Utira-C

You should not use this medicine if you are allergic to hyoscyamine, methenamine, methylene blue, phenyl salicylate, or sodium biphosphate.

During your treatment with this medicine, do not start or stop using any other medications unless your doctor tells you to.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease;

• a heart rhythm disorder;

• congestive heart failure;

• coronary heart disease;

• a heart valve disorder;

• glaucoma;

• an enlarged prostate or bladder obstruction;

• myasthenia gravis;

• an ulcer or obstruction in your stomach;

• an allergy to belladonna (Donnatal and others); or

• an allergy to salicylates (such as aspirin, choline magnesium trisalicylate, magnesium salicylate).

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium biphosphate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.

If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium biphosphate.

Many drugs can interact with methylene blue. Tell your doctor about all other medications you use. You may need to stop using certain medicines (in some cases for up to 5 weeks before you start treatment with hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate). However, do not stop taking any of your medications without your doctor's advice. This includes:

• any type of antidepressant;

• diet pills, stimulants, cold or allergy medicines, ADHD medication;

• narcotic pain medicine;

• medication to treat Parkinson's disease or restless leg syndrome; or

• a "triptan" migraine headache medication.

Taking any of the above medications while you are treated with medicine that contains methylene blue can cause high levels of serotonin in the body. Call your doctor right away if you have symptoms of this condition: agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, or fainting.

Many drugs can interact with this medicine. Not all possible interactions are listed here. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all your medications and any you start or stop using, especially:

• a diuretic or "water pill";

• medicines that change the acidity of your urine--sodium bicarbonate, potassium citrate, sodium citrate with citric acid or potassium;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or

• a sulfa drug.

This list is not complete and many other drugs can interact with hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• dizziness
• rapid pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blue-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with a full glass of water.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take antacids or drugs for loose stools (diarrhea) within 1 hour of Utira-C.
• If you also take ketoconazole, take it at least 2 hours before you take this medicine.
• To gain the most benefit, do not miss doses.
• Keep using Utira-C (methenamine/sodium phosphate/phenyl salicylate/methylene blue/hyoscyamine) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A fast heartbeat.
• Blurred eyesight.
• Dizziness.
• Shortness of breath.
• Trouble passing urine.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Feeling sleepy.
• Dry mouth.
• Flushing.
• Change in color of urine or stool to blue or green.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Utira-C or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Utira-C. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017