Tibolone

Tibolone is a type of hormone replacement therapy (HRT). It’s used to treat some of the effects of menopause that happen as a result of your body producing fewer female hormones, mainly oestrogen.

Tibolone can help relieve some of the common menopausal symptoms that can affect your quality of life, including:

• hot flushes
• night sweats
• vaginal dryness (vaginal atrophy)
• thinning of the lining of the vagina, which can lead to painful sex and an increase in vaginal infections
• mood changes, such as nervousness, depression, or irritability
• decrease in libido (sexual desire)

Tibolone can also help prevent osteoporosis. Some women develop osteoporosis as a result of menopause. Osteoporosis causes your bones to become more fragile, which means they can break or be damaged more easily.

If you are at risk of osteoporosis, your doctor may recommend tibolone to reduce the chance of you having a bone fracture.

Take 1 tibolone tablet once a day, at the same time each day. Swallow the tablet whole with water.

You can start tibolone straight away if you:

• have not taken HRT before, and your last period was more than 12 months ago
• are switching from a continuous combined HRT

If you’re switching from another type of HRT, such as sequential HRT, you can start the day after finishing your current treatment course.

What should I do if I miss a tibolone tablet?

If you forget to take a tibolone tablet and it’s less than 12 hours after your usual time, take a tibolone tablet as soon as you remember. If it’s more than 12 hours, skip the missed tablet and take your next dose at the usual time.

What happens if I take too much tibolone?

If you take more tibolone than recommended, you may feel sick (nausea), be sick (vomit), or have some vaginal bleeding. However, it should not cause any serious effects. If you are concerned about taking too much tibolone, speak to your doctor.

Tibolone is a synthetic steroid medication that works by mimicking the effects of various sex hormones, including oestrogen and progesterone, which are female sex hormones that occur naturally in the body.

During and after menopause, your body gradually reduces the production of oestrogen and progesterone. These hormones are important for several bodily functions, including:

• regulating your menstrual cycle
• sex drive (libido)
• bone density
• mood stabilisation

As your level of these hormones fall, this can lead to symptoms such as:

• hot flushes
• night sweats
• vaginal dryness
• lower sex drive
• mood swings, anxiety, and depression
• low bone density (osteoporosis)

Tibolone helps to regulate the levels of these hormones in your body, reducing and relieving the symptoms of menopause.

Some HRT therapies cause monthly bleeding. Tibolone does not stimulate the lining of the womb to grow, so does not cause monthly vaginal bleeding.

Tibolone is effective in reducing the effects of menopause in most women. It can also be effective at reducing osteoporosis. Most women taking tibolone will see an improvement in their menopausal symptoms during the first few weeks of treatment.

In one UK study, 65.9% of women said their menopause symptoms improved after taking tibolone for 48 weeks. The study also found that tibolone caused fewer side effects, like breast tenderness and unexpected bleeding, than some other types of HRT.

While tibolone is safe for most people who take it, some may experience side effects. These side effects are usually mild and will go away on their own as your body gets used to the medication. This usually takes a few weeks, but can last up to 3 months.

Common side effects of tibolone include:

• breast tenderness
• stomach pain or pelvic pain
• unusual hair growth
• vaginal bleeding or spotting
• vaginal problems, such as an increase in discharge, itching, irritation, or thrush
• thickening of the lining of the womb or the cervix
• increase in weight
• abnormal growth in the cells of the cervix

Uncommon side effects include:

• fluid retention leading to swollen hands, ankles, or feet
• upset stomach
• acne (spots)
• painful nipples
• breast discomfort
• fungal infections of the vagina

Rare side effects include:

• itchy skin

Some women experience irregular bleeding or spotting in the first 3 to 6 months of taking tibolone. You should speak to your doctor if this:

• carries on for longer than 6 months
• starts after you have taken tibolone for 6 months
• carries on after you stop taking tibolone

Some conditions are reported more often in people using HRT compared to those not using it, such as:

• 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

These are rare but serious side effects, and your doctor will not prescribe tibolone if you have any risk factors for these conditions. Let your doctor know straight away if you get any symptoms of these conditions, or call 999 in an emergency.

Tibolone can be taken by postmenopausal women who had their last natural period at least 1 year (12 months) ago. If you do not wait for 1 year after your last period before taking tibolone, you may experience irregular bleeding.

You should not take tibolone if you are pregnant or think you might be pregnant, or if you are breastfeeding. If you become pregnant while taking tibolone, stop taking it and speak to your doctor straight away.

You should not take tibolone if you have:

• unexplained vaginal bleeding
• endometrial hyperplasia (excessive thickening of the womb lining) that is not being treated
• a blood clotting disorder such as a deficiency in protein C, protein S, or antithrombin
• porphyria (a rare, inherited blood condition)
• an allergy to tibolone or any of the other ingredients
• cancer that is sensitive to oestrogens, such as cancer of the lining of the womb (or if you are suspected of having it)

You should also not take tibolone if you have or have ever had:

• breast cancer (or are suspected of having it)
• blood clots (thrombosis), including in the legs (DVT or deep venous thrombosis) or lungs (pulmonary embolism)
• heart attack, stroke, or angina
• liver disease and your liver function tests have not returned to normal
• galactose intolerance
• Lapp lactase deficiency
• glucose galactose malabsorption

If any of these conditions develop while taking tibolone, you should stop taking it and speak to your doctor straight away.

With some conditions, there is a risk that they return or become worse during treatment with tibolone. Before starting treatment with tibolone, let your doctor know if you have ever had any of the following conditions, as you may need to have more frequent check-ups:

• fibroids in the womb
• endometriosis (growth of the womb lining outside the womb)
• endometrial hyperplasia
• increased risk of blood clots
• high blood pressure
• a liver disorder, for example, a benign liver tumour
• diabetes
• gallstones
• severe headaches or migraines
• an immune system disease such as systemic lupus erythematosus (SLE)
• epilepsy
• asthma
• otosclerosis (a disease affecting the eardrum and hearing)
• a very high level of triglycerides (a type of fat) in your blood
• fluid retention due to cardiac (heart) or kidney problems

If you have a family history of breast cancer, you should speak to your doctor before taking tibolone. You may be at a higher risk of developing oestrogen-sensitive breast cancer.

Some medications can interact with tibolone. Before taking it, you should let your doctor know about any other medicines you are taking, or are planning to take. This includes prescription and non-prescription medications and herbal remedies.

If you are taking any of the following, you may experience irregular bleeding while taking tibolone:

• blood clotting treatments, for example, warfarin
• epilepsy treatments, including phenobarbital, phenytoin, and carbamazepine
• tuberculosis treatments such as rifampicin
• a herbal remedy, such as St John’s wort

You may be able to take a different hormone replacement therapy (HRT) treatment if tibolone is not suitable for you.

The 2 main types of HRT are:

• oestrogen-only HRT, which only contains a type of synthetic oestrogen (such as Vagifem)
• combined HRT, which contains synthetic versions of oestrogen and progesterone (such as Elleste Duet Conti)

HRT may be in the form of tablets, patches, or gels. With some HRT treatments, you might still have periods. A ZAVA doctor can help you decide which type of HRT might be most suitable for you.

With ZAVA, you can order HRT online, without waiting for a GP appointment or needing a face-to-face appointment. Everything can be managed from the comfort of your own home, with prescription treatment delivered straight to your door.