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Details for: JAMP-GABAPENTIN TABLETS

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02402289JAMP-GABAPENTIN TABLETSGABAPENTIN600 MGTABLETORAL
02402297JAMP-GABAPENTIN TABLETSGABAPENTIN800 MGTABLETORAL
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Summary Reports

Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing Problems

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-GABAPENTIN Tablets (gabapentin) belongs to the family of medicines called antiepileptic drugs and is used for treating epilepsy (seizures).

What it does

Jamp-GABAPENTIN Tablets have been prescribed for you by your doctor to reduce your number of seizures.

When it should not be used

Do not use Jamp-GABAPENTIN Tablets if you are allergic to it or any of the components in the formulation (see list of components under nonmedicinal ingredients). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects while taking the drug.

What the medicinal ingredient is

Gabapentin

What the non-medicinal ingredients are

Copovidone, hydroxypropylcellulose, magnesium stearate, maize starch poloxamer 407, and purified talc.

What dosage form it comes in

Jamp-GABAPENTIN Tablets is available in tablets (containing 600 mg or 800 mg of gabapentin).

Warnings and precautions

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

  • Any health conditions or problems you may have, including kidney disease, breathing or lung problems.
  • If you are taking any other medicines (prescription and non-prescription).
  • If you have ever had an allergic reaction to medication, food, etc.
  • If you are pregnant or thinking about becoming pregnant.
  • If you are breast-feeding or plan to breastfeed your baby. Jamp-GABAPENTIN Tablets passes into breast milk; however, it is not known if JampGABAPENTIN Tablets can harm your baby. You and your doctor should decide whether you should take Jamp-GABAPENTIN Tablets or breastfeed, but not both.
  • If you have a history of alcohol or drug abuse.
  • Your habits of alcohol consumption.
  • If you drive a vehicle or perform hazardous tasks during your work.
  • A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking Jamp-GABAPENTIN Tablets, contact your doctor immediately.
It is important for your doctor to have all of the above information before prescribing treatment and dosage.
Interactions with this medication

Tell your doctor if you start or stop taking opioids such as morphine or hydrocodone. Opioids may increase the levels of Jamp-GABAPENTIN Tablets in your blood.

Tell your doctor immediately if you experience increased side effects such as drowsiness or slowed breathing while taking Jamp-GABAPENTIN Tablets with an opioid or other sedatives and tranquilizers. The dose of these drugs or Jamp-GABAPENTIN Tablets may need to be adjusted.

Avoid alcoholic drinks while taking JampGABAPENTIN Tablets.

Proper use of this medication

Usual dose

  • It is very important that you take JampGABAPENTIN Tablets exactly as your doctor has instructed.
  • Jamp-GABAPENTIN Tablets may be taken with or without food.
  • You should not increase or decrease the amount of Jamp-GABAPENTIN Tablets you are taking unless your doctor tells you to.
  • Do not stop taking it abruptly because your seizures may increase.
Overdose:
If you think you have taken too much JampGABAPENTIN Tablets, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include: dizziness, drowsiness, unusually weak breathing, and loss of consciousness.

Missed Dose:
If you miss a dose, take it as soon as possible. However, if it is within 4 hours of your next dose do not take the missed dose and return to your regular dosing schedule. Do not allow more than 12 hours to go by between doses because your seizures may increase. If that happens, consult your doctor as soon as possible.

REMINDER: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.
Side effects and what to do about them

This is not a complete list of side effects. For any unexpected effects while taking Jamp-GABAPENTIN Tablets, contact your doctor or pharmacist.
Like all medications, Jamp-GABAPENTIN Tablets can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may need to be adjusted.

  • Call your doctor immediately if your seizures get worse.
  • When you first begin taking Jamp-GABAPENTIN Tablets you may experience some side effects such as agitation, drowsiness, dizziness, lack of muscle coordination, and fatigue. Consult your doctor if you experience any of these, as the dose may have to be adjusted.
  • If your epilepsy is not controlled, it is very important not to perform any potentially hazardous tasks, such as driving a car or operating dangerous machines. If your epilepsy is controlled, it is important to refrain from potentially dangerous tasks until you are sure this medication does not affect your mental alertness or physical coordination.
  • The following side effects have been reported when Jamp-GABAPENTIN Tablets is abruptly stopped: anxiety, sleeplessness, nausea, pain, and sweating.
    • 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 Seek Emergency Medical Attention
    Common
    Edema: Swelling of legs, ankle or feet   ✔  
    Uncommon
    Severe allergic reactions: fever, rash, swollen lymph nodes, hives, sore mouth, sore eyes or swelling of lips, throat or tongue, difficulty breathing     ✔
    Respiratory Depression: slow, shallow or weak breathing.     ✔
    Heart palpitations   ✔  
    Chest pains   ✔  
    Seizures   ✔  
    Hallucinations     ✔
    Unusual changes in mood   ✔  
    Suicidal thoughts or hurting yourself   ✔  
    Jaundice: yellowing of skin, dark urine   ✔  
    Rhabdomyolysis: Unusual muscle movement or tone; unexplained muscle pain or tenderness or weakness, dark urine, nausea and/or vomiting   ✔  
    Incontinence: inability to control urination   ✔  
    Ringing or whistling in the ears   ✔  
    Unknown
    Sleeplessness   ✔  
    Confusion   ✔  
    Loss of consciousness   ✔  
    Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching or worsening of convulsions   ✔  
    Hypoglycemia or Hyperglycemia   ✔  
    Blood glucose fluctuations (for patients suffering from diabetes)   ✔  
    This is not a complete list of side effects. If you have any unexpected effects while taking JampGABAPENTIN Tablets, contact your doctor or pharmacist.
    How to store

  • Keep all medicines out of the reach of children.
  • Store at room temperature (15 - 30°C).
  • Do not use this medicine after the expiry date, which is printed on the package label.
  • If your doctor tells you to stop taking JampGABAPENTIN Tablets, or if you find that they have passed their expiry date, please return any left over medicine to you 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

    If you want more information about JampGABAPENTIN Tablets:

    • Talk to your healthcare professional
    • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp); 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, Canada

    Last revised: July 10, 2020
    Date modified: