Consumer Information for: SANDOZ OXYCODONE/ACETAMINOPHEN

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Oxycodone/Acetaminophen. Talk about any health conditions or problems you may have, including if you:

• Have a history of illicit or prescription drug or alcohol abuse.
• Have severe kidney, liver or lung disease.
• Are taking other products containing acetaminophen. Acetaminophen can cause decreased liver function. Taking more than the maximum daily dose of acetaminophen may cause severe or possibly fatal liver damage People with liver disease or reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
• Have heart disease.
• Have low blood pressure.
• Have past or current depression.
• Suffer from chronic or severe constipation.
• Have problems with your adrenal or prostate gland.
• Have, or had in the past hallucinations or other severe mental problems.
• Suffer from migraines.
• Are planning to become pregnant.

DO NOT take with other products containing acetaminophen. Taking more than the maximum daily dose of acetaminophen may cause severe or possibly fatal liver damage.

Serious Skin Reactions (Acute Generalized Exanthematous Pustulosis, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis): Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is lifethreatening.

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery:
Do not use Sandoz Oxycodone/Acetaminophen while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. Sandoz Oxycodone/Acetaminophen can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Sandoz Oxycodone/Acetaminophen. Sandoz Oxycodone/Acetaminophen can cause:

• drowsiness
• dizziness or
• lightheadedness.

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Sandoz Oxycodone/Acetaminophen.

Serotonin Syndrome: Sandoz Oxycodone/Acetaminophen can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take Sandoz Oxycodone/Acetaminophen with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.