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INTUNIV®
(in-TOO-niv)
(guanfacine) Extended-Release Tablets

Read the Patient Information that comes with INTUNIV® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is INTUNIV®?

INTUNIV® is a prescription medicine used to treat the symptoms of attention deficit/hyperactivity disorder (ADHD).

INTUNIV® is not a central nervous system (CNS) stimulant.

INTUNIV® should be used as a part of a total treatment program for ADHD that may include counselling or other therapies.

It is not known if INTUNIV® is effective:

• for use longer than 9 weeks

It is not known if INTUNIV® is safe or effective:

• in children younger than 6 years old
• in adults

What should I tell my doctor before taking INTUNIV®?

Before you take INTUNIV®, tell your doctor if you:

• have heart problems or a low heart rate
• have fainted
• have low blood pressure
• have liver or kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if INTUNIV® will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It is not known if INTUNIV® passes into your breast milk. You and your doctor should decide if you will take INTUNIV® or breastfeed.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

INTUNIV® may affect the way other medicines work, and other medicines may affect how INTUNIV® works.

Especially tell your doctor if you take:

• ketoconazole
• medicines that can affect enzyme metabolism
• valproic acid
• high blood pressure medicine
• sedatives
• benzodiazepines
• barbiturates
• antipsychotics

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take INTUNIV®?

• Take INTUNIV® exactly as your doctor tells you.
• Your doctor may change your dose. Do not change your dose of INTUNIV® without talking to your doctor.
• Do not stop taking INTUNIV® without talking to your doctor.
• INTUNIV® should be taken 1 time a day, either alone or in combination with an ADHD stimulant medication that your doctor may prescribe. Your
• INTUNIV® should be swallowed whole with a small amount of water, milk, or other liquid.
• Do not crush, chew, or break INTUNIV®. Tell your doctor if you can not swallow INTUNIV® whole.
• Do not take INTUNIV® with a high-fat meal.
• Your doctor will check your blood pressure and heart rate while you take INTUNIV®.
• If you take too much INTUNIV®, call your local Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking INTUNIV®?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how INTUNIV® affects you. INTUNIV® can slow your thinking and motor skills.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking INTUNIV® until you talk with your doctor. INTUNIV® taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

What are the possible side effects of INTUNIV®?

INTUNIV® may cause serious side effects including:

• low blood pressure
• low heart rate
• fainting
• sleepiness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of INTUNIV® include:

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of INTUNIV®.

For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store INTUNIV®?

• Store INTUNIV® between 590F to 860F (15°C to 30°C)

Keep INTUNIV® and all medicines out of the reach of children.

General Information about INTUNIV®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use INTUNIV® for a condition for which it was not prescribed. Do not give INTUNIV® to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about INTUNIV®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INTUNIV® that is written for health professionals.

For more information, go to www.INTUNIV.com or call 1-800-828-2088.

What are the ingredients in INTUNIV®?

Active ingredient: guanfacine hydrochloride

Inactive ingredients: hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glycerol behenate. In addition, the 3 mg and 4 mg tablets also contain green pigment blend PB-1763.

Last reviewed on RxList: 6/17/2011
This monograph has been modified to include the generic and brand name in many instances.