IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does NOT assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DIPHENOXYLATE/ATROPINE - ORAL

(DYE-fen-OX-i-late/AT-roe-peen)

COMMON BRAND NAME(S): Lomotil

USES: This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Diphenoxylate is similar to narcotic pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement.

HOW TO USE: Take this medication by mouth, usually 4 times a day or as directed by your doctor. Dosage is based on your medical condition and response to therapy. In children, dosage is also based on weight. If you need to continue treatment once your diarrhea is controlled, your doctor may direct you to lower your dosage. Do not increase your dose, take it more often, or use it for longer than prescribed. A liquid formulation is available for use in children. Use only the dropper that comes with the bottle to carefully measure out each dose. It is important that you drink the proper amount of fluids and minerals (electrolytes) to prevent loss of body water (dehydration). Tell your doctor immediately if you develop signs of dehydration (e.g., extreme thirst, decreased urination, muscle cramps, weakness, fainting). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as stomach cramps, nausea, vomiting) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Inform your doctor if your condition does not improve after 2 days.

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 U.S. - 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.

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.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: ambenonium, pramlintide. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting diphenoxylate with atropine. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), naltrexone, potassium tablets/capsules. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), barbiturates (e.g., phenobarbital), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. U.S. residents can call the U.S. National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, muscle weakness, fast heartbeat, high fever, unusually fast/slow/irregular breathing, seizures, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze the liquid. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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