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Climen (estradiol valerate, cyproterone acetate) 2mg, 84 Tablets, Bayer

Model Bayer
Manufacturer Bayer
Price:   $98.00
Reviews

Climen (estradiol valerate, cyproterone acetate) 2mg, 84 Tablets, Bayer

Products name: Climen
Pharmaceutical name:estradiol valerate, cyproterone acetate
Manufacturer: Bayer
Pack: 2mg, 84 Tablets

This listing is for 4 boxes
Ea. box-21 Tablets
84 Tablets Total

Climen tablets are packed in blister packs, containing tablets of color coated pills in white and pink tablets:
white tablets of 2 mg estradiol valerate
pink tablets of 2 mg estradiol valerate plus 1 mg cyproterone acetate.

This product is able to be sourced and supplied at excellent prices because of favourable cross border currency conversions. All products are authentic brand names and will include a product information insert in English.


Medical Information:

COMPOSITION

11 white tablets each containing estradiol-17-valerate (estra-1,3,5(10)-triene-3,17beta-diol-17-valerate) 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6-diene-3,20-dione-acetate) 1 mg, plus 7 non-hormonal tablets.


INDICATIONS:

Climen is indicated in patients (with intact uteri) suffering from climacteric symptomatology. Climen therapy may be used as an adjunct in preventing osteoporosis in postmenopausal women.


CONTRA-INDICATIONS

Pregnancy, lactation, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, previous or existing tumours of the liver, uterus, ovaries or breast or a suspicion of such tumours, endometriosis, existing or previous thromboembolic processes, severe diabetes mellitus with vascular changes, sickle-cell anaemia, disturbances of lipometabolism, a history of herpes of pregnancy, otosclerosis with deterioration during pregnancy.


DOSAGE AND DIRECTIONS FOR USE

Before Climen is used, a thorough general medical (including measurement of blood pressure, analysis of urine for sugar, if applicable performance of special liver diagnostics as well) and gynaecological (including the breast and a cytological smear of the cervix and portio) examination should be performed in order to detect any diseases requiring treatment or risk factors and, where applicable, to rule out pregnancy. During the use, checks are recommended at intervals of about 6 months.

The pack contains seven self-adhesive strips marked with the days of the week. Each strip starts with a different day of the week. Stick the strip that starts with your "Start" day along the top of the memo-pack where indicated. For example, if the tablets are started on a Wednesday, the strip that starts with "Wed" should be selected. Each tablet is thus marked with the corresponding day of the week and one can see at a glance whether the tablet for that day has been taken or not. Tablet-taking is always started from the blister marked "Start" and continued daily in the direction of the arrows until all 28 tablets have been taken. At the start of therapy the first tablet is taken on day 5 of the cycle (1st day of menstruation = 1st day of cycle). Menstruation will usually take place whilst the 7 non-hormonal tablets are being taken, before the next pack is started. The tablets are to be swallowed whole with some liquid.

Patients with amenorrhoea (rule out pregnancy beforehand) and postmenopausal women can start taking the tablets - 1 per day over 28 days - on any day they like.

After the 1st pack has been finished, the next pack of Climen is started on the following day. If no withdrawal bleeding occurs whilst taking the 7 non-hormonal tablets at the end of the pack, tablet-taking from the new pack should not be commenced until pregnancy has been ruled out.

If a tablet is not taken at the usual time, it should be taken within 12 hours of that time in order to avoid the occurrence of intermenstrual bleeding.


How does Climen work?

Climen tablets are a two-phase sequential hormone replacement therapy (HRT) and comprise a mixture of oestrogen only tablets followed by a combination of oestrogen and progestogen tablets.


Climen for transgender hormone therapy

Climen tablets contain a combination of estradiol valerate a precursor of oestrogen, and cyproterone acetate, which is a derivative of progestagen and is also an anti-androgen. The cyproterone component can be used as a substitute for spironolactone as the anti-androgen component of transgender feminising hormone therapy for male to female transsexuals, if small doses of anti-androgen are required.


What CLIMEN

Each white tablet contains 2 mg estradiol valerate, and each pink tablet contains 2 mg estradiol valerate and 1 mg cyproterone acetate as drugs.


