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Who should not take ONYDA XR?

Do not take ONYDA XR if you are allergic to clonidine.

Before taking ONYDA XR, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• have low or high blood pressure
• have a history of passing out (syncope)
• have heart problems, including slow heart rate or other heart rhythm problems
• had a stroke or have stroke symptoms
• had an allergic reaction after taking clonidine through your skin in a transdermal system (patch)
• are pregnant or plan to become pregnant - It is not known if ONYDA XR will harm the unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  There is a pregnancy registry for females who are exposed to ADHD medications, including ONYDA XR, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ONYDA XR and their baby. If you become pregnant during treatment with ONYDA XR, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
• are breastfeeding or plan to breastfeed - ONYDA XR passes into the breast milk. Babies who are breastfed during treatment with ONYDA XR may become very sleepy, develop relaxed or floppy muscles, and develop trouble breathing. Call the baby’s healthcare provider if the baby is breastfed during treatment with ONYDA XR and develops any of these symptoms. Talk to your healthcare provider about the best way to feed your baby if you take ONYDA XR.

Tell your healthcare provider about all of the medicines that you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

ONYDA XR and certain other medicines may affect each other causing serious side effects. Especially tell your healthcare provider if you take:

• anti-depression medicines
• other medicines for ADHD
• heart or blood pressure medicines
• medicines that cause sleepiness (sedation)
• other medicines that contain clonidine

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.

Know the medicines that you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking ONYDA XR?

• Do not become dehydrated or too hot (overheated) to decrease your chance of passing out during treatment with ONYDA XR.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ONYDA XR affects you because ONYDA XR can cause sleepiness and tiredness that could cause slow reaction times.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy during treatment with ONYDA XR until you talk with your healthcare provider. Taking ONYDA XR with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not suddenly stop ONYDA XR. Tell your healthcare provider if you have been vomiting and cannot take ONYDA XR, you may be at risk for rebound hypertension.

What are possible side effects of ONYDA XR?

ONYDA XR may cause serious side effects, including:

• Decreased blood pressure and heart rate. ONYDA XR can decrease your blood pressure and heart rate, which can increase your chance of passing out (syncope). If you have a history of passing out or have other medical problems or take other medicines that increase your risk of passing out, your risk is higher. Your healthcare provider should check your heart rate and blood pressure before starting treatment and regularly during treatment with ONYDA XR. See “What should I avoid while taking ONYDA XR?”
• Sleepiness and tiredness that could cause slow reaction times (sedation and somnolence). See “What should I avoid while taking ONYDA XR?”
• Rebound high blood pressure (hypertension). Suddenly stopping ONYDA XR can cause high blood pressure to return if you have a history of high blood pressure. Suddenly stopping ONYDA XR may also cause withdrawal symptoms including headache, increased heart rate, nausea, flushing or warm feeling lightheadedness, tightness in your chest and nervousness or anxiety. Do not suddenly stop ONYDA XR treatment without first talking to your healthcare provider.
• Allergic reactions. You may develop an allergic reaction to ONYDA XR if you had an allergic reaction to clonidine taken through your skin in a patch. Stop taking ONYDA XR and call your healthcare provider right away or go to the nearest emergency room if you develop any signs or symptoms of an allergic reaction (including skin rash, hives, swelling of the eyes, face, lips, or tongue).

The most common side effects of ONYDA XR when used alone include:

• falling asleep or sleepiness and tiredness that could cause slow reaction times
• nightmare
• constipation
• irritability
• trouble sleeping
• dry mouth

The most common side effects of ONYDA XR when used with other ADHD medicines include:

• falling asleep or sleepiness and tiredness that could cause slow reaction times
• decreased appetite
• dizziness

ONYDA XR may cause fertility problems in females and males, which may affect your ability to have a child. Talk to your healthcare provider, if this is a concern for you.

These are not all of the possible side effects of ONYDA XR. Call your doctor for medical advice about side effects. You may report side effects to Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088.