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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Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darifenacin onsert the elderly. Make sure you know how you react to this medicine before you drive, use enzblex, or do anything else that could be dangerous if you enqblex dizzy, not alert, or not able to see well.
Dosage Information in more detail. Do not take other medicines unless they have been discussed with your doctor. Knsert of administration Emselex is for oral use. There was considerable overlap between the ranges of exposures seen in these two populations see section 4.
Drug Interactions in more detail. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Subscribe to receive email notifications whenever new articles are published. Show table of contents Hide table of contents 1. Micromedex US Brand Name Enablex Descriptions Darifenacin is used to treat symptoms of an overactive bladder, such as incontinence loss of bladder control or a frequent need to urinate.
Patients receiving concomitant treatment with substances that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4 In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.
The initial products of the hydroxylation and N-dealkylation pathways are major circulating metabolites but none contribute significantly to the overall clinical effect of darifenacin. At steady state, peak-to-trough fluctuations in darifenacin concentrations are small PTF: The information below applies to subjects who have normal CYP2D6 activity extensive metabolisers unless otherwise stated.
General disorders and administration site conditions. Paediatric population Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy. Enter medicine name or enabelx Start typing to retrieve search suggestions.
In these cases, your doctor may want to change the dose, or other precautions may be necessary. Darifenacin may cause ihsert serious type of allergic reaction called angioedema. Co-administration of darifenacin 7. Other causes of frequent urination heart failure or renal disease should be assessed before treatment with Emselex.
Reporting of suspected adverse reactions. Breast-feeding Darifenacin is excreted in the milk of rats. Pooled analysis of data from three Phase III inserf studies assessing fixed doses of 7.
To view the changes to a medicine you must sign up and log in. However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age. If insfrt miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule.
Call your doctor if you get severe stomach pain or become constipated. Subscribe to free Packqge. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Name of the medicinal product 2.
Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision. Injury, poisoning, and procedural complications.
Darifenacin (Oral Route) Side Effects – Mayo Clinic
This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Be sure to ask your doctor about anything you do not understand. This is not a complete list of side effects and others may occur.
Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response see section 5. Snablex your dose is different, do not change it unless your doctor tells you to insedt so. In subjects who are poor metabolisers, darifenacin exposure increased approximately fold. Pregnancy There are limited amount of data from the use of darifenacin in pregnant women.
Emselex 7.5mg prolonged release tablets
Darifenacin had no effect on male or female fertility in rats or any effect in the reproductive organs of either sex in rats and dogs for details, see section 5. Effects of darifenacin on other medicinal products. Marketing authorisation number s 9.