Climonorm 21 tablets


Climonorm is hormone replacement therapy (HRT). It contains two types of female hormones, estrogen and progestogen. Clomonor is used in menopausal women with the last cycle for at least 6 months.


Climonorm 21 tablets

What Climonorm is and what it is used for
Climonorm is hormone replacement therapy (HRT). It contains two types of female hormones, estrogen and progestogen. Clomonor is used in menopausal women with the last cycle for at least 6 months.

Climonorm is used to:

Relief of post-menopausal symptoms
During menopause, the amount of estrogen produced in the female organism declines. This can cause symptoms such as burning of the face, neck and chest ("hot flushes"). Clonormor alleviates these symptoms after menopause. Clonormor will only be prescribed if your symptoms severely make your daily life difficult.

Prophylaxis of osteoporosis
After menopause, some women may develop bone fragility (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you may use Clonormor to prevent post-menopausal osteoporosis.
Experience in the treatment of women over 65 is limited.

2. What you need to know before using Climonorm

Medical history and regular check-ups
Using HRT brings risks that need to be considered when deciding whether to start or continue to use HRT.

Experience in treating women with premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of using HRT may be different. Please talk to your doctor.

Before you start (or resume) HRT, your doctor will ask for your medical history and that of your family. Your doctor may decide to conduct a physical examination. This may include breast examination and / or internal investigations, if necessary.

Once you start using Clomonor, you should visit your doctor for regular check-ups (at least once a year). During these examinations, discuss with your doctor the benefits and risks of continuing treatment with Climonor.

Take regular breast examination as recommended by your doctor.

Do not use Climonorm
if any of the following applies to you. If you are not sure about any of the conditions below, talk to your doctor before taking Clonormor.
• If you have or have ever had breast cancer or if there is any doubt about it
• If you have estrogen-sensitive cancer such as uterine lining (endometrium) or if there is any doubt about it
• If you have unspecified vaginal bleeding
• If you have excessive thickening of the uterine lining (endometrial hyperplasia) that is not treated
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C deficiency, protein S or antithrombin)
• If you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• If you have or have ever had liver disease and liver function tests have not been normalized
• If you have a rare blood disorder called "porphyria" that is transmitted to the family (inherited)
• If you are allergic to oestradiol or any of the other ingredients of this medicine (listed in section 6)
• If you have or have recently developed arterial thromboembolic disease (such as angina pectoris, myocardial infarction)
• If you are pregnant or breast-feeding

If any of the above conditions appear for the first time during treatment with Clonormor, stop using the product immediately and consult your doctor immediately.

Warnings and precautions
Talk to your doctor before taking Clonormor.

Tell your doctor if you have ever had any of the following problems before starting treatment as they may return or get worse during treatment with Climonor. If so, you should visit your doctor more often for screening:
Clonormor should be admitted only in the presence of complaints that impair the quality of life. The physician must at least make a careful assessment of the benefit and risks of treatment at least once a year. Treatment should be used as long as the benefits outweigh the risks.

Please remember that treatment with Climolinor has no contraceptive effect and does not protect against HIV or other sexually transmitted diseases.

Medical review / tracking:

Before starting or resuming HRT, a complete medical and family history must be taken. According to the contraindications and warnings for use, a physical examination (including the genitals and breasts) should be undertaken. During treatment, periodic check-ups, such as frequency, are recommended
When to take special care with Clonormor Tell your doctor if you have ever had any of the following problems before starting treatment as they may recur or worsen during treatment with Clonormor. If so, you should visit your doctor more often for screening:

fibroma in the uterus;
growth of uterine lining outside the uterus (endometriosis) or a history of excessive uterine lining (endometrial hyperplasia);
increased risk of blood clots (see "Blood clots in the veins (thrombosis)");
increased risk of developing estrogen-sensitive cancer (for example, if you have a mother, nurse or grandmother who has had breast cancer);
high blood pressure;
hepatic impairment as a benign liver tumor;
gallstones; migraine or severe headache;
immune system disease that affects many organs in the body (systemic lupus erythematosus, CJIE);
a disease that affects the eardrum and hearing (otosclerosis); very high level of fat in the blood (triglycerides); fluid retention due to heart or kidney problems; lumps or soreness in the breast (benign breast disease); episodes of swelling in parts of the body such as the hands, feet, face, airways caused by a defect in the gene that controls a blood protein called C1-inhibitor (hereditary angioedema);
a disease with unusual movements (minor chorea);
if you suffer from hereditary angioedema.
Conditions requiring special medical attention:

