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|Paregoric

Paregoric

Paregoric is used for:

Treating diarrhea.

Paregoric is an opiate. It works by decreasing intestinal muscle contractions, which helps to reduce diarrhea.

Do NOT use Paregoric if:

• you are allergic to any ingredient in Paregoric or any other opium- or morphine-related medicine (eg, codeine)
• you are taking sodium oxybate (GHB)
• you have severe bowel motility problems (eg, paralytic ileus), diarrhea due to poisoning, or severe diarrhea associated with antibiotic use (pseudomembranous colitis)
• you have seizures, severely slow or difficult breathing or severe asthma, or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paregoric :

Some medical conditions may interact with Paregoric . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
• if you have a history of recent head injury, increased pressure in the brain, brain blood vessel problems, growths in the brain (eg, tumors), or seizures
• if you have a history of heart problems, fast or irregular heartbeat, low blood pressure, liver or kidney problems, an underactive thyroid, adrenal gland problems (eg, Addison disease), stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria
• if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Paregoric . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), cimetidine, furazolidone, monoamine oxidase (MAO) inhibitors (eg, phenelzine), narcotics (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased
• Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of Paregoric may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paregoric may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paregoric :

Use Paregoric as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Paregoric may be taken with or without food.
• Use the dropper that comes with Paregoric to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Paregoric and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Paregoric .

Important safety information:

• Paregoric may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Paregoric . Using Paregoric alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Paregoric . Paregoric will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Paregoric may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Paregoric .
• Use Paregoric with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Paregoric with extreme caution in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant while taking Paregoric , discuss with your doctor the benefits and risks of using Paregoric during pregnancy. Paregoric is excreted in breast milk. If you are or will be breast-feeding while you are using Paregoric , check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Paregoric may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Paregoric stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Paregoric . This is known as DEPENDENCE or addiction.

If you suddenly stop taking Paregoric , you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Paregoric :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; confusion; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; slow breathing; slow heartbeat.

Store Paregoric at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Paregoric out of the reach of children and away from pets.

General information:

• If you have any questions about Paregoric , please talk with your doctor, pharmacist, or other health care provider.
• Paregoric is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paregoric . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.