Uses of Belladonna and Opium:

• It is used to ease pain.

What do I need to tell my doctor BEFORE I take Belladonna and Opium?

For all patients taking belladonna and opium:

• If you have an allergy to atropine, belladonna, morphine, opium, or any other part of belladonna and opium.
• If you are allergic to belladonna and opium; any part of belladonna and opium; 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: Bad reactions to opioid drugs, early labor, glaucoma, kidney disease, liver disease, or seizures.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you are going through alcohol withdrawal.
• If you have recently drunk a lot of alcohol.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.

Children:

• If your child is younger than 12 years of age. Do not give belladonna and opium to a child younger than 12 years of age.

This is not a list of all drugs or health problems that interact with belladonna and opium.

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 belladonna and opium 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 Belladonna and Opium?

• Tell all of your health care providers that you take belladonna and opium. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how belladonna and opium affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• If you have been taking belladonna and opium for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if belladonna and opium stops working well. Do not take more than ordered.
• Long-term or regular use of opioid drugs like belladonna and opium may lead to dependence. Lowering the dose or stopping belladonna and opium all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop belladonna and opium. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking belladonna and opium.
• Bright lights may bother you. Wear sunglasses.
• Do not take belladonna and opium with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• If you are 65 or older, use belladonna and opium with care. You could have more side effects.
• 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 belladonna and opium, call your doctor right away.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

How is this medicine (Belladonna and Opium) best taken?

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

• Use suppository rectally.
• To use, take off foil wrapper and wet suppository with cold water. Use your finger to push the suppository well up into the rectum.

What do I do if I miss a dose?

• If you use belladonna and opium on a regular basis, use 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 use 2 doses or extra doses.
• Many times belladonna and opium is used on an as needed basis. Do not use more often than told by the doctor.

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 breathing, slow breathing, or shallow breathing.
• Very bad dizziness or passing out.
• Very bad belly pain.
• Very bad constipation.
• Seizures.
• Chest pain or pressure or a fast heartbeat.
• Feeling very sleepy.
• Feeling confused.
• Trouble passing urine.
• Blurred eyesight.
• If bright lights bother your eyes.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take belladonna and opium with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• Taking an opioid drug like belladonna and opium may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).

What are some other side effects of Belladonna and Opium?

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:

• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Constipation.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Headache.
• Belly pain.

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 Belladonna and Opium?

• Store at room temperature. Do not refrigerate or freeze.
• 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time belladonna and opium is refilled. If you have any questions about belladonna and opium, please talk with the doctor, 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.