The patient should be monitored if any of the following conditions occur during or during previous hormonal treatment. It should be borne in mind that these conditions may recur or worsen during treatment with Clonormor, especially in:
• nodal change in mammary gland tissue (fibrocystic mastopathy)
• severe birth defects in lipid metabolism (fat metabolism)
• pathological (obesity) obesity
• hereditary deformation of blood cells (sickle cell anemia)

Stop using Clonormor and see your doctor immediately If you notice any of the following while using HRT:
• any of the conditions mentioned in the "Do not use Climonor" section;
• yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver disease;
• a significant increase in blood pressure (symptoms may be headache, fatigue, dizziness);
• a migraine-like headache that occurs for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:

o painful swelling and redness of the legs;
o sudden chest pain;
difficulty in breathing.

For more information, see "Blood clots in the veins (thrombosis)".
• sudden visual disturbances

Note: Climonorm is not a contraceptive. If it has been less than 12 months since your last menstrual period or you are under 50, you may still need to use an additional contraceptive to prevent pregnancy. Talk to your doctor for advice.

HRT and cancer
Excessive thickening of the lining of the uterus (endometrial hyperplasia) and uterine lining of the uterus (endometrial cancer)

Applying estrogen alone may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and uterine lining (endometrial cancer).

The progestogen used in Climonorm protects you from this additional risk.

For women who have not removed the uterus and who do not take HRT, an average of 5 out of 1000 will be diagnosed with endometrial cancer aged 50-65 years.

For women 50 to 65 years of age who have not removed the uterus and who receive estrogen only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (ie between 5 and 55 additional cases) depending on the dose and duration of intake.

Data from studies show that 5 out of 1000 women between 50 and 65 years of age who do not use HRT develop endometrial carcinoma. In women using estrogen monotherapy, there is a 2 to 12-fold increase in risk in proportion to the duration of treatment and the dose of estrogen compared to women who do not receive such therapy. In women with an intact uterus, this risk is significantly reduced by taking gestagen plus estrogen (at least 12 days within one cycle). Clonormor contains such a gestagen in 12 brown tablets.

During the first months of hormone replacement therapy, breakthrough bleeding and spotting may occur. Record all stains and bleeding events between the cycles that occur during the treatment with Climonor. If this bleeding continues after the first months of treatment, if it occurs after prolonged treatment or continues beyond the end of
Visit your doctor as soon as possible.

Breast cancer
Data suggest that taking an estrogen-progestogen combination and possibly estrogen-only HRT increases the risk of breast cancer. The increased risk depends on how long you take HRT. The additional risk occurs within a few years. However, it returns to normal within a few years (at most 5) after discontinuation of treatment.

For comparison
In women aged 50-79 years who do not take HRT, an average of 9 to 17 per 1000 will be diagnosed with breast cancer for a 5-year period. For women aged 50-79 years who receive HRT with estrogen-progestogen for 5 years, there will be 13 to 23 cases per 1,000 users (ie 4 to 6 additional cases).

The risk of breast cancer is higher when women use a combined hormone replacement therapy that consists of one estrogen and one gestagen, regardless of the type of gestagen and the way it is combined with estrogen (prolonged or in pieces). There is no difference in risk in the different routes of administration (eg tablet or patch).

There is evidence that breast tumors in women using a particular combination of estrogen and gestagen (conjugated horse estrogens combined with medroxyprogesterone acetate) are slightly larger and more often give metastases to adjacent lymph nodes than tumors of untreated women .
The number of additional cases of breast cancer is largely independent of age in women in the 45-65 age group at the beginning of hormone replacement therapy.

