Details for: MAR-PREGABALIN
Company: MARCAN PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02417529 | MAR-PREGABALIN | PREGABALIN | 25 MG | CAPSULE | ORAL |
| 02417537 | MAR-PREGABALIN | PREGABALIN | 50 MG | CAPSULE | ORAL |
| 02417545 | MAR-PREGABALIN | PREGABALIN | 75 MG | CAPSULE | ORAL |
| 02417561 | MAR-PREGABALIN | PREGABALIN | 150 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
MAR-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)
- MAR-PREGABALIN is also used for the symptomatic relief of pain associated with fibromyalgia (a condition which includes widespread pain).
What it does
MAR-PREGABALIN can relieve pain. Some patients taking MAR-PREGABALIN showed improvement as early as the first week of treatment.
When it should not be used
You should not take MAR-PREGABALIN if you are allergic to pregabalin, the main ingredient in MAR-PREGABALIN, or any other ingredient in MAR-PREGABALIN (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 iron oxide red.
The markings on the capsules are in black ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide, potassium hydroxide and water.
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 MAR-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. MAR-PREGABALIN passes into breast milk and it is not known if it can harm your baby. You and your health care provider should discuss whether you should take MAR-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 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 MAR-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 MAR-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. MAR-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 MAR-PREGABALIN:
- Alcohol
- Medicines for anxiety (such as lorazepam)
- Narcotic pain medicine (such as oxycodone)
- Any medicines that make you sleepy
Proper use of this medication
You can take MAR-PREGABALIN with or without food.
Avoid alcoholic drinks while taking MAR-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 MAR-PREGABALIN with your next scheduled dose.
Do not suddenly stop taking MAR-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 MAR-PREGABALIN.
Side effects are usually mild. In studies, few
patients stopped taking MAR-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 MAR-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 MAR-PREGABALIN.
When MAR-PREGABALIN is taken with other medications that
may cause constipation (such as opioid pain medications), it is
possible that gastrointestinal problems may occur (e.g.,
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 talk with your doctor or pharmacist |
|---|---|---|---|
| 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 | |||
| Very rare Seizures | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects while taking MAR-PREGABALIN, contact your doctor or pharmacist.
How to store
Keep MAR-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
- 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 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at 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 MAR-PREGABALIN?
- MAR-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.
- Do not drive a car, work with machines, or do other dangerous activities until you know how MAR-PREGABALIN affects how alert you are. Ask your doctor when it is okay to do these activities.
More information
This leaflet was prepared by MARcan Pharmaceuticals Inc.
77 Auriga Drive, unit#4,
Ottawa, ON, K2E 7Z7
Toll Free: +1- 855-627-2261
www.marcanpharma.com
Date of Revision: August 23, 2017.