Riselle 25 mg
Estradiol is a female hormone that your body produces. During and after menopause (menopause), the production of estrogen in your body decreases. If the ovaries are removed surgically (ovariectomy) before menopause, lowering estrogen production occurs very sharply.
Riselle 25 mg
RISELLE WHAT IS AND WHAT IT IS USED
RISELLE 25 mg, is an implant containing estradiol.
Estradiol is a female hormone that your body produces. During and after menopause (menopause), the production of estrogen in your body decreases. If the ovaries are removed surgically (ovariectomy) before menopause, lowering estrogen production occurs very sharply. This reduction may lead to the occurrence of hot flashes, bone loss, vaginal irritation, frequent urinary tract infections, and urinary incontinence. RISELLE may be prescribed to treat such complaints. Once implanted subcutaneously estradiol is gradually released and absorbed into the blood, thereby providing long-term and permanent effect. So it replaces the natural production of estrogen (estrogen - replacement therapy).
2. Before applying the RISELLE
Do not embed RISELLE, if:
In the past or currently have established breast cancer or suspicion of any;
Have or may have estrogen-dependent tumor such as cancer of the uterine wall;
You have abnormal vaginal bleeding that has not been investigated by your doctor;
You aberrant growth of the uterine wall (endometrial hyperplasia);
Have or have had blood flow as blood clots (in the veins of the legs or the lungs);
Have had heart problems such as angina or heart attack;
Have or have had liver disease and liver functions are not normalized;
If you are allergic to estradiol;
If you have porphyria (an inherited disease).
Be especially careful with RISELLE
Besides the positive results from the use of RISELLE, hormone replacement therapy (HRT) poses risks that you should be aware before you decide whether to use or continue using the drug.
Before starting hormone replacement therapy, tell your doctor about your present and past health and the health problems in your family. Your doctor may examine your chest and / or abdomen, and explore your inner organs. Along with this, you will be scheduled periodic medical examinations, especially breast examinations. Once you start HRT periodically (at least once a year) You should be conducted medical examination, during which your doctor will discuss with you the benefits and risks of continuing HRT.
Certain health problems can be exacerbated / degraded due to HRT. If you have suffered or are suffering from any of these conditions, talk to your doctor, who will closely monitor your condition: Fibroid growth of the uterus, endometriosis, blood clots in the blood vessels if you or a member of your family has had estrogen-dependent cancer (eg, a close relative who has had breast cancer), high blood pressure, liver disease, diabetes, gallstones, migraine or severe headaches, systemic lupus erythematosus (rare condition) over endometrial hyperplasia, epilepsy, asthma, otosclerosis (inherited deafness). Talk to your doctor if you notice any change in your condition while taking RISELLE.
HRT can sometimes lead to fluid retention.
Immediately stop using RISELLE at:
Jaundice (yellowing of the skin);
Abrupt rise in blood pressure;
Migraine or severe headaches that have not have suffered to date;
Influence the risk for cancer induction
Endometrial cancer (cancer of the uterine wall)
Application only to estrogen HRT for a prolonged period of time may increase the risk of development of uterine cells or cervical wall (endometriosis). Concomitant use of progestogen and estrogen helps to reduce this risk.
In women with a uterus, a progestagen is displayed with estrogen - individually or as a combined HRT product.
In women with a uterus removed (hysterectomy), ask your doctor whether it is safe to take estrogen without a progestogen.
After surgery due to endometriosis, endometrium in the uterus remains at risk with HRT. You may be prescribed HRT that includes a progestogen and estrogen.
RISELLE only contain estrogen.
In women with a uterus, aged 50-65 years, who are not receiving HRT, the risk of endometrial cancer is 5 to 1000. Women undergoing HRT for a period of 5 years, the risk is 9 1000 (i.e. . has increased risk 4 cases).
In women undergoing estrogen only HRT increases the risk of endometrial cancer increases to 10-60 per 1000 in this case, depending on the length of treatment and the dose of estrogen.
The addition of progestogen to estrogen HRT significantly reduces the risk of endometrial cancer.
Occurrence of bleeding or smudging, especially in the first few months after starting HRT should not scare you.
But if the bleeding or spotting:
Not disappear after the first few months;
If you get after a while you start taking XZT;
If they continue even after cessation of HRT.
Ask your doctor. They may be a sign that the endometrium has grown (bold).
