Kliovance

Kliovance is a continuous combined hormone replacement therapy (HRT). It contains two types of female hormones: an estrogen and a progestogen. Kliovance is used in postmenopausal women whose last natural period occurred in the latest year.

Estradiol: The active substance, synthetic 17ß-estradiol, is chemically and biologically identical to endogenous human estradiol. Substitutes loss of estrogen production in postmenopausal women and relieves menopausal symptoms

Estrogens prevent bone loss after menopause or ovariectomy.

Norethisterone Acetate: A synthetic progestogen with actions similar to progesterone, a natural female sex hormone. Because estrogens promote endometrial growth, unopposed estrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestogen reduces the risk of estrogen-induced endometrial hyperplasia in non-hysterectomies women.

Kliovance is used to:

Relieve symptoms that occur after menopause

During menopause, the amount of estrogen produced by a woman's body drops. This can produce symptoms such as heat on the face, neck, and chest ("hot flashes"). Kliovance relieves these symptoms after menopause. You will only be prescribed Kliovance if the symptoms seriously hinder your daily life.

Prevent osteoporosis

After menopause, some women may have brittle bones (osteoporosis). You should discuss with your doctor what options are available. If your risk of fractures due to osteoporosis increases, and there are no other medications that are right for you, you can use Kliovance to prevent osteoporosis after menopause. Kliovance is prescribed for women who have not had their uterus removed and whose periods ended more than 1 year ago. Only limited experience with Kliovance treatment of women over 65 years is available.

Always use this medicine exactly as your doctor has told you. If in doubt, ask your doctor or pharmacist.

Take one tablet once a day, at about the same time each day. When you have finished the 28 tablets in the pack, start a new pack to continue the treatment without interruption.

You can start Kliovance treatment any day of the week. However, if you have switched from another HRT product with which you had menstrual bleeding, start the new treatment right after the bleeding has ended.

Your doctor should prescribe the lowest effective dose and for the shortest possible time to provide relief from symptoms. Talk to your doctor if you think the dose is excessive or insufficient.

If you take more Kliovance than you should

Kliovance overdose can cause dizziness or vomiting. If you take more Kliovance than you should, immediately consult your doctor or pharmacist.

If you forget to take Kliovance

If you have forgotten to take the tablet at the usual time, take it within 12 hours. If more than 12 hours have passed, skip the missed dose and take it the next day as usual. Do not take a double dose to make up for a missed dose. Missing a dose can increase the chance of breakthrough bleeding and spotting unless your uterus has been removed.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following disorders have been reported more frequently in women who use HRT than in those who do not:

• breast cancer
• abnormal growth or cancer of the lining of the uterus (endometrial hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over 65 years of age.

Hypersensitivity/allergy (rare side effect - affects 1 to 10 users in 1,000)

Although it is a rare effect, hypersensitivity/allergy may occur. Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, shortness of breath, decreased blood pressure (pallor and cooling of the skin, increased heart rate), feeling dizzy and sweating They may be signs of an anaphylactic reaction or shock. If one of the above symptoms occurs, stop taking Kliovance and seek medical help immediately.

The following section details the known Kilovance tablet side effects and their respective frequency, for more details, please look at the patient information leaflet:

Very common side effects (may affect more than 1 in 10 people)

• Breast pain or tenderness
• Vaginal bleeding.

Common side effects (may affect up to 1 in 10 people)

• Headache
• Weight gain due to fluid retention
• Vaginal inflammation
• Migraine, of new appearance or worsening of the existing one
• Vaginal yeast infection
• Depression, new-onset or worsening of existing
• nausea
• Increase in size or swelling of the breasts (breast edema)
• Back pain
• Worsening, appearance or reappearance of uterine fibroid (benign tumor)
• Swelling of arms and legs (peripheral edema)
• Weight gain.

Uncommon side effects (may affect up to 1 in 100 people)

• Bloating, abdominal pain or discomfort, or flatulence
• Acne
• Hair loss (alopecia)
• Abnormal growth (male pattern) of hair
• Itching or hives (urticaria)
• Inflammation of a vein (superficial thrombophlebitis)
• Leg cramps
• Pharmacological ineffectiveness
• Allergic reaction
• Nervousness

Rare side effects (may affect up to 1 in 1,000 people)

• Formation of blood clots in the veins of the legs or lungs (deep vein thrombosis, pulmonary embolism).

Very rare side effects (may affect up to 1 in 10,000 people)

• Cancer of the lining of the uterus (endometrial cancer)
• Excessive thickening of the lining of the uterus (endometrial hyperplasia)
• Increased blood pressure or worsening of existing hypertension
• Gallbladder disease, gallstones that may be new, recurrence or worsening of existing ones
• Excessive sebum secretion, skin rash
• Acute or recurrent edema (angioneurotic edema)
• Insomnia, dizziness, anxiety
• Changes in sexual desire
• Vision disturbances
• Weight Loss
• vomiting
• Gastric acidity
• Vaginal and genital itching
• Myocardial infarction and cerebrovascular accident.
• Other adverse effects of combined HRT
• gallbladder disease
• various skin disorders:

pigmentation of the skin, especially on the face and neck, known as the "pregnancy cloth" (chloasma) red and painful skin nodules (nodular erythema) rash with ulcers or redness in the form of a target (erythema multiforme). Red or purple discoloration of the skin and / or mucous membranes (vascular purpura)

Warnings and precautions

For the treatment of postmenopausal symptoms, HRT should only be started when these symptoms impair a woman's quality of life. In all cases, a careful assessment of the risks and benefits of HRT should be carried out at least once a year, which should only be maintained as long as the benefits outweigh the risks.

Data indicative of risks associated with HRT in the treatment of premature menopause are limited. However, due to the absolute low risk in young women, the balance of benefits and risks for these women should be more favorable than for older women.

Medical examination / follow-up

Before starting or reinstating HRT, a complete medical history, both personal and family, should be performed. Physical history (including pelvis and breast) will take into account this history, as well as contraindications and precautions for use. During treatment, periodic evaluations are recommended whose nature and frequency will be adapted to each woman. Women should be informed of what breast changes to report to their doctor or nurse. Periodic examinations should be performed using appropriate imaging techniques (eg, mammography) in accordance with currently accepted screening practices and adapted to the clinical needs of each case.

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