GD-Gabapentin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

GD-gabapentin has been prescribed for you by your doctor to reduce your number of seizures.

When it should not be used:

Do not use GD-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 nonmedicinal ingredients are:

GD-gabapentin Capsules:

Corn starch, gabapentin, lactose, and talc, Capsule shells may contain: FD&C Blue No. 2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide

GD-gabapentin Tablets:

Candelilla wax, copolyvidone, corn starch, hydroxypropylcellulose, poloxamer 407 NF, magnesium stearate, and talc.

What dosage forms it comes in:

GD-gabapentin 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 GD-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 anti-epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking GD-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 GD-gabapentin in your blood.

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

Avoid alcoholic drinks while taking GD-gabapentin.

PROPER USE OF THIS MEDICATION

Usual dose

• It is very important that you take GD-gabapentin exactly as your doctor has instructed.

• GD-gabapentin may be taken with or without food.

• You should not increase or decrease the amount of GD-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 GD 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 GD-gabapentin, contact your doctor or pharmacist.

Like all medications, GD-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 GD-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 GD-gabapentin is abruptly stopped: anxiety, sleeplessness, nausea, pain, and sweating.

This is not a complete list of side effects. If you have any unexpected effects while taking GD-gabapentin, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medicines out of the reach of children.
• Store capsules at room temperature (15° to 30°C) and tablets at controlled room temperature (20° to 25°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 GD-gabapentin, or if you find that they have passed their expiry data, please return any left over medicine to you pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at: http://www.Pfizer.ca

or by contacting the sponsor, GenMed, a division of Pfizer Canada Inc. at:

1-800-463-6001.

Last revised: April 19, 2018

REPORTING SUSPECTED SIDE EFFECTS