Pregnancy while taking progyluton | Trying to Conceive & Women's

                                                          {{..PROGYLUTON..}}

                                     (ESTRADIOL VALERATE NORGESTRAL)

                                                                    TABLETS

NAME OF THE MEDICINAL PRODUCT:

PROGYLUTON


QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each white sugar-coated tablet contain estradiol valerate 2.0 mg
Each light brown sugar-coated tablet contain estradiol valerate 2.0 mg and nosrgestral 0.5 mg

                                           
                    

                                              CLINICAL PARTICULARS

INDICATION (S)
Hormone replacement therapy for the treatment of signs and symptoms of estrogen deficiency due to neutral menopause or  hypogonadism Castration or primary ovarian failure in women with an intact uterus Prevention of postmenopausal osteoporosis.Control of irregular menstrual cycles treatment of primary or secondary amenorrhea.


                                                       DOSAGE REGIMEN

HOW TO START PROGYLUTON:

If the patient is in minus protein treatment should begin on the 5th day of the cycle first day of menstrual bleeding equal to first day of the cycle patient with amenorrhea  or very infrequent period or who are postmenopausal may start at anytime provided pregnancy has been excluded.

DOSAGE:
1 white tablet is taken daily for the first 11 days followed by 1 light brown tablet daily for 10 days.
 Following the 21 days of tablet taking there will be a tablet free interval of 7 days

ADMINISTRATION:
Each pack covers 21 days of treatment.A new pack of progyluton should be started after the seven days Tablet free interval on the same day of the week as the previous one.The tablets are  be swallowed whole with some liquid the tablet should preferably be taken at the same time everyday.

MISSED TABLETS:
In case a tablet is forgotten, it should be taken as soon as possible if more than 24 hours have elapsed no extra tablet need to be taken if several tablet are forgotten bleeding may occur bleeding usually occur during the tablet free interval of 7 days within a few days after the last tablet was taken

         
                {{..ADDITIONAL INFORMATION ON A SPECIAL POPULATIONS..}}


                                             CHILDREN AND ADOLESCENTS

Progyluton is not indicated for use in children and adolescents

GERIATRIC PATIENTS:
There are no data suggesting a need for dosage adjustment in elderly patients in women aged 65 years or older see-section special warnings and precautions for use


PATIENT WITH RENAL IMPAIRMENT:
Progyluton has not been specifically studied in patient with hepatic impairment. Progyluton is contraindicated  in women with severe hepatic diseases.

PATIENT WITH RENAL IMPAIRMENT:
Progyluton have not been specifically studied in renally impaired patients available data do not suggest a need for Dosage adjustment in this patient population.


SPECIAL WARNING AND PRECAUTION FOR USE:
Before initiating therapy all conditions/risk factor mentioned below should be considered when determining the individual benefit/ risk of treatment for the patient during HRT use therapy should be discontinued immediately in case a contraindication is discovered heavy rain in the following situation.Migrainous frequent and unusually severe headache is that accur for the first time or other symptoms that are possible for prodroma of cerebrovascular occlusion.Recurrence of cholestatic jaundice or cholestatics pruprite which occurred first during pregnancy or previous of sex steroid.


PREGNANCY AND LACTATION:
HRT is not indicated for use during pregnancy or lactation.if pregnancy occur during medication with progyluton treatment should be discontinued immediately small amount of sex hormones may be excreted in human milk.
 .

                                        CHILDREN AND ADOLESCENTS

                                    Progyluton is not indicated for use in children and adolescents.

GERIATRIC PATIENTS:
There are no data suggesting a need for dosage adjustment in elderly patients in women aged 65 years or older see-section special warnings and precautions for use.

PATEINT WITH HEPATIC  IMPAIRMENT:
Progyluton has not been specifically studied in patient with hepatic impairment. Progyluton is contraindicated  in women with severe hepatic diseases.

PATIENT WITH RENAL IMPAIRMENT:
Progyluton have not been specifically studied in renally impaired patients available data do not suggest a need for Dosage adjustment in this patient population.

                                SPECIAL WARNING AND PRECAUTION FOR USE

Before initiating therapy all conditions/risk factor mentioned below should be considered when determining the individual benefit/ risk of treatment for the patient during HRT use therapy should be discontinued immediately in case a contraindication is discovered heavy rain in the following situation.Migrainous frequent and unusually severe headache is that accur for the first time or other symptoms that are possible for prodroma of cerebrovascular occlusion.Recurrence of cholestatic jaundice or cholestatics pruprite which occurred first during pregnancy or previous of sex steroid.



                                              PREGNANCY AND LACTATION

HRT is not indicated for use during pregnancy or lactation.if pregnancy occur during medication with progyluton treatment should be discontinued immediately small amount of sex hormones may be excreted in human milk.

                                            PHARMACOLOGICAL PROPERTIES

PRECLINICAL SAFETY DATA:
The result from toxicity with repeated administration including tumorigenicity studies with the two active substances are not suggest of a particular risk related to use in human however, it has to be Born in mind that sex sreriod can promote the growth of certain hormone dependent tissues and tumor.
 .



MANUFACTURED BY:

BAYER WEIMAR GMBH AND CO.KG, WEIMAR                                                                                                      GERMANY