Clonidine Hydrochloride Extended-Release Tablets

The only authorized generic of KAPVAY® Clonidine Hydrochloride Extended-Release Tablets (0.1 mg)

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CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS- IMPORTANT SAFETY INFORMATION AND INDICATION

WHAT ARE CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS?

  • Clonidine Hydrochloride Extended-Release Tablets are a prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD). Your doctor may prescribe Clonidine Hydrochloride Extended-Release Tablets alone or together with certain other ADHD medicines.
  • Clonidine Hydrochloride Extended-Release Tablets are not a central nervous system stimulant.
  • Clonidine Hydrochloride Extended-Release Tablets should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

WHO SHOULD NOT USE CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS?  Do not take Clonidine Hydrochloride Extended-Release Tablets:

  • If you have a history of an allergic reaction to clonidine. Reactions have included generalized rash, hives, and swelling.

What should I tell my healthcare provider before taking Clonidine Hydrochloride Extended-Release Tablets?

Before you take Clonidine Hydrochloride Extended-Release Tablets, tell your healthcare provider if you:

  • have low or high blood pressure
  • have heart problems, including history of heart attack
  • have a history of passing out
  • have had a stroke or have stroke symptoms
  • have kidney problems
  • have any other medical conditions
  • take other medicines

What should I avoid while taking Clonidine Hydrochloride Extended-Release Tablets?

  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Clonidine Hydrochloride Extended-Release Tablets until you talk with your healthcare provider.  Clonidine Hydrochloride Extended-Release Tablets taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Clonidine Hydrochloride Extended-Release Tablets will affect you.
  • Do not stop taking Clonidine Hydrochloride Extended-Release Tablets without talking to your healthcare provider.
  • Avoid becoming dehydrated or overheated.

What are the possible side effects of Clonidine Hydrochloride Extended-Release Tablets?

Clonidine Hydrochloride Extended-Release Tablets may cause serious side effects, including:

  • Low blood pressure and low heart rate.  Your doctor should check your heart rate and blood pressure before starting treatment and regularly during treatment with Clonidine Hydrochloride Extended-Release Tablets.
  • Sleepiness
  • Withdrawal symptoms.  Suddenly stopping Clonidine Hydrochloride Extended-Release Tablets may cause withdrawal symptoms including: increased blood pressure, headache, increased heart rate, lightheadedness, tightness in your chest and nervousness.

The most common side effects of Clonidine Hydrochloride Extended-Release Tablets include:

  • Sleepiness, tiredness, irritability, trouble sleeping, nightmares, constipation, dry mouth, decreased appetite and dizziness.

These are not all the possible side effects of Clonidine Hydrochloride Extended-Release Tablets.  For more information, call your healthcare provider.  You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Prasco Laboratories at 1-866-525-0688. Full prescribing information can be found here. (click for prescribing information and patient information).

AG.CL.ISI-09/2018

PP-MA-AG-US-0036