Livial

What is Livial?

Livial is a brand name for tibolone, a prescription-only hormone replacement therapy that’s used to treat menopausal symptoms and help prevent osteoporosis. It is suitable for women who are postmenopausal or have not had a period for at least 12 months and can treat symptoms such as vaginal dryness, hot flushes, night sweats, and low mood.

Tibolone is a synthetic steroid that is broken down by the body to produce substances that mimic the natural hormones oestrogen, progesterone, and testosterone to provide relief from menopause symptoms.

It’s important to note that Livial is not a contraceptive. If you are aged under 50, or it has been less than 12 months since your last period, you may still have to use contraception to protect against pregnancy. Consult your clinician for further advice.

Understanding Menopause Symptoms

Menopause symptoms develop as levels of hormones such as oestrogen begin to change and decline. They often start during perimenopause, before periods have stopped completely, and may continue after menopause. Symptoms vary considerably: some women experience only mild changes, while others find that menopause affects their sleep, mood, relationships and everyday life.

Common menopause symptoms include:

Hot Flushes and Night Sweats

Hot flushes cause a sudden feeling of warmth, usually across the face, neck and chest. They may be accompanied by sweating, reddened skin or a rapid heartbeat. When they occur at night, they can disturb sleep and contribute to tiredness and difficulty concentrating the following day.

Changes to Sleep and Mood

Hormonal changes and night sweats can make it harder to fall asleep or stay asleep. Some women also experience low mood, anxiety, irritability, reduced confidence, poor concentration or problems with memory, sometimes described as “brain fog”. These symptoms can overlap and may feel worse when sleep is disrupted.

Vaginal and Urinary Symptoms

Lower oestrogen levels can make the tissues in and around the vagina thinner, drier and less elastic. This may cause vaginal dryness, itching, discomfort during sex or reduced sexual desire. Some women also experience urinary symptoms, including needing to urinate more often and recurrent urinary tract infections.

Physical Symptoms

Other possible symptoms include:

• headaches or migraines
• aching muscles and joints
• heart palpitations
• dry or itchy skin
• changes in body shape or weight
• reduced energy
• changes in sexual desire

How Does Livial Work?

Livial contains the artificial ingredient tibolone, which, unlike traditional HRT that often contains synthetic oestrogen or progesterone, is broken down in the body to produce substances that mimic the effects of oestrogen, progesterone, and testosterone, to restore hormone balance and relieve menopause symptoms.

Tibolone, by mimicking the effects of these naturally occurring sex hormones, also helps preserve bone mineral density (BMD), thereby preventing fractures and the onset of osteoporosis, which is common in postmenopausal women due to declining hormone levels.

How Long Does Livial Take to Work?

Some people find that Livial starts to improve their symptoms within a few weeks of starting treatment. However, it can take up to 3 months to notice its full benefits.

If your symptoms haven’t improved after 3 months of taking Livial, you should contact your clinician as you may benefit from an alternative treatment.

How Effective is Livial HRT?

Research shows that the active ingredient in Livial, tibolone, is particularly effective in relieving symptoms such as vaginal dryness, hot flushes, and sweating. It has also been shown to have a greater effect on increasing arousal and sex drive compared to oestrogen therapy alone.

Another study found that if 67% of people taking a placebo experienced vasomotor symptoms such as hot flushes and night sweats; 35 to 45% of people taking tibolone will. This demonstrates that Livial can reduce these symptoms in postmenopausal women.

Research also shows that a daily 2.5 mg dose of tibolone for 24 months increases bone mineral density in the lumbar spine and femoral neck (hip), which are risk factors for postmenopausal women.

How to Take Livial Tablets

Livial is available as an oral tablet to be swallowed. It comes in 28-tablet strips, with each pack containing 3 strips. Each Livial tablet contains 2.5 mg of tibolone. The recommended dose is 1 tablet daily for as long as your clinician tells you to. You should take Livial at the same time every day.

To take Livial, you should:

1. Start by taking a tablet marked with the current day. So if today is Monday, take a tablet marked Monday from the top row of the strip.
2. Press the tablet out of the strip so it comes through the foil.
3. Swallow one tablet whole with some water without chewing.
4. Follow the arrows until the strip is empty.
5. Start the next strip the next day. Do not leave a break between strips.

Your clinician will prescribe the lowest dose to treat your symptoms for as short as necessary. If you think the dose is too strong or too weak, speak to your clinician for advice.

When to Start Taking Livial

You cannot take Livial if you are still having periods or you have had a natural period within the last 12 months. If you have started the menopause, you must wait until 12 months after your last natural period before starting Livial. Taking it sooner can cause irregular bleeding.

You can start taking Livial straight away if you:

• Are switching from a period-free HRT, which is a type that does not cause you to have a period or monthly bleed
• Were prescribed HRT because you have had your womb removed (hysterectomy)
• Are being treated for endometriosis, which is a condition that causes womb lining tissues to move around the body
• Have never used HRT before

You will need to wait for your next period and start taking Livial as soon as your period ends if you are changing from another type of HRT that causes you to have a period.

If You Take More Livial Than You Should

If you take too many Livial tablets, you may feel nauseous, vomit, or experience some vaginal bleeding. However, it is unlikely that taking more than one pill will do you much harm.

If You Forget to Take Livial

If you forget to take Livial HRT, take it as soon as you remember, unless you are more than 12 hours late. In this case, just skip the missed dose and take your next tablet at the usual time. Do not try to take a double dose to make up for the one you missed.

Livial Side Effects and Cautions

Because Livial can cause side effects, it is important that you are aware of potential adverse events and cautions, so that you know what to expect and when to get medical help.

Potential Side Effects of Livial HRT

Livial HRT tablets can cause side effects in some people, although not everyone will get them. Most side effects are mild and can be managed at home, but if you get any that are persistent, difficult to manage, or cause concern, speak to your clinician.