Women with breast cancer, or those who have had breast cancer, not to be taken HRT.
Adoption of estrogen or estrogen-progestagen combined HRT for several years slightly increases the risk of breast cancer. The risk increases with increasing duration of HRT and resolves to about five years after her termination Women taking combination HRT are at a slightly lower risk of breast cancer than those taking estrogen-only HRT.
At an average of 32 to 1000 women aged 50 years who are not undergoing HRT finding breast cancer. In 1000 women, aged 50 years who were undergoing HRT for a period of 5 years, can be registered from 2 to 6 more cases of breast cancer, and in women receiving HRT for a period of 10 years - from 5 to 19 additional cases.
Periodically inspect your breasts for changes such as indentations in the skin, changes in nipple or lumps you can see or feel.
Ovarian cancer occurs very rare but very serious. It can be hard to find because there is often no obvious symptoms of the disease.
Some studies have shown that taking only estrogen HRT for a longer period of 5 years increases the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk similarly.
Influence on the heart and circulation
HRT is not recommended for women with current or recently passed heart disease. If this is the case, discuss with your doctor whether to take HRT.
HRT helps prevent heart disease.
Studies looking HRT (containing conjugated estrogen and progestogen MPA) have shown that women are likely to be marginally more prone to heart disease in the first year of administration of the drug. For other types of HRT is assumed that the risk is the same, although this is not proven yet.
If you feel:
Pain in the chest, covering the upper arms or neck: Visit as soon as your doctor and stop taking HRT until it your resolve. The pain may be a symptom of heart disease.
Recent studies looking HRT (containing conjugated estrogen and progestogen MPA) show slightly increased risk of heart attack.
In women aged 50 years and not taking HRT are expected every 5 years, an average of 3 in 1000 to a heart attack. In women aged 50 years who received HRT 4 of 1000 is likely to have a heart attack. In women aged 60 years and not taking HRT, every 5 years, it is expected an average of 11 in 1000 to a stroke. In women aged 60 years who were undergoing HRT, an average of 15 in 1000 is likely to have a heart attack.
It is not yet known whether other similar types of HRT increase the risk of heart attack.
If you are experiencing:
Unexplained headaches (migraine) with or without disturbed vision: Visit as soon as your doctor and stop taking HRT until it your resolve. Pain can be a warning sign of a possible heart attack.
Thrombosis (formation of blood clots)
Estrogen HRT and estrogen-progestogen combined HRT may increase the risk of venous blood clots (known. Deep vein thrombosis - DVT), especially during the first year of treatment. It is not known whether the risk increases RISELLE analogously. These blood clots are not always serious, but if one of them reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death. This condition is known as pulmonary embolism (PE).
DVT and PE are examples of a condition called venous thromboembolism.
The risk of blood clot formation is higher if you:
You are severely overweight;
You ever had similar blood clots;
Member of your family has ever had similar blood clots;
If you have had one or more miscarriages;
If you had any health problems related to blood clots that have been treated with drugs such as Warfarin;
If you have been a long time in bed because of major surgery, injury or disease;
If you suffer from a rare disease systemic lupus erythematosus.
If any of these conditions apply to you, talk to your doctor to determine if HRT is not contraindicated for you.
In women aged 50 years and not taking HRT are expected every 5 years, an average of 3 1000 have problems with the formation of blood clots. In women aged 50 years who use HRT is expected every 5 years, an average of 7 of 1000 have problems with the formation of blood clots.
In women aged 60 years and not taking HRT, every five years, is expected to average 8 1000 have problems with the formation of blood clots.
In women aged 60 years who use HRT is expected every 5 years, an average of 17 from 1000 have problems with the formation of blood clots.
If you get:
Painful swelling of the feet;
Sudden chest pain;
Difficulty in breathing.
Visit as soon as your doctor and discontinue HRT until it your resolve. Some of these conditions may indicate a blood clot formed.
If you are going to have surgery, tell your doctor. You may need to stop HRT 4 to 6 weeks before surgery to reduce the risk of a blood clot. Your doctor will tell you when you can resume taking HRT.
Diet and use of Riselle
You can eat normally and drink fluids while taking Riselle
Estradiol implants are contraindicated during pregnancy because of epidemiological evidence that their use is harmful to the fetus.
Estradiol implants are not recommended for nursing mothers.
Driving and using machines
You can drive or operate machines. Estradiol does not affect alertness and ability to concentrate.
