oestraclin gel
oestraclin gel 0.6 mg / g
1 tube 80 g
drug estradiol
What is it and how is it used?
oestraclin gel is a gel for application to the skin, containing estradiol. Once applied to the skin Estradiol is released, which penetrates the skin and passes directly into the bloodstream.
Estradiol is a female sex hormone.
It belongs to the hormone group of estrogens.
It is the estradiol produced in the ovaries of women, identical.
oestraclin gel belongs to a group of medicines called hormone replacement therapy are referred to.
It is used to relieve typical symptoms after menopause (or surgically induced menopause), such as Hot flashes, insomnia, palpitations, sweating and associated with these complaints mental disorders (for example depression), changes in the genitourinary tract (dryness and inflammation of the mucous membranes, urine leakage) applied. These are caused by a drop in estrogen levels in your body.
During menopause, estradiol is no longer produced enough in the organism. oestraclin gel works by replacing the estrogen which is normally produced in the ovaries of women.
can oestraclin gel as a means second choice for the prevention of increased bone loss (osteoporosis) in postmenopausal women at high risk of future fractures (fractures) are applied when these women other medicines to prevent osteoporosis intolerant of, or when these medicines at these women are contraindicated (should not be used).
The sole use of this medicinal product for the treatment for menopause can only occur in women who have had their womb removed.
What you need to consider before using it?
Medical history and regular check-ups
Hormone replacement treatment is associated with risks that must be considered before deciding to begin treatment with oestraclin gel or resume. Before you begin a hormone replacement treatment (or resume), your doctor will record your own medical history and your family. Your doctor will decide on the need for a physical examination. This can, if necessary, include the examination of the breasts and / or a pelvic exam.
Please go regularly, as recommended by your doctor, health checks of your breasts.
oestraclin gel should not be used,
if you are allergic (hypersensitive) to estradiol or any of the excipients listed in section 6 of oestraclin gel.
if you are suffering from breast cancer or were once ill or suspected there.
if you suffer from a form of cancer whose growth is dependent on estrogens, eg., cancer of the uterine lining (endometrium), or a corresponding suspicion.
if vaginal bleeding of unknown cause occurs.
if untreated excessive thickening of the womb lining (endometrial hyperplasia) is present.
if you have had a blood clot has formed in a vein (thrombosis) or had once formed, z. B. in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
if you suffer from a bleeding disorder (eg. as protein C, protein S, or antithrombin deficiency).
if you have a disease or previously had, which is caused by blood clots in the arteries, z. B. heart attack, stroke or paroxysmal occurring chest pain with chest tightness (angina).
if you have liver disease, or once had, and as liver function values have not returned to normal.
if you suffer from a rare hereditary blood disease, the so-called porphyria.
If one of the above mentioned diseases during the application of gel oestraclin first appears, please stop immediately the use and immediately consult your doctor.
Warnings and Precautions
Talk before starting treatment with your doctor if you are affected by any of the health problems listed below, or ever were, or they have been aggravated during pregnancy or previous hormone replacement therapy. In this case, you should see your doctor more often to carry out check-ups. There is the possibility that it may cause a recurrence of the disease or to a deterioration in the application of oestraclin gel.
asthma
epilepsy
diabetes
gallstones
high blood pressure
Migraine or severe headaches
Liver disease, eg. As a benign liver tumor
Growth outside the uterus (endometriosis) or earlier-onset overgrowth of the uterine lining (endometrial hyperplasia)
Disease that affects the eardrum and hearing (otosclerosis)
Immune system disease that affects many organ functions of the body (systemic lupus erythematosus, SLE)
increased risk of estrogen-dependent cancer (eg. as if your mother, sister or grandmother had breast cancer)
increased risk of blood clots (see "Venous blood clots (thrombosis)")
benign tumors in the uterus (fibroids)
very high blood lipids (triglycerides)
Fluid retention due to cardiac or kidney disease
Benign tumors of the breast
Specific tumors of the pituitary gland
Superficial phlebitis (thrombophlebitis)
Varicose veins (varices)
depressions
hereditary angioedema
Quit the application of oestraclin gel and seek medical attention immediately if any of the following diseases or conditions occurring during use of hormone replacement therapy:
migraine headaches that occur for the first time
Yellowing of your skin or the whites of your eyes (jaundice). This may indicate a liver disease.
significant increase in your blood pressure (symptoms may include headache, fatigue and dizziness be)
Diseases listed in the "oestraclin gel should not be used" are mentioned
if you are pregnant
If you notice any signs of blood clots, z. B.
o painful swelling and redness of the legs sudden chest pain o
o shortness of breath
For more information, see "Venous blood clots (thrombosis)".
