CLIMARA 50 mcg patches
CLIMARA 50 mcg patches
What Climara? (Composition)
Climara is a transdermal system (patch) containing the active ingredient estradiol.
Climara patch is an area of 05.12 square centimeters containing 3.8 mg of estradiol (3.9 mg estradiol hemihydrate) which releases 50 micrograms estradiol per 24 hours.
Climara patch contains the following inactive ingredients:
ethyl oleate, isopropyl myristate, glycerol monolaurate, an acrylate kopolimer.Kakvo Climara (Pharmaceutical form and pharmaco-therapeutic group) Climara is a transdermal system (patch) for hormone replacement therapy (HRT).
In what package is available Climara?
Climara is available in cartons containing 4 patches.
How does Climara? (Product Features)
Climara contains estrogen estradiol, identical to natural human estradiol. Estradiol is absorbed from the patch through the skin into the bloodstream. During menopause ("change of life") production of estradiol in the ovaries decrease. However, that change in life is a natural phenomenon, it often causes the appearance of troublesome symptoms that are related to gradual loss of hormones produced by the ovaries. Furthermore, in some women, the loss of these hormones can lead to thinning of the bones with age (postmenopausal osteoporosis). Climara hormone replaces estradiol, the body no longer produces. Estradiol prevent or relieve unpleasant symptoms (menopausal symptoms) such as hot flushes, sweats, sleep disturbances, nervousness, irritability, dizziness, headache, and less need for release, dry vagina, burning and pain during intercourse.
If you have had a hysterectomy (surgical removal of the uterus), your doctor will prescribe another hormone - progestogen, which take both the application of Climara.
Some women likely to develop osteoporosis as they age depending on the history and way of life is greater. If appropriate, you can have a c Climara therapy to prevent osteoporosis. Your doctor may give you further instructions.
What applies Climara? (Statement)
Climara provides hormone replacement therapy (HRT) to treat menopausal complaints after menstrual bleeding stops or after removal of the ovaries. Additionally, the product is used to prevent bone disease osteoporosis in the elderly, the so-called postmenopausal osteoporosis.
When you must not use Climara? (Contra)
You should not use Climara, if any of the following conditions applies to you. Please seek further advice from your doctor.
If you are pregnant or breastfeeding
If you have vaginal bleeding unspecified
If you have breast cancer or suspected of such
If you have a malignancy by affecting hormones or suspected of such
If you have or have had liver tumors (benign or malignant)
If you have or have had a thrombosis (formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism)
If you have recently had a heart attack and / or stroke
If you are allergic to any ingredient of Climara (please see composition)
If any of these conditions occur for the first time during treatment with Climara, immediately
discontinue use of product and consult your doctor.
What you should keep in mind before you start using Climara?
Your doctor will make the necessary examination, including gynecological, breast, blood pressure and other studies are required, as before treatment and at regular intervals during treatment.
If there is suspicion of adenoma of the anterior pituitary gland, this condition should be excluded from your doctor before you start treatment.
What precautions should be taken? (Warnings and precautions for use)
Before you start using Climara
Your doctor will discuss the benefits and risks of treatment with Climara!
Two large clinical trials with conjugated estrogens (CEE) and medroxyprogesterone acetate (MPA), the hormone used for hormone replacement therapy (HRT) have shown that the risk of heart attack (myocardial infarction) may be slightly higher during the first year of use. This risk is not observed in a large clinical trial with private use of CEE. In two large studies of these hormones, the risk of stroke is increased from 30 to 40%.
Although there are no data on Climara, the product should not be used to prevent heart disease and / or stroke.
If HRT is carried out at any of the below listed conditions should be closely monitored. In this connection, if any of these apply to you, tell your doctor before you start using Climara.
If you have an increased risk of thrombosis (the formation of blood clots) in the veins
The risk increases with age, also can be higher:
If you or any of your immediate relatives ever had a thrombosis in the blood vessels of the legs or lungs
If you are overweight
If you have varicose veins.
If you already are using Climara, tell your doctor well in advance of planned hospitalization or surgery. This is due to the fact that surgery, severe trauma or immobilization risk of deep vein thrombosis may be temporarily increased.
Do uterine fibroids
have or have had endometriosis (presence of endometrial tissue in other parts of the body, which usually does not occur)
you have liver disease or gallbladder
You received jaundice during pregnancy or previous use of sex steroids
have high blood pressure
have or have had chloasma (yellowish-brown spots on the skin) if so, avoid standing in sunlight or ultraviolet radiation
if you suffer from epilepsy
if you have lumps or tenderness in the breasts (benign breast disease)
if you suffer from asthma
if you suffer from migraines
if you have a hereditary disease called porphyria
if you suffer from congenital deafness (otosclerosis)
you have systemic lupus erythematosus (SLE, a chronic inflammatory disease) have or have had minor chorea (a disease with abnormal movements) HRT and cancer
The risk of cancer of the lining of the uterus (endometrial cancer) increased with the use of estrogen alone for an extended period of time. Treatment with estrogen and Climara, should not be conducted as a single agent in women who had undergone hysterectomy were not. If you use Climara and have not had an hysterectomy, you will need to treating you to add a progestogen. Your doctor will give you the necessary savet.Molya, tell your doctor if treatment with Climara often have irregular bleeding or persistent bleeding.
Some studies found that breast cancer is found slightly more often in women who take hormone replacement therapy (HRT) for several years. The risk increases with duration of treatment. It can be lower or even neutral for estrogen-only therapy. If women stop taking HRT, the increased risk disappears within a few years. As higher rates of breast cancer was observed for late natural menopause, alcohol intake and obesity. HRT increases the density of mammographic obrazi.Tova can complicate mammographic detection of breast cancer in some sluchai.Vashiyat doctor may decide to use another method of screening for breast cancer.
