Ryzolt is a narcotic-like pain reliever.

Ryzolt extended-release tablets are used to treat moderate to severe chronic pain when treatment is needed around the clock

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

You should not take Ryzolt if you have used alcohol, sedatives, tranquilizers, or narcotic medications within the past few hours.

Ryzolt can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Ryzolt in larger amounts, or for longer than prescribed. Do not crush or break an extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Seizures (convulsions) have occurred in some people taking this medicine. Ryzolt may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting

Tramadol may be habit-forming, even at regular doses. Take Ryzolt exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Ryzolt may cause life-threatening withdrawal symptoms in a newborn.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Ryzolt.

Do not crush the Ryzolt tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

Take Ryzolt exactly as prescribed. Follow all directions on your prescription label. Tramadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Ryzolt in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Ryzolt can be taken with or without food, but take it the same way each time.

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

Never crush or break a Ryzolt pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tramadol and similar prescription drugs.

The Ryzolt tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Do not stop using Ryzolt suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tramadol.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

You should not take Ryzolt if you are allergic to tramadol, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines;

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

Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:

• a history of head injury, epilepsy or other seizure disorder;

• a history of drug or alcohol addiction;

• a metabolic disorder; or

• if you are also using certain medicines to treat migraine headaches, muscle spasms, depression, mental illness, or nausea and vomiting.

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

• liver or kidney disease;

• a stomach disorder; or

• a history of drug abuse, alcohol addiction, mental illness, or suicide attempt.

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

Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share Ryzolt with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Ryzolt to any other person is against the law.

It is not known whether Ryzolt will harm an unborn baby. If you use tramadol 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.

Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Ryzolt.

Do not give this medication to anyone younger than 16 years old without the advice of a doctor. Ultram ER should not be given to anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tramadol 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, cold and clammy skin, and fainting.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Ryzolt. Check your food and medicine labels to be sure these products do not contain alcohol.

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

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

Call your doctor at once if you have:

• seizure (convulsions);

• weak or shallow breathing;

• high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Ryzolt side effects may include:

• headache, dizziness, drowsiness, tired feeling;

• constipation, diarrhea, nausea, vomiting, stomach pain; or

• feeling nervous or anxious.

• itching, sweating, flushing (warmth, redness, or tingly feeling).

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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Ryzolt with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.