Patient Medication Information: uses, side effects, how to take - Sig-Gabapentin
ABOUT THIS MEDICATION
What the medication is used for:
Sig-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 Sig-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 important nonmedicinal ingredients are: Non-medicinal ingredients in the capsules include lactose, maize starch, talc, gelatin, titanium dioxide, yellow iron oxide and red iron oxide.
What dosage forms it comes in:
100 mg, 300 mg, and 400 mg capsules
WARNINGS AND PRECAUTIONS
BEFORE you use Sig-Gabapentin talk to your doctor or pharmacist:
All your medical conditions, especially if you have any
kidney disease
If you are taking any other medicines (prescription and
nonprescription).
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.
- Your habits of alcohol consumption.
If you drive a vehicle or perform hazardous tasks during your work.
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 morphine. Morphine may increase the levels of Sig-Gabapentin in your blood. If you experience increased side effects such as drowsiness or slowed breathing while taking these drugs together, the dose of Sig-Gabapentin or morphine may need to be adjusted.
PROPER USE OF THIS MEDICATION
Usual dose:
- It is very important that you take Sig-Gabapentin exactly as your doctor has instructed.
Sig-Gabapentin may be taken with or without food. • You should not increase or decrease the amount of Sig-
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 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 Sig-Gabapentin, contact your doctor or pharmacist.
Like all medications, Sig-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. • Stop taking the drug and contact your doctor immediately if you
experience any severe, unusual or allergic reactions (including skin rash or redness and/or breathing difficulties). • When you first begin taking Sig-Gabapentin you may
experience some side effects such as drowsiness, dizziness, lack of muscular 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.
- Avoid alcoholic drinks while taking Sig-Gabapentin.
The following side effects have been reported since gabapentin
has been marketed. At this time it is unknown if these side effects were caused by the use of gabapentin. If you develop any of the following side effects tell your doctor immediately: skin rash or redness, blood glucose fluctuations for patients suffering from diabetes, chest pain, shortness of breath, hallucinations, unusual muscle movement or tone, heart palpitations, ringing or whistling in the ear, unusual changes in mood, sleeplessness, jaundice (yellowing of skin), dark urine, nausea and/or vomiting, swelling of legs, ankles or feet, and inability to control urination.
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 with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Common |
| T | ||
| Uncommon |
| T T T T T T T T | ||
This is not a complete list of side effects. If you have any unexpected effects while taking Sig-Gabapentin, contact your doctor or pharmacist.
HOW TO STORE IT
Keep all medicines out of the reach of children. • Store Sig-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 Sig-Gabapentin, or if you find that they have passed their expiry date, please return any left over medicine to your pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
On-line: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Health Products and Food Branch
Heath Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Canada Vigilance, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sigmacon Lifesciences Inc., at: 1-800-898-7455.
Sigmacon Lifesciences Inc.
436 Limestone Crescent
North York, Ontario M3J 2S4
Canada