Details for: PRIVA-GABAPENTIN
Company: PHARMAPAR INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02450097 | PRIVA-GABAPENTIN | GABAPENTIN | 100 MG | CAPSULE | ORAL |
| 02450100 | PRIVA-GABAPENTIN | GABAPENTIN | 300 MG | CAPSULE | ORAL |
| 02450119 | PRIVA-GABAPENTIN | GABAPENTIN | 400 MG | CAPSULE | ORAL |
Summary Reports
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
Priva-GABAPENTIN (gabapentin) belongs to the family of medicines called antiepileptic drugs and is used for treating epilepsy (seizures).
What it does
Priva-GABAPENTIN has been prescribed for you by your doctor to reduce your number of seizures.
When it should not be used
Do not use Priva-GABAPENTIN 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
Priva-GABAPENTIN Capsules:
Capsules contain: copovidone, magnesium stearate, maize starch, and poloxamer. Capsule shells contain: Gelatin, sodium lauryl sulfate, titanium dioxide (all three strengths), yellow iron oxide (300 mg & 400 mg) and red iron oxide (400 mg).
Priva-GABAPENTIN Tablets contain: copovidone, hydroxypropylcellulose, magnesium stearate, maize starch poloxamer 407, and purified talc.
What dosage form it comes in
Gabapentin are is available in both capsules (containing 100 mg, 300 mg or 400 mg gabapentin) and in tablets (containing 600 mg or 800 mg of gabapentin).
Warnings and precautions
BEFORE you use Priva-GABAPENTIN, tell your doctor or pharmacist:
- All your medical conditions, especially if you have any kidney disease.
- 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.
- 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 anti- epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking Priva-GABAPENTIN, 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 gabapentin in your blood. If you experience increased side effects such as drowsiness or slowed breathing while taking these drugs together, the dose of Priva-GABAPENTIN or opioids may need to be adjusted.
Avoid alcoholic drinks while taking Gabapentin Capsules USP and Gabapentin Tablets USP.
Proper use of this medication
Usual dose
- It is very important that you take Priva-GABAPENTIN exactly as your doctor has instructed.
- Priva-GABAPENTIN may be taken with or without food.
- You should not increase or decrease the amount of Priva-GABAPENTIN you are taking unless your doctor tells you to.
- Do not stop taking it abruptly because your seizures may increase.
Overdose
If you have taken a large number of tablets or capsules all at once, contact your doctor or nearest hospital emergency department, even though you may not feel sick. Show the doctor your bottle of medication.
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 Priva-GABAPENTIN, contact your doctor or pharmacist.
Like all medications, Priva-GABAPENTIN 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 Priva-GABAPENTIN you may experience some side effects such as 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 Priva-GABAPENTIN is abruptly stopped: anxiety, sleeplessness, nausea, pain, and sweating.
| 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, ankles 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 | ✔ | ||
| 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 Priva-GABAPENTIN, 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 Priva-GABAPENTIN, 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect
- 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 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmapar Inc.
This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC, H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Preparation: July 22, 2016