Please note that the above is not an exhaustive list of possible Livial side effects. More information can be found in the Patient Information Leaflet included with the treatment. You can report any side effects you experience, including any that aren’t listed here, to the Yellow Card Scheme. This will give clinicians a better understanding of Livial's safety.

Serious Side Effects of Livial

Sometimes Livial can cause serious side effects. If you get any of the following, see a doctor straight away as you may need to stop taking Livial:

• A rise in blood pressure
• Your skin or the whites of your eyes turn yellow (jaundice)
• Sudden migraine-type headaches
• Signs of a blood clot (painful swelling and redness of the legs, sudden chest pain, or difficulty breathing)
• You become pregnant

Side Effects of HRT

Like all medicines, hormone replacement therapy (HRT) can cause side effects, although not everyone experiences them. Side effects vary depending on the hormones used, the dose and whether HRT is taken as tablets, patches, gels, sprays or another form. They are often mild and improve within the first 3 months as your body adjusts.

Common side effects of HRT can include:

• breast tenderness or swelling
• headaches
• feeling sick
• indigestion, bloating or stomach discomfort
• mood changes
• leg cramps
• fluid retention
• acne or changes to the skin
• vaginal bleeding or spotting

Irregular bleeding or spotting is particularly common during the first few months of treatment. Speak to your doctor if bleeding becomes heavier, lasts longer than 6 months, begins after you have been taking HRT for some time or occurs after a period without bleeding.

Does HRT Cause Weight Gain?

There is little evidence that most types of HRT directly cause weight gain. Changes in weight and body shape commonly occur during menopause and as people get older, whether or not they use HRT. A balanced diet and regular physical activity may help you manage these changes.

Are There Any Serious Risks?

Serious side effects are uncommon. However, some types of HRT can slightly increase the risk of breast cancer, blood clots or stroke. The level of risk depends on factors including your age, medical history, the type of HRT used and how long you take it. Your prescriber will assess your individual benefits and risks before recommending treatment.

Seek urgent medical help if you experience:

• pain, redness or swelling in one leg
• sudden chest pain or difficulty breathing
• difficulty speaking, weakness on one side or facial drooping
• swelling of the lips, mouth, tongue or throat
• severe breathing difficulties

Speak to your doctor or pharmacist if side effects are persistent, troublesome or difficult to manage. They may recommend adjusting the dose or changing the type or method of HRT rather than stopping treatment completely.

Livial Interactions and Warnings

Although Livial is an effective HRT, it may not be suitable for everyone. It can make some existing conditions worse or interact with other medications you may be taking. You should pay close attention to the warnings or precautions to help you make an informed decision about whether Livial is suitable for you.

You should not take Livial HRT if you:

• Have or have ever had breast cancer or are suspected of having it
• Have oestrogen-sensitive cancer, such as cancer of the womb lining (endometrium) or are suspected of having it
• Have any unexplained vaginal bleeding
• Have excessive thickening of the womb lining, known as endometrial hyperplasia, that is untreated
• Have or have ever had a blood clot in a vein such as in the legs or lungs
• Have a blood clotting disorder
• Have or have recently 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 yet returned to normal
• Have a rare, inherited blood problem called porphyria
• Are allergic to tibolone or any other ingredients listed in this medication
• Are pregnant or think you might be pregnant
• Are breastfeeding

If you get any of these for the first time while taking Livial, stop taking it and speak to a doctor straight away.

Risk of Blood Clots

Although the risk of getting a blood clot in a vein is lower than with other types of HRT, it is important to be aware of the risks. Among women in their 50s who do not use HRT, around 4 to 7 in every 1,000 are expected to develop a blood clot in a vein over 5 years. Among those using combined oestrogen-progestogen HRT for more than 5 years, this rises to around 9 to 12 in every 1,000, which is approximately 5 additional cases.

Risk of Breast Cancer

Evidence suggests that tibolone can increase the risk of breast cancer, with the level of risk rising the longer it is used. Research into other forms of HRT shows that this additional risk falls after treatment stops, although it may remain for 10 years or longer after more than 5 years of use. It is not known whether this also applies to tibolone.

The breast cancer risk associated with Livial appears lower than with combined HRT and similar to that associated with oestrogen-only HRT.

Check your breasts regularly and contact your doctor if you notice:

• dimpling or sinking of the skin
• changes to a nipple
• a lump that you can see or feel

You can find more information about the risks of taking Livial in the Patient Information Leaflet that comes with your medication.

Precautions Before Taking Livial

Before taking Livial, speak to your clinician if you have ever had any of the following, as you may need more check-ups than usual to see how your body reacts to tibolone:

• fibroids inside your womb
• growth of the 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

You should also let your doctor know if you are taking Livial and are going to have an operation. You may need to stop taking HRT 4 to 6 weeks before surgery to reduce the risk of a blood clot. Your doctor will tell you when it is safe to start taking HRT again.

Livial HRT and Other Medicines

Before taking Livial, tell your clinician if you are taking any prescribed, over-the-counter, or herbal medications. Some medicines can impact the effectiveness of Livial, which can cause irregular bleeding, such as:

• Blood clotting medicines like warfarin
• Epilepsy medicines such as phenobarbital, phenytoin, and carbamazepine
• Tuberculosis medicines including rifampicin
• Herbal remedies containing St John’s Wort

Pregnancy and Breastfeeding

Livial is for postmenopausal women only. If you become pregnant while taking Livial, stop taking it and contact your doctor immediately.

If you are pregnant, breastfeeding, think you might be pregnant, or planning to have a baby, speak to your clinician, doctor, or pharmacist before taking Livial.

Frequently Asked Questions About Livial HRT