Qdolo is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management of pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

• Get emergency help right away if you take too much Qdolo (overdose). When you first start taking Qdolo, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking Qdolo with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your Qdolo. They could die from taking it. Selling or giving away Qdolo is against the law.
• Store Qdolo securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients:

• Do not give Qdolo to a child younger than 12 years of age.
• Do not give Qdolo to anyone younger than 18 years of age after surgery to remove the tonsils, adenoids, or both.
• Avoid giving Qdolo to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

When taking Qdolo:

• Do not change your dose. Take Qdolo exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Always use a calibrated oral syringe or other oral dosing device obtained from your doctor or pharmacist to correctly measure your dose. Never use a household teaspoon or tablespoon to measure Qdolo.
• Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 10 mL to 20 mL every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 80 mL per day. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Qdolo regularly, do not stop taking Qdolo without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Qdolo by taking your drug to an authorized Drug Enforcement Administration (DEA)-registered collector or drug take-back program. If one is not available, you can dispose of Qdolo by mixing Qdolo with dirt, cat litter, or used coffee grounds; placing the mixture in a container such as a sealed plastic bag; and throwing the container in the household trash.

While taking Qdolo DO NOT:

• Drive or operate heavy machinery, until you know how Qdolo affects you. Qdolo can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Qdolo may cause you to overdose and die.

Do not take Qdolo if you have:

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.
• An allergy to tramadol
• Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking Qdolo

Before taking Qdolo, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Qdolo during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended; it may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Qdolo with certain other medicines can cause serious side effects that could lead to death.

The possible side effects of Qdolo include:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Qdolo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.