Trisequens

What is Trisequens?

Trisequens is a hormone replacement therapy used to treat the symptoms of the menopause. The menopause usually occurs between the ages of 45 and 55, with around 80% of women experiencing symptoms, including night sweats, hot flushes, vaginal discomfort and dryness, sleep disturbance, mood changes, and loss of libido. These symptoms primarily occur due to a drop in the amount of oestrogen produced by a woman's body.

Trisequens tablets are arranged in a cyclical calendar pack, which you take every day without interruption. Trisequens contains two hormones, known as estradiol and norethisterone. They mimic the two natural sex hormones in the female body, oestrogen and progesterone. Hormone replacement is an effective treatment option for women who are experiencing symptoms of menopause that seriously hinder daily life.

How Do Trisequens Tablets Work?

Trisequens is a continuous-sequential HRT product containing blue, white, and red tablets. Tablets are taken in a fixed order to deliver either estradiol alone or a combination of estradiol and norethisterone, depending on the point in a 28-day calendar cycle. This approach seeks to provide a safe and balanced replacement of sex hormones.

Estradiol is a form of oestrogen found naturally in the body. By replacing the low levels that occur following menopause, Trisequens can help to alleviate the symptoms of menopause. Norethisterone is a synthetic hormone that mimics the effects of progesterone in the body.

While taking Trisequens, norethisterone will be included in the tablet for 10 days of the 28-day cycle (during the white tablet phase). This is included to protect the lining of the womb and usually results in regular, predictable endometrial shedding (a period) during the red tablet phase. Unopposed oestrogen replacement therapy (i.e., without including a progesterone replacement) is usually considered unsafe in women who have a uterus.

How Long Does it Take for Trisequens to Work?

The amount of time it takes for Trisequens to work varies from person to person. You may start to notice an improvement within a few weeks. However, it can take up to 3 months to reach its full desired effect. The time to see symptom improvement is broadly the same across all sequential combined HRT products, including Trisequens.

How Effective is Trisequens HRT?

Trisequens HRT is a well-established product first used in the 1980s. An early study sought to compare the vasomotor symptoms (hot flushes and night sweats) of women taking Trisequens to those taking a placebo. It found that the average number of vasomotor symptoms experienced by women taking Trisequens dropped from 7 to 1.3 per day (compared to a drop of 6 to 4.2 for women taking the placebo). The average number of severe symptoms also decreased from 1.3 per day to 0.1 (no reduction was observed in the placebo group).

This demonstrates that Trisequens could provide effective relief from the most frequently reported symptoms of menopause.

How to Take Trisequens Tablets

Trisequens should always be taken exactly as directed by your prescriber, and you should seek advice if you are unsure. You can start Trisequens on any convenient day if you are not switching from an alternative HRT product. If you are switching HRT, seek advice from your doctor before taking Trisequens.

Take one tablet a day at roughly the same time each day. Each pack contains 28 tablets. Pay attention to the colour of the tablets and take them in order as follows:

Take tablets with a glass of water. Once you have finished the pack, start a new pack and continue the treatment without interruption.

Trisequens tablets are packaged in calendar packs to support ease of use. Set the day reminder by turning the inner disc to set the day of the week opposite the little plastic tab. You can then take the first tablet by breaking the plastic tab and tipping it out. The next day, move the transparent dial clockwise by 1 space, as indicated by the arrow, and tip out the next tablet. Only take 1 tablet per day.

More detailed instructions and a useful diagram are available in the Patient Information Leaflet that comes with the medication.

What If You Take Too Many Trisequens Pills

You should only take one Trisequens tablet per day. If you take more Trisequens than you should, seek advice from your doctor or pharmacist. An overdose of Trisequens could result in nausea or vomiting.

If You Forget to Take Trisequens

If you forgot to take Trisequens at your usual time, take it within the next 12 hours. If it has been more than 12 hours since your usual tablet time, take your next dose at your next scheduled time. Do not take a double dose to make up for a forgotten tablet. Forgetting doses may increase the risk of breakthrough bleeding and spotting.

If You Need to Have Surgery

If you are going to have surgery, tell your surgeon that you are taking Trisequens. You may need to stop taking Trisequens 4 to 6 weeks before an operation to reduce the risk of blood clots. Your doctor can advise you on when you can safely resume taking Trisequens.

Trisequens Side Effects and Cautions

Like any medication, the use of Trisequens may result in unwanted side effects. Trisequens use may also put you at increased risk of certain serious conditions. It is important that you review the following information carefully to determine if Trisequens is right for you.