The Million Women Study tests the effects of various hormone replacement therapy drugs on the risk of breast cancer. Calculated for 1,000 women the results show the following:
In the observation of 1,000 women who do not use hormones, breast cancer appears on average on 32 women aged 50-64 years old.
In 1,000 women treated with only one estrogen (ie without gestagen), the mean age

- after 5 years of treatment, 1.5 additional cases of breast cancer
- and after 10 years of treatment 5 additional cases of breast cancer.

In 1,000 women treated only with a combination (ie estrogen and gestagen), mean age was observed in the corresponding age range

- after 5 years of treatment 6 additional cases of breast cancer
- and after 10 years of treatment 19 additional cases of breast cancer.

According to an estimate of the WHI-Study trial (the use of combined estrogen and gestagen medicines), the following breast cancer risk estimates are calculated:

Of 1,000 women in the 50-79 age group who do not take hormone replacement therapy, breast cancer in 16 women appears within 5 years.

Of the 1,000 women being treated with a combination of estrogen and gestagen, there are 4 additional cases within 5 years.

Hormone replacement therapy, especially the combination of estrogen and gestagen, reduces the permeability of the mammary gland tissue to X-rays. This makes it difficult to diagnose breast cancer by breast examination with X-ray (mammography).

Regularly check your chest. Visit your doctor if you notice any changes, such as:
• skin wrinkle;
• Grain changes;
• all the lumps you can see or feel;

It is also advisable, if you are offered, to join screening mammography programs. For screening mammography, it is important to inform your nurse / medical practitioner that you are using XTT because the medicine can increase the density of your breasts, which may affect the outcome of mammography. In case of increased breast density, mammography may not capture all lumps.

Ovarian cancer
Ovarian cancer is rare, much less rare than breast cancer. The use of estrogen alone or combined estrogen-progestogen HRT was associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not take HRT, about 2 women in 2000 will be diagnosed with ovarian cancer for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 women (ie about 1 extra case).

Effect of HRT on the heart and blood circulation Blood sputtering in the veins (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher in HRT than in the unused ones, especially during the first year of treatment.
Blood clots can be serious and if one of them reaches the lungs, it can cause chest pain, shortness of breath, loss of consciousness, or even death.
It is more likely that a blood clot is formed in your veins if you are older and if you
The risk of venous thromboembolic disease may be temporarily increased with prolonged immobilization (eg forced bed rest, gypsum limb), severe injuries or larger operations. Patients who receive HRT, like all patients after surgery, should be extremely careful with all precautions to prevent venous thromboembolic disease.

Tell your doctor if you have a planned operation. In case the operation is associated with a long period of immobilization, especially in abdominal and orthopedic surgery, consideration should be given to whether it is possible to temporarily discontinue HRT within 4 to 6 weeks. If possible, treatment should be restarted after regaining mobility.

If signs of venous thromboembolic disease develop after your onset of HRT, or if there is a suspicion of such a disease, you should immediately discontinue Clonormor.

If you notice possible signs of venous thromboembolic disease (especially painful leg swelling, sudden chest pain, difficulty in breathing), you should contact your doctor immediately.

Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

Women over 60 years of age who use estrogen-progestogen HRT are less likely to develop cardiovascular disease than those who did not use any HRT.

In women with uterus who are on estrogen-only therapy, there is no increased risk of developing cardiovascular disease.

Diseases of the coronary vessels
In large clinical trials, there is no evidence of coronary artery disease benefits in relation to the use of HRT medicines with a certain combination of active substances (conjugated horse oestrogens combined with medroxyprogesterone acetate).

Two large clinical trials give evidence of a possible increase in cardiovascular disease risk in the first year of application and generally no benefit. Concerning other HRT drugs with other active substances compared to those in the Climonorm tablets, there are currently no larger clinical trials in which coronary action is being studied.

Heart attack
In a large study ("WHI-Study"), an increased risk of heart attack was reported in healthy women during treatment with a certain combination of active substances (conjugated horse estrogens combined with medroxyprogesterone acetate).
According to these data, about 3 out of 1,000 women aged 50-59 who do not take hormones receive a heart attack within 5 years or about 11 out of 10,000 women aged 60 to 69 years.

