Details for: JAMP-PREGABALIN
Company: JAMP PHARMA CORPORATION
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02435977 | JAMP-PREGABALIN | PREGABALIN | 25 MG | CAPSULE | ORAL |
02435985 | JAMP-PREGABALIN | PREGABALIN | 50 MG | CAPSULE | ORAL |
02435993 | JAMP-PREGABALIN | PREGABALIN | 75 MG | CAPSULE | ORAL |
02436000 | JAMP-PREGABALIN | PREGABALIN | 150 MG | CAPSULE | ORAL |
02436019 | JAMP-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
JAMP-Pregabalin is a prescription medicine used for the symptomatic relief of neuropathic pain associated with:
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:
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:
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:
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).
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?
- 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.
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.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Revision Date: March 23, 2020