Side Effects of Trisequens HRT

The following side effects have been documented in women taking Trisequens. Rare and very rare side effects are not included in this table but are available in the Patient Information Leaflet provided with the medication. Tell your doctor if you experience any of the following side effects:

The table above does not contain a full list of possible Trisequens side effects. For further information, please see the Patient Information Leaflet. If you do experience any adverse reactions to the treatment, you can also report them using the MHRA's Yellow Card Scheme.

Allergies or Hypersensitivity

Allergic or hypersensitivity reactions to Trisequens may occur (though this is uncommon). Signs of an allergic reaction include:

• Raised rash that is possibly itchy (hives)
• Swelling
• Difficulty in breathing
• Low blood pressure (alongside pale, cool skin and a rapid pulse)
• Dizziness and sweating

If you do develop signs of an allergic reaction, stop taking Trisequens and seek immediate medical help.

Possible HRT Side Effects

Certain diseases have been reported more frequently in women taking Trisequens compared to women not using HRT. These include:

• 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.

Using HRT carries a risk that needs to be considered before taking Trisequens. The risks associated with women with premature menopause may be different and need to be discussed with a doctor. Once you are taking Trisequens, you should have regular check-ups with your doctor. You should discuss the continued benefits and risks of Trisequens use at these appointments.

Stop taking Trisequens and see a doctor immediately if you notice any of the following:

• Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of liver disease
• Swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing, are suggestive of an angioedema
• A large rise in your blood pressure (symptoms may be headache, tiredness, and dizziness)
• Migraine-like headaches that happen for the first time
• If you become pregnant
• If you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing.

You should also stop taking Trisequens and seek immediate medical help if you develop symptoms of a condition that would prevent Trisequens from being prescribed to you in the first place.

You will have a bleed once a month when taking Trisequens. However, if you have unexpected bleeding or spotting besides your monthly bleeding that carries on for more than the first 6 months, starts after taking Trisequens for 6 months, or carries on after stopping Trisequens, seek advice from your doctor as soon as possible.

The Patient Information Leaflet contains detailed information on risks and symptoms to be aware of for cardiovascular conditions (blood clots, stroke, and heart disease) and cancers (breast, endometrial, and ovarian) that you may be at increased risk of when taking Trisequens. Be vigilant for any new symptoms, check your breasts regularly, and attend regular check-ups with your doctor when taking Trisequens. More information about the risks of HRT is also available from the NHS.

Warnings and Interactions for Trisequens HRT

Everyone's circumstances are different, meaning not all medicines will be suitable for you to take. As a result, it's important to have a thorough understanding of what to expect from a treatment before you begin.

Do not take Trisequens tablets if you:

• Have, have had, or suspect having breast cancer
• Have, have had, or suspect having cancer of the womb lining (endometrial cancer) or any other oestrogen-dependent cancer
• Have any unexplained vaginal bleeding
• Have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• 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)
• Have a blood-clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• Have or previously have had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina
• Have or have ever had a liver disease, and your liver function tests have not returned to normal
• Are allergic (hypersensitive) to estradiol, norethisterone acetate, or any of the other ingredients of Trisequens
• You have a rare blood problem called 'porphyria' which is passed down in families (inherited).

Precautions Before Taking Trisequens

Before taking Trisequens, you should tell your doctor if you have ever had any of the following problems:

• 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
• 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
• A hereditary condition causing recurrent episodes of severe swelling (hereditary angioedema), or if you have had episodes of rapid swelling of the hands, face, feet, lips, eyes, tongue, throat (airway blockage), or digestive tract (acquired angioedema)

Trisequens contains lactose and may not be suitable for individuals who have been told by their doctor that they have a sugar intolerance.

Trisequens and Other Medicines

Tell your prescriber if you are taking or have recently taken any prescription medications, over-the-counter medicines, supplements, or herbal remedies. Some medications may interfere with how Trisequens works, including:

• 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)
• Medicines for hepatitis C infections (such as telaprevir)
• Herbal remedies containing St John's Wort (Hypericum perforatum).

Trisequens can also affect how some other medicines work, including lamotrigine (an epilepsy medicine) and medicines used to treat hepatitis C. Medicines containing ketoconazole (a fungicide) may increase the effect of Trisequens. Trisequens may also have an impact on treatment with cyclosporine. You must tell your prescriber if you are taking any of these medications.

Pregnancy and Breastfeeding

Trisequens is for use in postmenopausal women only. If you become pregnant, stop taking Trisequens and contact your doctor. You should not take Trisequens if you are breastfeeding.

Trisequens is not a contraceptive. If it has been less than 12 months since your last menstrual period, or you are under 50 years old, you may still need to use contraception to prevent pregnancy. Speak to your doctor for advice.

Frequently Asked Questions About Trisequens Tablets