Details for: AG-GABAPENTIN
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02477920 | AG-GABAPENTIN | GABAPENTIN | 300 MG | CAPSULE | ORAL |
| 02477939 | AG-GABAPENTIN | GABAPENTIN | 400 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
AG-GABAPENTIN (gabapentin) belongs to the family of medicines called antiepileptic drugs and is used for treating epilepsy (seizures).
What it does
Gabapentin has been prescribed for you by your doctor to reduce your number of seizures.
When it should not be used
Do not use AG-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 USP
What the non-medicinal ingredients are
Non-medicinal ingredients in the capsules include Maize starch, Mannitol and Talc. Capsule shells may contain: Gelatin, titanium dioxide, sodium lauryl sulfate, yellow iron oxide and red iron oxide.
What dosage form it comes in
AG-GABAPENTIN is available in capsules (containing 100 mg, 300 mg or 400 mg gabapentin).
Warnings and precautions
Serious Warnings and Precautions
Taking AG-GABAPENTIN 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 AG-GABAPENTIN tell your doctor or pharmacist:
- 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. AG-GABAPENTIN passes into breast milk; however, it is not known if AG-GABAPENTIN can harm your baby. You and your doctor should decide whether you should take AG- GABAPENTIN 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 anti- epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking AG-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 AG-GABAPENTIN in your blood.
Tell your doctor immediately if you experience increased side effects such as drowsiness or slowed breathing while taking AG-GABAPENTIN with an opioid or other sedatives and tranquilizers. The dose of these drugs or AG- GABAPENTIN may need to be adjusted.
Avoid alcoholic drinks while taken AG-GABAPENTIN.
Proper use of this medication
Usual Dose
- It is very important that you take AG- GABAPENTIN exactly as your doctor has instructed.
- AG-GABAPENTIN may be taken with or without food.
- You should not increase or decrease the amount of AG-GABAPENTIN 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 AG- GABAPENTIN, 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, 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 AG-GABAPENTIN, contact your doctor or pharmacist.
Like all medications, AG-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 AG-GABAPENTIN 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 gabapentin is abruptly stopped: anxiety, sleeplessness, nausea, pain, and sweating.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 | ✔ | ||
| RespiratoryDepression: 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 AG-GABAPENTIN, contact your doctor or pharmacist.
How to store
- Keep all medicines out of the reach of children.
- Store AG-GABAPENTIN capsules at room temperature (15°C to 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 AG- GABAPENTIN, or if you find that they have passed their expiry date, please return any leftover medicine to your 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 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at 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
If you want more information about AG-GABAPENTIN:
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This leaflet was prepared by:
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
Canada J4B 5H3
Last revised: June 23, 2020