Promethazine; Phenylephrine; Codeine Solution

What is this medication?

PROMETHAZINE; PHENYLEPHRINE; CODEINE (proe METH a zeen; fen il EF rin; KOE deen) treats the symptoms of the common cold, allergies, or flu. It works by reducing cough, a runny or stuffy nose, and red, itchy eyes. It is a combination of an antihistamine, a decongestant, and an opioid cough suppressant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Pentazine VC with Codeine, Prometh VC with Codeine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison's disease
• Brain tumor
• Diabetes
• Gallbladder disease
• Glaucoma
• Head injury
• Heart disease
• History of irregular heartbeat
• History of substance use disorder
• If you frequently drink alcohol
• Kidney disease
• Liver disease
• Low blood pressure
• Lung or breathing disease, like asthma
• Mental health condition
• Pancreatic disease
• Seizures
• Stomach or intestine problems
• Thyroid disease
• Trouble passing urine
• An allergic or unusual reaction to codeine, phenylephrine, promethazine, phenothiazines, sulfites, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Do not to overfill. Rinse the measuring device with water after each use. Take your medication at regular intervals. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take extra or double doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol
• Antihistamines or decongestants for allergy, cough and cold
• Certain medications for anxiety or sleep
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Cisapride
• Dofetilide
• Dronedarone
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Herbal or dietary supplements containing ephedra or ephedrine
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Metoclopramide
• Other narcotic medications (opiates) for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Pimozide
• Quinidine

This medication may also interact with the following:

• Antiviral medications for hepatitis, HIV or AIDS
• Atropine
• Bromocriptine
• Certain antibiotics like erythromycin, clarithromycin
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for Parkinson disease like benztropine, trihexyphenidyl
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Ipratropium
• Linezolid
• Methyldopa
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Rifampin
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Yohimbine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Use exactly as directed by your care team. Do not take more than the recommended dose. You may develop tolerance to this medication if you take it for a long time. Tolerance means that you will get less cough relief with time. Tell your care team if your symptoms do not improve or if they get worse.

If you have been taking this medication for a long time, do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medications (opiates). If you take more than one type at the same time or if you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Call emergency services for help if you have problems breathing or unusual sleepiness.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

This medication will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating drops may help. See your eye care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart palpitations—rapid, pounding, or irregular heartbeat
• High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome
• Increase in blood pressure
• Infection—fever, chills, cough, or sore throat
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Trouble passing urine
• Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Anxiety, nervousness
• Confusion
• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep this medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and is against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light.

This medication may cause harm and death if taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.