PROMETHAZINE-PHENYLEPH-CODEINE

Do not use this drug:

• To children younger than 18 after certain surgeries including tonsil or adenoid removal
• To children under 6 years due to an increased risk for serious breathing problems such as slow or shallow breathing
• To children under 12 years to treat cough or pain unless specifically directed by the doctor
• Along with other drug that contain the same ingredients or may also cause drowsiness and breathing problems. Overdose may cause serious complications.

Common side effects may include:

• Drowsiness
• Dizziness
• Headache
• Lightheadedness
• Blurred Vision
• Upset Stomach
• Nausea
• Nervousness
• Trouble Sleeping
• Constipation
• Dry Mouth

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.

Unlikely but serious side effects may include:

• Involuntary Behaviors or Movements (e.g., Fixed Upward Stare, Neck Twisting, Tongue Movements)
• Mental/Mood Changes (e.g., Hallucinations)
• Ringing In The Ears
• Shaking (Tremors)
• Trouble Urinating
• Weakness

Rare but very serious side effects may occur, including:

• Chest Pain
• Easy Bruising or Bleeding
• Slow Heartbeat
• Persistent Nausea or Vomiting
• Severe Abdominal Pain
• Yellowing Eyes or Skin
• Neuroleptic Malignant Syndrome (NMS)
• Severe Allergic Reaction

Precautions

Before taking this medication, tell your doctor or pharmacist:

• If you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); 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, Ileus, Pancreatitis)
  • Gallbladder Disease
  • Adrenal Gland Problem (e.g., Addison’s Disease)
  • Blood or Immune System Problems (e.g., Bone Marrow Depression)
  • Brain Disorders (e.g., Seizures, Head Injury, Tumor, Increased Intracranial Pressure)
  • Breathing Problems (e.g., Asthma, Emphysema, Sleep Apnea)
  • Diabetes
  • Glaucoma
  • Heart Problems (e.g., Angina, Irregular Heartbeat)
  • High Blood Pressure
  • Liver Disease
  • Mental or Mood Problems (e.g., Depression, Psychosis)
  • A Certain Spinal Problem (Kyphoscoliosis)
  • Stomach or Intestinal Problems (e.g., Ulcers, Blockage)
  • Thyroid Disease
  • Trouble Urinating (e.g., Due to Enlarged Prostate or Urethral Stricture)
  • Use or Abuse of Drugs and 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:

• Antihistamines Applied to the Skin (such as Diphenhydramine Cream, Ointment, Spray)
• Cimetidine
• Methyldopa
• Metoclopramide
• Narcotic Antagonists (e.g., Naltrexone, Naloxone)
• Quinidine
• Reserpine
• Mao Inhibitors (Isocarboxazid, Linezolid, Methylene Blue, Moclobemide, Phenelzine, Procarbazine, Rasagiline, Selegiline, Tranylcypromine)
• Opioid Pain or Cough Relievers (such as Morphine, Hydrocodone)
• Alcohol
• Drugs For Sleep or Anxiety (such as Alprazolam, Lorazepam, Zolpidem)
• Muscle Relaxants (such as Carisoprodol, Cyclobenzaprine)
• Other Antihistamines (such as Cetirizine, Diphenhydramine)
• Azole Antifungals (such as Ketoconazole)
• Macrolide Antibiotics (such as Erythromycin)
• HIV Medications (such as Ritonavir), Rifamycins (such as Rifabutin, Rifampin)
• Certain Drugs Used to Treat Seizures (such as Carbamazepine, Phenytoin)

This medication may interfere with certain laboratory tests such as some pregnancy tests, blood sugar tests, and 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
• Fast, Slow and Irregular Heartbeat
• Slow or Shallow Breathing
• Seizures
• Fainting
• Coma

Available brand/s:

• Acalka
• Adrecort