Climen contains the following inactive ingredients:
lactose monohydrate, maize starch, povidone 25000, talc, magnesium stearate, sucrose, povidone
700 000, macrogol 6000, calcium carbonate, montanglikolov wax, 85% glycerol, titanium dioxide, iron oxide yellow colorant, red iron oxide colorant.


What is climate? (Formulation and pharmaco-therapeutic group)

CLIMEN is coated tablet for hormone replacement therapy (HRT). What size is available climate? One package contains 21 coated tablets. How does it change? (Properties of the product)
Climen contain two types of hormones that decrease and disappear during menopause ("change of life") - estradiol and progesterone. Thus it replaces the hormones that the body no longer produces. Although this change in life is natural, it often leads to an alarming symptoms that are associated with the gradual loss of the hormones produced by the ovaries. In some women, the loss of the hormones leads to loss of bone mass in later life (postmenopausal osteoporosis).
Contained climate estradiol prevents and relieves symptoms disturbing characteristic of menopause: hot flashes, sweating, sleep disturbances, nervousness, irritability, dizziness, headaches and urinary incontinence, burning and dryness in the vagina.
After inclusion of progesterone (cyproterone acetate), in women with a uterus, was prepared in the menstrual cycle-free tablet 7-day interval. Therefore, change can be used in women with menstrual disorders or in cases where an off pregnancy and no organic cause menstruation.
Climen likely cause bleeding regularly even if you are in menopause.
In young women Climene helps establish menstrual cycle in the absence of menstrual bleeding (primary amenorrhea) or monthly cycles have ceased (secondary amenorrhea) switched off pregnancy, lactation or organic cause.
Some women are at greater risk of osteoporosis, which is dependent on their history and lifestyle. Clinical studies with HRT showed a reduction in the risk of bone fractures with prolonged treatment. If you are suitable, you may be given change for the prevention of osteoporosis. Your doctor will advise you on further treatment.
According to clinical studies, the risk of developing colon cancer in postmenopausal women (after last bleeding) may decrease.


Why should it accept CLIMEN? (Statement)

Climate provides hormone replacement therapy for menopausal complaints, degenerative changes in the skin, bladder and genitals, depressive mood swings during menopause, climacteric complaints after the monthly cycle. It is also used for the treatment of complaints due to reduced activity of the ovaries (hypogonadism) or after the removal or, in case the ovaries do not function (primary ovarian failure). In addition, it is used for prevention of osteoporosis in later stages of life, so-called post-menopausal osteoporosis.

Change can be helpful in women with menstrual disorders (primary and secondary amenorrhea) or in cases where an off pregnancy, lactation and organic cause, missing menstruation.


When should it not be accepted CLIMEN? (Contra)

You should not take climate, if you have or have had any of the following conditions. If any of these applies to you, tell your doctor, he will advise you what to do.

  • If you are pregnant or breast-feeding;
  • Do you have undiagnosed vaginal bleeding;
  • If you have breast cancer or are suspected as such;
  • If you have other malignancies influenced by sex hormones or suspected as such;
  • If you have or have had a benign or malignant tumor in the liver;
  • If you have severe liver disease;
  • If you have recently had a heart attack and / or stroke;
  • If you have or have ever had a thrombosis (blood clot formation) of the blood vessels of the legs (deep venous thrombosis) or lungs (pulmonary embolism);
  • If you repeatedly elevated triglycerides (a type of blood lipids);
  • If you are allergic to any component of the change (see Composition)

  • If any of these conditions appear for the first time while using change, stop taking and consult your doctor.


    What you should know before you start taking CLIMEN?

    Your doctor will perform a pelvic examination, breast screening and blood pressure, and other relevant studies. If you have a history of liver disease, your doctor will monitor liver function.

    Before the start of therapy is necessary to exclude adenoma anterior pituitary.
    If you still have the opportunity to become pregnant, the climate does not prevent it. In the event that taking contraceptive measures other than oral (or other hormonal) contraception, continue with them until your doctor thinks you need contraceptive protection. If you take oral (or other hormonal) contraception should switch to an alternative non-hormonal method of contraception before beginning therapy with change.
    On the other hand, if your doctor has told you that you do not need more contraceptive protection is not necessary to take measures while taking climate.

