PROMETHAZINE-PHENYLEPHRINE

Do not use this drug:

• More often than prescribed. Overdose may cause serious complications.
• To make a child sleepy.
• To children younger than 2 years and 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.

This medication may make you more sensitive to the sun. Limit your sun exposure and provide protection to your skin such as applying sunscreens. Also, avoid tanning booths and sunlamps. Tell your doctor right away if you get sunburned or have skin blisters or redness.

Common side effects may include:

• Drowsiness
• Dizziness
• Headache
• Upset Stomach
• Nausea
• 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:

• Mental or Mood Changes (such as Confusion, Hallucinations)
• Ringing In The Ears
• Shaking (Tremors)
• Difficulty Urinating
• Vision Changes (such as Blurred or Double Vision)

Rare but serious side effects may occur, including:

• Easy Bruising or Bleeding
• Slow or Shallow Breathing
• Involuntary Behaviors or Movements (such as Fixed Upward Stare, Neck Twisting, Tongue Movements)
• Seizure
• Neuroleptic Malignant Syndrome (NMS)
• 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 promethazine or phenylephrine; 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:
  • Blood or Immune System Problems (such as Bone Marrow Depression)
  • Breathing Problems (such as Asthma, Emphysema, Sleep Apnea)
  • Diabetes
  • Glaucoma
  • Heart Problems (such as Angina, Irregular Heartbeat)
  • High Blood Pressure
  • Liver Problems
  • Seizure
  • Stomach/Bowel Problems (such as Ulcer, Blockage)
  • Overactive Thyroid (Hyperthyroidism)
  • Difficulty Urinating (such as Due to Enlarged Prostate)

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)
• Cabergoline
• Metoclopramide
• Pergolide
• 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)
• Other Antihistamines (such as Cetirizine, Diphenhydramine)

This medication may interfere with certain laboratory tests such as pregnancy tests, blood sugar tests, and skin test for allergies. 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
• Slowed Breathing
• Seizure

Available brand/s:

Precedex