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Livial

Buy Livial, Tibolone

Brand Names: Livial
Generic Name:
Tibolone
Manufacturer: Organon

What Livial does
Livial is one of a group of medicines called Hormone Replacement Therapy (HRT). It's used for problems that start affecting women when their body no longer produces certain hormones (for example after the change of life (the menopause)).

It's also used to prevent bones becoming brittle (osteoporosis) if you are unable to use other treatments.
There are three different kinds of HRT:

• Oestrogen-only HRT
• Combined HRT, containing two kinds of female hormone, an oestrogen and a progestagen
• Livial, which contains a substance called tibolone

Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestagen) it contains tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined HRT.

The benefits of Livial
Replacing lost hormones

At the time of the menopause (or after an operation to remove the ovaries) a woman's body stops producing the female hormone, oestrogen.

You may also have too little oestrogen if you are being treated for endometriosis. Whatever the reason, too little oestrogen may cause a range of problems: hot flushes, night sweats, vaginal dryness or irritation, depression or reduced sex drive. Livial can help and you should notice an improvement after a few weeks.

Preventing brittle bones
Too little oestrogen may also cause brittle bones (osteoporosis). As you get older, the bones become porous, which means they become brittle and break more easily.

If you are at an increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatments, or if other treatments don’t work for you, you may be able to use HRT. Your doctor should discuss all the available options with you.

Make sure Livial is OK for you
For information on when you can start taking Livial, (including after a hysterectomy) see Taking Livial .

As well as benefits, HRT has some risks that you need to consider when you're deciding whether to start taking it, or whether to carry on taking it. This is especially important if you are more than 60 years old.

Before you start taking HRT
Your doctor should ask about your own and your family's medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

• Tell you doctor if you have any medical problems or illnesses.

Regular check-ups
Once you've started on HRT, you should see your doctor for regular check-ups (at least once a year). During these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to
• go for regular breast screening and cervical smear tests
• regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.

Some women shouldn't take Livial
Don’t take Livial

• if you have had breast cancer or any other cancer (especially a hormone-dependent cancer)
• if you are pregnant or breastfeeding
• if you have or have had a blood circulation disorder such as blood clots (in the veins of the legs, or the lungs)
• if you have or have had a stroke or a mini-stroke (transient ischaemic attack)
• if you have or have had a heart condition such as angina or a heart attack
• if you have ever had an allergic reaction to tibolone, lactose or any of the other ingredients in Livial tablets
• if you have porphyria (an inherited disorder)
• if you have recently had unexpected vaginal bleeding
• if you have abnormal growth of the lining of the womb
• if you have liver disease

If you have any of these above you should not take these tablets.

If you have started the menopause you should not take Livial until 12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.

Some women need special care
With some medical problems, your doctor will want to keep a close watch on you as HRT can make them worse.

Do you have (or have you had):

• asthma
• blood clots
• relatives who have had blood clots
• close relatives (mother, sister or grandmother) who has had breast cancer or cancer of the lining of the womb
• diabetes
• epilepsy
• gallstones
• high blood pressure
• liver disease
• migraine or severe headache
• otosclerosis (a hearing disorder)
• a rare disease called systemic lupus erythematosus
• uterine fibroids or endometriosis
• endometrial hyperplasia (overgrowth of the lining of the womb)

If you have any of these, have you talked it over with your doctor?

If you haven't, talk to your doctor as soon as you can before taking these tablets. He or she may want to do some tests, or give you more advice about taking Livial.

Whatever your history, your doctor will arrange regular check-ups.

Reasons to stop taking Livial
• If your blood pressure increases your doctor may decide that you should stop taking Livial.
• Your doctor may do liver tests. If the results aren't normal, your doctor may decide that you should stop taking Livial.
• If your skin goes yellow (jaundice)
• If you begin to get migraine, or severe headaches
• If you get painful swelling in your leg, sudden chest pain or difficulty in breathing.
• If you start to have any of the conditions listed earlier in the Section 'Some women shouldn't take Livial'

Stop taking Livial and talk to your doctor straight away.

Livial and cancer
Endometrial cancer (cancer of the lining of the womb)

There have been reports of an increased cell growth or cancer of the lining of the womb in women using tibolone. The risk of cancer of the lining of the womb increases the longer you take the medicine.

If you get breakthrough vaginal bleeding or spotting, it's usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:
• carries on for more than 6 months
• starts after you've been on HRT for a while
• carries on even after you've stopped taking HRT

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT for 5 years or more may slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who's still having periods over that time and not taking HRT.

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take HRT, but returns to normal within about 5 years after stopping HRT.

Women using Livial have a lower risk than women using Combined HRT, and about the same risk as those taking oestrogen-only HRT.

Your risk of breast cancer is also higher:
• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight

Compare
For women who take tibolone, the number of extra cases of breast cancer is about the same as the number for oestrogen-only HRT.

Looking at women aged 50 who are not taking HRT − on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 64.

For women who start taking Livial at age 50 and take it for 5 years, the figure may be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take Livial for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

If you notice these changes in your breast, such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel

Make an appointment to see your doctor as soon as possible.

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT or Livial increase the risk in the same way.

Livial and your heart or circulation
Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestagen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:
• a pain in your chest that spreads to your arm or neck

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke
Recent research suggests that HRT and Livial slightly increases the risk of having a stroke. The increased risk is seen mainly in women over 60 years old. Other things that can increase the risk of stroke include:

• getting older
• high blood pressure
• smoking
• drinking too much alcohol
• an irregular heartbeat

If you are worried about any of these things, talk to your doctor to see if you should take HRT.