For scheduled operations (4 weeks ago)
Immobility as after accidents
Risks of hormone replacement therapy (HRT)
Hormone replacement therapy generally involves certain risks.
Other diseases
Hormone replacement treatment prevents any memory problems. There is some evidence of an increased risk of memory disorders in women who were older at the beginning of the application of hormone replacement treatment than 65 years. Ask your doctor for advice.
Influence of oestraclin gel to certain laboratory values
If a blood test is required to you, tell your doctor or the laboratory staff that you apply Estrogel gel, as this medicine may affect the results of some laboratory tests (glucose tolerance, blood clotting, metyrapone, Schilddrüsenfunktions- tests).
Application of oestraclin gel with other medicines
Tell your doctor or pharmacist if you are taking other medicines / apply, have recently taken / used any other medicines or intend to take / apply other medicines.
Medicines may increase or decrease the effect of oestraclin gel. This is true for drugs with the following ingredients:
Phenobarbital, phenytoin, carbamazepine, primidone (agent used to treat epilepsy)
Griseofulvin (antifungal agents)
Rifampicin, rifabutin (used to treat tuberculosis)
Nevirapine, efavirenz, ritonavir, nelfinavir (agent for the treatment of HIV infections)
St. John's wort (a herbal remedy for depression)
Meprobamate (a tranquilizer) and phenylbutazone (a painkiller)
Concomitant use of ascorbic acid (vitamin C) and estrogens may increase the effect of estrogens.
Also oestraclin gel may alter the effect of drugs. Estrogens may increase the effects of theophylline (an asthma drug), certain tranquilizers (benzodiazepines), antidepressants and called glucocorticoids.
oestraclin gel can change the effect of anticoagulants (anticoagulants), medicines for diabetes (antidiabetic), medicines used to lower blood lipids (lipid-lowering agents) and antihypertensive drugs (antihypertensives).
Concomitant administration of metoprolol (medicines for high blood pressure) and imipramine (whitening agent mood psychological disorders) may be strengthened or extended action of these active compounds.
pregnancy and breast feeding period
oestraclin gel is intended for use only in postmenopausal women. If you become pregnant, stop the use of oestraclin gel and consult your doctor. oestraclin gel should not be used during breastfeeding.
Driving and using machines
No known effects.
How is it used?
Apply oestraclin gel exactly like in this leaflet described. Ask yourself if you are not sure with your doctor or pharmacist.
Instructions for Posology and method of administration
The following information applies, unless oestraclin gel was prescribed to you otherwise directed by your doctor. You must always comply with the following instructions. If you do not, acts may not work properly oestraclin gel.
The usual dose is:
2 dosing (2.5 g oestraclin gel) per day.
can remain if the symptoms persist, the dose to 4 dosing (5 g oestraclin gel) to increase daily.
It is important that the treatment in the lowest possible effective dose and no longer is carried out as necessary.
oestraclin gel is applied for 3 weeks, then followed by a treatment-free week. During the treatment-free week a bleeding may occur.
A continuous treatment comes after surgical removal of the uterus or after a special arrangement of the doctor in question.
Application of oestraclin gel with luteal hormones (progestin)
Women with a uterus must take yellow twill hormones concomitantly.
Continuous application of oestraclin gel:
If oestraclin gel applied constantly, the concomitant progesterone should be taken in each case to 12 to 14 consecutive days per month.
Cyclic application of gel oestraclin
The cyclic compounds can be used according to the following scheme: From 1st to 21st day of the cycle 2 dosing oestraclin gel daily.
