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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Along with its needed effects, a medicine may cause some unwanted effects. Respiratory, thoracic and mediastinal disorders. Digoxin Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose. Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.

Studies in animals have shown toxicity to parturition for details, see section 5. However the data available do not indicate that darifenacin paxkage either midazolam clearance or bioavailability.

Patients experiencing these side effects should not drive or use machines. Follow your doctor’s orders or the directions on the label.

Darifenacin (Oral Route) Side Effects – Mayo Clinic

Do not double doses. Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients. Reporting of suspected adverse reactions. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Certain paackage should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Therefore, inhibitors of these enzymes may increase darifenacin exposure.

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For this medicine, the following should be considered:. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

The information below applies to subjects who have normal CYP2D6 activity extensive metabolisers unless otherwise stated. Marketing authorisation number s 9. Subscribe to free Drugs. The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated. It is not known whether darifenacin passes into enable milk or if it could harm a nursing baby.

The interaction with midazolam lacks clinical relevance, and ensblex no dose adjustment is needed for CYP3A4 substrates. Patients with moderate hepatic impairment Child Pugh B should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7. Hepatic insufficiency 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.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Marketing authorisation holder 8. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If urinary tract infection is present, an appropriate antibacterial therapy should be started.

As seen in Table 2 below, a enablxe analysis of 3 of the studies for the treatment with both Emselex 7. Medically reviewed on Mar 13, Date of revision of the text. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

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Emselex 7.5mg prolonged release tablets

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Get emergency medical help if you have any of these signs of enableex allergic reaction to Enablex: Reproductive system and breast disorders.

It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome. Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth A few percent of the population have increased CYP2D6 enzyme levels ultrafast metabolisers.

Emselex is for oral use. However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age. Injury, poisoning, and procedural complications. Subscribe to receive email notifications whenever new articles are published.

Darifenacin may cause a serious type of allergic reaction called angioedema. Also, do not change your dose without checking first with your doctor. Not all possible interactions are listed in this medication guide. Anticholinergic effects, in general, are dose-dependent.

Enablex: Uses, Dosage & Side Effects –

Differences from placebo 1 median. In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.

Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.