Lomotil (Diphenoxylate and Atropine Tablets)

• If you have an allergy to diphenoxylate, atropine, or any other part of Lomotil (diphenoxylate and atropine tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Loose stools caused by infection, loose stools caused by a very bad bowel problem (pseudomembranous colitis), or yellowing of the skin or eyes.
• If your child is younger than 13 years of age. Do not give this medicine to a child younger than 13 years of age.

This is not a list of all drugs or health problems that interact with Lomotil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

• Take with or without food.
• Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

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.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Trouble breathing, slow breathing, or shallow breathing.
• Numbness or tingling in the hands or feet.
• Fever.
• A fast heartbeat.
• Trouble passing urine.
• Flushing.
• Mood changes.
• Change in the way you act.
• Feeling confused.
• Restlessness.
• Change in eyesight.
• Very hard stools (constipation).
• Very bad belly pain.
• Swelling of belly.

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:

• Feeling sleepy.
• Dizziness.
• Headache.
• Upset stomach or throwing up.
• Not hungry.
• Belly pain.
• Dry mouth.
• Dry skin.
• Feeling tired or weak.

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.