PREGABALIN - pregabalin capsule 
Novadoz Pharmaceuticals LLC

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MEDICATION GUIDE


PREGABALIN  CAPSULES, CV 
(pre GAB a lin) 

Read this Medication Guide before you start taking pregabalin capsules 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. If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist.

What is the most important information I should know about pregabalin capsules?

Pregabalin capsules may cause serious side effects including:

These serious side effects are described below:

Stop taking pregabalin capsules and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:

 If you have suicidal thoughts or actions, do not stop pregabalin capsules without first talking to a healthcare provider.

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

What is pregabalin capsule?

Pregabalin capsule is a prescription medicine used in adults, 18 years and older, to treat:

It is not known if pregabalin capsules is safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.
Pregabalin Capsule is a prescription medicine used in people 17 years of age and older to treat:

For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin capsules is safe and effective in children under 1 month of age

Who should not take pregabalin capsules?

Do not take pregabalin capsules if you are allergic to pregabalin or any of the ingredients in pregabalin capsules.

See “What is the most important information I should know about pregabalin capsules?” for the signs of an allergic reaction.

See the end of this Medication Guide for a complete list of ingredients in pregabalin capsules.

What should I tell my healthcare provider before taking pregabalin capsules?

Before taking pregabalin capsules, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin capsules and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

How should I take pregabalin capsules?

What should I avoid while taking pregabalin capsules?

What are the possible side effects of pregabalin capsules?

Pregabalin capsules may cause serious side effects, including:

The most common side effects of pregabalin capsules in adults are:

Pregabalin capsules caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin capsules and tell your healthcare provider about any sores or skin problems.

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

These are not all the possible side effects of pregabalin capsules. 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 pregabalin capsules?  

 Keep pregabalin capsules and all medicines out of the reach of children.


General information about the safe and effective use of  pregabalin capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin capsules for a condition for which it was not prescribed. Do not give pregabalin capsules to other people, even if they have the same symptoms you have. It may harm them.You can ask your healthcare provider or pharmacist for information about pregabalin capsules that is written for health professionals.

What are the ingredients in pregabalin capsules?

Active ingredient: pregabalin
Inactive ingredients:
Pregabalin capsules: Mannitol, talc
The capsule shells contain FD&C Blue No. 2, gelatin, titanium dioxide, sodium lauryl sulfate and is imprinted with black ink.

Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.

Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
You can also visit the pregabalin capsules at Novadoz Pharmaceuticals LLC or call 1-855-668-2369.
This Medication Guide has been approved by the U.S. Food and Drug Administration
Manufactured by:
MSN Laboratories Private Limited
Telangana – 509 228, INDIA

Distributed by:
Novadoz Pharmaceuticals LLC

Piscataway, NJ 08854-3714

Issued on:
June 2020

Revised: 6/2021
Novadoz Pharmaceuticals LLC