Details for: NRA-PREGABALIN
Company: NORA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02479117 | NRA-PREGABALIN | PREGABALIN | 25 MG | CAPSULE | ORAL |
| 02479125 | NRA-PREGABALIN | PREGABALIN | 50 MG | CAPSULE | ORAL |
| 02479133 | NRA-PREGABALIN | PREGABALIN | 75 MG | CAPSULE | ORAL |
| 02479168 | NRA-PREGABALIN | PREGABALIN | 150 MG | CAPSULE | ORAL |
| 02479192 | NRA-PREGABALIN | PREGABALIN | 300 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
NRA-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
- NRA-Pregabalin is also used for the symptomatic relief of pain associated with fibromyalgia (a condition which includes widespread pain).
What it does
NRA-Pregabalin can relieve pain. Some patients taking NRA-Pregabalin showed improvement as early as the first week of treatment.
When it should not be used
You should not take NRA-Pregabalin capsules if you are
allergic to Pregabalin, the main ingredient in NRA-Pregabalin
capsules, or any other ingredient in NRA-Pregabalin
capsules (see “What the non-medicinal
ingredients are”).
Children under the age of 18 years.
What the medicinal ingredient is
Pregabalin
What the non-medicinal ingredients are
The non-medicinal ingredients that make up the capsule core are pregelatinized starch and talc.
The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide.
The markings on the capsules are in black ink, which contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.
What dosage form it comes in
Capsules containing 25, 50, 75, 100, 150, 200, 225 or 300 mg of Pregabalin.
Warnings and precautions
BEFORE you use NRA-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, or think you might be pregnant.
- you are breast feeding. NRA-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 NRA-Pregabalin 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 NRA-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 NRA-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.aedpregnancyregistry.org/
Interactions with this medication
While you are taking NRA-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. NRA-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 NRA-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 NRA-Pregabalin.
Proper use of this medication
You can take NRA-Pregabalin with or without food. Avoid alcoholic drinks while taking NRA-Pregabalin.
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 NRA-Pregabalin with your next scheduled dose.
Do not suddenly stop taking NRA-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 NRA-Pregabalin.
Side effects are usually mild. In studies, few patients
stopped taking NRA-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 NRA-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 NRA-Pregabalin.
When NRA-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).
| 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 emergency medical assistance |
|---|---|---|---|
| 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 NRA-Pregabalin, contact your doctor or pharmacist.
How to store
Keep NRA-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 report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Rapport en ligne à www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
- 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 1908C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
What is the most important information I should know about NRA-Pregabalin?
- NRA-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.
- NRA-Pregabalin may cause dizziness and sleepiness.
- Do not drive a car, work with machines, or do other dangerous activities until you know how NRA-Pregabalin affects how alert you are. Ask your doctor when it is okay to do these activities.
- NRA-Pregabalin may cause problems with your eyesight, including blurry vision. Call your doctor if you have any changes in your eyesight.
More information
This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing. For more information, please contact your doctor, pharmacist or other healthcare professional. This leaflet is prepared by
Nora Pharma Inc.
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec
H4R 3E8
Date of Preparation: July 20, 2018