    What precautions should be taken? (Warnings and precautions for use)

    Before initiation of therapy with Climen
    Your doctor will explain the benefits and risks of taking the drug.
    Two large clinical trials with conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) -hormoni HRT, show that the risk of angina (myocardial infarction) may be slightly increased in the first year of use. This risk was not seen in a large clinical trial with CEE alone. In two large clinical trials of these hormones, the risk of stroke was increased 30 to 40%.
    Although there are no data change, it must not be used for the prevention of cardiovascular diseases and stroke.
    If you meet any of the conditions listed below and use HRT may need to be kept under close observation. Your doctor will explain everything.
    Therefore, before taking the drug inform it if:
    • You or someone from relatives in your family have or have had an increased risk of thrombosis in the veins of the legs or lungs;
    • you are overweight;
    • have varicose veins;
    • If you are treated with change, warn your doctor before any planned surgery or hospitalization. This is necessary in connection with temporarily increased risk of deep venous thrombosis in operations, serious injuries and disability.
    • have uterine fibroids;
    • have or have had endometriosis (presence of uterine tissue from atypical locations of the body);
    • you have gallbladder or liver disease;
    • have a history of jaundice during a previous pregnancy or previous use of sex hormones;
    • suffer from diabetes;
    • have elevated levels of triglycerides (a type of blood fat);
    • you have high blood pressure;
    • have or have had chloasma (yellowish-brown pigment spots on the skin). In such cases, avoid too much exposure to the sun or ultraviolet rays.
    • suffer from epilepsy;
    • have breast tenderness or nodes (benign breast disease);
    • suffer from asthma;
    • you suffer from migraine;
    • have an inherited disease called porphyria;
    • suffer from hereditary gluhota- otosclerosis;
    • suffer from systemic lupus erythematosus (SLE, a chronic inflammatory disease);
    • have or have had chorea minor (illness accompanied by unusual movements). HRT and cancer
    • Endometrial cancer
    The risk of cancer of the uterine lining (endometrial cancer) increases when estrogens are administered alone for a long period of time. Progesterone used in climates counteract this risk.
    Please tell your doctor if you frequently suffer from irregular cycles or have prolonged bleeding during treatment with climate.

    • Breast Cancer
    According to some studies, breast cancer is detected slightly more often in women on HRT for several years. This risk increases with duration of therapy. It may be less than, or possibly in neutral products containing only estrogen. When the patient stops taking HRT, the increased risk disappears for several years.
    A similar increase in diagnosed breast cancer was observed eg. for delay of natural menopause, alcohol intake or obesity.
    HRT increases the density of mammographic images. In some cases this may complicate the mammographic detection of breast cancer. Therefore, your doctor may choose other screening techniques for the detection of breast cancer.

    • Tumors of the liver
    During or after use of hormones, such as those contained in the climate, rarely appear benign and even more rarely - malignant liver tumors. In isolated cases appear life-threatening bleeding in the abdominal cavity. Although such events are extremely unlikely, tell your doctor immediately if you have unusual pain in the upper abdomen that do not pass a short time.
    Reasons for immediate discontinuation change
    You should immediately discontinue the treatment and consult your doctor at each lower cases:
    • First attack of migraine (typically a throbbing headache and nausea preceded by visual disturbances);
    • Worsening of pre-existing migraine or any unusually strong or frequent headaches;
    • Sudden disturbances of vision or hearing;
    • inflammation of the veins (phlebitis).
    If you get thrombosis or suspected of such an incident, while taking climate immediately stop taking and contact your doctor. The warning signs are:
    • coughing up blood;
    • unusual pain and swelling of the extremities;
    • sudden breathlessness;
    • fainting.
    Accept change should be discontinued immediately in the event you become pregnant or have jaundice.
    What should you expect when participating in traffic or operate machinery?
    No effects.

