Gabapentin (Page 11 of 11)

What should I avoid while taking gabapentin?

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Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

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Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin affects you. Gabapentin can slow your thinking and motor skills.

What are the possible side effects of gabapentin?

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

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The most common side effects of gabapentin include:

• dizziness

• lack of coordination

• viral infection

• feeling drowsy

• feeling tired

• fever

• jerky movements

• difficulty with speaking

• temporary loss of memory (amnesia)

• tremor

• difficulty with coordination

• double vision

• unusual eye movement

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin. 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 gabapentin?

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Store Gabapentin Tablets USP between 59°F to 86°F (15°C to 30°C).

Keep gabapentin and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin for a condition for which it was not prescribed. Do not give gabapentin 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 gabapentin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin that was written for healthcare professionals.

For more information about gabapentin, go to . For medical inquiries or to report side effects regarding gabapentin, please call 1 (888)721-7115. www.glenmarkgenerics.com

What are the ingredients in gabapentin?

gabapentin USP Active ingredient:

corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water. Inactive ingredients in the tablets:

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

Manufactured by:

Colvale-Bardez, Goa 403 513, India Glenmark Generics Ltd.

Manufactured for:

Mahwah, NJ 07430 Glenmark Generics Inc., USA

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

June 2013

GABAPENTIN gabapentin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0126(NDC:68462-126) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN COPOVIDONE K25-31 POLOXAMER 407 MAGNESIUM STEARATE POLYETHYLENE GLYCOLS HYPROMELLOSES TITANIUM DIOXIDE TALC POLYSORBATE 80 WATER

Product Characteristics Color WHITE (White to off-white) Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code G;31 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64725-0126-1 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077662 04/01/2006

Labeler — TYA Pharmaceuticals (938389038)

Registrant — TYA Pharmaceuticals (938389038)

Establishment
Name	Address	ID/FEI	Operations
TYA Pharmaceuticals		938389038	RELABEL (64725-0126), REPACK (64725-0126)

Revised: 06/2013 TYA Pharmaceuticals