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Details for: JAMP-PREGABALIN

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02435977JAMP-PREGABALINPREGABALIN25 MGCAPSULEORAL
02435985JAMP-PREGABALINPREGABALIN50 MGCAPSULEORAL
02435993JAMP-PREGABALINPREGABALIN75 MGCAPSULEORAL
02436000JAMP-PREGABALINPREGABALIN150 MGCAPSULEORAL
02436019JAMP-PREGABALINPREGABALIN300 MGCAPSULEORAL
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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

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

    JAMP-Pregabalin can relieve pain. Some patients taking JAMP-Pregabalin showed improvement as early as the first week of treatment.

    When it should not be used

    You should not take JAMP-Pregabalin if you are allergic to pregabalin, the main ingredient in JAMPPregabalin, or any other ingredient in JAMPPregabalin (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 fill 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 black iron oxide, butyl alcohol dehydrated alcohol, Isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution, shellac and water.

    What dosage form it comes in

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

    Warnings and precautions

    Taking JAMP-Pregabalin with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

    BEFORE you use JAMP-Pregabalin tell your doctor or pharmacist if:

  • you are taking any other prescription medicines including narcotic pain medicines like oxycodone, 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. JAMP-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 JAMP-Pregabalin or breastfeed, 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 ingredientsare”.
  • you have a history of heart disease called congestive heart failure.
  • you have a history of lower gastrointestinal problems (e.g., constipation ,blocked or paralyzed bowel), or you are taking medication(s) that may cause constipation.

    • Pregnancy Registry: If you become pregnant while taking JAMP-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.
    Interactions with this medication

    While you are taking JAMP-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. JAMP-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 JAMP- 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 JAMP- Pregabalin
    Proper use of this medication

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

    Do not suddenly stop taking JAMP-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 JAMPPregabalin. Side effects are usually mild. In studies, few patients stopped taking JAMP-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 JAMP-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 JAMP-Pregabalin.

    When JAMP-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 paralyzed bowel).

    Serious side effects 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 emergency medical assistance
    Common
    Dizziness ✔    
    Sleepiness ✔    
    Blurred vision   ✔  
    Uncommon
    Weightgain ✔    
    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 JAMP-Pregabalin, contact your doctor or pharmacist.

    How to store

    Keep JAMP-Pregabalin out of reach and sight of children. Store it at room temperature (15°C to 30°C) in the package it came in from the doctor or pharmacist.

    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/healthcanada/services/drugs-health-products/medeffectcanada/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

    What is the most important information I should know about JAMP-Pregabalin?

    1. JAMP-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.
  • JAMP-Pregabalin may cause dizziness and sleepiness.
  • Do not drive a car, work with machines, or do other dangerous activities until you know how JAMP- Pregabalin affects how alert you are. Ask your doctor when it is okay to do these activities.
  • JAMP-Pregabalin may cause problems with your eyesight, including blurry vision. Call your doctor if you have any changes in your eyesight

    • If you want more information about Jamp-Pregabalin:

    • Talk to your healthcare professional
    • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp) or the manufacturer’s website (www.jamppharma.com),or by calling 1-866-399-9091.
    This leaflet was prepared by:
    JAMP Pharma Corporation
    1310 rue Nobel
    Boucherville, Québec
    J4B 5H3

    Revision Date: March 23, 2020
    Date modified: