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Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stressThereforebefore having surgery or emergency treatmentor if you get a serious illness/injurytell your doctor or dentist that you are using this medication or have used this medication within the past 12 monthsTell your doctor right away if you develop unusual/extreme tiredness or weight lossIf you will be using this medication for a long timecarry a warning card or medical ID bracelet that identifies your use of this medication.

During pregnancythis medication should be used only when clearly neededDiscuss the risks and benefits with your doctorBabies born to mothers who have used corticosteroids for a long time may develop hormone problemsTell your doctor right away if you notice symptoms such as persistent nausea/vomitingsevere diarrheaor weakness in your newborn.

Use of ENTOCORT EC in this age group is supported by evidence from adequate and well-controlled studies of ENTOCORT EC in adultsand by safety and pharmacokinetic studies performed in pediatric patients.

In patients with mildChild-Pugh Class An=4or moderateChild-Pugh Class Bn=4hepatic impairmentbudesonide 4 mg was administered orally as a single doseThe patients with moderate hepatic impairment had a 3.5-fold higher AUC compared to the healthy subjects with normal hepatic function while the patients with mild hepatic impairment had an approximately 1.4-fold higher AUCThe Cmax values demonstrated similar increasessee DOSAGE AND ADMINISTRATIONWARNINGS AND PRECAUTIONSThe increased systemic exposure in patients with mild hepatic impairment was not considered to be clinically relevantPatients with severe liver impairmentChild-Pugh Class Cwere not studied.

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ingestion of grapefruit or grapefruit juice should be avoided in connection with entocort ec administration.

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