Ratio-Pregabalin: Uses, Side Effects and Dosage

What the medication is used for:

ratio-PREGABALIN 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)

• Pain from damaged nerves in the spinal cord

• ratio-PREGABALIN is also used for the symptomatic

  relief of pain associated with fibromyalgia (a condition

  which includes widespread pain).

What it does:

ratio-PREGABALIN 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 ratio-PREGABALIN if you are allergic to

pregabalin, the main ingredient in ratio-PREGABALIN, or

any other ingredient in ratio-PREGABALIN (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 mannitol and talc.

The capsule shells contain gelatin and titanium dioxide. In addition, the orange and peach capsule shells contain red iron oxide and yellow iron oxide. The black markings contain ammonium hydroxide, black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

BEFORE you use ratio-PREGABALIN 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, think you might be pregnant, or are breast feeding

• 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 ratio-PREGABALIN, 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.massgeneral.org/aed/.

INTERACTIONS WITH THIS MEDICATION

While you are taking ratio-PREGABALIN, don't start any new medicines, including natural or herbal medicines, without

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

Usual adult dose:

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

Overdose:

In case of a drug overdose, immediately go to the nearest emergency room even if you do not feel sick. Make sure you take your medicine bottle with you to show the doctor.

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 ratio-PREGABALIN

with your next scheduled dose.

Do not suddenly stop taking ratio-PREGABALIN. 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 ratio-

PREGABALIN. Side effects are usually mild. In studies, few

patients stopped taking ratio-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 ratio-PREGABALIN, 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 ratio-PREGABALIN.

When ratio-PREGABALIN 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 ratio-PREGABALIN, contact your doctor or pharmacist.

HOW TO STORE IT

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

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance

Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

MORE INFORMATION This document plus the full Product Monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited at:

1-800-268-4127 ext. 1255005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Last revised: May 15, 2013