Uses of Donnatal:

• It is used to treat irritable bowel syndrome.
• It is used to treat ulcer disease.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Donnatal?

• If you are allergic to Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets); any part of Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Heart problems due to bleeding, bowel block, enlarged colon, glaucoma, a hernia that involves your stomach (hiatal hernia), myasthenia gravis, slow-moving GI (gastrointestinal) tract, trouble passing urine, or ulcerative colitis.
• If you have ever had porphyria.
• If you have been restless or overexcited in the past after taking phenobarbital.
• If you are addicted to drugs or alcohol, or have been in the past.

This is not a list of all drugs or health problems that interact with Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets).

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 Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Donnatal?

• Tell all of your health care providers that you take Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• If you have been taking Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets) for many weeks, talk with your doctor before stopping. You may want to slowly stop Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets).
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets) affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• If you are 65 or older, use Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets) with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets).
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets), call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Donnatal) best taken?

Use Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

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.

What are some side effects that I need to call my doctor about right away?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble sleeping.
• Diarrhea.
• Not sweating during activities or in warm temperatures.
• Muscle pain or cramping.
• Fast or abnormal heartbeat.
• Trouble passing urine.
• Change in eyesight, eye pain, or very bad eye irritation.
• Not able to get or keep an erection.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Donnatal?

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 dizzy, sleepy, tired, or weak.
• Headache.
• Constipation.
• Bloating.
• Dry mouth.
• Upset stomach or throwing up.
• Feeling nervous and excitable.
• Change in taste.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Donnatal?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Donnatal (hyoscyamine, atropine, scopolamine, and phenobarbital tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.