Consumer Information for: GABAPENTIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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 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

GABAPENTIN Capsules: Maize Starch and Talc. Capsule shell is composed of Titanium Dioxide (E171) Ph.Eur., Sodium Lauryl Sulfate Ph.Eur., Gelatin Ph.Eur. Additionally 300 mg contains Yellow Iron Oxide (E172) and 400 mg contains Red Iron Oxide (E172) and Yellow Iron Oxide (E172).

What dosage form it comes in

GABAPENTIN is available in capsules (containing 100 mg, 300 mg or 400 mg gabapentin).

Warnings and precautions

SERIOUS WARNINGS AND PRECAUTIONS

Taking 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 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. GABAPENTIN passes into breast milk; however, it is not known if GABAPENTIN can harm your baby. You and your doctor should decide whether you should take 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 antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking 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.

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

Avoid alcoholic drinks while taking GABAPENTIN.

Proper use of this medication

Usual Dose

  • It is very important that you take GABAPENTIN exactly as your doctor has instructed.
  • GABAPENTIN may be taken with or without food.
  • You should not increase or decrease the amount of 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 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 GABAPENTIN, contact your doctor or pharmacist.

Like all medications, 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 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
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, 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     ✔
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 GABAPENTIN, contact your doctor or pharmacist.

How to store
  • Keep all medicines out of the reach of children
  • Store in well-closed containers between 15°C and 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 GABAPENTIN, or if you find that they have passed their expiry data, please return any left-over medicine to you pharmacist.
Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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 GABAPENTIN:

  • 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/index-eng.jsp) or by calling 1-855-788-3153.
  • Or at www.sivem.ca

This leaflet was prepared by
Sivem Pharmaceuticals ULC
4705 Dobrin Street,
Saint-Laurent, Quebec
H4R 2P7

Last revised: August 20, 2020

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