Apply gel to the last 12 to 14 days of the 21 days when you oestraclin a progesterone is also occupied. Last 7 days (total of 28 days) the cycle remain free treatment.
In both types of application occurs after the luteal hormone intake usually a menstruation similar, rather weaker circulation on.
As applied oestraclin gel?
The gel is an approximately two palms large (20 x 20 cm) area of skin applied (abdomen, shoulders, arms or thighs). The gel should not be applied on the breasts! oestraclin gel should not be applied to mucous membranes. Contact with the eyes should be avoided.
They are used at best after washing morning or evening. The gel does not need to be massaged. Before covering with clothing the application surface to dry for about two minutes. The gel will not stain. After applying you should wash your hands.
If you use a larger amount of oestraclin gel than you should
If you have too much applied oestraclin gel, there is usually a feeling of tension in the breasts, swelling of the abdominal and pelvic region, to anxiety and irritability.
If you forget to use oestraclin gel
If you forget an application with oestraclin gel, the treatment can be made up if forgetting is noted. Then proceed back to the usual dosing schedule. Apply by oestraclin gel not double the dose at a time to.
If you stop using oestraclin gel
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, also oestraclin gel side effects, although not everybody gets them.
It uses the following categories to indicate the frequency of side effects:
Very common: more than 1 in 10 patients Common: 1 to 10 in 100 Uncommon: 1 to 10 of 1 000 patients Rare: 1 to 10 of 10 000 patients Very rare: less than 1 in 10 000 patients
Not known: frequency can not be estimated from the available data
Blood and lymphatic system disorders:
Uncommon: heaviness in the legs
Unknown: Purpura
Psychiatric disorders:
Common: depressed mood
Nervous system disorders:
Very common: easy headache
Common: irritability, dizziness, nervousness, lethargy, headache, increased sweating, hot flashes
Uncommon: migraine, anxiety, insomnia, apathy, emotional lability, decreased concentration, tingling (paraesthesia), altered libido
Very rare: aggravated epilepsy
Unknown: altered euphoria, tremors, restlessness
Eye disorders:
Very rare: contact lens intolerance
Not known: abnormal vision, dry eyes
Heart disease:
Uncommon: palpitations
Not known: Hypertension
Immune system disorders:
Unknown: aggravation of hereditary angioedema (hereditary disease, which is to recurrent swelling (edema) of the skin, mucous membranes and internal organs come)
Metabolism and nutrition disorders:
Common: water retention, weight gain
Unknown: increased cholesterol
Musculoskeletal and connective tissue disorders:
Uncommon: joint disease, muscle cramps
Respiratory, thoracic and mediastinal disorders:
Uncommon: dyspnea, rhinitis
vascular disorders:
Uncommon: cardiovascular diseases
Rare: blood clots
Unknown: superficial phlebitis
Diseases of the stomach / intestinal tract
Common: nausea, abdominal cramps, flatulence Uncommon: Increased Appetite, constipation, vomiting
Unknown: indigestion, diarrhea, Rektalerkrankungen
Hepatobiliary disorders:
Rare: jaundice, swelling of the liver
Skin and subcutaneous tissue disorders:
Very common: rash at the application site Common: itching at the application site
Uncommon: skin discoloration (sometimes permanently), acne, hair loss, dry skin
Unknown: nail disorder, skin nodule, increased body hair, contact dermatitis
Sex organs and breast disorders:
Very common: Breast tenderness
Common: irregular bleeding, vaginal discharge, breast changes, menstrual dysfunction, disorders of the vulva / vagina
Uncommon: Vaginal dryness, benign tumor of the endometrium, benign tumor of the breast, breast augmentation, breast sensitivity
Rare: uterine cancer, breast milk outflow
Unknown: uterine disorders, benign tumor of the muscle tissue of the uterus, breast pain
Renal and urinary disorders:
Uncommon: increasing urine output, increased urination
Not known: urinary incontinence, cystitis, Harnentfärbung, blood in the urine
General disorders:
Common: pain, accumulation of fluid (edema) in the limbs
Uncommon: hot flashes, fatigue, changes in laboratory results, weakness, fever, flu syndrome, malaise
Reporting of adverse reactions
If you notice any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
1 tube 80 g
drug estradiol
What is it and how is it used?
oestraclin gel is a gel for application to the skin, containing estradiol. Once applied to the skin Estradiol is released, which penetrates the skin and passes directly into the bloodstream.
