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How Boltin works and what it 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. In addition, the menopause may cause thinning of the bones (osteoporosis). Boltin can relieve menopausal complaints and prevent bone loss. It can also relieve these symptoms in women who have had their ovaries removed. Relief of symptoms usually starts within a few weeks, but optimal results are obtained after at least three months of treatment. For prevention of bone loss long-term therapy is required. Boltin is not intended for contraceptive use.
The most important natural sex hormones in women are estrogens and progestagens. These hormones are necessary for the normal sexual development of women and play an important role in the control of the menstrual cycle. Estrogens and progestagens are mainly produced by the ovaries.
When women get older the ovaries gradually stop producing sex hormones. The period in which this happens (usually around the age of 50) is called the climacteric or menopause. If the ovaries are removed surgically (oophorectomy) before the menopause, the decrease in hormone production occurs very abruptly.
The decrease in hormone production often leads to the well-known climacteric complaints, such as hot flushes and night-sweating. The shortage of sex hormones may also cause the lining of the vagina to become thin and dry. As a result sexual intercourse may be painful and vaginal infections may occur more frequently.
These physical problems are in some women accompanied by mood changes, nervousness, depression, irritability and loss of sexual desire.
A problem which often goes unnoticed is the accelerated loss of bone in the years around and after the menopause. As a result of this process the bones become brittle and may easily break (osteoporosis).
Boltin contains tibolone, a substance that can replace the natural sex hormones after the menopause. Boltin can alleviate climacteric complaints such as hot flushes and night sweats. It also has a beneficial effect on the lining of the vagina and a favourable effect on mood and sexual desire.
Boltin can also prevent bone loss that occurs after the menopause.
Unlike some other preparations used for hormone replacement therapy, Boltin does not stimulate the lining of the womb. Treatment with Boltin therefore does not lead to monthly vaginal bleeding.
Boltin. Each tablet contains 2.5 mg of the active ingredient called tibolone. Boltin also contains the following inactive ingredients: potato starch, lactose, ascorbyl palmitate, and magnesium stearate.
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DOSAGE AND DIRECTIONS FOR USE
The dosage is one tablet per day. A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the latter case, the missed dose should be skipped and the next dose should be taken at the normal time.
Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.
Administration: Boltin tablets should be swallowed with some water or other drink, preferably at the same time each day.
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WARNINGS
Boltin is not intended for contraceptive use.
The use of Boltin should be avoided until 12 months after the last natural menstrual bleed. If Boltin is taken sooner than this, the frequency of irregular bleeding may be increased.
Treatment should be discontinued if signs of thrombo-embolic processes occur, if results of liver function tests become abnormal or if cholestatic jaundice appears.
Vaginal bleeding may occur during Boltin therapy, because of an apparently stimulated endometrium due to some estrogen production. Normally such bleeding is of short duration. Bleedings commencing after three months of treatment, or recurrent or of longer duration should be investigated.
In women changing from another form of hormonal substitution therapy to Boltin therapy, it is always advisable to induce a withdrawal bleeding with a progestogen before starting Boltin.
Tibolone has been shown to be teratogenic in experimental animals, and should not be used in premenopausal women.
Periodic examinations must be done for endometrial hyperplasia, as well as possible signs of virilisation.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following adverse reactions have been observed: headache and migraine, oedema, change in body mass, dizziness, seborrhoeic dermatosis (pruritus) rash, abdominal pain and depression. Vaginal bleeding or spotting may occur, mainly during the first months of treatment.
A higher dosage than the recommended may induce vaginal bleeding.
Safety on long-term administration has not been established.
Patients with the following conditions should be monitored frequently:
Renal dysfunction, epilepsy or migraine or a history of these conditions, since the use of steroids with hormonal activity may induce fluid retention;
Impaired carbohydrate metabolism since Boltin may diminish glucose tolerance and increase the need for insulin or other antidiabetic medicines.
Risk-benefit should be considered when any of the following medical conditions exist:
Liver disease or a history of this condition;.
Hypercholesterolemia, since during Boltin treatment changes in the serum lipid profile (lower values of lipid constituents of HDL-lipoprotein fraction) occur.
Boltin may not be suitable for you if you suffer from certain medical conditions.
Before you start to take Boltin 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 kidney or liver disease?
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