Trisequens

Trisequens belongs to a category of medicines called hormone replacement therapy (HRT). These medicines are only prescribed if your symptoms seriously hinder your daily life. For instance, if you suffer from intense hot flashes or from night sweats so severe that they soak through bedding. Trisequens hormone tablets restore hormonal balance to relieve these symptoms.

Trisequens contains two types of female hormones, an oestrogen (estradiol) and a progestogen (norethisterone acetate). This medicine is used in postmenopausal women with at least six months since their last natural period. Note: You will have a bleed once a month (so-called withdrawal bleed) while taking Trisequens. This withdrawal bleed will be very light.

Each package contains 28 tablets. The tablets should be taken with water, preferably at the same time each day. They can be taken with or without food.

The tablets are categorised according to colour. The composition of the tablets differs per colour. Use as follows:

• 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

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.

Talk to your doctor if you should continue if you do not experience symptom relief after three months of treatment.

Alcohol/driving

This medicine does not interact with alcohol or affect your ability to drive safely.

Taken too much/forgot to take/stop taking Trisequens

If you have taken more Trisequens tablets than you should, contact your doctor or pharmacist.

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.

Do not stop using Trisequens without talking to a doctor first.

Trisequens is not suitable for everyone. Do not take this medicine if:

• You have, or have had, breast cancer, or if you are suspected of having it.
• You have, or have had, cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium) or if you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have, or have had, a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
• You have, or recently have had, a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have, or have had, a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called ‘porphyria’ which is passed down in families (inherited).
• You are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients in this medicine (see section ‘What Trisequens contains').

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

If you are going to have surgery, tell the surgeon that you are taking Trisequens. You may need to stop taking Trisequens several weeks before the operation.

When should this medicine be used with caution?

Tell your doctor if you have ever had any of the following problems before you start the treatment:

• 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 or increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer).
• Increased blood pressure.
• A liver disorder, such as a benign liver tumour.
• Diabetes.
• Gallstones.
• Migraine or severe headaches.
• Systemic lupus erythematosus (SLE).
• Epilepsy.
• Asthma.
• Otosclerosis.
• A very high level of fat in your blood (triglycerides).
• Fluid retention due to cardiac or kidney problems.
• Acquired or hereditary angioedema.
• Thyroid disease for which you are being treated with thyroid hormone replacement therapy.
• Lactose intolerance.

Stop taking Trisequens and see a doctor immediately if you notice any of the following while taking Trisequens: Yellowing of your skin or the whites of your eyes (jaundice), a severe allergic reaction, signs of a blood clot, a large rise in your blood pressure or migraine-like headaches which happen for the first time. For more information, see the package leaflet.

Pregnancy and breastfeeding

Trisequens is for use in menopausal women only. If you become pregnant, stop using Trisequens and contact your doctor.

Do not use Trisequens if you are breastfeeding.

Note: Trisequens does not protect against pregnancy. If you are still capable of becoming pregnant you should use a form of contraception as a precaution.

Other medicines and Trisequens

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

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

• Medicines for epilepsy.
• Medicines for tuberculosis.
• Medicines for HIV infection.
• Antibiotics.
• Herbal medicines containing St John’s wort (Hypericum perforatum).

Other medicines may increase the effect of Trisequens:

• Medicines containing ketoconazole.
• Medicines for Hepatitis C virus (HCV) (see the package leaflet for more information).
• Trisequens may have an impact on a concomitant treatment with cyclosporine and lamotrigine.

Trisequens can affect the results of some laboratory tests.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

It is important to be aware that all women using HRT have a slightly increased risk of a number of serious side effects such as certain types of cancer and thrombosis compared with women who don’t use HRT. See the package leaflet for more information.

Other side effects that are known to be associated with Trisequens include:

Very common:

• Breast pain or breast tenderness.
• Irregular periods or excessive bleeding during your periods.

Common: 

• Headache.
• Weight gain caused by fluid retention.
• Vaginal inflammation or yeast infection (vaginal thrush).
• Migraine, new or worse than before.
• Depression, new or worse than before.
• Nausea, abdominal pain, bloating.
• 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 gain.

For a list of uncommon and rare side effects, see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

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.