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Dinogest®

Dienogest BP 2 mg

Dosage Form: Tablet
Pack Size: 12's
Composition:

Dienogest BP 2 mg



Allygest
Description:

Dinogest is the preparation of Dienogest which belongs to the class of medications called progestins. Progestins, reduce the effects of estrogen on tissues such as the endometrium lining of the uterus) and the breast. By reducing the growth effect of estrogen on the endometrium, Dienogest helps to reduce the pelvic pain experienced by women with endometrosis.



Pharmacokinetics:

Tablet taking can be started on any day of the menstrual cycle.

The dosage of Dinogest is 1 tablet daily wilhout any break, taken preferably al the same time each day with some liquid as needed. Tablet must be taken continuously without regard to vaginal beeding When a pack is linished, the next one should be started without interruption.

In the event of missed tablets), the woman should take 1 tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or dianea should likewise be replaced by 1 tablel.


Indications:

Treatment of endometriosis.


Dosage & Administration:

Tablet taking can be started on any day of the menstrual cycle.

The dosage of Dinogest is 1 tablet daily wilhout any break, taken preferably al the same time each day with some liquid as needed. Tablet must be taken continuously without regard to vaginal beeding When a pack is linished, the next one should be started without interruption.

In the event of missed tablets), the woman should take 1 tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or dianea should likewise be replaced by 1 tablel.


Contraindications:

Hypersensiunty to diemogest or to any of the excipients of Dinogest. Dinggest should not be used an the presence of any of the conditions such as

Active venousthromboembolic disorder arterial and cardiovascular disease, (eg. myacardial infarction, cerebrovascular accident, ischemic heart diseasel, diabetes melitus with vascular Involvement: presence or history of severe hepatic disease as long as liver function values have not returned to normal, presenice or hision of diver tumors (benign or malignant known or suspected sex hormone-dependent malignancies and undiagnosed vaginal bleeding.


Warning & Precautions:

Belore starting Dinagestetreatment. pregnancy must be excluded. During Treatment palients are anvised to use nonharmonal methods of contraception fe.g berrier method) if contreceplionis required.

As Dinogest is a progestogan only preparation, it can be assumed that special wamings and special precautions or use of other progealoger-only preparations are also wellid for the use of Dinogest.

 

Changes in Bleeding Pattern: Dinogest" treatment affects the menstrual bleeding patter in the mejority of women.

 

Hepatic Impairment:Dinogestis contraindicated in patients with present or past severe hepatic disease.

 

Impairment of Fertility: Based on available data ovulation is inhibited in the majory al patients, during treatment wth Dinagest However, Dinogest" is not a contraceptive.

I contraception is required, a nonhormonal method should be used.

 

Use in Pregnancy: There are limited data from the use of dienogest in pregnant women Animal studies and data from women exposed 19 dienogest during pregnange reveal no special risks on pregnancy, embryonialletal development, with or development alter birth or humans. However, Dinogest should not be admintstered to pregnant womon because there is no need to treat endomstross during pregnancy:

 

Use In Lactatlon: Treatmant with Dinogest during lactation Is not recommended.

Phystochemical proparties and animal data indicate excretion of dienogest in breast milk, A decision must be made whether lo discontinue breastfeeding or to abstain from Dinogost therapy taking into assount the benefit of breastleeding for the chid and the benefit of therapy for the woman.

 

Use in Children: Dinogest" is not indicaled in children prior to menarche. The safety and eflicacy of Dinogest® in adolescents (menarche to 18 years) has not yet been established.

 

Uise In the Elderly: There Is no relevant Indication for the use of Dinogest* in the geriatric population.