Quest for the right Drug
פמוסטון קונטי 0.5 מ"ג/ 2.5 מ"ג FEMOSTON CONTI 0.5 MG/2.5 MG (DYDROGESTERONE, ESTRADIOL AS HEMIHYDRATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects The most commonly reported adverse drug reactions of patients treated with estradiol/dydrogesterone in clinical trials are headache, abdominal pain, breast pain/tenderness and back pain. The following undesirable effects have been observed with the frequencies indicated below during clinical trials (n=4929). *Undesirable effects from spontaneous reporting not observed in clinical trials have been attributed to the frequency “rare”: MedDRA system Very common Common Uncommon Rare organ class ≥1/10 ≥1/100 to <1/10 ≥1/1,000 to <1/100 ≥1/10,000 to <1/1,000 Infections and Vaginal candidiasis Cystitis- like symptoms infestations Neoplasms benign, Increase in size of malignant and leiomyoma unspecified Blood and the Haemolytic lymphatic system anaemia* disorders Immune system Hypersensitivity disorders Psychiatric disorders Depression, Influence on libido nervousness Nervous system Headache Migraine, dizziness Meningioma* disorders Eye disorders Steepening of corneal curvature*, contact lenses intolerance* Cardiac disorders Myocardial infarction Vascular disorders Venous Stroke* thromboembolism*, hypertension, peripheral vascular disease, varicose vein Gastrointestinal Abdominal pain Nausea, vomiting, Dyspepsia disorders abdominal distension (including flatulence) Hepatobiliary Abnormal hepatic disorders function occasionally with jaundice asthenia or malaise, and abdominal pain, gall bladder disorder Skin and Allergic skin reactions Angio-edema, subcutaneous tissue ( e.g. rash, urticaria, vascular purpura, disorders pruritus) erythema nodosum*, Chloasma or melasma, which may persist when drug is discontinued* Musculoskeletal and Back pain Leg cramps* connective tissue disorders Reproductive system Breast pain/tenderness Menstrual disorders Breast enlargement, and breast disorders (including premenstrual syndrome postmenopausal spotting, metrorrhagia, menorrhagia, oligo-/ amenorrhoea, irregular menstruation, dysmenor-rhoea), pelvic pain, cervical discharge General disorders and Asthenic conditions administration site (asthenia, fatigue, reactions malaise), peripheral oedema Investigations Increased weight Decreased weight Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years. • Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestogen combinations. • The level of risk is dependent on the duration of use (see section 4.4). • Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented. Million Women study– Estimated additional risk of breast cancer after 5 years' use Additional cases Age range per 1000 never- Risk ratio # Additional cases per 1000 HRT users over 5 years (95%CI) (years) users of HRT over a 5 year perioda Oestrogen only HRT 50 - 65 9 - 12 1.2 1-2 (0 - 3) Combined oestrogen-progestogen 50 - 65 9 - 12 1.7 6 (5 - 7) #Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately. US WHI studies - additional risk of breast cancer after 5 years' use Age range Incidence per 1000 women in Additional cases per 1000 HRT users Risk ratio & 95%CI (yrs) placebo arm over 5 years over 5 years (95%CI) CEE oestrogen-only 50 - 79 21 0.8 (0.7 – 1.0) -4 (-6 – 0)b CEE+MPA oestrogen & progestogen‡ 50 - 79 17 1.2 (1.0 – 1.5) +4 (0 – 9) ‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non- users. Endometrial cancer risk Postmenopausal women with a uterus: The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT. In women with a uterus, use of oestrogen-only HRT is not recommended because it increases the risk of endometrial cancer (see section 4.4). Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65. Adding a progestogen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million Women Study the use of five years of combined (sequential or continuous) HRT did not increase the risk of endometrial cancer (RR of 1.0 (0.8-1.2)). Ovarian cancer Use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4). A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. Risk of venous thromboembolism HRT is associated with a 1.3- to 3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HRT (see section 4.4). Results of the WHI studies are presented: WHI Studies - Additional risk of VTE over 5 years' use Age range (years) Incidence per 1000 women in Risk ratio and 95%CI Additional cases per 1000 HRT placebo arm over 5 years users Oral oestrogen-onlyc 50 - 59 7 1.2 (0.6-2.4) 1 (-3 – 10) Oral combined oestrogen-progestogen 50 - 59 4 2.3 (1.2 – 4.3) 5 (1 - 13) Risk of coronary artery disease The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestogen HRT over the age of 60 (see section 4.4). Risk of ischaemic stroke The use of oestrogen-only and oestrogen+progestogen therapy is associated with an up to 1.5-fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT. This relative risk is not dependent on age or duration of use, but as the baseline risk is strongly age- dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.4). WHI studies combined - Additional risk of ischaemic stroked over 5 years' use Age range (years) Incidence per 1000 women Risk ratio and 95%CI Additional cases per 1000 in placebo arm over 5 years HRT users over 5 years 50 - 59 8 1.3 (1.1 - 1.6) 3 (1 - 5) a Taken from baseline incidence rates in developed countries b WHI study in women with no uterus, which did not show an increase in risk of breast cancer c Study in women with no uterus d no differentiation was made between ischaemic and haemorrhagic stroke. Other adverse reactions have been reported in association with oestrogen/progestogen treatment Neoplasms benign, malignant and unspecified: Oestrogen dependent neoplasms both benign and malignant, e.g. endometrial cancer, ovarian cancer. Increase in size of meningioma. Immune system disorders: Systemic lupus erythematosus Metabolism and nutrition disorders: Hypertriglyceridemia Nervous system disorders: Probable dementia, chorea, exacerbation of epilepsy Vascular disorders: Arterial thromboembolism Gastrointestinal disorders: Pancreatitis (in women with pre-existing hypertriglyceridemia) Skin and subcutaneous tissue disorders: Erythema multiforme Renal and urinary disorders: Urinary incontinence Reproductive system and breast disorders: Fibrocystic breast disease, uterine cervical erosion Congenital, familial and genetic disorders: Aggravated porphyria Investigations: Total thyroid hormones increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
שימוש לפי פנקס קופ''ח כללית 1994
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