progynova tablets for treatment of oestrogen deficiency

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Progynova Tablets (Estradiol Valerate) is used as Hormone replacement therapy (HRT) for the treatment of signs and symptoms of oestrogen deficiency due to the menopause or after surgical removal of the ovaries.

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  • 1. Progynova TabletsProgynova Tablets is used as Hormonereplacement therapy (HRT) for the treatmentof signs and symptoms of oestrogendeficiency due to the menopause. The Swiss Pharmacy, Geneva Switzerland

2. Progynova TabletsChemical Structure The Swiss Pharmacy, Geneva Switzerland 3. Progynova TabletsActive IngredientThe active pharmaceuticalingredient contained in ProgynovaTablets is Estradiol Valerate(Oestradiol Valerate) .Each 1 mg Progynova tablet fororal administration contains 1 mg ofEstradiol Valerate. The Swiss Pharmacy, Geneva Switzerland 4. Progynova TabletsIndicationsProgynova Tablets is used to treat shortterm treatment of climacteric complaintsafter the cessation of monthly bleeding, ordeficiency symptoms after oophorectomyor radiological castration for non-carcinomatousdiseases, such as hotflushes, outbreaks of sweat, sleepdisturbances, depressive moods,irritability, headaches, dizziness. The Swiss Pharmacy, Geneva Switzerland 5. Progynova TabletsIndicationsProgynova also has a favourableinfluence on bladder irritation, signs ofcutaneous and mucosal involution whichnormally occur with advancing age. The Swiss Pharmacy, Geneva Switzerland 6. Progynova TabletsRecommended Adult DosageHysterectomised patients may start at anytime.If the patient is still menstruating and has anintact uterus, a combination regimen ofProgynova and a progestogen should beginwithin the first 5 days of menstruation.Patients whose periods are very infrequent orwith amenorrhoea or who are postmenopausalmay start at any time, provided pregnancy hasbeen excluded. The Swiss Pharmacy, Geneva Switzerland 7. Progynova TabletsRecommended Adult DosageThe tablet should be taken at the same timeof day every day.One tablet is taken daily. The tablets are tobe swallowed whole with some liquid. The Swiss Pharmacy, Geneva Switzerland 8. Progynova TabletsMissed DoseIn case of a missed dose, take the tabletas soon as you remember, within thefollowing 12 to 24 hours.If the treatment is discontinued for longer,irregular bleeding may occur. The Swiss Pharmacy, Geneva Switzerland 9. Progynova TabletsContraindicationsProgynova Tablets is contraindicated inwomen with the following conditions:Hypersensitivity to Estradiol Valerate(Oestradiol Valerate) or any inactivecomponent of this medication.Pregnancy or lactationUndiagnosed vaginal bleedingAcute arterial thromboembolism(myocardial infarction, stroke) or a recenthistory of these conditions The Swiss Pharmacy, Geneva Switzerland 10. Progynova TabletsContraindicationsKnown or suspected cancer of the breastKnown or suspected premalignantconditions or malignancies, if sex steroidinfluencedPresence or history of liver tumours(benign or malignant)Severe hepatic diseaseActive deep venous thrombosis,thromboembolic disorders, thrombophlebitis,or a documented history of these conditions The Swiss Pharmacy, Geneva Switzerland 11. Progynova TabletsContraindicationsSevere hypertriglyceridamiaHereditary or acquired predisposition tovenous thrombosisA high risk of venous or arterial thrombosis The Swiss Pharmacy, Geneva Switzerland 12. Progynova TabletsSide Effects of Progynova TabletsThe common side effects of ProgynovaTablets are Weight increase or Weightdecrease, Headache, Abdominal pain,Nausea, Rash, Pruritus, Uterine/ Vaginalbleeding including spotting.Uncommon side effects of ProgynovaTablets include Hypersensitivity reaction,Depressed mood, Dizziness, Visualdisturbances, Palpitations, Dyspepsia,Erythema nodosum, Urticaria, Breast pain,Breast tenderness and Oedema The Swiss Pharmacy, Geneva Switzerland 13. Progynova TabletsSide Effects of Progynova TabletsRarely occuring side effects of ProgynovaTablets are Anxiety, Libido decreased orLibido increased, Migraine, Contact lensintolerance, Bloating, Vomiting, Hirsutism,Acne, Muscle cramps, Dysmenorrhoea,Vaginal discharge, Premenstrual-likesyndrome, Breast enlargement, and Fatigue The Swiss Pharmacy, Geneva Switzerland 14. Progynova TabletsWarnings And PrecautionsProgynova Tablets cannot be used as acontraceptive.Therapy with Progynova should be discontinuedimmediately in case a contraindication is discovered,as well as in the following situations:Migrainous or frequent and unusually severeheadaches that occur for the first time or othersymptoms that are possible prodroma ofcerebrovascular occlusion.Recurrence of cholestatic jaundice or cholestaticpruritus which occurred first during pregnancy orprevious use of sex steroids.Symptoms of a thrombotic event or suspicionthereof. The Swiss Pharmacy, Geneva Switzerland 15. Progynova TabletsWarnings And PrecautionsSome women are predisposed to gallbladder diseaseduring oestrogen therapy.Hormonal treatment may increase the risk ofprobable dementia if initiated in women aged 65 orolder.Suspected prolactinoma should be ruled out beforestarting Progynova treatment.Prolonged monotherapy with oestrogens increasesthe risk of endometrial hyperplasia and carcinoma inpostmenopausal women.Chloasma may occur occasionally, especially inwomen with a history of chloasma gravidarum. The Swiss Pharmacy, Geneva Switzerland 16. Progynova TabletsWarnings And PrecautionsAn increased risk of ovarian cancer inmenopausal women taking oestrogen onlyreplacement therapy was observed in a largeUS study Clinical and observational studieshave reported an increased risk of havingbreast cancer diagnosed in women who haveused HRT for several years.In rare cases benign, and even more rarely,malignant liver tumours have been observedafter the use of hormonal substances such asthose contained in HRT products. The Swiss Pharmacy, Geneva Switzerland 17. Progynova TabletsStorage InstructionsKeep Progynova Tablets in a cool, dryplace where the temperature stays below25 C. Do not store Progynova Tablets, orany other medicine, in a bathroom or neara sink. Keep away from children and pets. The Swiss Pharmacy, Geneva Switzerland 18. Progynova TabletsOverdose TreatmentEven in the case of inadvertent intake of amultiple of the recommended dose, noacute toxicity risk is to be expected.Overdose may cause nausea and vomitingand irregular bleeding may occur in somewomen.There are no antidotes and treatmentshould be symptomatic. The Swiss Pharmacy, Geneva Switzerland 19. Progynova TabletsProgynova Tablets manufactured by Schering AGBerlin. (Manufactured in India in collaboration withZydus Healthcare)For more information click here The Swiss Pharmacy, Geneva Switzerland