Compare
Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking Livial, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking Livial, the figure would be 24 in 1000.

If you get:
• unexplained migraine-type headaches, with or without disturbed vision

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots
Oestrogen-only and Combined HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. It’s not known if Livial increases the risk in the same way.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:
• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have had blood clots
• if you have had one or more miscarriages
• if you have any blood clotting problem that needs treatment with a medicine such as warfarin
• if you're off your feet for a long time because of major surgery, injury or illness
• if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare
Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty in breathing

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

Having an Operation
If you're going to have an operation, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot.

Your doctor will tell you when you can start taking HRT again.

Taking other medicines
Tell your doctor or pharmacist if you are taking (or about to take) any other medicines, Remember to mention medicines you bought over the counter, without a prescription. Other medicines may influence the effects of Livial, or Livial may affect other medicines especially:

• medicines for blood clotting problems such as warfarin, as your doctor may need to change the dose of these medicines

Taking Livial with food and drink
You can eat or drink normally while you’re taking Livial.

Pregnancy and breast-feeding
Do not use Livial if you are pregnant, or if you think you might be pregnant. Do not use Livial if you are breast-feeding.

Driving and using machines
Livial has no known effect on the ability to drive or use machines.

Livial contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Livial.

If you are worried about anything in this section, talk to your doctor about the risks and benefits of HRT.


Taking Livial
When can you start taking Livial?

If it is not yet 12 months since your last natural period… Wait before taking Livial’ (see Section 2.1)…
If you are changing over from a period-free HRT ... (see the note below)... Start taking Livial straight away
If you have never used HRT before ...
If you were prescribed HRT because you have had a hysterectomy ...
If you are being treated for endometriosis (a condition in which parts of the womb lining move around the body).

If you are changing over from another type of HRT with which you have periods
(see the note below)...
Wait for your next period. Start taking Livial as soon as your period ends.

If you are changing over from another type of HRT:
There are several different types of HRT, such as tablets patches and gels. Most contain either oestrogen, or oestrogen and a progestogen. With some you still have periods, and with some you don't (these are called period-free HRT).

How to take Livial
The usual dose is one tablet every day. Take this dose unless your doctor or pharmacist told you to do something different.

Press the tablet so that it comes through the foil. Swallow the tablet with some water or other drink, without chewing. Take Livial at the same time each day.

The strips of tablets are marked with the days of the week. Start by taking a tablet marked with the current day. For example, if it is Monday, take a tablet marked Monday on the top row of the strip. Follow the arrows until the strip is empty. Start the next strip the next day. Do not leave a break between strips or packs.

If you take more Livial than you should
It is unlikely that taking more than one tablet will do you any harm, but you may feel sick, be sick or have some vaginal bleeding.

If you forget to take Livial
If you forget to take a tablet, take it as soon as you remember, unless you are more than 12 hours late. If you are more than 12 hours late, just skip it, and take your next tablet at the usual time. Don't take a double dose.

Possible side effects
Like all medicines, Livial may have side effects, although not everybody gets them. Most side effects are mild.

Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Livial. (See also Section: Reasons to stop taking Livial)

Serious side effects - see a doctor straight away
• If you think you may have signs of a serious side effect, see a doctor straight away.

You may need to stop taking Livial:
• if your blood pressure rises
• if your skin or the whites of your eyes go yellow (jaundice)
• if you suddenly have migraine-type headaches (see Section 2.5 above)
• if you have signs of a blood clot (see Section 2.5 above)
• if you get any of the problems listed in the Section 2.1 above (‘Don’t take Livial’).

Other side effects
Common (affect up to 1 in 10 women):

• breast pain
• stomach or pelvic pain
• unusual hair growth
• vaginal bleeding or spotting.
This is usually nothing to worry about in the first few months of taking HRT. If bleeding continues, or starts after you have been on HRT for a while See Section 2.4.
• vaginal problems such as more secretions, itching, irritation and thrush
• thickening of the lining of the womb or the lining of the cervix
• weight gain.

Uncommon (affects up to 1 in 100 women):

• acne
• painful nipples or breasts feeling uncomfortable
• vaginal infections

Some women taking Livial have also reported:
• depression, dizziness, headache
• joint pain or muscle pain
• skin problems such as rash or itching
• swollen hands, ankles or feet – a sign of fluid retention
• tummy upset
• loss of vision or blurred vision
• changes in liver tests

There have been reports of breast cancer and of an increased cell growth or cancer of the lining of the womb in women using Livial.

• Tell your doctor if any of the above mentioned side effects continues or becomes troublesome.

Other side effects, which may occur with oestrogen-progestogen combined HRT are:
• oestrogen-dependent tumours
• blood clots in the veins
• dementia (decline in mental function, and memory loss)
• gall bladder disease
• heart attack and stroke
• skin problems such as rashes, discoloration or red patches on the skin.

• Tell your doctor or pharmacist if you notice any side effects not mentioned here.


How to store Livial
Keep your tablets where children cannot see or reach them.

Do not use after the ‘use by’ date on the pack. The expiry date refers to the last day of that month.

Keep your tablets in the blister strip in the pack, in a dry place, away from the light, below 25°C, but not in the fridge.

Further information
What Livial contains

Each tablet contains 2.5 milligrams of tibolone.

Each tablet also contains the inactive ingredients: potato starch, lactose, ascorbyl palmitate and magnesium stearate.

News Update

September 7th, 2016:

October 26, 2015:
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