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This medication requires careful consideration due to its potential risks and side effects. Please review the following guidelines to ensure safe use and consult your healthcare provider if you have any concerns.

• Abuse and Addiction Risk: This medication has a potential for misuse and addiction, which can result in overdose and even death. It is crucial to use the smallest effective dose for the shortest duration necessary. Especially at the beginning of treatment or if the prescribed dose is exceeded, there is an increased risk of severe breathing issues. Combining this medication with alcohol or other substances that induce drowsiness or respiratory problems can lead to severe, possibly fatal, side effects.

• Serious Breathing Issues: The risk of respiratory depression is heightened when starting this medication or increasing the dose. High-risk groups include older adults, children under 12, and individuals with certain genetic profiles. Avoid combining this drug with alcohol or medications like benzodiazepines that can exacerbate breathing difficulties.

• Extreme Drowsiness and Impaired Concentration: This medication may cause significant drowsiness and affect your ability to focus. Caution should be exercised when engaging in activities that require alertness, such as driving. Consult your healthcare provider if you experience excessive sleepiness.

• Drug Interactions: This medication can interact with various drugs, potentially increasing the risk of side effects. Notable interactions include drugs like erythromycin and ritonavir, which can elevate codeine levels, and others like rifampin, which may reduce its effectiveness.

• Pregnancy and Newborn Risks: Using this medication during pregnancy can affect the unborn baby, leading to dependency and withdrawal symptoms in the newborn. Such symptoms include persistent crying, breathing difficulties, and feeding issues. Discuss with your doctor the risks and benefits if you are pregnant or planning to become pregnant.

• Low Blood Pressure: This medication may lead to extremely low blood pressure, causing dizziness or fainting. Rise slowly from sitting or lying positions to minimize these effects.

• Adrenal Hormone Levels: Prolonged use of this medication may lower adrenal hormone levels, leading to symptoms such as nausea and fatigue. Consult your healthcare provider if you experience such symptoms.

• Seizures: Individuals with a history of seizures may experience an increase in frequency. Report any changes to your healthcare provider.

• Neuroleptic Malignant Syndrome (NMS): Although rare, this medication can cause NMS, a life-threatening condition. Symptoms include fever and muscle stiffness. Immediate medical attention is required if symptoms occur.

• Uncontrolled Body Movements: Some users may experience involuntary movements, especially if dehydrated. Contact your healthcare provider if you experience such symptoms.

• Certain Medical Conditions: Inform your healthcare provider about existing health conditions, as this medication may not be suitable for everyone.

• Lab Test Interference: This medication may cause false results in certain lab tests, such as pregnancy and blood sugar tests. Inform your healthcare provider if you are undergoing any tests.

In case of overdose, seek immediate medical assistance. Keep this medication out of reach of others to prevent misuse. If accidental ingestion occurs, contact medical help right away. For individuals with contraindications, such as severe asthma or allergies to components of the medication, consult your healthcare provider before use.

Common side effects:

• drowsiness
• dizziness
• headache
• lightheadedness
• blurred vision
• upset stomach
• nausea
• constipation
• dry mouth

Less common but important to monitor:

• interrupted breathing during sleep (sleep apnea)
• involuntary movements
• mental changes like hallucinations or confusion
• ringing in the ears
• tremors
• difficulty urinating
• weakness
• persistent nausea or vomiting
• easy bruising
• slow heartbeat
• severe abdominal pain
• yellowing of the skin or eyes
• seizures

Serious side effects:

• dangerously slow or shallow breathing
• extreme drowsiness
• confusion
• severe allergic reactions
• Neuroleptic malignant syndrome (NMS)
• opioid withdrawal symptoms

Interactions with high risk of serious adverse effects and should be avoided:

• Bepridil
• Bromopride
• Calcium Oxybate
• Cisapride
• Dronedarone
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Magnesium Oxybate
• Mesoridazine
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Phenelzine
• Pimozide
• Piperaquine
• Potassium Oxybate
• Procarbazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sodium Oxybate
• Sparfloxacin
• Terfenadine
• Thioridazine
• Toloxatone
• Tranylcypromine
• Ziprasidone

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Abametapir
• Acepromazine
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amphetamine
• Bupropion
• Carbamazepine
• Carisoprodol
• Cetirizine
• Cimetidine
• Cyclobenzaprine
• Diphenhydramine
• Doxepin
• Fentanyl
• Fluoxetine
• Hydrocodone
• Ketoconazole
• Lorazepam
• Metoclopramide
• Morphine
• Paroxetine
• Quinidine
• Rifabutin
• Rifampin
• Ritonavir
• Zolpidem