Uro-BLUE

Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe dizziness, blurred vision, fast heart rate;
• agitation, confusion, feeling restless or excited;
• painful or difficult urination; or
• shortness of breath.

Older adults may be more likely to have side effects from this medication.

Common side effects may include:

• mild dizziness;
• dry mouth; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, 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, and sodium biphosphate.

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:

• neostigmine or pyridostigmine;
• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• bronchodilators such as ipratropium or tiotropium;
• cold or allergy medicine that contains an antihistamine;
• a diuretic or "water pill";
• an MAO inhibitor--furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine;
• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
• medication to treat gout, kidney stones, or an electrolyte imbalance (such as low levels of potassium);
• medication to treat symptoms of Alzheimer's disease or Parkinson's disease;
• narcotic pain or cough medication--codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, propoxyphene, and others; or
• sulfa drugs.

This list is not complete and many other drugs can interact with hyoscyamine, methenamine, methylene blue, and 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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you take aspirin, antacids, or drugs that raise the pH of the urine while on Uro-BLUE.
• Some other drugs may need to be taken at some other time than this medicine. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Uro-BLUE.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Uro-BLUE while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Take with or without food.
• Drink lots of noncaffeine liquids every day unless told to drink less liquid by your doctor.

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.
• Feeling very sleepy.
• Feeling confused.

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

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.

Some side effects of Uro Blue may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.