Darifenacin (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Darifenacin extended-release tablet 7.5 mg are white to off white colored circular biconvex film coated tablet debossed with “C” on one side and “431” on the other side.

Bottle of 30 …………………………………………………………………………………………………NDC 69097-431-02

Bottle of 90 …………………………………………………………………………………………………NDC 69097-431-05

Bottle of 1000 ……………………………………………………………………………………………..NDC 69097-431-15

Darifenacin extended-release tablet 15 mg are light peach colored circular biconvex film coated tablet debossed with “C” on one side and “432” on the other side.

Bottle of 30………………………………………………………………………………………………….NDC 69097-432-02

Bottle of 90………………………………………………………………………………………………….NDC 69097-432-05

Bottle of 1000 ……………………………………………………………………………………………..NDC 69097-432-15

Storage

Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Protect from light.

Keep this and all drugs out of the reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

Patients should be informed that anticholinergic agents, such as darifenacin extended-release tablets, may produce clinically significant adverse effects related to anticholinergic pharmacological activity including constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur when anticholinergics such as darifenacin extended-release tablets are used in a hot environment. Because anticholinergics, such as darifenacin extended-release tablets, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects have been determined. Patients should read the patient information leaflet before starting therapy with darifenacin extended-release tablets.

Patients should be informed that darifenacin may produce clinically significant angioedema that may result in airway obstruction. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

Darifenacin extended-release tablets should be taken once daily with water. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.

Manufactured by:

Cipla Ltd.

MIDC Patalganga, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Revised: 7/2021

FDA-Approved Patient Labeling

Darifenacin Extended-Release Tablets

Read this Patient Information leaflet about darifenacin extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

What are darifenacin extended-release tablets?

Darifenacin extended-release tablets are prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

  • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • Urgency: a strong need to urinate right away
  • Frequency: urinating often

It is unknown if darifenacin extended-release tablets are safe and effective in children.

Who should not take darifenacin extended-release tablets?

Do not take darifenacin extended-release tablets if you:

  • are not able to empty your bladder (“urinary retention”)
  • have delayed or slow emptying of your stomach (“gastric retention”)
  • have an eye problem called “uncontrolled narrow-angle glaucoma”

What should I tell my healthcare provider before starting darifenacin extended-release tablets?

Before starting darifenacin extended-release tablets, tell your doctor if you:

  • have trouble emptying your bladder or if you have a weak urine stream
  • have any stomach or intestinal problems, or problems with constipation
  • have liver problems
  • have any other medical conditions
  • are pregnant or are planning to become pregnant. It is not known if darifenacin extended-release tablets can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if darifenacin passes into breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you take darifenacin extended-release tablets.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Darifenacin extended-release tablets and certain other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take a:

  • antifungal medicine ketoconazole (Nizoral®) or itraconazole (Sporanox®)
  • antibiotic medicine clarithromycin (Biaxin®)
  • anti-HIV medicine ritonavir (Norvir®) or nelfinavir (Viracept®)
  • medicine to treat depression nefazadone (Serzone®)
  • medicine to treat an abnormal heartbeat flecainide (Tambocor®)
  • antipsychotic medicine thioridazine (Mellaril®)
  • medicine to treat depression called a tricyclic antidepressant

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I take darifenacin extended-release tablets?

  • Take darifenacin extended-release tablets exactly as prescribed. Your doctor will prescribe the dose that is right for you. Take darifenacin extended-release tablets 1 time daily with water.
  • Darifenacin extended-release tablets should be swallowed whole. Do not chew, cut or crush darifenacin extended-release tablets.
  • Darifenacin extended-release tablets may be taken with or without food.
  • If you take too much darifenacin extended-release tablets call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking darifenacin extended-release tablets?

Darifenacin extended-release tablets can cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how darifenacin extended-release tablets affects you.

What are the possible side effects of darifenacin extended-release tablets?

Darifenacin extended-release tablets may cause serious side effects including:

  • Serious allergic reaction. Stop taking darifenacin extended-release tablets and get medical help right away if you have:
    • hives, skin rash or swelling
    • severe itching
    • swelling of your face, mouth or tongue
    • trouble breathing

The most common side effects with darifenacin extended-release tablets are:

  • constipation
  • dry mouth
  • headache
  • heartburn
  • nausea
  • urinary tract infection
  • blurred vision
  • heat exhaustion or heat-stroke. This can happen when darifenacin extended-release tablet is used in hot environments.

Symptoms of heat exhaustion may include:

  • decreased sweating
  • dizziness
  • tiredness
  • nausea
  • increase body temperature

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of darifenacin extended-release tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store darifenacin extended-release tablets?

  • Store darifenacin extended-release tablet at room temperature, between 59° F to 86° F (15° C to 30° C).
  • Keep darifenacin extended-release tablet out of the light.

Keep darifenacin extended-release tablets and all medicines out of the reach of children.

General information about darifenacin extended-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use darifenacin extended-release tablets for a condition for which it was not prescribed. Do not give darifenacin extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about darifenacin extended-release tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about darifenacin extended-release tablets that is written for health professionals.

What are the ingredients in darifenacin extended-release tablets?

Active ingredient: darifenacin

Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide.

The 15 mg tablet also contains iron oxide red and iron oxide yellow.

The brands listed are the trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured by:

Cipla Ltd.

MIDC Patalganga, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Revised: 2/2020

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