Trisequens Tablets - Leaflet (2024)

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(estradiol hemihydrate and norethisterone acetate)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again

• If you have further questions, ask your doctor or pharmacist

• This medicine has been prescribed for you. Do not pass it on toothers. It may harm them, even if their symptoms are the sameas yours

• If any of the side effects gets serious, or if you notice any sideeffects not listed in this leaflet, please tell your doctor orpharmacist.

In this leaflet:

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. Howto store Trisequens

6. Further information

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 suitable for postmenopausal women with at least 6months since their last natural period.

Trisequens contains the female sex hormone estradiol and norethisterone acetate. The estradiol in Trisequens is identical tothe estradiol in the ovaries of women, and is classified as anatural oestrogen. Norethisterone acetate is a syntheticprogestogen, which acts in a similar manner as the body’s ownhormone progesterone, another important female sex hormone.

Trisequens is indicated:

• To relieve unpleasant symptoms of menopause like hotflushes, night sweats, vaginal dryness in postmenopausalwomen who still have their womb.

• For the prevention of osteoporosis (thinning of the bones) inpostmenopausal women if they are at high risk of futurefractures and if they are unable to take other medications forthis purpose.

The experience of treating women older than 65 years is limited.

2. Before you take TrisequensSafety of HRT

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether tocarry 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 toexamine your breasts and/or your abdomen, and may do aninternal examination - but only if these examinations arenecessary for you, or if you have any special concerns.

Once you have 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 ofcontinuing with Trisequens.

As well as regular check-ups with your doctor, be sure to:

• Regularly check your breasts for any changes such asdimpling of the skin, changes in the nipple, or any lumps youcan see or feel.

• Go for regular breast screening (mammography) andcervical smear tests.

Do not take Trisequens

If any of the following applies to you, talk to your doctor. Do not start taking Trisequens:

• If you have, have had or suspect having breast cancer,

• If you have, have had, or suspect having cancer of the womblining (endometrial cancer), or any other oestrogen dependentcancer.

• If you have abnormal vaginal bleeding of an unknown cause.

• If you have endometrial hyperplasia (excessive growth of thewomb lining) that is not being treated

• If you have or have had blood clots in a vein (venousthromboembolism), in the legs (deep venous thrombosis) orthe lungs (pulmonary embolism).

• If you have a blood clotting disorder (thrombophilic disorder,such as protein C, protein S, or antithrombin deficiency).

• If you have or have had a heart attack, stroke, or have anginapectoris which causes discomfort, pressure or pain in thechest.

• If you have or have had liver problems and your liver functiontests have not returned to normal

• If you have porphyria (a liver enzyme disease)

• If you are allergic (hypersensitive) to estradiol, norethisteroneacetate or any other ingredients in Trisequens (listed in section6,“Further information’’).

Take special care with Trisequens

If you have (or have had) any of the following conditions, tell your doctor. Your doctor may want to monitor you more closely.These conditions may in rare cases come back or get worseduring treatment with Trisequens:

• If you have or have had leiomyoma (benign tumours of thewomb) or endometriosis, a condition in which the lining of theuterus (womb) grows outside the uterus, causing pain orbleeding.

• If you have a history of blood clots (thrombosis) or have riskfactors for blood clots (see blood clots in a vein) (these riskfactors and symptoms for a blood clot are listed in section 4,"other side effects of combined HRT”)

• If you have risk factors for development of oestrogendependent tumours, such as immediate relatives (mother,sister, maternal or paternal grandmother) with breast and/orendometrial cancer.

• If you have high blood pressure

• If you have a liver disorder such as liver adenoma (a benigntumour)

• If you have diabetes mellitus with or without vasculardisorders

• If you have gallstones

• If you have migraines or severe headache

• If you have systemic lupus erythematosus (SLE) - an

autoimmune disease.

• If you previously have had endometrial hyperplasia

(excessive growth of the lining of the womb).

• If you have epilepsy.

• If you have asthma

• If you have otosclerosis (progressive hearing loss).

If you need a blood test, tell your doctor that you are taking Trisequens, since oestrogen can affect the results of certainlaboratory tests.