Estradiol is a female sex hormone.
It belongs to the hormone group of estrogens.
It is the estradiol produced in the ovaries of women, identical.
oestraclin gel belongs to a group of medicines called hormone replacement therapy are referred to.
It is used to relieve typical symptoms after menopause (or surgically induced menopause), such as Hot flashes, insomnia, palpitations, sweating and associated with these complaints mental disorders (for example depression), changes in the genitourinary tract (dryness and inflammation of the mucous membranes, urine leakage) applied. These are caused by a drop in estrogen levels in your body.
During menopause, estradiol is no longer produced enough in the organism. oestraclin gel works by replacing the estrogen which is normally produced in the ovaries of women.
can oestraclin gel as a means second choice for the prevention of increased bone loss (osteoporosis) in postmenopausal women at high risk of future fractures (fractures) are applied when these women other medicines to prevent osteoporosis intolerant of, or when these medicines at these women are contraindicated (should not be used).
The sole use of this medicinal product for the treatment for menopause can only occur in women who have had their womb removed.
What you need to consider before using it?
Medical history and regular check-ups
Hormone replacement treatment is associated with risks that must be considered before deciding to begin treatment with oestraclin gel or resume. Before you begin a hormone replacement treatment (or resume), your doctor will record your own medical history and your family. Your doctor will decide on the need for a physical examination. This can, if necessary, include the examination of the breasts and / or a pelvic exam.
Please go regularly, as recommended by your doctor, health checks of your breasts.
oestraclin gel should not be used,
if you are allergic (hypersensitive) to estradiol or any of the excipients listed in section 6 of oestraclin gel.
if you are suffering from breast cancer or were once ill or suspected there.
if you suffer from a form of cancer whose growth is dependent on estrogens, eg., cancer of the uterine lining (endometrium), or a corresponding suspicion.
if vaginal bleeding of unknown cause occurs.
if untreated excessive thickening of the womb lining (endometrial hyperplasia) is present.
if you have had a blood clot has formed in a vein (thrombosis) or had once formed, z. B. in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
if you suffer from a bleeding disorder (eg. as protein C, protein S, or antithrombin deficiency).
if you have a disease or previously had, which is caused by blood clots in the arteries, z. B. heart attack, stroke or paroxysmal occurring chest pain with chest tightness (angina).
if you have liver disease, or once had, and as liver function values have not returned to normal.
if you suffer from a rare hereditary blood disease, the so-called porphyria.
If one of the above mentioned diseases during the application of gel oestraclin first appears, please stop immediately the use and immediately consult your doctor.
Warnings and Precautions
Talk before starting treatment with your doctor if you are affected by any of the health problems listed below, or ever were, or they have been aggravated during pregnancy or previous hormone replacement therapy. In this case, you should see your doctor more often to carry out check-ups. There is the possibility that it may cause a recurrence of the disease or to a deterioration in the application of oestraclin gel.
asthma
epilepsy
diabetes
gallstones
high blood pressure
Migraine or severe headaches
Liver disease, eg. As a benign liver tumor
Growth outside the uterus (endometriosis) or earlier-onset overgrowth of the uterine lining (endometrial hyperplasia)
Disease that affects the eardrum and hearing (otosclerosis)
Immune system disease that affects many organ functions of the body (systemic lupus erythematosus, SLE)
increased risk of estrogen-dependent cancer (eg. as if your mother, sister or grandmother had breast cancer)
increased risk of blood clots (see "Venous blood clots (thrombosis)")
benign tumors in the uterus (fibroids)
very high blood lipids (triglycerides)
Fluid retention due to cardiac or kidney disease
Benign tumors of the breast
Specific tumors of the pituitary gland
Superficial phlebitis (thrombophlebitis)
Varicose veins (varices)
depressions
hereditary angioedema
Quit the application of oestraclin gel and seek medical attention immediately if any of the following diseases or conditions occurring during use of hormone replacement therapy:
migraine headaches that occur for the first time
Yellowing of your skin or the whites of your eyes (jaundice). This may indicate a liver disease.
significant increase in your blood pressure (symptoms may include headache, fatigue and dizziness be)
Diseases listed in the "oestraclin gel should not be used" are mentioned
if you are pregnant
If you notice any signs of blood clots, z. B.
o painful swelling and redness of the legs sudden chest pain o
o shortness of breath
For more information, see "Venous blood clots (thrombosis)".
