codeine

Pronunciation: KOE deen

Codeine Sulfate 15 mg-ROX

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Codeine Sulfate 30 mg-ROX

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Codeine Sulfate 60 mg-ROX

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What is the most important information I should know about codeine?

You should not use this medicine if you have severe breathing problems, a blockage in your stomach or intestines, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Codeine is not for use in children younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking codeine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use codeine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What is codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic.

Codeine is used to treat mild to moderately severe pain.

Codeine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking codeine?

You should not use this medicine if you are allergic to it, or if you have:

  • severe asthma or breathing problems;
  • a blockage in your stomach or intestines; or
  • frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Codeine should not be given to a child younger than 12 years old.

Do not give codeine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • liver disease;
  • asthma, COPD, sleep apnea, or other breathing disorders;
  • abnormal curvature of the spine that affects breathing;
  • kidney disease;
  • a head injury or brain tumor;
  • low blood pressure;
  • blockage in your digestive tract (stomach or intestines);
  • a gallbladder or pancreas disorder;
  • underactive thyroid;
  • Addison's disease or other adrenal gland disorder;
  • enlarged prostate, urination problems;
  • mental illness;
  • drug or alcohol addiction; or
  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

How should I take codeine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use codeine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take codeine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking codeine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medicine, flush any unused pills down the toilet.

What happens if I miss a dose?

Since codeine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking codeine?

Do not drink alcohol. Dangerous side effects or death could occur.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how codeine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What are the possible side effects of codeine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness;
  • seizure (convulsions);
  • problems with urination;
  • infertility, missed menstrual periods;
  • impotence, sexual problems, loss of interest in sex; or
  • low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects include:

  • feeling dizzy or drowsy;
  • nausea, vomiting, stomach pain;
  • constipation;
  • sweating; or
  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect codeine?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications --opioid pain medicine or prescription cough medicine;
  • drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
  • drugs that affect serotonin levels in your body --medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about codeine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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