Generic Name: DIPHENOXYLATE/ATROPINE - ORAL
Pronounced: (DYE-fen-OX-i-late/AT-roe-peen)

Lomotil Oral Precautions

Before taking diphenoxylate with atropine, tell your doctor or pharmacist if you are allergic to either drug; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• liver disease (e.g., obstructive jaundice, cirrhosis)
• diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella)

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current dehydration or mineral imbalance
• a certain type of bowel disease (acute ulcerative colitis)

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid forms of this product may contain alcohol. Caution is advised if you have alcohol dependence or liver disease. Ask your doctor or pharmacist about using this product safely.

This drug is not recommended for use in children younger than 2 years. Caution is advised when using this drug in children, particularly those with Down's syndrome, because they may be more sensitive to the following side effects: high fever, fast heartbeat, decreased urination, flushing, dry skin/mouth, thirst. Very serious (possibly life-threatening) effects may occur if too much of this medication is taken by children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Lomotil Oral Side Effects

See also Precautions for side effects seen in children.

Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 immediately if any of these unlikely but serious side effects occur:

• stomach/abdominal pain or swelling
• severe nausea
• vomiting
• mental/mood changes (e.g., confusion, depression)
• restlessness
• numbness/tingling of arms/legs

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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