DrugindexOnline^{2nd edition}

Generic Name: Atropine/Benzoic Acid/Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate Delayed-Release Tablets (A-troe-peen/ben-ZOE-ik AS-id/hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late)
Brand Name: Prosed ED and Uritact-EC

Prosed ED Delayed-Release Tablets is used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Prosed ED Delayed-Release Tablets is a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Prosed ED Delayed-Release Tablets if:

• you are allergic to any ingredient in Prosed ED Delayed-Release Tablets
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
• you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
• you are taking a sulfonamide (eg, sulfamethoxazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prosed ED Delayed-Release Tablets:

Some medical conditions may interact with Prosed ED Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
• if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
• if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
• if you are on a low-salt diet

Some MEDICINES MAY INTERACT with Prosed ED Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, benztropine) because they may increase the risk of Prosed ED Delayed-Release Tablets's side effects.
• Ketoconazole because it may decrease Prosed ED Delayed-Release Tablets's effectiveness.
• Monoamine oxidase inhibitors (MAOIs)or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased.
• Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Prosed ED Delayed-Release Tablets.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prosed ED Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prosed ED Delayed-Release Tablets:

Use Prosed ED Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prosed ED Delayed-Release Tablets by mouth with or without food.
• Swallow Prosed ED Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Do not take an antacid or antidiarrheal medicine (eg, loperamide) within 1 hour before or after you take Prosed ED Delayed-Release Tablets.
• Drinking extra fluids while you are taking Prosed ED Delayed-Release Tablets is recommended. Check with your doctor for instructions.
• If you miss a dose of Prosed ED Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prosed ED Delayed-Release Tablets.

Important safety information:

• Prosed ED Delayed-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prosed ED Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
• Prosed ED Delayed-Release Tablets may discolor the urine or stools a blue-green color. This is normal and not a cause for concern.
• Prosed ED Delayed-Release Tablets contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Prosed ED Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Use Prosed ED Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
• Prosed ED Delayed-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Prosed ED Delayed-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prosed ED Delayed-Release Tablets while you are pregnant. Prosed ED Delayed-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Prosed ED Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Prosed ED Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry mouth; flushing; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Prosed ED Delayed-Release Tablets:

Store Prosed ED Delayed-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prosed ED Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Prosed ED Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Prosed ED Delayed-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Prosed ED Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.