Using other medicines
Other medications can affect the action of Riselle or Riselle can influence the effect of other drugs. Be sure to tell your doctor or pharmacist if you are taking (or intend to start taking) other drugs such as:
Medicines for epilepsy (such as Phenobarbital, Fenytoin and carbamazepin);
Medicines for tuberculosis (Rifampicin, Rifabutin);
Anti-infective drugs (Nevirapine, Efavirenz, Ritonavir, Nelfinavir, Rifampicin);
Herbal products containing St. John's wort (Hypericum Perforatum).
3. APPLICATION OF RISELLE
Implantation of the drug should only be performed by a doctor or nurse.
When implanted Riselle
The usual dosage is 1 implant every 6 months. Some patients may need to simultaneously implant 2. In general, the new implant must be applied at a recurrence of climacteric symptoms (usually after 4-8 months).
If the interval between two consecutive implant is less than 4 months, the doctor may prescribe taking a blood sample to the level of estardiol blood.
How implanted Riselle
Using the supplied applicator (a trocar) under local anesthesia implant is inserted under the skin of weak mobile location, such as the upper outer buttock or lower abdomen.
Since the implant is dissolved completely, not any components which must be removed.
If you think that the effect of Riselle is too strong or too weak, immediately consult your doctor.
Effects after stopping use of Riselle
If you want to stop using Riselle, and you're with preserved uterus, your doctor will prescribe a progestogen, which can take orally. Adoption of progestagen preparation should continue to stop vaginal bleeding to prevent your uterus from overgrowth. Depending on the duration of use and dose vaginal discharge can last up to 1-2 years after the last implantation.
4. SIDE EFFECTS
Like all other medicines Riselle can also have side effects.
Adverse reactions are usually due to the use of estrogens, which may occur with the use of Riselle, are:
Complaints of chest (tenderness, pain, swelling and secretion);
Fluid retention (which is usually expressed by swelling of the ankles or legs), weight gain;
Skin problems such as redness (erythema), rash, discoloration or red spots, brown spots on the skin exposed to the sun (chloasma);
Headaches, migraines, fatigue, nervousness and mood changes;
Dementia (deterioration in mental activities due to the loss of memory);
Nausea, bloating, gallstones, gallbladder disease;
Yellowing of the eclairs or skin (jaundice);
Thrombosis (blood clots);
High blood pressure;
Heart attack and stroke;
Discomfort in the eye, especially in the use of contact lenses;
Benign and malignant hormone-dependent tumors such as breast cancer and endometrial cancer;
Exacerbation of endometriosis.
When using Riselle possible to display subcutaneous incision site of the implant.
If any of the side effects become unbearable or too long, consult a doctor. It is important to tell your doctor or pharmacist if you show up and other unusual or unexpected symptoms during treatment with Riselle.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORAGE RISELLE
Riselle Keep out of reach of children.
Riselle not use after the expiry date printed on the box. The latest version of this leaflet was made in March 2004
6. MORE ABOUT RISELLE
The active substance in Riselle estardiol is one of the natural estrogens (female sex hormones). Estrogens are mainly produced in the ovaries. They are necessary for the normal sexual development of women and regulating the menstrual cycle in fertile age. When a woman gets older, the ovaries begin to produce less estrogen. The period during which it works (usually at the age of about 50 years), is called the menopausal or post-menopausal. If the ovaries are removed surgically (ovariectomy) before menopause, the decrease in the level of estrogen occurs very sharply.
Estrogens have an important role in bone formation. Bone is built in youth years and the largest bone mass is reached at the age of 20-30 years, after which it decreases slowly at first, and later in the life cycle - accelerated, especially after menopause.
Reducing hormone production often leads to the occurrence of a well-known symptoms of the menopause such as hot flashes and night sweats. Estrogen deficiency can cause vaginal walls become thin and dry. Estrogen deficiency is the cause of the occurrence of such symptoms as incontinence and frequent cystitis. These complaints can generally respond well when taking products containing estrogen. The first signs of improvement may feel a few days or even weeks after the start of treatment.
Problem that is often not enough attention is accelerated bone loss in the years around and after menopause. Gradually, the bones become brittle and easily break (osteoporosis), especially those in the spine, hips and wrists. Osteoporosis can also cause back pain, slouching and height loss.
Riselle can prevent osteoporosis.