Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision 7 .
Opium usage may result in constipation, nausea or vomiting.
Pruritis and urticaria may occasionally occur.
Hypersensitivity to opium or belladonna may occur.
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [ see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [ see Warnings and Precautions (5.2) ] • Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.3) ] • Interactions with Benzodiazepines and Other CNS Depressants [ see Warnings and Precautions (5.4) ] • Adrenal Insufficiency [ see Warnings and Precautions (5.6) ] • Severe Hypotension [ see Warnings and Precautions (5.7) ] • Gastrointestinal Adverse Reactions [ see Warnings and Precautions (5.9) ] • Seizures [ see Warnings and Precautions (5.11) ] • Withdrawal [ see Warnings and Precautions (5.12) ] Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomiting.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of opioids.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
5 WARNINGS AND PRECAUTIONS These preparations are not recommended for use in children.
• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
(5.5) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
(5.6) • Severe Hypotension: Monitor during dosage initiation and titration.
Avoid use of Morphine Sulfate Oral Solution in patients with circulatory shock.
Like all medications, Belladonna And Opium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: