Consumer Information for: DOM-PREGABALIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Dom-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
  • Dom-PREGABALIN is also used for the symptomatic relief of pain associated with fibromyalgia (a condition which includes widespread pain).
What it does

Dom-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 Dom-PREGABALIN if you are allergic to pregabalin, the main ingredient in Dom-PREGABALIN, or any other ingredient in Dom-PREGABALIN (see “What the nonmedicinal ingredients are”). Children under the age of 18 years.

What the medicinal ingredient is

Pregabalin

What the non-medicinal ingredients are

Each capsule of Dom-PREGABALIN contains 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, or 300 mg of pregabalin and the following nonmedicinal ingredients: ammonium hydroxide, gelatin, iron oxide black, pregelatinized starch, propylene glycol, shellac glaze, talc, titanium dioxide. In addition the 75, 225 and 300 mg strengths contain also red iron oxide.

What dosage form it comes in

Capsules: 25 mg, 50 mg, 75 mg, 150 mg, 225 mg or 300 mg.

Warnings and precautions

BEFORE you use Dom-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
  • 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 Dom-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 Dom-PREGABALIN, 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. Dom-PREGABALIN does not interfere with birth control pills.

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

  • 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 Dom-PREGABALIN

Proper use of this medication

You can take Dom-PREGABALIN with or without food. Avoid alcoholic drinks while taking Dom-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 Dom-PREGABALIN with your next scheduled dose.

Do not suddenly stop taking Dom-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 DomPREGABALIN. Side effects are usually mild. In studies, few patients stopped taking Dom-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 Dom-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 Dom-PREGABALIN.E

When Dom-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).

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and seek immediate emergency medical attention
Common
Dizziness ✔    
Sleepiness ✔    
Blurred vision   ✔  
Uncommon
Weight gain ✔    
Swelling of hands and feet (edema)   ✔  
Swelling of the face, mouth, lips, gums, neck or throat, trouble breathing     ✔
Extreme fatigue   ✔  
Increased cough   ✔  
Allergic reactions (skin rash, hives, blisters)     ✔
Decrease in the amount of urine   ✔  
Thoughts of suicide   ✔  
Very Rare
Seizures     ✔

This is not a complete list of side effects. If you have any unexpected effects while taking Dom-PREGABALIN, contact your doctor or pharmacist.

How to store

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

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect (www.healthcanada.gc.ca/medeffect);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect ( www.healthcanada.gc.ca/medeffect).

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

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

1. Dom-PREGABALIN 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. Dom-PREGABALIN may cause dizziness and sleepiness.

  • Do not drive a car, work with machines, or do other dangerous activities until you know how DomPREGABALIN affects how alert you are. Ask your doctor when it is okay to do these activities.

3. Dom-PREGABALIN may cause problems with your eyesight, including blurry vision. Call your doctor if you have any changes in your eyesight.

More Information

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-550-6060.

This leaflet was prepared by
        Dominion Pharmacal
        Montréal, Canada
        H4P 2T4

Last revised: March 20, 2017

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