Codeine Phosphate, Chlorpheniramine Maleate Oral tablet, extended-release

What is this medicine?

CHLORPHENIRAMINE; CODEINE (klor fen IR a meen; KOE deen) is a combination of an antihistamine and cough suppressant. It is used to treat the symptoms of cough, allergies, and colds.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not crush, cut or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Follow the directions on the prescription label. Take your medicine 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 pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

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

• constipation

• dry mouth

• nausea, vomiting

• tiredness

What may interact with this medicine?

Do not take this medication with any of the following medicines:

• alcohol

• certain medicines for anxiety or sleep

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin, primidone

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• local anesthetics like lidocaine, pramoxine, tetracaine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines that relax muscles for surgery

• other antihistamines for allergy, cough and cold

• other narcotic medicines for pain or cough

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• atropine

• certain antibiotics like erythromycin and clarithromycin

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for irregular heart beat like amiodarone, propafenone, quinidine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• ipratropium

• rifampin

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 double or extra doses.

Where should I keep my medicine?

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

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Keep container tightly closed. Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

What should I tell my health care provider before I take this medicine?

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

• head injury

• history of a drug or alcohol abuse problem

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• other chronic illness

• prostate disease

• stomach or intestine problems

• thyroid disease

• an unusual or allergic reaction to chlorpheniramine, codeine, other pain medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

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

There are different types of narcotic medicines (opiates). If you take more than one type at the same time or if you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency 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 medicine 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 medicine. Avoid alcoholic drinks.

Children may be at higher risk for side effects. If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.

Immediately call your physician or get emergency help if you are breast-feeding and your baby is sleepier than usual, is limp, or has difficulty breast-feeding or breathing.

The medicine 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 doctor or health care professional.

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