If you are going to have surgery, talk to your doctor. You may need to stop taking these tablets 4 to 6 weeks before theoperation, to reduce the risk of a blood clot. Your doctor will tellyou when you can start HRT again.

HRT and cancer

Excessive growth of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrialcancer)

In women with an intact womb taking oestrogen-only HRT over a long period of time, the risk of excessive growth of the lining ofthe womb (endometrial hyperplasia) and cancer of the womblining (endometrial cancer) is increased.

Taking a progestogen in addition to the oestrogen, such as Trisequens, helps to lower the extra risk.

Compare

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.

For women who still have a womb and take oestrogen-only HRT, the number of extra cases could vary between 5 and 55 in 1,000users between the ages of 50 and 65 depending on the dose andfor how long it is taken.

The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breastcancer.

This depends on how long you take HRT. The additional risk is visible after about 3 years. However, it returns to normal within afew years (at most 5) after stopping treatment.

Compare

Women aged 50 to 65 who are not taking HRT, on average 9 to 12 in 1,000 will be diagnosed with breast cancer over a 5-yearperiod.

For women aged 50 to 65 who are taking oestrogen-progestogen HRT over 5 years, the number of extra cases will be 6 in 1,000users.

Looking at women aged 50 to 79 who are not taking HRT, on average 14 in 1,000 will be diagnosed with breast cancer over a5-year period.

For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, the number of extra cases will be 4 in 1,000users.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Long-term (at least 5 to 10 years) use of oestrogen-only HRT products isthought to carry a slightly increased risk of ovarian cancer. Somestudies suggest that the long-term use of combined HRT maycarry a similar or slightly smaller risk.

For women who have been taking HRT for over 5 years there will be 1 extra case per 2,500 users.

Effect of HRT on heart and circulation

Blood clots in a vein (venous thromboembolism)

HRT increases the risk of blood clots in the veins 1.3- to 3-fold, especially during the first year of taking it.

You are generally more likely to get a blood clot in your veins if one or more of the following applies to you:

• You are older

• You are pregnant or have recently had a baby

• You use oestrogens

• You or any of your close relatives have ever had a blood clot inthe leg, lung or another organ

• You are seriously overweight

• You have systemic lupus erythematosus (SLE)

• You have a blood clotting problem that needs long-termtreatment with a medicine used to prevent blood clots(anticoagulant)

• You are unable to walk or stand for a long time because ofmajor surgery, injury or illness (prolonged immobilisation)

• You have cancer

Compare

Women in their 50s who are not taking HRT, on average over a 5-year period, 4 in 1,000 would be expected to get a blood clot ina vein.

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, the number of extra cases will be 5 in 1,000 users.

Coronary artery disease (CAD)

There is no evidence that HRT will help to prevent heart disease. Women taking oestrogen-progestogen HRT are slightly morelikely to develop heart disease than those not taking any HRT. Asthe baseline absolute risk of heart disease strongly depends onage, the number of extra cases of heart disease due to use ofoestrogen-progestogen HRT is very low in healthy women closeto menopause, but will rise with more advanced age.

Stroke

Combined oestrogen-progestogen and oestrogen-only HRT increase the risk of stroke up to 1.5-fold. The comparable risk forusers versus non-users does not change with age or time sincemenopause. However, as the risk of stroke is strongly agerelated, the overall general risk of stroke in women who use HRTwill increase with age.

Compare

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, the number of extracases will be 3 in 1,000 users over 5 years.

Other conditions

HRT will not prevent memory loss.

The risk of probable memory loss may be somewhat higher in women who start using any kind of HRT after the age of 65.

Stop taking Trisequens

If you experience any of the following conditions below, stop taking Trisequens, and contact your doctor immediately.

• If you get a migraine-type headache for the first time.

• If you develop yellow skin or eyes (jaundice) or other liverproblems.

• If your blood pressure goes up significantly while you aretaking Trisequens (symptoms of high blood pressure e.g.headache, tiredness and dizziness).

• If you become pregnant.

