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Special warnings, undesirable effects and contraindications for
Elleste Solo 1 mg and 2 mg
Please refer to Summary of Product Characteristics for details on
Special Warnings and Precautions for Use
Before initiating/restarting HRT an appraisal of risks and benefits
should be made and women should be reassessed at least annually.
A complete personal and family medical history should be taken
before starting/reinstituting HRT, and the patient should also be
advised regarding what breast changes to report to their physician.
If particular conditions are present, have occurred previously,
and/or have been aggravated during pregnancy or previous hormone
treatment, the patient should be closely supervised.
These include leiomyoma (uterine fibroids) or endometriosis, risk
factors for thromboembolic disorders; risk factors for oestrogen
dependent tumours; hypertension; liver disorders; diabetes mellitus;
cholelithiasis; migraine or (severe) headache; systemic lupus
erythematosus (SLE); a history of endometrial hyperplasia; epilepsy;
asthma; otosclerosis.
Therapy should be discontinued if a contraindication is discovered
and in the following situations: jaundice or deterioration in liver
function; significant increase in blood pressure; new onset of
migraine-type headache; pregnancy.
Special warnings: For the treatment of postmenopausal
symptoms, HRT should only be initiated for symptoms that adversely affect
quality of life. In all cases a careful appraisal of the risks and benefits
should be undertaken at least annually and HRT should only be continued
as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of
premature menopause is limited. Due to the low level of absolute
risk in younger women, however, the balance of benefits and risks
for these women may be more favourable than in older women.
Contraindications: known, past or suspected breast cancer;
known or suspected oestrogen-dependent malignant tumours (e.g. endometrial
cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia;
previous idiopathic or current venous thromboembolism (deep venous thrombosis,
pulmonary embolism); known thrombophilic disorders; active or recent
arterial thromboembolic disease (e.g. angina, myocardial infarction);
acute liver disease, or a history of liver disease as long as liver function
tests have failed to return to normal; known hypersensitivity to the
active substances or to any of the excipients; porphyria.
Common (>1/100,<1/10) undesirable effects: weight
increased, weight decreased, mood alterations including anxiety and depressed
mood, libido disorder, metrorrhagia, breast tenderness, breast enlargement,
uterine/vaginal bleeding including spotting, nausea, abdominal pain,
headache, rash, pruritus, oedema.
Other serious undesirable effects (frequency unknown):
breast cancer, VTE.
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Special warnings, undesirable effects and contraindications for
Elleste Duet 1 mg and 2 mg
Please refer to Summary of Product Characteristics for details on
Special Warnings and Precautions for Use
Before initiating/restarting HRT an appraisal of risks and benefits
should be made and women should be reassessed at least annually.
A complete personal and family medical history should be taken
before starting/reinstituting HRT, and the patient should also be
advised regarding what breast changes to report to their physician.
If particular conditions are present, have occurred previously,
and/or have been aggravated during pregnancy or previous hormone
treatment, the patient should be closely supervised.
These include leiomyoma (uterine fibroids) or endometriosis, risk
factors for thromboembolic disorders; risk factors for oestrogen
dependent tumours; hypertension; liver disorders; diabetes mellitus;
cholelithiasis; migraine or (severe) headache; systemic lupus
erythematosus (SLE); a history of endometrial hyperplasia; epilepsy;
asthma; otosclerosis.
Therapy should be discontinued if a contraindication is discovered
and in the following situations: jaundice or deterioration in liver
function; significant increase in blood pressure; new onset of
migraine-type headache; pregnancy.
Special warnings: For the treatment of postmenopausal
symptoms, HRT should only be initiated for symptoms that adversely affect
quality of life. In all cases a careful appraisal of the risks and benefits
should be undertaken at least annually and HRT should only be continued
as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of
premature menopause is limited. Due to the low level of absolute
risk in younger women, however, the balance of benefits and risks
for these women may be more favourable than in older women.
Contraindications: known, past or suspected breast cancer;
known or suspected oestrogen-dependent malignant tumours (e.g. endometrial
cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia;
previous or current venous thromboembolism (deep venous thrombosis, pulmonary
embolism); known thrombophilic disorders (e.g. protein C, protein S,
or antithrombin deficiency); active or recent arterial thromboembolic
disease (e.g. angina, myocardial infarction); acute liver disease, or
a history of liver disease as long as liver function tests have failed
to return to normal; hypersensitivity to the active substances or to
any of the excipients; porphyria
Very common (≥ 1/10) undesirable effects: headache*,
breast pain*, breast tenderness, dysmenorrhoea*, menstrual disorder*
Common (≥ 1/100 to <1/10) undesirable effects: depression*,
nervousness*, affect lability, libido disorder, dizziness*, insomnia*,
nausea, abdominal distension*, diarrhoea*, dyspepsia*, abdominal pain,
acne*, rash, pruritus*, dry skin, back pain*, pain in extremity*, breast
enlargement*, menorrhagia*, genital discharge *, irregular vaginal bleeding,
uterine spasms, vaginal infection, endometrial hyperplasia, pain, asthenia,
oedema peripheral*, weight increased*
*Adverse reactions associated with oestrogen and progestogen have
been found to be relatively less frequent with the lowest dosage
strength.
Other serious undesirable effects: breast cancer (uncommon
≥ 1/1,000 to <1/100), VTE (rare ≥ 1/10,000 to <1/1,000)
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Special warnings, undesirable effects and contraindications for
Elleste Duet Conti
Please refer to Summary of Product Characteristics for details on
Special Warnings and Precautions for Use
Before initiating/restarting HRT an appraisal of risks and benefits
should be made and women should be reassessed at least annually.
A complete personal and family medical history should be taken
before starting/reinstituting HRT, and the patient should also be
advised regarding what breast changes to report to their physician.
