Diphenoxylate Hydrochloride, Atropine Sulfate Oral solution

What is this medicine?

ATROPINE; DIPHENOXYLATE (A troe peen dye fen OX i late) is used to treat diarrhea.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bacterial food poisoning

• colitis

• dehydration

• Down's syndrome

• jaundice or liver disease

• an unusual or allergic reaction to atropine, diphenoxylate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or dropper to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. For children, only use a specially marked dropper to measure the liquid. Take your medicine at regular intervals. Do not take it more often than directed. Once your diarrhea has been brought under control your doctor or health care professional may reduce your doses.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• alcohol

• antihistamines for allergy, cough and cold

• barbiturate medicines for inducing sleep or treating seizures

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems

• muscle relaxants

• narcotic medicines (opiates) for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If your symptoms do not start to get better after taking this medicine for two days, check with your doctor or health care professional, you may have a problem that needs further evaluation. Check with your doctor or health care professional right away if you develop a fever or bloody diarrhea.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

Drinking plenty of water can also help prevent dehydration that can occur with diarrhea.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bloated, swollen feeling

• breathing problems

• changes in vision

• fast, irregular heartbeat

• stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• loss of appetite

• mood changes

• nausea, vomiting

• pain, tingling, numbness in the hands or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Keep container tightly closed.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Diphenoxylate Hydrochloride, Atropine Sulfate Oral tablet

What is this medicine?

ATROPINE; DIPHENOXYLATE (A troe peen dye fen OX i late) is used to treat diarrhea.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bacterial food poisoning

• colitis

• dehydration

• Down's syndrome

• jaundice or liver disease

• an unusual or allergic reaction to atropine, diphenoxylate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take the tablets with food. Take your doses at regular intervals. Do not take your medicine more often than directed. Once your diarrhea has been brought under control your doctor or health care professional may reduce your doses.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients may be more sensitive to the effects of this medicine.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• alcohol

• antihistamines for allergy, cough and cold

• barbiturate medicines for inducing sleep or treating seizures

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems

• muscle relaxants

• narcotic medicines (opiates) for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If your symptoms do not start to get better after taking this medicine for two days, check with your doctor or health care professional, you may have a problem that needs further evaluation. Check with your doctor or health care professional right away if you develop a fever or bloody diarrhea.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase possible drowsiness and dizziness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe. Drinking plenty of water can also help prevent dehydration that can occur with diarrhea.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bloated, swollen feeling

• breathing problems

• changes in vision

• fast, irregular heartbeat

• stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• loss of appetite

• mood changes

• nausea, vomiting

• numbness or tingling in the hands and feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.