Opium preparation (sometimes called "opium tincture") is an opioid medication that is used to treat diarrhea. opium preparation is not for use as an opioid pain medicine.

Opium preparation 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.

Follow the directions on your prescription label and read all medication guides. Never use opium preparation 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.

Opium preparation is usually taken 1 to 4 times daily to treat diarrhea. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Do not use opium preparation if the safety seal on the cap is broken or missing.

You should not use opium preparation to treat diarrhea that is caused by poisoning (until the toxin is no longer in the digestive tract).

Do not give this medicine to a child.

Tell your doctor if you have ever had:

• asthma, emphysema, or other breathing problem;

• a head injury, brain tumor, or seizure;

• cirrhosis or other liver disease;

• stomach bleeding; or

• alcoholism or drug addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 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.

Avoid using any other anti-diarrhea medications that your doctor has not prescribed.

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

Opium preparation may cause serious side effects. Stop using opium preparation and call your doctor at once if you have:

• weak or shallow breathing;

• a light-headed feeling, like you might pass out; or

• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky.

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

Common side effects of opium preparation may include:

• nausea, vomiting;

• constipation; or

• itching, rash.

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.

Using opium preparation with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect opium preparation, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.