If particular conditions are present, have occurred previously,
and/or have been aggravated during pregnancy or previous hormone
treatment, the patient should be closely supervised.
These include leiomyoma (uterine fibroids) or endometriosis, risk
factors for thromboembolic disorders; risk factors for oestrogen
dependent tumours; hypertension; liver disorders; diabetes mellitus;
cholelithiasis; migraine or (severe) headache; systemic lupus
erythematosus (SLE); a history of endometrial hyperplasia; epilepsy;
asthma; otosclerosis.
Therapy should be discontinued if a contraindication is discovered
and in the following situations: jaundice or deterioration in liver
function; significant increase in blood pressure; new onset of
migraine-type headache; pregnancy.
Special Warnings: For the treatment of postmenopausal
symptoms, HRT should only be initiated for symptoms that adversely affect
quality of life. In all cases a careful appraisal of the risks and benefits
should be undertaken at least annually and HRT should only be continued
as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of
premature menopause is limited. Due to the low level of absolute
risk in younger women, however, the balance of benefits and risks
for these women may be more favourable than in older women.
Contraindications: known, past or suspected breast cancer;
known or suspected oestrogen-dependent malignant tumours (e.g. endometrial
cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia;
previous or current venous thromboembolism (deep venous thrombosis, pulmonary
embolism); known thrombophilic disorders (e.g. protein C, protein S,
or antithrombin deficiency); active or recent arterial thromboembolic
disease (e.g. angina, myocardial infarction); acute liver disease, or
a history of liver disease as long as liver function tests have failed
to return to normal; hypersensitivity to the active substances or to
any of the excipients; porphyria.
Very common (≥ 1/10) undesirable effects: headache*,
breast pain*, breast tenderness, dysmenorrhoea*, menstrual disorder*,
depression*, nervousness*, affect lability, libido disorder.
Common (≥ 1/100 to <1/10) undesirable effects: depression*,
nervousness*, affect lability, libido disorder, dizziness*, insomnia*,
nausea, abdominal distension*, diarrhoea*, dyspepsia*, abdominal pain,
acne*, rash, pruritus*, dry skin, back pain*, pain in extremity*, breast
enlargement*, menorrhagia*, genital discharge *, irregular vaginal bleeding,
uterine spasms, vaginal infection, endometrial hyperplasia, pain, asthenia,
oedema peripheral*, weight increased*.
*Adverse reactions associated with oestrogen and progestogen have
been found to be relatively less frequent with the lowest dosage
strength.
Other serious undesirable effects: breast cancer (uncommon
≥ 1/1,000 to <1/100), VTE (rare ≥ 1/10,000 to <1/1,000)
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Special warnings, undesirable effects and contraindications for
Gepretix
Please refer to Summary of Product Characteristics for details on
Special Warnings and Precautions for Use
Before initiating or reinstituting HRT, a complete personal and
family medical history should be taken. Physical (including pelvic
and breast) examination should be guided by this and by the
contraindications and warnings for use. During treatment, periodic
check-ups are recommended of a frequency and nature adapted to the
individual woman. Women should be advised what changes in their
breasts should be reported to their doctor or nurse.
Investigations, including appropriate imaging tools, e.g.
mammography, should be carried out in accordance with currently
accepted screening practices, modified to the clinical needs of the
individual.
If any of the following conditions are present, have occurred
previously, and/or have been aggravated during pregnancy or previous
hormone treatment, the patient should be closely supervised.
It should be taken into account that these conditions may recur or
be aggravated during treatment with Progesterone 100 mg soft
capsules, in particular: leiomyoma (uterine fibroids) or
endometriosis; risk factors for thromboembolic disorders; risk
factors for oestrogen dependent tumours, e.g. 1st degree heredity
for breast cancer; hypertension; liver disorders (e.g. liver
adenoma); diabetes mellitus with or without vascular involvement;
cholelithiasis; migraine or (severe) headache; systemic lupus
erythematosus; a history of endometrial hyperplasia; epilepsy;
asthma; otosclerosis; depression; photosensitivity.
Therapy should be discontinued in case a contra-indication is
discovered and in the following situations: jaundice or
deterioration in liver function; significant increase in blood
pressure; new onset of migraine-type headache; pregnancy; sudden or
gradual, partial or complete loss of vision; proptosis or diplopia;
papilloedema; retinal vascular lesions.
Special warnings: For the treatment of postmenopausal
symptoms, HRT should only be initiated for symptoms that adversely affect
quality of life. In all cases, a careful appraisal of the risks and benefits
should be undertaken at least annually, and HRT should only be continued
as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of
premature menopause is limited. Due to the low level of absolute
risk in younger women, however, the balance of benefits and risks
for these women may be more favourable than in older women.
Progesterone 100 mg soft capsules are not suitable: in confirmed
pregnancy, in the treatment of premature labour or as a
contraceptive.
Contraindications: when used in conjunction with oestrogens,
progesterone should not be used in patients with any of the following
conditions: known hypersensitivity to the active substances, soybean
lecithin, peanut or to any of the excipients, known, past or suspected
breast cancer, known or suspected oestrogen-dependent malignant tumours
(e.g. genital tract carcinoma), undiagnosed genital bleeding, previous
or current thromboembolism disorders (e.g. deep venous thrombosis, pulmonary
embolism) or thrombophlebitis, known thrombophilic disorders, acute liver
disease, or a history of liver disease as long as liver function tests
have failed to return to normal, porphyria, cerebral haemorrhage, breast-feeding.
Very common (≥ 1/10) undesirable effects: abdominal
bloating, abdominal pain, headache, dizziness, depression, breast tenderness,
hot flushes, vaginal discharge, joint pain, urinary problems.
