Prescription Drug Information: DARIFENACIN (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Darifenacin Extended-Release Tablets 7.5 mg are white colored, round, biconvex film-coated tablets debossed with L408 on one side and plain on other side.

Bottle of 30 NDC 46708-223-30

Bottle of 90 NDC 46708-223-90

Bottle of 1000 NDC 46708-223-91

80 (10 x 8) Tablets Unit Dose Blister Pack NDC 46708-223-08

Darifenacin Extended-Release Tablets 15 mg are light Peach colored, round, biconvex film-coated tablets debossed with L409 on one side and plain on other side.

Bottle of 30 NDC 46708-224-30

Bottle of 90 NDC 46708-224-90

Bottle of 1000 NDC 46708-224-91

80 (10 x 8) Tablets Unit Dose Blister Pack NDC 46708-224-08

Storage

Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 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, 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 are used in a hot environment. Because anticholinergics, such as darifenacin, 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.

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.
FDA-Approved Patient Labeling
Darifenacin (dar-i-FEN-a-sin)
Extended-Release Tablets
Read this Patient Information leaflet about darifenacin 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 is darifenacin ?
Darifenacin is 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 is safe and effective in children.

Who should not take darifenacin?
Do not take darifenacin 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?
Before starting darifenacin, 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 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.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Darifenacin 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?
• Take darifenacin exactly as prescribed. Your doctor will prescribe the dose that is right for you. Take darifenacin 1 time daily with water.
• Darifenacin should be swallowed whole. Do not chew, cut or crush darifenacin.
• Darifenacin may be taken with or without food.
• If you take too much darifenacin call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking darifenacin?
Darifenacin can cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how darifenacin affect you.

What are the possible side effects of darifenacin?
Darifenacin may cause serious side effects including:
Serious allergic reaction. Stop taking darifenacin and get medical help right away if you have:
o hives, skin rash or swelling
o severe itching
o swelling of your face, mouth or tongue
o trouble breathing
The most common side effects with darifenacin is:
• constipation
• dry mouth
• headache
• heartburn
• nausea
• urinary tract infection
• blurred vision
• heat exhaustion or heat-stroke. This can happen when darifenacin is used in hot environments.
Symptoms of heat exhaustion may include:
o decreased sweating
o dizziness
o tiredness
o nausea
o 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. 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?
• Store darifenacin at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep darifenacin out of the light.

Keep darifenacin and all medicines out of the reach of children.

General information about darifenacin.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use darifenacin for a condition for which it was not prescribed. Do not give darifenacin 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about darifenacin that is written for health professionals.

What are the ingredients in darifenacin extended-release tablets?
Active ingredient: darifenacin
Inactive ingredients: hypromellose, povidone, dibasic calcium phosphate anhydrous, magnesium stearate, titanium dioxide, polyethylene glycol, talc. 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 Alembic Pharmaceuticals Limited.

Manufactured by:
Alembic Pharmaceuticals Limited (Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.

Revised: 04/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -7.5 mg

Darifenacin Extended-Release Tablets 7.5 mg (30 Tablets in 1 HDPE Bottle)
Each tablet contains 8.929 mg of darifenacin hydrobromide to provide 7.5 mg darifenacin.
46708-223-30

30's bottle pack
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -15 mg

Darifenacin Extended-Release Tablets 15 mg (30 Tablets in 1 HDPE Bottle)
Each tablet contains 17.858 mg of darifenacin hydrobromide to provide 15 mg darifenacin. 46708-224-30

30's bottle pack
(click image for full-size original)
DARIFENACIN darifenacin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARIFENACIN HYDROBROMIDE (DARIFENACIN) DARIFENACIN 7.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
POVIDONE K30
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 1500
TALC
Product Characteristics
Color WHITE (White Colored) Score no score
Shape ROUND (BICONVEX) Size 8mm
Flavor Imprint Code L408
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-223-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:46708-223-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:46708-223-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:46708-223-08 08 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207681 12/12/2017
DARIFENACIN darifenacin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-224
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARIFENACIN HYDROBROMIDE (DARIFENACIN) DARIFENACIN 15 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
POVIDONE K30
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 1500
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (Light Peach Colored) Score no score
Shape ROUND (BICONVEX) Size 8mm
Flavor Imprint Code L409
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-224-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:46708-224-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:46708-224-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:46708-224-08 08 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207681 12/12/2017
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-223), MANUFACTURE (46708-224)

Revised: 01/2023 Alembic Pharmaceuticals Limited

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