    What to do if you are taking other medicines? (Interactions)

    They should not use oral contraceptives. In case you need contraception, consult your doctor.
    Some medicines may affect the effect of hormone replacement therapy (HRT). These include drugs for the treatment of epilepsy (hydantoins, primidone, barbiturates, carbamazepine) and tuberculosis (rifampicin), and antibiotics (penicillins and tetracyclines). Always tell the doctor prescribing HRT for any medication you use, as well as any other doctor or dentist prescribes another medicine that you are taking climate.
    In case you are diabetic, your doctor may change the dose of antidiabetic drugs. If you have any doubt about any medication you are taking, check with your doctor.
    Alcohol abuse during hormone replacement therapy has an effect on treatment. Your doctor will advise you.
    HRT may affect certain laboratory tests. Always tell your doctor and the laboratory personnel that you are using hormone replacement therapy.

    How to take the CLIMEN? (Dosage and Administration)


    In case you still have your period should start climate of the 5th day of the cycle. In all other cases, your doctor may advise you to start immediately.
    In the first 11 days is considered one white tablet, followed by a pink tablet in the remaining 10 days. Each pack covers 21 days of treatment, after which a pause of 7 days without taking tablets.
    It does not really matter the time of day you take your tablet, but once selected, follow it every day. The tablet is swallowed whole with some liquid.
    During free from tablet 7-day interval was prepared bleeding usually several days after the last tablet.
    The next climate package starts after a pause of 7 days. This means that it will start a new pack on the same day of the week and the previous package.
    Please observe the above instructions, otherwise you will have no overall treatment effect in use change.

    What to do if you miss a tablet?

    If you are late with less than 24 hours, take the tablet as soon as you remember and the next tablet at the usual time. But if you are overdue by more than 24 hours, leave the tablet pack. Continue to take the remaining tablets at the set time every day.
    In case that stop taking tablets for several days, it may appear irregular bleeding.
    What happens if you take more tablets than prescribed? (Overdose)
    No information on the harmful effects of an overdose. Overdose can cause nausea, vomiting, irregular bleeding. No specific treatment is required, but consult a doctor.


    CLIMEN is causing any side effects?

    Like all medicines, climate can also have side effects.
    Serious side effects
    Serious adverse reactions and symptoms are described in What precautions should be taken? (Warnings and precautions for use), especially in Sub: Before use change, HRT and cancer and Reasons for immediate withdrawal of the change.
    Please read these subsections enimatelno and consult your doctor immediately when necessary.
    The following symptoms, which may be, but may not have been caused by HRT, and in some cases, symptoms of menopause have been reported in patients of different oral HRT:
    • Common side effects (between 1 and 9 cases 100 can have such effects)
    Metabolism and nutrition disorders Weight gain or weight loss.
    Nervous system disorders Headache.
    Gastrointestinal disorders Abdominal pain, nausea.
    Skin and subcutaneous tissue Redness, itching.
    Breast disorders and reproductive system
    Uterine / vaginal bleeding including spotting (irregular bleeding, usually disappearing after prolonged therapy).
    • Uncommon side effects (between 1 and 9 cases of 1000 may have these effects)
    Immune system disorders hypersensitivity reactions.
    Psychiatric disorders
    Depressive moods
    Nervous system disorders: Dizziness
    Eye disorders Visual disturbances
    Cardiac disorders Palpitations
    Gastrointestinal disorders Dyspepsia
    Nyarusheniya Skin and subcutaneous tissue Erythema nodosum, Urticaria
    Reproductive system and breast pain in the chest, tightness in the chest.
    General disorders and administration site conditions Eden.
    Rare side effects (between 1 and 9 cases of 10.000 may have such effects)
    Psychiatric disorders
    Anxiety, increased or decreased libido
    Nervous system disorders Migraine
    Eye disorders contact lens intolerance
    Gastrointestinal disorders Swelling, vomiting.
    Nyarusheniya Skin and subcutaneous tissue hirsutism, acne.
    Musculo-skeletal and connective tissue disorders Muscle cramps.
    Reproductive system and breast
    Dysmenorrhea, vaginal secretion, Pre-menstrual syndrome similar to breast enhancement.
    General disorders and administration site conditions Fatigue.
    If you notice any of undesirable effect which is not mentioned in this leaflet and you are not sure about the effect of the product, please freely informed your doctor or pharmacist.

    How should I store change?

    Please refer to the expiry date stated on the packaging. Do not use after this date. Keep out of reach of children.