Rufinamide: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Rufinamide Tablets, USP 200 mg (containing 200 mg rufinamide, USP) are pink, film-coated, oblong-shaped tablets with functional scoring, embossed with ‘713’ and a ‘G’ on either side of a break line on one side and plain with a break line on the other side. They are available in:

Bottles of 30 (NDC 68462-713-30)
Bottles of 120 (NDC 68462-713-08)
Bottles of 500 (NDC 68462-713-05)

Rufinamide Tablets, USP 400 mg (containing 400 mg rufinamide, USP) are pink, film-coated, oblong-shaped tablets with functional scoring, embossed with ‘714’ and a ‘G’ on either side of a break line on one side and plain with a break line on the other side. They are available in:

Bottles of 120 (NDC 68462-714-08)
Bottles of 500 (NDC 68462-714-05)

16.2 Storage and Handling

Store the tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Replace cap securely after opening.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Administration Information

Advise patients to take rufinamide with food [see Dosage and Administration (2.2) ].

Suicidal Thinking and Behavior

Inform patients, their caregivers, and families that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.1) ].

Central Nervous System Reactions

Inform patients about the potential for somnolence or dizziness and advise them not to drive or operate machinery until they have gained sufficient experience on rufinamide to gauge whether it adversely affects their mental and/or motor performance [see Warnings and Precautions (5.2) ].

Multi-organ Hypersensitivity Reactions

Advise patients to notify their physician if they experience a rash associated with fever [see Warnings and Precautions (5.4) ].

Drug Interactions

Inform female patients of childbearing age that the concurrent use of rufinamide with hormonal contraceptives may render this method of contraception less effective. Recommend patients use additional non-hormonal forms of contraception when using rufinamide [see Drug Interactions (7.3) and Use in Specific Populations (8.3)].
Inform patients that alcohol in combination with rufinamide may cause additive central nervous system effects.

Pregnancy

Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Encourage patients to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant. To enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1) ].

Breastfeeding

Advise patients to notify their physician if they are breastfeeding or intend to breastfeed [see Use in Specific Populations (8.2) ].

Medication Guide available at:

www.glenmarkpharma-us.com/medguides

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Manufactured for:

http://druginserts.com/lib/images-rx/rufinamide-3/logo.jpg

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

January 2021

Medication Guide

Rufinamide (roo fin’ a mide) Tablets

Read this Medication Guide before you start taking rufinamide tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about rufinamide tablets?

Do not stop taking rufinamide tablets without first talking to your healthcare provider.

Stopping rufinamide tablets suddenly can cause serious problems.

Rufinamide tablets can cause serious side effects, including:

1. Like other antiepileptic drugs, rufinamide tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempt to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop rufinamide tablets without first talking to a healthcare provider.

Stopping rufinamide tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

2. Rufinamide tablets may cause you to feel sleepy, tired, weak, dizzy, or have problems with coordination and walking.

What are rufinamide tablets?

Rufinamide tablets are a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older.

It is not known if rufinamide tablets are safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.

Who should not take rufinamide tablets?

Do not take rufinamide tablets if you have a genetic condition called familial short QT syndrome, a problem that affects the electrical system of the heart.

What should I tell my healthcare provider before taking rufinamide tablets?

Before you take rufinamide tablets, tell your healthcare provider if you:

have heart problems
have liver problems
have any other medical problems
have or have had suicidal thoughts or actions, depression or mood problems
are pregnant or plan to become pregnant. It is not known if rufinamide tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking rufinamide tablets. You and your healthcare provider will decide if you should take rufinamide tablets while you are pregnant.
rufinamide tablets may make certain types of birth control less effective. Talk to your healthcare provider about the best birth control methods for you while you take rufinamide tablets.
o
If you become pregnant while taking rufinamide tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
are breastfeeding or plan to breastfeed. It is not known if rufinamide will pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take rufinamide tablets.

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

Taking rufinamide tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take rufinamide tablets?

Take rufinamide tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how much rufinamide tablets to take.
Your healthcare provider may change your dose. Do not change your dose of rufinamide tablets without talking to your healthcare provider.
Take rufinamide tablets with food.
Rufinamide tablets can be swallowed whole, cut in half or crushed.
If you take too many rufinamide tablets, call your local Poison Control Center or get emergency medical help right away.

What should I avoid while taking rufinamide tablets?

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking rufinamide tablets until you talk to your healthcare provider. Rufinamide 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 rufinamide tablets affect you. Rufinamide tablets can slow your thinking and motor skills.

What are the possible side effects of rufinamide tablets?

See “What is the most important information I should know about rufinamide tablets?”

Rufinamide tablets may cause serious side effects including:

Rufinamide tablets can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following. Symptoms may include:

swelling of your face, eyes, lips, or tongue
trouble swallowing or breathing
a skin rash
hives
fever, swollen glands, or sore throat that do not go away or come and go
swollen glands
yellowing of your skin or eyes
dark urine
unusual bruising or bleeding
severe fatigue or weakness
severe muscle pain
your seizures happen more often or become worse

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of rufinamide tablets include:

headache
dizziness
tiredness
sleepiness
nausea
vomiting

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of rufinamide tablets. For more information, ask your healthcare provider 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 rufinamide tablets?

Store rufinamide tablets at 20°C to 25°C (68°F to 77°F).
Keep rufinamide tablets in a dry place. Protect from moisture. Replace cap securely after opening.

Keep rufinamide tablets and all medicines out of the reach of children.

General Information about the safe and effective use of rufinamide tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rufinamide tablets for a condition for which they were not prescribed. Do not give rufinamide tablets to other people, even if they have the same symptoms that you have. It may harm them.

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

For more information, call 1 (888) 721-7115.

What are the ingredients in rufinamide tablets?

Active ingredient: rufinamide

Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide available at:

www.glenmarkpharma-us.com/medguides

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Manufactured for:

http://druginserts.com/lib/images-rx/rufinamide-3/logo.jpg

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

January 2021

Package/Label Display Panel

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Package/Label Display Panel

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(click image for full-size original)
RUFINAMIDE
rufinamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-713
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUFINAMIDE (RUFINAMIDE) RUFINAMIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (oblong shape) Size 15mm
Flavor Imprint Code G;713
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-713-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-713-08 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-713-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205075 05/16/2016
RUFINAMIDE
rufinamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-714
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUFINAMIDE (RUFINAMIDE) RUFINAMIDE 400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (oblong shape) Size 18mm
Flavor Imprint Code G;714
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-714-08 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-714-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205075 05/16/2016
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (68462-713), ANALYSIS (68462-714), MANUFACTURE (68462-713), MANUFACTURE (68462-714)

Revised: 01/2021 Glenmark Pharmaceuticals Inc., USA

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