In women between 50 and 59 years of age, taking these medicines, there is one additional case of heart attack per 1,000 women. In women aged 60 to 69 years, taking these medicines, there are about 4 extra cases per 1,000 women.


The risk of stroke is about 1.5 times higher in patients with HRT than those who are not. The number of additional stroke cases due to the use of HRT will increase with age.

For comparison
In women in the 50s who do not take HRT, an average of 8 per 1000 is expected to get a stroke within a 5-year period. For women in the 50s who receive HRT, 11 cases per 1000 users are expected for 5 years (ie 3 additional cases).

Other conditions
• HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women starting HRT after 65 years of age. Contact your doctor for advice.
• Careful medical supervision (including periodic monitoring of prolactin levels) is necessary in patients suffering from adenoma in the anterior pituitary gland.
• Sometimes pigment spots on the skin (chloasma) may develop. Women with a predisposition to chloasma should avoid exposure to sun or ultraviolet rays during HRT.
• The hormone estradiol valerate in Climonorm may provoke or aggravate the symptoms of hereditary angioedema (swelling of parts of the body such as the hands, feet, face, airways).
• Your doctor will monitor you closely if you have heart or kidney problems.

Patients with renal and heart failure:
Estrogens can cause fluid to retention throughout the body; therefore, patients with heart or kidney failure should be closely monitored.

Patients with severe renal insufficiency should be carefully monitored as the level of Clononorm active substances in the blood stream is expected to increase.

Patients with certain dysfunction of lipid metabolism (hypertriglyceridemia):

If you are experiencing elevated cholesterol (triglyceride) cholesterol levels, your cholesterol should be monitored with extreme caution during treatment with Clonormor, as treatment with
Laboratory tests

If you need a blood test, tell your doctor or laboratory staff that you are taking Clomonor as this medicine may affect the results of some tests.

Estrogens may affect the results of laboratory tests such as those on thyroid function (see also section "Take special care with Climonorm").

If you have diabetes and you need medication, take care when taking Clonormor, especially when dosing. Dose adjustments (dose increase) may be necessary as estrogen may impair carbohydrate tolerance.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Clomonor is only for use in postmenopausal women. If you become pregnant, stop taking Clonormor and contact your doctor.

Clinical data from a limited number of pregnancies on drug administration indicate undesirable effects of levonogestrel on the embryo.

Most of the available studies that are relevant for inadvertent exposure to the embryo of oestrogens and gestagens do not show deviations or toxic effects.

Small amounts of sex hormones can be excreted in breast milk. HRT is not shown during breast-feeding.

Driving and using machines
No effects on ability to drive and use machines have been observed with Clionorm users.

Climomorn contains lactose
This medicine contains lactose (sugar milk), sucrose (sugar cane sugar) and glucose (grape sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to use Climonorm
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will seek to prescribe the lowest dose to treat your symptoms for as short a time as necessary. Talk to your doctor if you think this dose is too strong or insufficient.

If the doctor does not prescribe you otherwise, the recommended dose is:
During the first 9 days, one yellow tablet is taken each day and then for 12 days one brown tablet.

To facilitate the control of the daily ingestion of tablets, a packet is placed in the packaging with weekday abbreviations. On this card there is a printed guide to mark the beginning of the reception with the respective day.

The first yellow tablet is taken from the field marked with the corresponding day of the week (for example, MON for Monday). The next acceptance follows in the direction of the arrow.

After all tablets are used within three weeks, a 7-day tablet break-in is followed by no tablets. During this time, regular bleeding-like appearance should be expected.

After a 7-day pause, the dose is continued with the next blister pack, regardless of whether the bleeding continues or not. The first day after pause should be the same as the day of the week in which you started taking the medicine.

Start of Clinonorm's intake:
• If you have not used HRT

You can start by taking Clonormor at any time.
• Changing from another medicine for HRT

If you have taken a medication for HRT without a pause before you start Climonor, use the wrapper to the end. You can then immediately start using Climonorm.

If you previously have a HRT medication, where you have a regular pause, take Clonormor on the day after the pause.

Application method:
This medicine is for oral use.