• If you experience any of the conditions listed in Section 2Before you take Trisequens

Bleeding with Trisequens

Trisequens will cause a menstruation-like monthly bleeding, which usually occurs at the beginning of a new pack. If theperiods get heavier than normal, you should tell your doctor.However, some women may also experience breakthroughbleeding or spotting during the first few months of takingTrisequens. This kind of bleeding is different from themenstruation-like bleeding. If you have any breakthroughbleeding or spotting that continues for longer than the first fewmonths, starts after some time on HRT, or continues even if youhave stopped taking Trisequens, you should tell your doctor assoon as possible.

Using other medicines

Some medicines may reduce the effects of Trisequens:

• Drugs used for epilepsy (such as phenobarbital, phenytoin andcarbamazepine)

• Drugs used for tuberculosis (such as rifampicin, rifabutin)

• Drugs used for HIV infections (such as nevirapine, efavirenz,ritonavir and nelfinavir)

• Herbal products with St John’s Wort (Hypericum perforatum).

Other medicines may increase the effects of Trisequens:

• Drugs containing ketoconazole (a fungicide).

Concomitant administration of ciclosporine 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 obtainedwithout a prescription.

Taking Trisequens with food and drink

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

Pregnancy and breast-feeding

Pregnancy: You should not take Trisequens if you are pregnant. If you become pregnant while using Trisequens, you should stopthe treatment immediately and contact your doctor.Breast-feeding: You should not use Trisequens if you arebreast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Trisequens does not affect the use of any machines or the ability to drive safely.

Important information about some of the ingredients of Trisequens:

Trisequens contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before takingTrisequens.

1. Set the day reminder

Turn the inner disc to set the day of the week opposite the little plastictab.

Trisequens Tablets - Leaflet (1)


3. How to use Trisequens

Always take Trisequens exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Take one tablet once a day, at about the same time each day

Take the tablet with a glass of water.

Take a tablet every day without stopping. Begin by taking the blue tablets for 12 days followed by the white tablets for 10 daysand finally the red tablets for 6 days.

After taking the last red tablet, treatment is continued with the first blue tablet of a new calendar pack on the next day withoutinterruption.

You should start treatment with Trisequens on the fifth day of your bleed (whether it has stopped or not) if you are still havingperiods, or if you are switching from an HRT product where youhave a monthly bleed. If you no longer have periods or they areinfrequent, you can start treatment with Trisequens on anyconvenient day. This also applies if you are switching from anHRT product where you do not have a monthly bleed.

Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms.

Talk to your doctor if your symptoms are not better after three months.

The tablet comes in calendar dial pack. A translation of the days of the week is as follows:

LU MAMEJEVESADl

MON TUEWEDTHURFRISATSUN

USER INSTRUCTIONS How to use the calendar pack

2. Take the first day’s tablet

Break the plastic and tip out the first tablet (blue)

3. Move the dial every day

On the next day simply move the transparent dial clockwise 1 spaceas indicated by the arrow. Tip outthe next tablet. Remember to takeonly 1 tablet once a day.

You can turn the transparent dial after the tablet in the openinghas been removed.

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 youfeel sick or vomit.

If you forget to take Trisequens

Do not take double dose to make up for a forgotten individual dose, if you forget to take your tablet at the usual time, take itwithin 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 tomake up for a forgotten tablet. Forgetting a dose may increasethe likelihood of breakthrough bleeding and spotting.

If you stop taking Trisequens

If you would like to stop your treatment with Trisequens for any reason, please discuss your decision with your doctor, who willexplain the effects of stopping treatment and discuss otherpossibilities with you. If you have any further questions on theuse of this product ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trisequens can have side effects, although not everybody gets them.

Hypersensitivity/allergy

(uncommon side effects - Affects 1 to 10 users in 1,000)

Though it is an uncommon event, hypersensitivity/allergy may occur.

Sign 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 ofanaphylactic reaction/shock. If one of the mentioned symptomsappears, stop taking Trisequens and seek immediate medicalhelp.

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

• Breast pain or breast tenderness

• Irregular menstrual periods or excessive bleeding during yourperiods.

Common side effects

• Headache

• Weight gain caused by fluid retention

• Vaginal inflammation (thrush)

• 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 fibroids (benign tumour of the womb), aggravation,occurrence or reoccurrence

• Swelling of arms or 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

• Painful periods

• Endometrial hyperplasia (excessive growth of the lining of the

womb)

• NervousnessRare side effects

• Pulmonary embolism (blood clot) (See also Blood clots insection 2 Before you take Trisequens)

• Deep inflammation of a vein associated with thrombosis (bloodclot)

POM


Very rare side effects

• Cancer of the lining of the womb (endometrial cancer).