For scheduled operations (4 weeks ago)
Immobility as after accidents
Risks of hormone replacement therapy (HRT)
Hormone replacement therapy generally involves certain risks.
Other diseases
Hormone replacement treatment prevents any memory problems. There is some evidence of an increased risk of memory disorders in women who were older at the beginning of the application of hormone replacement treatment than 65 years. Ask your doctor for advice.
Influence of oestraclin gel to certain laboratory values
If a blood test is required to you, tell your doctor or the laboratory staff that you apply Estrogel gel, as this medicine may affect the results of some laboratory tests (glucose tolerance, blood clotting, metyrapone, Schilddrüsenfunktions- tests).
Application of oestraclin gel with other medicines
Tell your doctor or pharmacist if you are taking other medicines / apply, have recently taken / used any other medicines or intend to take / apply other medicines.
Medicines may increase or decrease the effect of oestraclin gel. This is true for drugs with the following ingredients:
Phenobarbital, phenytoin, carbamazepine, primidone (agent used to treat epilepsy)
Griseofulvin (antifungal agents)
Rifampicin, rifabutin (used to treat tuberculosis)
Nevirapine, efavirenz, ritonavir, nelfinavir (agent for the treatment of HIV infections)
St. John's wort (a herbal remedy for depression)
Meprobamate (a tranquilizer) and phenylbutazone (a painkiller)
Concomitant use of ascorbic acid (vitamin C) and estrogens may increase the effect of estrogens.
Also oestraclin gel may alter the effect of drugs. Estrogens may increase the effects of theophylline (an asthma drug), certain tranquilizers (benzodiazepines), antidepressants and called glucocorticoids.
oestraclin gel can change the effect of anticoagulants (anticoagulants), medicines for diabetes (antidiabetic), medicines used to lower blood lipids (lipid-lowering agents) and antihypertensive drugs (antihypertensives).
Concomitant administration of metoprolol (medicines for high blood pressure) and imipramine (whitening agent mood psychological disorders) may be strengthened or extended action of these active compounds.
pregnancy and breast feeding period
oestraclin gel is intended for use only in postmenopausal women. If you become pregnant, stop the use of oestraclin gel and consult your doctor. oestraclin gel should not be used during breastfeeding.
Driving and using machines
No known effects.
How is it used?
Apply oestraclin gel exactly like in this leaflet described. Ask yourself if you are not sure with your doctor or pharmacist.
Instructions for Posology and method of administration
The following information applies, unless oestraclin gel was prescribed to you otherwise directed by your doctor. You must always comply with the following instructions. If you do not, acts may not work properly oestraclin gel.
The usual dose is:
2 dosing (2.5 g oestraclin gel) per day.
can remain if the symptoms persist, the dose to 4 dosing (5 g oestraclin gel) to increase daily.
It is important that the treatment in the lowest possible effective dose and no longer is carried out as necessary.
oestraclin gel is applied for 3 weeks, then followed by a treatment-free week. During the treatment-free week a bleeding may occur.
A continuous treatment comes after surgical removal of the uterus or after a special arrangement of the doctor in question.
Application of oestraclin gel with luteal hormones (progestin)
Women with a uterus must take yellow twill hormones concomitantly.
Continuous application of oestraclin gel:
If oestraclin gel applied constantly, the concomitant progesterone should be taken in each case to 12 to 14 consecutive days per month.
Cyclic application of gel oestraclin
The cyclic compounds can be used according to the following scheme: From 1st to 21st day of the cycle 2 dosing oestraclin gel daily.
