What Livial is used for
During and after the menopause the production of sex hormones by the body decreases. Women may then suffer from complaints such as hot flushes, night sweats, vaginal irritation, depression, and loss of sexual desire. Livial can relieve menopausal complaints. It can also relieve these symptoms in women who have had their ovaries removed, because it is the ovaries that produce your sex hormones. Relief of symptoms usually starts within a few weeks, but optimal results are obtained after at least three months of treatment. If you are at increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatments or if other therapies prove to be ineffective, Livial may also be used to prevent your bones becoming brittle. Your doctor should discuss all the available options with you. Livial is not intended for contraceptive use, it is for use only by postmenopausal women.
Before you use Livial
Livial may not be suitable for you if you suffer from certain medical conditions. Before you start to take Livial make sure you tell your doctor if the answer is YES to any of the following questions:-
- are you pregnant or do you think you may be pregnant?
- do you have a tumour (e.g. a breast tumour or a tumour in your womb)?
- do you have or have you ever had heart disease or blood vessel problems?
- do you have or have you ever had thrombosis (blood clots)?
- have you recently had unexpected vaginal bleeding?
- do you have or have you ever had liver disease?
- are you allergic to any of the ingredients listed at the end of this leaflet?
Also tell you doctor if:
• you have or have ever had too much cholesterol or other fatty substances in the blood
• you have been treated with other hormone replacement therapies recently.
Effects on your risk of developing cancer:
Endometrium (lining of the womb)
Like estrogen-progestogen HRT, Livial does not increase the cell growth of the lining of the womb. Therefore, there is no need to add a progestogen when you are taking Livial.
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb. Taking a progestogen as well as the estrogen helps to lower this increased risk. There have been reports of cancer of the lining of the womb in women using Livial.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking Livial. But if the bleeding or spotting:
• carries on for more than 6 months after starting Livial
• starts after you have been on Livial for a while
• carries on even after you’ve stopped taking Livial
Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
Before starting with hormone therapy (HT) you have to inform your doctor of your personal and family medical history. You should have a general and gynaecological examination. You should also have periodic check ups, especially examination of the breasts. Every woman is at risk of getting breast cancer, whether or not she takes HT. Breast cancer has been found slightly more often in women using HT than in women of the same age who have never had HT.
It is not known if Livial is associated with the same higher chance of having breast cancer diagnosed since it acts differently to other hormone replacement therapies.
Nevertheless, if you are concerned about the risk of breast cancer, discuss the risk compared to the benefits of treatment with your doctor.
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are no obvious signs of the disease.
Some studies have indicated that taking estrogen only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Effects on your heart or circulation
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 suggest that women who use HRT may be slightly more likely to get heart disease during the first year of taking medication.
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 Livial until your doctor says you can. This pain could be a sign of heart disease.
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
• getting older
• high blood pressure
• drinking too much alcohol
• an irregular heartbeat
If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take Livial.
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 Livial until your doctor says you can. These headaches may be an early warning sign of a stroke.
All women have a very small chance of having a blood clot in the veins of the leg, lung or other parts of the body. Taking other HT slightly increases this small chance. Livial does not have the same effect on the blood clotting system seen with other HT so we do not know yet whether Livial increases it too.
You are more likely to have a blood clot (whether or not you use HT) if:
• you are very overweight
• you have had a blood clot in the veins of your legs or in your lungs before
• blood clots run in your family
• you have systemic lupus erythematosus (a disease of your immune system)
• you are unable to move for long periods, for example after a long illness or major operation
• maybe also if you have varicose veins
If any of these apply to you, you should talk to your doctor about whether you should use Livial.
If an operation is planned, which is likely to keep you off your feet for some time, you should talk to your doctor. You may need to stop taking Livial about a month before the operation.
Other medicines may influence the effects of Livial, or Livial may affect other medicines. You must tell your doctor or pharmacist if you are taking (or intend to take) other medicines such as:
- anticoagulants (medicines for prevention of blood clots), your doctor can safely manage the use of Livial and warfarin with careful monitoring and an appropriate adjustment of the warfarin dose when you start, finish or change your dose of Livial
- barbiturates, carbamazepine and hydantoins (medicines for epilepsy or sleeplessness)
- rifampicin (product for bacterial infections)
If you are pregnant or breast-feeding, or think you may be pregnant, do not take Livial.
Livial should not be taken until twelve months after your last natural menstrual bleed. If Livial is taken sooner than this, the risk of irregular menstrual bleeding may be increased.
Regular (6 monthly) medical check ups are recommended during treatment with Livial.
Take Livial as directed by your doctor. You should also read the instructions on the label of your product. If you are not sure how to take Livial ask your doctor or pharmacist.
How and when to take Livial. Take one tablet daily, preferably at the same time each day. The Livial pack contains 28 white tablets. The first tablet should be taken from the upper row of the pack marked with the corresponding day of the week. You should then follow the days of the week and continue taking one tablet each day until the pack is empty. Swallow the tablets with some water or other cool non-alcoholic drink.
What to do if you miss a dose. If you forget to take a tablet, take it as soon as you remember, unless you are more than twelve hours late. If so, do not take the missed dose, just take the next tablet at the usual time.
While you are using Livial
Ability to drive or operate machinery. As far as is known, Livial has no effect on alertness and concentration.
If you are unsure of any of the aspects of this product, please discuss them with your doctor or pharmacist.
Side Effects of Livial
In some women, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other side-effects may occasionally occur which may or may not be due to Livial. These include headache, dizziness, itching, weight gain, nausea, abdominal pain, abdominal enlargement, breast pain, rash, vaginal complaints (such as discharge itching and irritation) and high blood pressure.
There have been reports of an increased cell growth or cancer of the lining of the womb in women treated with Livial, but it has not been demonstrated to be caused by the treatment.
Tell your doctor if vaginal bleeding or spotting occurs, or if any side effects become troublesome or continue. It is also important to tell your doctor or pharmacist if you experience any other unusual or unexpected symptoms during treatment with Livial.
You should stop taking Livial and contact your doctor if you experience any signs of thrombosis (headache, migraine or pain elsewhere in your body, dizziness, vertigo, fainting, disturbances in vision, swollen ankle or leg), or jaundice (yellowing of the eyes or skin) or a rash.
Do not be alarmed by this list of side effects. You may not experience any of them.
If someone has taken several tablets at once, there is no need for urgent medical treatment. However, you should consult a doctor. Symptoms that may arise are nausea and vomiting. Vaginal bleeding may occur after a few days.
After Using Livial
Keep your Livial tablets in the original container in a safe place out of the reach of children. Check if there are special storage conditions given on the box. The expiry date (sometimes written as exp) is also printed on the strip of tablets - do not use after this month.
Return any unused product to your pharmacist.