Guanfacine Extended-Release (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets in 100 count and 1000 count bottles.

1 mg 2 mg 3 mg 4 mg
Color White White Blue Blue
Shape Round Caplet Round Caplet
Debossment (top/bottom) A533/ 1 mg A534/ 2 mg A536/ 3 mg A538/ 4 mg
NDC number 100 count:

60429-960-01

100 count:

60429-961-01

100 count:

60429-962-01

100 count:

60429-963-01

Storage — Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read theFDA-approved patient labeling (Patient Information).

Dosing and Administration

Instruct patients to swallow guanfacine extended-release tablets whole with water, milk or other liquid. Tablets should not be crushed, chewed or broken prior to administration because this may increase the rate of release of the active drug. Patients should not take guanfacine extended-release tablets together with a high-fat meal, since this can raise blood levels of guanfacine extended-release tablets. Instruct the parent or caregiver to supervise the child or adolescent taking guanfacine extended-release tablets and to keep the bottle of tablets out of reach of children.

Advise patients not to abruptly discontinue guanfacine extended-release tablets as abrupt discontinuation can result in clinically significant rebound hypertension. Concomitant stimulant use and abrupt discontinuation of guanfacine extended-release tablets may increase this hypertensive response. Instruct patients on how to properly taper the dose to minimize the risk of rebound hypertension [see Dosage and Administration ( 2.5) and Warnings and Precautions ( 5.4] .

Adverse Reactions

Advise patients that sedation can occur, particularly early in treatment or with dose increases. Caution against operating heavy equipment or driving until they know how they respond to treatment with guanfacine extended-release tablets [see Warnings and Precautions ( 5.2) ] . Headache and abdominal pain can also occur. If any of these symptoms persist, or other symptoms occur, the patient should be advised to discuss the symptoms with the health care provider.

Advise patients to avoid becoming dehydrated or overheated, which may potentially increase the risks of hypotension and syncope [see Warnings and Precautions ( 5.1)] . Advise patients to avoid use with alcohol.

Patient Information

Guanfacine Extended-Release Tablets

Read the Patient Information that comes with guanfacine extended-release tablets 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 are guanfacine extended-release tablets?

Guanfacine extended-release tablets are prescription medicine used to treat the symptoms of attention deficit hyperactivity disorder (ADHD). Guanfacine extended-release tablets may be used alone or with ADHD stimulant medicines.

Guanfacine extended-release tablets are not central nervous system (CNS) stimulant.

It is not known if guanfacine extended-release tablets are safe and effective in children younger than 6 years of age.

Who should not take guanfacine extended-release tablets?

Do not take guanfacine extended-release tablets if you are allergic to guanfacine or any of the ingredients in guanfacine extended-release tablets. See the end of this leaflet for a complete list of ingredients in guanfacine extended-release tablets.

What should I tell my doctor before taking guanfacine extended-release tablets?

Before you take guanfacine extended-release tablets, tell your doctor if you:

  • have heart problems or a low heart rate
  • have fainted
  • have low or high blood pressure
  • have liver or kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if guanfacine extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if guanfacine extended-release tablets pass into your breast milk. Talk to your doctor about the best way to feed your baby while taking guanfacine extended-release tablets.

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

Guanfacine extended-release tablets may affect the way other medicines work, and other medicines may affect how guanfacine extended-release tablets work.

Especially tell your doctor if you take:

  • ketoconazole
  • medicines that can affect enzyme metabolism
  • 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 guanfacine extended-release tablets?

  • Take guanfacine extended-release tablets exactly as your doctor tells you.
  • Your doctor may change your dose. Do not change your dose of guanfacine extended-release tablets without talking to your doctor.
  • Do not stop taking guanfacine extended-release tablets without talking to your doctor.
  • Try not to miss your dose of guanfacine extended-release tablets. If you miss a dose of guanfacine extended-release tablets, take the next dose at your regular time. If you miss 2 or more doses, talk to your doctor, as you may need to restart guanfacine extended-release tablets with a lower dose.
  • Do not take a double dose to make up for a missed dose.
  • Guanfacine extended-release tablets should be taken 1 time a day in the morning or in the evening, either alone or in combination with an ADHD stimulant medicine that your doctor may prescribe. Your doctor will tell you when to take guanfacine extended-release tablets and when to take your ADHD stimulant medication.
  • Guanfacine extended-release tablets should be swallowed whole with a small amount of water, milk, or other liquid.
  • Do not crush, chew, or break guanfacine extended-release tablets. Tell your doctor if you cannot swallow guanfacine extended-release tablets whole.
  • Do not take guanfacine extended-release tablets with a high-fat meal.
  • Your doctor will check your blood pressure and heart rate while you take guanfacine extended-release tablets.
  • If you take too much guanfacine extended-release tablets, call your local Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking guanfacine extended-release tablets?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how guanfacine extended-release tablets affect you. Guanfacine extended-release tablets can slow your thinking and motor skills.
  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking guanfacine extended-release tablets until you talk with your doctor. Guanfacine extended-release tablets taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not become dehydrated or overheated. This may increase your chance of having low blood pressure or fainting while taking guanfacine extended-release tablets.
  • Do not suddenly stop guanfacine extended-release tablets. Tell your healthcare provider if you have been vomiting and cannot take guanfacine extended-release tablets, you may be at risk for rebound hypertension.

What are the possible side effects of guanfacine extended-release tablets?

Guanfacine extended-release tablets may cause serious side effects including:

  • low blood pressure
  • low heart rate
  • fainting
  • sleepiness
  • increased blood pressure and heart rate after suddenly stopping guanfacine extended-release tablets (rebound hypertension). Suddenly stopping guanfacine extended-release tablets can cause increased blood pressure and heart rate and other withdrawal symptoms such as headache, confusion, nervousness, agitation, and tremors. If these symptoms continue to get worse and are left untreated, it could lead to a very serious condition including very high blood pressure, feeling very sleepy or tired, severe headache, vomiting, vision problems, seizures.

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

The most common side effects of guanfacine extended-release tablets include:

  • sleepiness
  • tiredness
  • trouble sleeping
  • low blood pressure
  • nausea
  • stomach pain
  • dizziness
  • dry mouth
  • irritability
  • vomiting
  • slow heart rate

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 guanfacine extended-release tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to TWi Pharmaceuticals, inc. 1-844-518-2989 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch.

How should I store guanfacine extended-release tablets?

  • Store guanfacine extended-release tablets at 20º to 25°C (68º to 77°F). [see USP Controlled Room Temperature].

Keep guanfacine extended-release tablets and all medicines out of the reach of children.

General Information about the safe and effective use guanfacine extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use guanfacine extended-release tablets for a condition for which it was not prescribed. Do not give guanfacine extended-release tablets 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 guanfacine extended-release tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about guanfacine extended-release tablets that is written for health professionals.

What are the ingredients in guanfacine extended-release tablets?

Active ingredient: guanfacine hydrochloride

Inactive ingredients: microcrystalline cellulose, hypromellose, polyvinyl acetate, povidone, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and silica. In addition, the 3 mg and 4 mg tablets also contain FD&C Blue #1.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All other trademarks are the property of their respective owners.

Manufactured for:
TWi Pharmaceuticals USA, Inc.
Paramus, NJ 07652

Manufactured by:

figure-5

TWi Pharmaceuticals, Inc.

Taoyuan City, 32063, Taiwan

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Revised: 05/19

OS24979533

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