• Increase in blood pressure or worsening of high blood pressure

• Gallbladder disease, gallstones occurrence/reoccurrence oraggravated

• Excessive secretion of sebum, skin eruption

• Acute or recurring attack of oedema (angioneurotic oedema)

• Insomnia, dizziness, anxiety

• Changes in sexual desire

• Visual disturbances

• Weight decreased

• Vomiting

• Heartburn

• Vaginal and genital itching

• Heart attack and stroke

Other side effects of combined HRT

Women using HRT have a slightly increased risk of developing the following diseases:

• Breast cancer (see also section 2 HRT and cancer, Breastcancer for more information).

• Excessive growth or cancer of the lining of the womb(endometrial hyperplasia or cancer) (see also section 2 HRTand cancer, Excessive growth of the lining of the womb(endometrial hyperplasia) and cancer of the womb lining(endometrial cancer) for more information).

• Ovarian cancer, (see also section 2 HRT and cancer, Ovariancancer for more information).

• Blood clots in the veins of the legs or lungs (venousthromboembolism) (see also section 2 Effects of HRT on heartand circulation, Blood clots in a vein (venousthromboembolism) for more information)

• Heart disease (see also section 2 Effects of HRT on heart andcirculation, Coronary artery disease (CAD) for moreinformation)

• Stroke (see also section 2 Effects of HRT on heart andcirculation, Stroke for more information).

• Skin and subcutaneous disorders:

- Darkening of the skin (chloasma)

- Severe condition of the skin that may affect the mouth andother parts of the body (erythema multiforme)

- Red-purple swellings on the shins, thighs and, lesscommonly, the arms. Joint and muscle pains and fever mayalso occur (erythema nodosum)

- Purple or red-brown spots visible through the skin (vascularpurpura)

• Probable memory loss if HRT is started over the age of 65

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor orpharmacist.

5. How to store your Trisequens

Do not store above 25°C. Protect from light and moisture. Do not refrigerate.

Keep out of the reach and sight of children

Do not remove the tablets from the calendar dial pack except when taking them.

Do not use after the expiry date on the carton, or if the product shows signs of deterioration or discolouration.

If your doctor decides to stop treatment return any remaining tablets you have left to the pharmacist for safe disposal. Onlykeep them if your doctor tells you to.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist howto dispose ofmedicines no longer required. These measures will help toprotect the environment.

6. Further Information

Trisequens 12 blue round film coated tablets marked ‘NOVO 280’ on one side and plain on reverse, each containing 2 milligrams ofestradiol (as hemihydrate) which is an oestrogen as activeingredient.

Trisequens 10 white round film coated tablets marked ' NOVO 28T on one side and plain on reverse, each containing 2milligrams of estradiol (as hemihydrate) and 1mg ofnorethisterone acetate as active ingredients.

Trisequens 6 red film coated tablets marked ‘NOVO 282’ on one side and plain on reverse, each containing 1 milligram ofestradiol (as hemihydrate) as active ingredient.

Each tablet also contains lactose monohydrate, maize starch, hydroxypropyl cellulose, talc, hypromellose and magnesiumstearate.

The blue tablets also contain: titanium dioxide (E171), indigo carmine (E132) and macrogol 400The white tablets also contain: triacetin

The red pills also contain: titanium dioxide (E171), red iron oxide and propylene glycol

Trisequens Tablets come in 3 calendar dial packs of 28 tablets (a total of 84 Tablets).

This medicine is manufactured by Novo Nordisk A/S, 2880 Bagsvaerd, Denmark. Procured from within the EU: ProductLicence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,LynstockWay, Lostock, Bolton, BL6 4SA. Repackaged byMaxearn Ltd, Bolton BL6 4SA.

Trisequens Tablets PL 20774/0640

Date of preparation: 20th May 2015

Trisequens is a registered trade mark of Novo Nordisk FemCare AG.

PP3/0640/V2

Trisequens Tablets - Leaflet (2024)

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