT for 10years, there will be 34cases in 1,000users (i.e. an extra 7cases). For women aged 50who start taking oestrogen-progestagen HRT for 10years, there will be 48cases in 1,000users (i.e. an extra 21cases).

Regularly check your breasts. See your doctor if you notice any changes such as:

  • dimpling of the skin
  • changes in the nipple
  • any lumps you can see or feel.

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 alllumps.

Ovarian cancer

Ovarian cancer is rare– much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen 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 50to 54who are not taking HRT, about 2women in 2,000will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5years, there will beabout

3cases per 2,000users (i.e. about 1extra case).

Effect of HRT on heart and circulation

Blood clots in a vein (venous thromboembolism)

The risk of blood clots in the veins is about 1.3to 3times higher in HRT users than in nonusers, especially during the first year of takingit.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or evendeath.

  • 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: you are unable to walk for a long time because of major surgery, injury or illness (see section 3, If you need to have surgery)
  • you are seriously overweight (BMI > 30kg/m2)
  • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent bloodclots
  • if any of your close relatives has ever had a blood clot in the leg, lung or anotherorgan
  • you have systemic lupus erythematosus (SLE)
  • you have cancer.

For signs of a blood clot, see Stop taking Trisequens® and see a doctor immediately.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4to 7in 1,000would be expected to get a blood clot in avein.

For women in their 50s who have been taking oestrogen-progestagen HRT for over 5years, there will be 9to 12cases in 1,000users (i.e. an extra 5cases).

Heart disease (heart attack) There is no evidence that HRT will prevent a heart attack.

Women over the age of 60years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking anyHRT.

Stroke

The risk of getting stroke is about 1.5times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase withage.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8in 1,000would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11cases in 1,000users over 5years (i.e. an extra 3cases).

Other conditions

HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65.Speak to your doctor for advice.

Using other medicines

Some medicines may interfere with the effect of Trisequens®. This might lead to irregular bleeding. This applies to the following medicines:

  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)
  • Medicines for tuberculosis (such as rifampicin and rifabutin)
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
  • Herbal remedies containing

St John’sWort (Hypericum perforatum).

Other medicines may increase the effects of Trisequens®:

  • Medicines containing ketoconazole (a fungicide).

Trisequens® may have an impact on a concomitant treatment with cyclosporine.

Medicines for Hepatitis C virus (HCV) (such as combination regimen ombitasvir/pa­ritaprevir/ri­tonavir with or without dasabuvir as well as a regimen with glecaprevir/ pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using Combined Hormonal Contraceptives (CHCs) containing ethinylestradiol. Trisequens contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme can occur when using Trisequens with this HCV combination regimen. Your doctor will adviseyou.

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.

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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 sometests.

Taking Trisequens® with food and drink

The tablets can be taken with or without food and drink.

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®.

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 28tablets

Days 1– 12Take one blue tablet every day for 12days

Days 13– 22Take one white tablet every day for 10days

Days 23– 28Take one red tablet every day for 6days.

Take the tablets with a glass of water.

Once you have finished the pack, start a new pack continuing the treatment without interruption. Amenstruation-like bleeding (period) usually occurs at the beginning of a newpack.

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 treatyour


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 3months of treatment. You should only continue treatment as long as the benefit outweighs therisk.

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 Trisequens® could make you feel sick orvomit.

If you forget to take Trisequens® If you forget to take your tablet at the usual time, take it within the next 12hours. If more than 12hours 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 4to 6weeks 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 getsthem.


The following diseases are reported more often in women using HRT compared to women not usingHRT:

  • 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 of65.

For more information about these side effects, see section 2What you need to know before you take Trisequens®.

Hypersensitivi­ty/allergy (uncommon side effect– affects 1to 10users in1,000)

Though it is an uncommon event, hypersensitivi­ty/allergy mayoccur.


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
  • 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.

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 thewomb)

  • Painful periods
  • Nervousness.

Rare side effects

  • Pulmonary embolism (blood clot) (see Blood clots in a vein in section 2What you need to know before you take Trisequens®)
  • Deep inflammation of a vein associated with thrombosis (bloodclot).

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

1user in 10)

Common (affects 1to 10users in

100)

Uncommon (affects 1to 10users in 1,000)

Rare (affects 1to 10users in

10,000)

Very rare (affects less than 1user in 10,000)

Not known (frequency cannot be estimated from the availabledata).

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 orneck,


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: 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 fromlight.

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 2mg (as estradiol hemihydrate). The white film-coated tablet contains: estradiol 2mg (as estradiol hemihydrate) and norethisterone acetate 1mg. The red film-coated tablet contains: estradiol 1mg (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 andtalc.

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 6mm. The blue tablets are engraved with NOVO 280.The white tablets are engraved with NOVO 281.The red tablets are engravedwith

NOVO 282.Each pack of 28tablets contains 12blue tablets, 10white tablets and 6red tablets.


Pack sizes available:

  • 1×28 film-coated tablets
  • 3×28 film-coated tablets




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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 plastictab.


2.Take the first day’stablet 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 1space as indicated by the arrow. Tip out the next tablet. Remember to take only 1tablet once aday.

You can only turn the transparent dial after the tablet in the opening has been removed.


Trisequens® is a trademark owned


by Novo Nordisk Health Care AG,


Switzerland

© 2022

Novo Nordisk A/S


/ bzj ® novo nordisk


20/01/2022 11:24:07



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TRISEQUENS FILM-COATED TABLETS - patient leaflet, side effects, dosage | Patient info (2024)

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