ENABLEX PACKAGE INSERT PDF

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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Do not take this medicine in larger or smaller amounts or for longer than recommended. Darifenacin works on the muscles of the bladder to prevent them from causing incontinence.

Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision. Not all possible interactions are listed in this medication guide.

This medication may cause blurred vision and may impair your thinking or reactions.

Store the medicine in a closed container at room temperature, away from heat, moisture, ebablex direct light. 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.

Tell your doctor about all medicines you use, and those enablwx start or stop using during your treatment with Enablex, especially:. Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth Enter medicine name or company Start typing to retrieve search suggestions. Metabolism Darifenacin is extensively metabolised by inert liver following oral administration. Reporting of suspected adverse reactions. This medicine comes with a patient information insert.

Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure e.

Active ingredient darifenacin hydrobromide. However, the patient discontinuation rates due to these adverse reactions were low dry mouth: Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.

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In subjects who are poor pqckage, darifenacin exposure increased approximately fold. This dose-dependency is probably caused by saturation of the CYP2D6 catalysed metabolism possibly together with some saturation of CYP3A4-mediated gut wall metabolism. Breast-feeding Darifenacin is excreted in the milk of rats.

Emselex 7.5mg prolonged release tablets

Follow your doctor’s orders or the directions on the label. Also tell your health care paciage if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.

In peri and post-natal studies in rats, dystocia, increased foetal deaths in utero and toxicity to post-natal development pup body weight and development land marks were observed at systemic exposure levels up to 11 times the AUC h of free plasma concentration at MRHD.

At steady state, peak-to-trough fluctuations in darifenacin concentrations are small PTF: Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7. The incidence of adverse reactions with the doses of Emselex 7.

Unbound darifenacin exposure was estimated to be 4. Medically reviewed on Mar 13, 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, ijsert if you stop urinating. Do not take other medicines unless they have been discussed with your doctor. Darifenacin is used to treat symptoms of an overactive bladder, such as incontinence loss of bladder control or a frequent need to urinate.

However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.

U.S. Prescribing Information Disclaimer

Other transporter-related interactions cannot be excluded. The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein. Skip the missed dose if it is almost time for your next scheduled dose. Pregnancy and breastfeeding warnings in more detail. As with other antimuscarinics, patients should be instructed to discontinue Emselex and seek immediate medical attention if they experience oedema of the tongue or laropharynx, or difficulty breathing see section 4.

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Print this page Add to My Med List. The recommended starting dose for the elderly is 7.

FDA alerts for all medications. Remember, keep this and all other medicines out of the reach of iinsert, never share your medicines with others, and use this medicine only for the indication prescribed.

A decision whether to avoid breast-feeding or to abstain from Emselex therapy during lactation should be based on a benefit and risk comparison.

The interaction with midazolam lacks clinical relevance, and therefore no dose adjustment is needed for CYP3A4 substrates. Call your doctor for medical advice about side effects. Polyethylene glycol Hypromellose Titanium dioxide E Talc 6. To view content sources eanblex attributions, please refer to our editorial policy. Take this medicine only as directed.

Darifenacin may cause a serious type of allergic reaction called angioedema. Always consult your healthcare provider to ensure the information displayed on this page applies to inaert personal circumstances. Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.

Drug information provided by: The elimination half-life of darifenacin following chronic dosing is approximately hours. Doubling the darifenacin dose from 7. Date of revision of the text.