ENABLEX PACKAGE INSERT PDF
December 20, 2019 | by admin
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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In these cases, your doctor may want to change the dose, or other precautions may be necessary. Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John’s wort Hypericum perforatum are likely to decrease the plasma concentrations of darifenacin. Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration.
Find out more here. Women of child bearing potential should be made aware of the lack of fertility data, and Emselex should only be given after consideration of individual pacage and benefits.
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.
Enablex can decrease perspiration and you may be more prone to heat stroke. Emselex is for oral use. Along with its needed effects, a medicine may cause some unwanted effects. Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth Emselex has been administered in clinical trials at doses up to 75 mg five times maximum therapeutic dose.
Do not take other medicines unless they have been discussed with your doctor. Qualitative and quantitative composition 3.
Emselex 7.5mg prolonged release tablets
Although not all of these side effects may occur, if they do occur they may need medical attention. Enzyme inducers Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John’s wort Hypericum inesrt are likely to decrease the plasma concentrations of darifenacin.
Dosage Information in more detail. Marketing authorisation number s 9. Stop using this medicine and check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble with breathing, or chest tightness while you are using this medicine.
Treatment with Emselex may possibly mask symptoms associated with gallbladder disease. This medicine comes with a patient information insert. To email a medicine you must sign up and log in.
Print this page Add to My Med List. It is not known whether darifenacin enbalex excreted in human milk. This list is not complete. 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.
They can be taken with or without food, enablec must be swallowed whole and not chewed, divided or crushed. Last updated on eMC: There was considerable overlap between the ranges of exposures seen in these two populations see section 4.
Enablex: Uses, Dosage & Side Effects –
However the data available do not indicate that darifenacin changes either midazolam clearance or bioavailability. Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
No dose adjustment is required in patients with impaired renal function. The following information includes only the average doses of this medicine. Description and Brand Names Drug information provided by: Your doctor may occasionally change your dose to make sure you get the best results.
No dose adjustment is required in patients with mild hepatic packqge Child Pugh A. Marketing authorisation holder Merus Pwckage Luxco S.
To view the changes to a medicine you must sign up and log in. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate Film coat: Not all possible interactions neablex listed in this medication guide. Angioedema may be life-threatening and requires immediate medical attention.
Back to top Merus Labs Luxco S. Skip the missed dose if it is almost time for your next scheduled dose. Also, do not change your dose without checking first with your doctor. Potent P-glycoprotein inhibitors such as ciclosporin and verapamil should also be avoided.
Darifenacin pharmacokinetics were investigated in subjects with mild Child Pugh A or moderate Child Pugh B impairment of hepatic function given darifenacin 15 mg once daily to steady state.