DARIFENACIN EXTENDED-RELEASE - ORAL

DARIFENACIN EXTENDED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (DAR-i-FEN-a-sin)

COMMON BRAND NAME(S): Enablex

GENERIC NAME(S): darifenacin hydrobromide

Uses

USES: Darifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, darifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.


How to use DARIFENACIN EXTENDED-RELEASE - ORAL

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using darifenacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once a day. Swallow this medication with a full glass of water (8 ounces/240 milliliters). Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Dry mouth, constipation, nausea, stomach upset, stomach pain, blurred vision, dry eyes, dizziness, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations). Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking darifenacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (urinary retention), other bladder problems (such as bladder outflow obstruction), stomach/intestinal blockage (gastric retention), liver disease, personal or family history of glaucoma (angle-closure type), bowel disease (such as ulcerative colitis), slowed movement of stomach/intestines, constipation, enlarged prostate, a certain muscle/nerve disease (myasthenia gravis). This drug may make you dizzy or blur your vision. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: pramlintide, potassium tablets/capsules.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include fast/irregular heartbeat, agitation.

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DARIFENACIN ER 7.5 MG TABLET

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DARIFENACIN ER 15 MG TABLET

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ENABLEX 15 MG TABLET

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ENABLEX 7.5 MG TABLET

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Faq for DARIFENACIN EXTENDED-RELEASE - ORAL

Darifenacin extended-release is used to treat overactive bladder symptoms, such as frequent urination, urgency, and incontinence.

Darifenacin works by relaxing the muscles in the bladder, reducing the frequency and urgency of urination.

You should avoid activities that require mental alertness, such as driving or operating machinery, as darifenacin can cause drowsiness or blurred vision.

Darifenacin may start to work within a few days, but it may take up to 4 weeks for the full effect to be seen.

Common side effects may include dry mouth, constipation, blurred vision, dizziness, and urinary tract infections.

It is important to inform your healthcare provider about all the medications you are taking, as darifenacin may interact with certain drugs, such as antifungal medications, antibiotics, and certain antidepressants.

Darifenacin should only be used during pregnancy or breastfeeding if the potential benefits outweigh the potential risks. It is recommended to consult with a healthcare provider for advice.

If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.

No, darifenacin extended-release tablets should not be crushed or chewed. They should be swallowed whole with water or other liquids.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.