Primalev

Primalev is part of the drug classes:

• Anilides

• Natural opium alkaloids

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not use Xartermis™ XR if you are using or have used an MAO inhibitor in the past 14 days. Using these medicine together may cause serious unwanted effects.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may reduce infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• black, tarry stools
• chills
• dark urine
• dizziness
• fever
• headache
• itching
• light-colored stools
• loss of appetite
• nausea
• rash
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

• Cough or hoarseness
• fever with or without chills
• general feeling of tiredness or weakness
• lower back or side pain
• painful or difficult urination
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• unusual bleeding or bruising

• Back, leg, or stomach pains
• bleeding gums
• bloating
• blood in the urine or stools
• blue lips and fingernails
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• clay-colored stools
• cloudy urine
• clumsiness
• confusion
• constipation
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• decreased frequency or amount of urine
• difficult or labored breathing
• difficult or painful urination
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• extremely shallow or slow breathing
• fainting
• fast or deep breathing
• fast, slow, irregular, pounding, or racing heartbeat
• feeling of warmth
• general body swelling
• increased sweating
• increased thirst
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• muscle aches
• muscle tremors
• muscle weakness
• nervousness
• noisy breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, deep or shallow breathing
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• seizures
• severe constipation
• severe sleepiness
• severe vomiting
• skin blisters
• skin rash, hives, or welts
• sleepiness
• sore throat
• stomach cramps
• sunken eyes
• sweating
• swelling of the face, fingers, lower legs, or ankles
• thirst
• tightness in the chest
• tiredness
• vomiting
• weakness or heaviness of the legs
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bluish lips or skin
• change in consciousness
• cold, clammy skin
• extreme sleepiness
• general feeling of discomfort or illness
• loss of consciousness
• low blood pressure or pulse
• slow breathing
• unconsciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Relaxed and calm feeling

• Acid or sour stomach
• agitation
• bad, unusual or unpleasant (after) taste
• belching
• change in taste
• cold sweats
• constricted, pinpoint, or small pupils (black part of the eye)
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• depression
• diarrhea
• difficulty with moving
• disturbed color perception
• double vision
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• flushed, dry skin
• fruit-like breath odor
• full feeling
• general feeling of discomfort or illness
• halos around lights
• hearing loss
• heartburn
• increased hunger
• increased urination
• indigestion
• joint pain
• lack or loss of strength
• muscle cramps or spasms
• muscle pain or stiffness
• night blindness
• nightmares
• overbright appearance of lights
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness
• sleepiness or unusual drowsiness
• slurred speech
• stomach discomfort, upset, or pain
• sweating
• swollen joints
• thirst
• trouble sleeping
• tunnel vision
• unexplained weight loss
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Acetaminophen and oxycodone is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and oxycodone may also be used for purposes not listed in this medication guide.

This medicine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share acetaminophen and oxycodone with another person.

Oxycodone 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.

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

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

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

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or oxycodone, or if:

• you have severe asthma or breathing problems;

• you have a blockage in your stomach or intestines, including paralytic ileus; or

• you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Some medicines can interact with oxycodone 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.

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

• any type of breathing problem or lung disease;

• liver disease, cirrhosis, or if you drink alcohol daily;

• a history of drug abuse, alcohol addiction, or mental illness;

• kidney disease, urination problems;

• problems with your gallbladder, pancreas, thyroid, or adrenal gland;

• a history of head injury, brain tumor, or seizures; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use oxycodone 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.

Acetaminophen and oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone 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 acetaminophen and oxycodone is against the law.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

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

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

Do not keep leftover acetaminophen and oxycodone pills or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills or liquid medicine down the toilet.

Never crush or break an acetaminophen and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using this 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.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness.

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 acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.