According to a study of ovarian cancer occur slightly more often in women who were on estrogen therapy for more than ten years. The analysis of 15 other studies showed no increased risk for women on estrogen therapy. So far, the impact of this replacement therapy for ovarian cancer has not been determined.
During or after the administration of hormones such as those contained Climara, rarely, develop benign tumors of the liver. The occurrence of malignant tumors of the liver is even more rare. In isolated cases, bleeding from such tumors in the abdominal cavity can be life-threatening. Although such events are extremely unlikely to tell your doctor about any unusual sensation in the upper abdomen that does not go away after a short period of time.
Reasons for immediate discontinuation of Climara
Should immediately discontinue treatment and consult your doctor if you experience any of the following:
Receive first migraine attack (usually a throbbing headache and nausea preceded by visual disturbances);
worsening migraine, any unusually frequent or unusually severe headaches;
suddenly disturbed vision or hearing;
inflamed veins (phlebitis).
If you form a clot while using Climara or have doubt about it, you should immediately discontinue treatment and consult your doctor.
Disturbing events that need to be careful:
Blood in cough;
Unusual pain or swelling in the hands or feet;
Sudden shortness of breath;
Application of Climara should be discontinued immediately if you become pregnant or become jaundiced.
What rules to follow when driving or operating machinery?
There are no side effects.
What to do if you are being treated with other medicines? (Interactions)
Should not use oral contraceptives. In need of contraception, seek advice from your doctor.
Some medicines may interfere with the full effect of hormone replacement therapy (HRT). These include medicines used to treat epilepsy (eg hydantoins, barbiturates, primidone, carbamazepine) and tuberculosis (eg rifampicin). Always tell the doctor who shows you what HRT drugs already in use. In addition, tell your doctor or dentist who prescribes another medicine (or the pharmacist at the pharmacy where you receive the product) that apply Climara.
If in doubt about any product you use, consult your doctor.
Taking large amounts of alcohol in the conduct of hormone replacement therapy has an effect on treatment. Your doctor can give you advice.
Use of HRT may have specific effects on laboratory tests. Always tell your doctor or the laboratory staff that you apply patch Climara.
How to apply Climara? (Dosage and administration)
If no specific hormone replacement therapy, you can start treatment with Climara.
If you're using another type of hormone replacement therapy with Climara start the day after treatment, or proceed as instructed by your lekar.Ako not you have had a hysterectomy, your doctor will prescribe another hormone (progestogen). It will give you instructions on how to take it.
Route of administration
The patch should be placed on a clean, dry area of skin, preferably on the trunk or buttocks. Climara should not be placed on or near the breasts. The selected site should not be oily, damaged or irritated, avoiding waist as tight clothing can come off the patch.
Remove the patch from the package. Remove the protective foil. Then immediately put patches on the skin and squeeze sharply with the palm of the hand for 10 seconds. Verify that the patch makes good contact with the skin, especially around the edges.
Apply the patch stays in place seven days, then removed and replaced with a new patch that should be applied in a different place. If the patch is well placed, you can bathe in a tub or shower as usual. The patch, however, can be peeled off the skin using very hot water or sauna.
However, it usually patches should be applied continuously, your doctor may advise you to apply the patch cycle. In this case, the patch should be applied once a week for three weeks and then follows a 7-day interval the patch before the start of the next course.
In women with an intact uterus 2-3 days after discontinuation of adjunctive progestogen may occur bleeding.
Please observe the instructions for use, otherwise you will not be able to take full advantage of the beneficial effects of Climara
What to do if you forget or lose the patch?
If the patch falls off before the end of the 7-day period, you can place the same patch again. If this is not possible, it is necessary to use a new patch, which remained until the end of the 7-day application period.
If you forget to replace a patch, do it as soon as possible after the next patch Use the usual 7-day period. If you lose or forget patch to replace it with a new one and take several days may occur bleeding.
What to do if you use more than your prescribed dose? (Overdose)
If it comes to extremely rare overdose could be nausea and vomiting occur. Once you have downloaded the patch may occur vaginal bleeding. No specific treatment is required, but if you have any concerns - talk to your doctor.
Climara cause you any side effects?
Serious side effects
Severe adverse drug reactions of Climara, and related symptoms, are described in the following sections: "Precautions and warnings for use / HRT and cancer / Reasons for immediate discontinuation of Climara". Please read these sections for more information and where necessary consult a doctor.
Other possible side effects
Like all medicines, Climara can have side effects. In some patients, the application of Climara may cause some skin irritation at the application site. In the first few months of treatment can occur suddenly vaginal bleeding (spotting or breakthrough bleeding) and some sensitivity and breast enlargement. These symptoms are usually transient and in the course of treatment usually disappear. If this does not happen, consult your doctor.
May occur in the following side effects:
Increasing the size of uterine fibroids, abnormal vaginal discharge.
Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice.
Increased pigmentation of the skin, especially the face (chloasma), which may be permanent. In some cases, you may develop allergic contact dermatitis, post-inflammatory generalized pruritus and exanthema.
Central nervous system
Headaches, migraines, vertigo.
Changes in body weight, worsening of inherited disease called porphyria, edema, altered libido, muscle cramps.
If you notice any side effects not listed in this leaflet or are not sure of the effect of this product, please consult your doctor.
How to Keep Climara?
Please check the expiry date stated on the pack. Do not use after this date.
Store in a place protected from moisture and light at temperatures below 30 ° C.
The patch should be removed from the packaging until you proceed to put mu.Pazete reach and sight of children.