Pregabalin Capsules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What is the most important information I should know about PREGABALIN CAPSULES?

1. 1.

   PREGABALIN CAPSULES may cause serious allergic

   reactions. Call your doctor right away if you think you have any of the following symptoms of a serious allergic reaction:

   • swelling of the face, mouth, lips, gums, tongue or

     neck

   • have any trouble breathing

   • other allergic reactions may include rash, hives

     and blisters.

2. 2.

   PREGABALIN CAPSULES may cause dizziness and

   sleepiness.

   • Do not drive a car, work with machines, or do

     other dangerous activities until you know how PREGABALIN CAPSULES affects how alert you are. Ask your doctor when it is okay to do these activities.

3. 3.

   PREGABALIN CAPSULES may cause problems with

   your eyesight, including blurry vision. Call your doctor if you have any changes in your eyesight.

What the medication is used for:

PREGABALIN CAPSULES is a prescription medicine used for the symptomatic relief of neuropathic pain associated with:

• Diabetic peripheral neuropathy (Pain from

  damaged nerves due to diabetes)

• Postherpetic neuralgia (Persisting pain following

  rash due to shingles)

• PREGABALIN CAPSULES is also used for the

  symptomatic relief of pain associated with fibromyalgia (a condition which includes widespread pain).

What it does:

PREGABALIN CAPSULES can relieve pain. Some patients taking pregabalin showed improvement as early as the first week of treatment.

When it should not be used:

You should not take PREGABALIN CAPSULES if you are allergic to pregabalin, the main ingredient in

PREGABALIN CAPSULES, or any other ingredient in PREGABALIN CAPSULES (see “What the non-medicinal ingredients are”). Children under the age of 18 years.

What the medicinal ingredient is:

Pregabalin

What the nonmedicinal ingredients are:

The non-medicinal ingredients that make up the capsule core are pregelatinized starch and talc.

The capsule shells contain gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the brown capsule shells contain red iron oxide.

What dosage forms it comes in:

Capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

WARNINGS AND PRECAUTIONS

BEFORE you use PREGABALIN CAPSULES tell your doctor or pharmacist if:

• you are taking any other prescription or

  nonprescription medicines, or natural/herbal remedies

• you have any kidney problems
• you are pregnant, plan to become pregnant, or think you might be pregnant
• you are breastfeeding. Pregabalin passes into breast milk and it is not known if it can harm your baby. You and your healthcare provider should discuss whether you should take PREGABALIN CAPSULES or breast-feed, but you should not do both.
• you have ever had an allergic reaction (itching, wheezing, hives, or swelling of the throat or face) to pregabalin or any of the nonmedicinal ingredients listed in “What the nonmedicinal ingredients are”:
• you have a history of heart disease called congestive heart failure.
• you have a history of lower gastrointestinal problems (eg., constipation, blocked or paralysed bowel), or you are taking medication(s) that may cause constipation.

Pregnancy Registry: If you become pregnant while taking PREGABALIN CAPSULES, talk to your doctor 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 anticonvulsant medicines during pregnancy. Any woman who is currently pregnant and is taking antiepileptic drugs for any reason, can enroll in the registry. Information on the registry can also be found at the website

http://www.aedpregnancyregistry.org/.

INTERACTIONS WITH THIS MEDICATION

While you are taking PREGABALIN CAPSULES, don't start any new medicines, including natural or herbal medicines, without talking to your doctor first. Your doctor or pharmacist will know which medicines are safe for you to take together. PREGABALIN CAPSULES does not interfere with birth control pills.

You may have a higher chance for dizziness and sleepiness if the following drugs are taken with PREGABALIN CAPSULES:

• Alcohol
• Medicines for anxiety (such as lorazepam)
• Narcotic pain medicine (such as oxycodone)
• Any medicines that make you sleepy

You may have a higher chance of weight gain or swelling if the antidiabetic pills, Avandia^® (rosiglitazone) or Actos^® (pioglitazone) are taken with PREGABALIN CAPSULES.

PROPER USE OF THIS MEDICATION

You can take PREGABALIN CAPSULES with or without food. Avoid alcoholic drinks while taking PREGABALIN CAPSULES.

Usual adult dose:

Your doctor will tell you how much to take and when to take it.

Overdose:

Missed Dose:

If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, do NOT take the missed capsules. Simply wait and restart PREGABALIN CAPSULES with your next scheduled dose.

Do not suddenly stop taking PREGABALIN CAPSULES. Talk to your doctor first. Plan ahead to have a refill so you don't run out.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Some patients may have side effects while taking PREGABALIN CAPSULES. Side effects are usually mild. In studies, few patients stopped taking pregabalin due to side effects.

The most common side effects were: dizziness, sleepiness, blurred vision, dry mouth, swelling of the extremities, weight gain, trouble concentrating, lack of energy, muscle weakness, constipation, and forgetfulness.

A small number of patients taking a drug of this type may experience thoughts of suicide. Your doctor should be informed immediately if this occurs.

When you start PREGABALIN CAPSULES, you may get sleepy or experience dizziness. Avoid potentially hazardous tasks: do not drive a car or operate machinery until you are sure that this medication does not affect your ability to drive or operate machinery or until you get used to

PREGABALIN CAPSULES.

When PREGABALIN CAPSULES is taken with other medications that may cause constipation (such as opioid pain medications), it is possible that gastrointestinal problems may occur (eg., constipation, blocked or paralysed bowel).

This is not a complete list of side effects. If you have any unexpected effects while taking PREGABALIN CAPSULES, contact your doctor or pharmacist. If you think you have taken too much PREGABALIN CAPSULES, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

HOW TO STORE IT

Keep PREGABALIN CAPSULES out of reach and sight of children. Store it at room temperature (15°C to 30°C) in the package it came in.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found by contacting the sponsor, Lupin Ltd. at: 1-800-567-2594

Kalpataru Inspire, Off Western Express Highway, Santacruz (East),

Mumbai, India 400055

Date of preparation: January 11, 2018

* Brand names listed are trademarks of their respective owners.