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This medication carries a significant risk of abuse and addiction, potentially resulting in overdose and death. It may also lead to severe, possibly fatal, breathing issues. To minimize these risks, it is crucial that your doctor prescribes the lowest effective dose for the shortest duration necessary.

Key Safety Information:

• Breathing Risks: The risk of severe breathing problems is heightened at the start of treatment, if the dosage is incorrect, or if the medication is taken in excess. Combining this medication with alcohol or other substances that cause drowsiness or breathing difficulties can lead to serious side effects, including death.
• Drug Interactions: Other medications can impact how this drug is metabolized in your body, altering its effectiveness. Ensure you understand how to take this medication and which other drugs to avoid.
• Emergency Symptoms: Seek immediate medical help if you experience slow or shallow breathing, unusual lightheadedness, severe drowsiness, difficulty waking up, seizures, or hallucinations.
• Safe Storage: Store this medication securely to prevent theft, misuse, or abuse. In the event of accidental ingestion, seek medical assistance immediately.

Special Considerations for Specific Populations:

• Pregnant Women: Women of childbearing age should discuss potential risks and benefits with their healthcare provider before using this medication. It is generally not recommended during pregnancy, especially early on, due to a slight increase in the risk of birth defects. Prolonged use near the time of delivery may adversely affect the unborn child. Newborns exposed to the drug for an extended period may show withdrawal symptoms; contact a healthcare provider if such symptoms appear.
• Older Adults (65+): There is an increased likelihood of pronounced drowsiness, which can impair cognitive and motor skills. Avoid driving or operating heavy machinery until you understand how the medication affects you.

Contraindications and Precautions:

• Medical History: Inform your healthcare provider of any existing or past medical conditions, especially breathing problems, heart conditions, high blood pressure, diabetes, glaucoma, or urinary issues, as the medication can exacerbate these.
• MAOI Interaction: Do not use this medication if you are currently taking or have recently taken (within the last 14 days) an MAOI, as this can lead to dangerous interactions.

Please consult your healthcare provider if you have any questions or concerns regarding your use of this medication.

When taking this medication, you might experience mild side effects such as drowsiness, dizziness, headache, blurry vision, upset stomach, nausea, constipation, or a dry mouth, nose, or throat. These effects are usually not serious, but if they persist or worsen, it's advisable to discuss them with your healthcare provider. To alleviate dry mouth, you might find relief by sucking on sugarless candy or ice chips, chewing sugarless gum, drinking water, or using a saliva substitute. Staying hydrated is also important to prevent the thickening of mucus in your lungs, which can make breathing more difficult.

For serious side effects, immediate medical attention is necessary. These include symptoms like interrupted breathing during sleep (sleep apnea), mental or mood changes such as hallucinations, ringing in the ears, tremors, trouble urinating, weakness, easy bruising or bleeding, and an irregular heartbeat. Particularly severe symptoms such as seizures, slow or shallow breathing, severe drowsiness, difficulty waking up, or confusion indicate the risk of serious complications and require urgent medical help. This is especially crucial as the medication may contain codeine or dihydrocodeine, which can convert into stronger opioids in the body, increasing the risk of dangerous side effects in some individuals.

Though a very serious allergic reaction is rare, seek immediate medical care if you experience symptoms like rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing. If you encounter any side effects not listed here, it is important to contact your healthcare provider for advice.

Certain medications may interact with this drug, potentially causing serious effects. Avoid using skin-applied antihistamines like diphenhydramine cream, ointment, or spray, as well as medications such as Naltrexone and samidorphan while taking this medicine. Taking MAO inhibitors (e.g., isocarboxazid, Linezolid, phenelzine, Selegiline) with this drug can lead to a severe, possibly life-threatening reaction. Do not use MAO inhibitors during your treatment and for two weeks prior. Consult your doctor for guidance on starting or stopping this medication.

The likelihood of experiencing severe side effects, such as slow or shallow breathing and extreme drowsiness, increases if this medication is combined with other substances that cause similar effects. Inform your healthcare provider if you are using opioid pain or cough relievers (like codeine or hydrocodone), alcohol, marijuana, sleep aids, anxiety medications (such as Alprazolam or Lorazepam), muscle relaxants (like Carisoprodol), or antihistamines (such as Cetirizine).

Check the labels of over-the-counter products for ingredients that might cause drowsiness and consult your pharmacist on their safe use. Additionally, some drugs can affect the way this medication is processed in your body, altering its effectiveness. These include azole antifungals (like Ketoconazole), certain antidepressants (such as bupropion or Fluoxetine), macrolide antibiotics (like Erythromycin), and seizure medications (such as Carbamazepine).

This drug might interfere with specific lab tests, possibly leading to incorrect results. It is important to inform all medical personnel about your use of this medication.