Apply gel to the last 12 to 14 days of the 21 days when you oestraclin a progesterone is also occupied. Last 7 days (total of 28 days) the cycle remain free treatment.
In both types of application occurs after the luteal hormone intake usually a menstruation similar, rather weaker circulation on.
As applied oestraclin gel?
The gel is an approximately two palms large (20 x 20 cm) area of skin applied (abdomen, shoulders, arms or thighs). The gel should not be applied on the breasts! oestraclin gel should not be applied to mucous membranes. Contact with the eyes should be avoided.
They are used at best after washing morning or evening. The gel does not need to be massaged. Before covering with clothing the application surface to dry for about two minutes. The gel will not stain. After applying you should wash your hands.
If you use a larger amount of oestraclin gel than you should
If you have too much applied oestraclin gel, there is usually a feeling of tension in the breasts, swelling of the abdominal and pelvic region, to anxiety and irritability.
If you forget to use oestraclin gel
If you forget an application with oestraclin gel, the treatment can be made up if forgetting is noted. Then proceed back to the usual dosing schedule. Apply by oestraclin gel not double the dose at a time to.
If you stop using oestraclin gel
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, also oestraclin gel side effects, although not everybody gets them.
It uses the following categories to indicate the frequency of side effects:
Very common: more than 1 in 10 patients Common: 1 to 10 in 100 Uncommon: 1 to 10 of 1 000 patients Rare: 1 to 10 of 10 000 patients Very rare: less than 1 in 10 000 patients
Not known: frequency can not be estimated from the available data
Blood and lymphatic system disorders:
Uncommon: heaviness in the legs
Unknown: Purpura
Psychiatric disorders:
Common: depressed mood
Nervous system disorders:
Very common: easy headache
Common: irritability, dizziness, nervousness, lethargy, headache, increased sweating, hot flashes
Uncommon: migraine, anxiety, insomnia, apathy, emotional lability, decreased concentration, tingling (paraesthesia), altered libido
Very rare: aggravated epilepsy
Unknown: altered euphoria, tremors, restlessness
Eye disorders:
Very rare: contact lens intolerance
Not known: abnormal vision, dry eyes
Heart disease:
Uncommon: palpitations
Not known: Hypertension
Immune system disorders:
Unknown: aggravation of hereditary angioedema (hereditary disease, which is to recurrent swelling (edema) of the skin, mucous membranes and internal organs come)
Metabolism and nutrition disorders:
Common: water retention, weight gain
Unknown: increased cholesterol
Musculoskeletal and connective tissue disorders:
Uncommon: joint disease, muscle cramps
Respiratory, thoracic and mediastinal disorders:
Uncommon: dyspnea, rhinitis
vascular disorders:
Uncommon: cardiovascular diseases
Rare: blood clots
Unknown: superficial phlebitis
Diseases of the stomach / intestinal tract
Common: nausea, abdominal cramps, flatulence Uncommon: Increased Appetite, constipation, vomiting
Unknown: indigestion, diarrhea, Rektalerkrankungen
Hepatobiliary disorders:
Rare: jaundice, swelling of the liver
Skin and subcutaneous tissue disorders:
Very common: rash at the application site Common: itching at the application site
Uncommon: skin discoloration (sometimes permanently), acne, hair loss, dry skin
Unknown: nail disorder, skin nodule, increased body hair, contact dermatitis
Sex organs and breast disorders:
Very common: Breast tenderness
Common: irregular bleeding, vaginal discharge, breast changes, menstrual dysfunction, disorders of the vulva / vagina
Uncommon: Vaginal dryness, benign tumor of the endometrium, benign tumor of the breast, breast augmentation, breast sensitivity
Rare: uterine cancer, breast milk outflow
Unknown: uterine disorders, benign tumor of the muscle tissue of the uterus, breast pain
Renal and urinary disorders:
Uncommon: increasing urine output, increased urination
Not known: urinary incontinence, cystitis, Harnentfärbung, blood in the urine
General disorders:
Common: pain, accumulation of fluid (edema) in the limbs
Uncommon: hot flashes, fatigue, changes in laboratory results, weakness, fever, flu syndrome, malaise
Reporting of adverse reactions
If you notice any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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