MEDICATION GUIDE

PRIMLEV™ is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and 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.

1. Important information about PRIMLEV™:
2. Get emergency help right away if you take too much PRIMLEV™ (overdose). When you first start taking PRIMLEV™, 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 PRIMLEV™ 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.
3. Never give anyone else your PRIMLEV™. They could die from taking it. Store PRIMLEV™ away from children and in a safe place to prevent stealing or abuse. Selling or giving away PRIMLEV™ is against the law.

Do not take PRIMLEV™ if you have:

• Severe asthma, trouble breathing, or other lung problems
• A bowel blockage or have narrowing of the stomach or intestines
• Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in PRIMLEV™

1. Before taking PRIMLEV™, tell your healthcare provider if you have a history of:
2. Head injury, seizures
3. Liver, kidney, thyroid problems
4. Problems urinating
5. Pancreas or gallbladder problems
6. Abuse of street or prescription drugs, alcohol addiction, or mental health problems
7. Tell your healthcare provider if you are:
8. Pregnant or planning to become pregnant. Prolonged use of PRIMLEV™ during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
9. Breastfeeding. PRIMLEV™ passes into breast milk and may harm your baby.
10. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking PRIMLEV™ with certain other medicines can cause serious side effects that could lead to death.

1. When taking PRIMLEV™:
2. Do not change your dose. Take PRIMLEV™ exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
3. Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
4. Call your healthcare provider if the dose you are taking does not control your pain.
5. If you have been taking PRIMLEV™ regularly, do not stop taking PRIMLEV™ without talking to your healthcare provider.
6. After you stop taking PRIMLEV™, dispose of unused tablets by flushing them down the toilet.

1. While taking PRIMLEV™ DO NOT:
2. Drive or operate heavy machinery, until you know how PRIMLEV™ affects you. PRIMLEV™ can make you sleepy, dizzy, or lightheaded.
3. Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with PRIMLEV™ may cause you to overdose and die.