Darifenacin

Brand(s)

Manufacturer

• Sun Pharmaceutical Industries Ltd.

Disease(s)

• Urine Leakage / Overactive Bladder

Darifenacine tablet

What is this medicine?

DARIFENACIN reduces muscle spasms of the bladder and urinary tract.

Darifenacine is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

Darifenacine may also be used for purposes not listed in this medication guide.

What should my health care professional know before I take this medicine?

You should not use Darifenacine if you are allergic to darifenacin, or have certain conditions. Be sure your doctor knows if you have:

• untreated or uncontrolled narrow-angle glaucoma;
• a stomach disorder causing delayed emptying; or
• if you are unable to urinate.

To make sure you can safely take Darifenacine, tell your doctor if you have any of these other conditions:

• glaucoma;
• liver disease;
• ulcerative colitis;
• a blockage in your stomach or intestines;
• a muscle disorder such as myasthenia gravis; or
• if you have very little urine or trouble emptying your bladder.

FDA pregnancy category C. It is not known whether Darifenacine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether darifenacin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take this medicine?

Take Darifenacine exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with water.

Darifenacine can be taken with or without food.

Store Darifenacine at room temperature away from moisture, heat, and light.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

The following drugs can interact with Darifenacine. Tell your doctor if you are using any of these:

• flecainide (Tambocor);
• thioridazine (Mellaril);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan, Silenor), imipramine (Janimine, Tofranil), nefazadone, or nortriptyline (Pamelor);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
• HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir, Kaletra);
• irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine);
• other bladder or urinary medicines such as flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
• ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with Darifenacine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What side effects may I notice from taking this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction to Darifenacine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Darifenacine and call your doctor at once if you have any of these serious side effects:

• hot, dry skin and extreme thirst;
• severe stomach pain or constipation;
• confusion, hallucinations;
• pain or burning when you urinate;
• urinating less than usual or not at all;
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Darifenacine side effects may include:

• dry mouth;
• dry eyes, blurred vision;
• mild constipation;
• diarrhea;
• nausea, mild stomach pain or upset;
• dizziness, weakness, drowsiness;
• headache; or
• fever, sore throat, body aches, or other flu symptoms.