Using opium/belladonna with other medications that may also cause drowsiness or breathing problems may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you use the smallest dose of opium/belladonna that works, and use it for the shortest possible time. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Who should not take Belladonna Alkaloids-Opium 16.2 Mg-60 Mg Rectal Suppository?
This product is used to treat moderate to severe pain from spasms of the urinary tract. It contains 2 medications, belladonna and opium. Belladonna helps to decrease the spasms. Opium is an opioid (narcotic) medication that helps to relieve pain.
This product is not recommended for use in children 12 years or younger.
Wash your hands before and after using the suppository. Unwrap the suppository and moisten it with water. Insert 1 suppository into the rectum as directed by your doctor. Lie down on your left side with right knee bent. Gently push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for use in the rectum only.
The dosage is based on your medical condition and response to treatment. Do not increase your dose, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
See also Warning section.
Nausea, vomiting, constipation, blurred vision, increased eye discomfort in bright light, lightheadedness, dizziness, drowsiness, increased/decreased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, fainting, slow/fast heartbeat, eye pain, vision changes, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using this product, tell your doctor or pharmacist if you are allergic to belladonna or opium; or to opioid pain medications (such as morphine, codeine); or to atropine or scopolamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain muscle/nerve disease (myasthenia gravis), certain stomach/bowel diseases (paralytic ileus, blockage, infectious diarrhea), glaucoma (narrow-angle).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), personal or family history of regular use/abuse of drugs/alcohol, heart problems (such as irregular heartbeat, heart failure, coronary artery disease), high blood pressure, brain disorders/injuries (such as seizures, head injury, tumor, increased intracranial pressure), thyroid disease, gallbladder disease, disease of the pancreas (such as pancreatitis), adrenal gland problems (such as Addison's disease), mental/mood disorders (such as toxic psychosis), stomach/intestinal disorders (such as colitis, ulcer), glaucoma (open-angle), heartburn.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist that you are using this medication.
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
It is unknown if belladonna passes into breast milk. Opium passes into breast milk, and the effect on a nursing infant is not known. Discuss the risks and benefits with your doctor before breast-feeding.
See also Warning section.
Your doctor or pharmacist may already be aware of any possibledrug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cimetidine, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), potassium tablets/capsules, pramlintide, rifampin.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, fast heartbeat, coma.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
If you are using this medication regularly and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not refrigerate. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.
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