If possible, take Clonormor at the same time without chewing the tablet and with enough fluid (such as a glass of water). To prevent gastrointestinal complaints, take the medicine in the evening.

Application duration
The duration of administration is determined by the attending physician.

Please consult your doctor if you feel that Climonorm's action is too strong or too weak.

If you have to undergo surgery
If you are going to have surgery, tell the surgeon that you are applying Climonorm. You may have to stop taking Clonormor for about 4 to 6 weeks before surgery to reduce the risk of blood clotting. Ask your doctor about when you may start using Clonormor again.

If you take more Clomorphine than you should
In some women, overdosage may cause nausea, vomiting, and bleeding waste. No specific treatment is required, but consult a doctor if you are worried about it.
Possible treatment should be consistent with the symptoms.
If you have taken too many tablets, you should go to your doctor.
The only undesirable reaction reported to be caused by the drug is in the "uncommon" category because of the small clinical trials (588 participants).

* Venous thromboembolism, i. deep vein thrombosis, as well as pulmonary embolism, occur more often in women using HRT than in women who do not receive such treatment. Further information is available under "Do not use Clonormor" and "Take special care with Clonormor".

The following side effects have been reported with other HRTs:
• Gallbladder diseases
• various skin disorders:
- Pigmentation of the skin, especially on the face or neck, known as "spots of pregnancy" (chloasma);
- painful reddish nodules of the skin (erythema nodosum)

- rash in the form of targets with redness or inflammation (erythema multiforme)
• uterine lining (endometrial carcinoma) (see "Take special care
caution when using Clonormor)

Other side effects of the medicine that are associated with treatment with estrogen and gestagen:
- Estrogen-dependent benign forms, as well as malignant tumors, predominantly uterine lining
- Venous thromboembolic diseases, i. blockage of the deep veins in the legs and pelvis of clots (thrombosis) as well as pulmonary embolism. These occur more often in patients who are using HRT medications than in patients who do not receive such treatment.
For more information, see "Before Using Climonorm"
Cardiac infarction and stroke
-Gall Bladder Diseases
- Crystalline pigmentation of the skin (chloasma), various skin diseases with blistering and nodule or bleeding in the skin (erythema multiforme, erythema nodosum, vascular purpura)
- Possible brain disorders (see "Take special care with Clonormor")
- Allergic reactions that may occasionally be severe (angioedema) with swelling of the skin and / or mucous membranes.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If any side effects occur when taking Climonor, tell your doctor who will decide whether or not to take the appropriate measures.

The side effects that you should immediately visit a doctor or who should immediately stop taking the product are listed under "Take special care with Climonorm".
How to Store Climonorm
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
Store below 30 ° C.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Clonormor contains
The active substances are estradiol valerate and levonogestrel

9 yellow coated tablets, each containing: estradiol valerate (equivalent to 1.53 mg oestradiol)
2.00 mg

12 brown coated tablets, each containing: estradiol valerate 2.00 mg (equivalent to 1.53 mg estradiol) levonogestrel 0.15 mg
- The other ingredients are:

Each yellow coated tablet contains:
Tablet core: Lactose monohydrate, potato starch, gelatin, talc, magnesium stearate (Ph. Eur.)
Tablet coat: Sucrose, calcium carbonate, magnesium carbonate, light, talc, glucose, liquid (Ph Eur.), Macro nugget 35,000, titanium dioxide (E171), gelatin, povidone K25, hydrated iron oxide , carnauba wax

Each brown coated tablet contains:
Tablet core: Lactose monohydrate, potato starch, gelatin, talc, magnesium stearate (Ph. Eur.)
Tablet coating: Sucrose, calcium carbonate, magnesium carbonate, light, talc, glucose, liquid (Ph.Eur.), Macrogol 35 000, titanium dioxide (E 171), gelatin, povidone K25, iron oxide ), hydrated iron oxide (E172), iron oxides and hydroxides (E172), carnauba wax

What Clonormor looks like and what the package contains
One blister pack contains 9 yellow and 12 brown coated tablets.
Clonormor is available in a blister of 21 coated tablets and as 3 blisters of 21 coated tablets. Not all types of packaging can be placed on the market.








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