PSEUDOEPHEDRINE-HYDROCODONE

Do not use this drug:

• Along with other products that cause drowsiness or breathing problems.
• To children younger than 18 years to treat cough or pain. Dihydrocodeine may cause serious complication. Wait for your doctor’s approval.
• To children under 12 years unless specifically prescribed by the doctor.

Common side effects may include:

• Dizziness
• Drowsiness
• Headache
• Upset Stomach
• Nausea
• Constipation
• Nervousness
• Trouble Sleeping

Notify your doctor promptly if any of these symptoms persist or worsen.

Your doctor may have prescribed this medication because he or she judged that the benefit to you is greater than the risk of side effects.

Serious side effects may include:

• Mental or Mood Changes (e.g., Hallucinations)
• Shaking (Tremors)
• Trouble Urinating
• Weakness
• Fast, Slow or Irregular Heartbeat
• Seizures
• Severe Allergic Reaction

Seek immediate medical attention if you experience any of these serious side effects.

Precautions

Before taking this medication, tell your doctor or pharmacist:

• If you are allergic to any of its ingredients; or if you have any other allergies.
• If you are to undergo any surgery.
• If you are pregnant or breastfeeding.
• Your medical history, especially of:
  • Abdominal Problems (e.g., Chronic Constipation, Gallbladder Disease, Pancreatitis)
  • Adrenal Gland Problems (e.g., Addison’s Disease)
  • Blood Vessel Problems (e.g., Raynaud’s Disease, Low Blood Flow to the Brain, Legs or Hands)
  • Brain Disorders (e.g., Head Injury, Tumor, Increased Pressure in the Brain)
  • Breathing Problems (e.g., Asthma, Emphysema, Sleep Apnea)
  • Diabetes
  • Glaucoma
  • Heart Problems
  • High Blood Pressure
  • Kidney Problems
  • Liver Disease
  • Mental or Mood Problems (e.g., Depression, Psychosis)
  • A Certain Spinal Problem (Kyphoscoliosis)
  • Recent Surgery
  • Thyroid Problems
  • Trouble Urinating (e.g., Due to Enlarged Prostate)
  • Use or Abuse of Drugs and/or Alcohol

This drug may cause dizziness, drowsiness or blurred vision. Avoid activities requiring alertness or clear vision such as driving until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness.

Older adults and children may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, mental or mood changes, constipation, fast heartbeat, trouble urinating, or blood pressure changes.

Interactions

Drug interactions may either lessen the effectiveness of this drug or heighten the risk for severe side effects. It’s important to inform your doctor all the medication including prescription and non-prescription and herbal medicines you are taking or going to take.

Possible interactions with this drug are:

• Drugs for High Blood Pressure (e.g., Methyldopa, Reserpine, Beta Blockers such as Metoprolol and Atenolol)
• Cimetidine
• Narcotic Antagonists (e.g., Naltrexone, Naloxone)
• MAO Inhibitors (Isocarboxazid, Linezolid, Methylene Blue, Moclobemide, Phenelzine, Procarbazine, Rasagiline, Selegiline, Tranylcypromine)
• 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)
• Antihistamines (such as Cetirizine, Diphenhydramine)

This medication may interfere with certain laboratory tests such as Amylase or Lipase levels. Make sure laboratory personnel and all your doctors know you use this drug to avoid false results.

Call emergency hotline if someone has overdosed and has serious symptoms such as passing out or trouble breathing.

Symptoms of overdose may include:

• Confusion
• Cold or Clammy Skin
• Fainting, Fast or Irregular Heartbeat
• Slow or Shallow Breathing
• Seizures
• Coma