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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Other drugs may interact with darifenacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. This medicine may cause blurred vision and may impair your thinking or reactions. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Some side effects may occur that usually do not need medical attention. Adverse reactions with Emselex 7.
Reporting of suspected adverse reactions. If you notice any other effects, check with your healthcare professional. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you ppackage dizzy, not alert, or not able to see well. Marketing authorisation holder Merus Labs Luxco S.
Method of administration Emselex is for oral use. If your dose is different, do not change it unless your doctor tells you to do so. 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.
The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme. Darifenacin may cause a serious type of allergic reaction called angioedema. 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.
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Darifenacin (Oral Route) Side Effects – Mayo Clinic
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Enablex, especially:. Address 15, rue Edward Steichen, L Luxembou. However, no studies involving the interaction with anti-parkinson agents and tricyclic antidepressants have been performed.
Emselex 7.5mg prolonged release tablets
FDA alerts for all medications. Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate Film coat: A single copy of these materials may be reprinted for noncommercial personal use only. To view content sources and attributions, please refer to our editorial policy. The effect of warfarin on prothrombin time was not altered inzert co-administered with darifenacin.
Fertility There are no human fertility data for darifenacin. 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.
This includes prescription or nonprescription over-the-counter [OTC] medicines and herbal or vitamin supplements. Treatment with Emselex administered at dosages of 7.
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Unbound darifenacin exposure was estimated to be 4. As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence. Medically reviewed on Mar 13, Subscribe to receive email notifications whenever new articles are published.
Follow all directions on your prescription label. However, caution should be exercised when treating this population see section 5. Darifenacin works on the muscles of the bladder to prevent them from causing incontinence. However, there is a risk of increased exposure in this population see section 5.
Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment Child Pugh A.