Belladonna and opium are natural substances made from plant sources. The medicinal form of opium is an opioid pain medication.

Belladonna and opium rectal is a combination medicine used to treat moderate to severe pain caused by muscle spasms in the tubes that connect the kidneys to the bladder.

Belladonna and opium may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use belladonna and opium in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bowel and bladder just before using the belladonna and opium suppository.

Wash your hands before and after inserting the rectal suppository.

Remove the wrapper before inserting the suppository. Moisten the suppository and your finger with water. Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first.

Stay lying down for a few minutes while the suppository melts. You should feel little or no discomfort. Avoid using the bathroom for at least an hour.

Drink plenty of water to prevent constipation while using belladonna and opium.

Belladonna and opium rectal is most often used 1 or 2 times per day. Do not use the suppositories more than 4 times per day.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using belladonna and opium suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze the suppositories.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not use belladonna and opium if you are allergic to belladonna or opium, or if you have:

• severe asthma or breathing problems;

• seizures;

• glaucoma;

• severe liver or kidney disease;

• a stomach or bowel obstruction (including paralytic ileus);

• if you have recently used alcohol, sedatives, tranquilizers, or other opioid medications; or

• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tell your doctor if you have ever had:

• sleep apnea (breathing stops during sleep);

• urination problems;

• problems with your thyroid, pancreas, or gallbladder;

• a head injury, brain tumor, or seizures; or

• alcoholism or drug addiction.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since belladonna and opium is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how belladonna and opium will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Belladonna and opium may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;

• confusion, feeling like you might pass out;

• painful or difficult urination;

• severe constipation and stomach pain;

• adrenal gland problems--nausea, vomiting, loss of appetite, dizziness, feeling weak or tired; or

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of belladonna and opium may include:

• fast heartbeats;

• urination problems;

• drowsiness, dizziness;

• blurred vision;

• constipation;

• nausea and vomiting;

• dry mouth; or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.