Intuniv (Guanfacine) Patient Information

Find out why ADHD medication, Intuniv, is prescribed, side effects of Intuniv, Intuniv warnings, how Intuniv should be taken, more - in plain English.

Generic Name: Guanfacine
Brand Name: Intuniv

Pronounced: in-TOO-niv

Full Intuniv (Guanfacine) prescribing information

Read the Patient Information that comes with INTUNIV^TM 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.

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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.
• 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
• tiredness
• drowsiness

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

The most common side effects of INTUNIV include:

• sleepiness
• drowsiness
• low blood pressure
• headache
• nausea
• stomach pain
• dry mouth
• dizziness
• irritability
• constipation
• not hungry (decreased appetite)

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 (15oC to 30oC)

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.comor 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 3mg and 4mg tablets also contain green pigment blend PB-1763.

Manufactured for Shire US Inc., Wayne, PA 19087.

INTUNIV is a trademark of Shire LLC.

©2009 Shire Pharmaceuticals Inc.

This product is covered by US patents including 5,854,290; 6,287,599; 6,811,794.

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Version: August 2009

Full Intuniv (Guanfacine) prescribing information

back to: Psychiatric Medication Patient Information Index