MEGACE Tablet Ref.[9741] Active ingredients: Megestrol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: PharmaSwiss ฤŒeskรก republika s.r.o., Jankovcova 1569/2c, 170 00, Prague 7, Czech Republic

Therapeutic indications

Megace is a progestational agent, indicated for the treatment of certain hormone dependent neoplasms, such as breast cancer.

Posology and method of administration

Breast cancer:

160 mg/day taken once daily.

At least two months of continuous treatment is considered an adequate period for determining the efficacy of Megace.

Children

Safety and effectiveness in paediatric patients have not been established.

Megace is not recommended for use in children.

Elderly

In general, use in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. See section 4.4.

Overdose

No acute toxicological effects have resulted from studies involving Megace (megestrol acetate) administered in dosages as high as 1600 mg/day for six months or more.

Reports of overdose have also been received in the postmarketing setting. Signs and symptoms reported in the context of overdose included diarrhoea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megace. In case of overdose, appropriate supportive measures should be taken.

Shelf life

Shelf life:

  • 36 months – Blister packs
  • 36 months – Amber glass bottles

Special precautions for storage

Do not store Megace Tablets above 25ยฐC. Store in the original package in order to protect from moisture.

Nature and contents of container

Amber glass bottles of 30, 60 or 100.

Blister packs of 30 tablets.

Special precautions for disposal and other handling

No special requirements.

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