Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Enablex (darifenacin). mg and 15 mg darifenacin (as darifenacin hydrobromide). Muscarinic M3 This leaflet is part III of a three-part Product. Monograph. Enablex (darifenacin) is used to treat symptoms of overactive bladder. Includes Enablex side effects, interactions and indications. See also: Drug Interactions ( in more detail).
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Doubling the darifenacin dose from 7. Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision.
Your doctor may occasionally change your dose to make sure you get the best results. Method of administration Emselex is for oral use. Pregnancy There are limited amount of data from the use of darifenacin in pregnant women.
Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population. Other drugs may interact with darifenacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Patients experiencing these side effects should not drive or use machines. Angioedema may be life-threatening and requires immediate medical attention. At steady state, peak-to-trough fluctuations in darifenacin concentrations are small PTF: Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
For Emselex, these side effects have been reported to be uncommon.
Emselex 7.5mg prolonged release tablets
No dose adjustment is required in patients with impaired renal function. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Make sure you tell your paxkage if you have any other medical problems, especially:. The amount of medicine that you take depends on the strength of the medicine.
For both doses of 7. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Fertility There are no human packqge data for darifenacin.
Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment pavkage start with the 7.
U.S. Prescribing Information Disclaimer
This packsge allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If urinary tract infection is present, an appropriate antibacterial therapy should be started. It is not known whether Enablex will harm an unborn baby. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do.
Co-administration of darifenacin 7. It is not known whether darifenacin is excreted in human milk. Studies in animals have shown toxicity to parturition for details, see section 5.
General disorders and administration site conditions. For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
Warfarin Standard therapeutic prothrombin time monitoring for warfarin should be continued. This is not a complete list of side effects and others may occur.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated. In patients receiving substances insetr are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7. Hepatic insufficiency Darifenacin pharmacokinetics were investigated in subjects paciage mild Child Pugh A or moderate Child Pugh B impairment of hepatic function given darifenacin 15 mg once daily to steady state.