Act Gabapentin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ACT 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 ACT GABAPENTIN if you are allergic to it or any of the components in the formulation (see list of components under “What the non-medicinal ingredients are”). 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 nonmedicinal ingredients are:

Non-medicinal ingredients in the capsules include lactose monohydrate, maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg, 400 mg) and red iron oxide (400 mg).

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

BEFORE you use ACT 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 take ACT 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 ACT 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 ACT GABAPENTIN with an opioid or other sedatives and tranquilizers. The dose of these drugs or ACT GABAPENTIN may need to be adjusted.

Avoid alcoholic drinks while taking ACT GABAPENTIN.

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take ACT GABAPENTIN exactly as your doctor has instructed.

• ACT GABAPENTIN may be taken with or without food.

• You should not increase or decrease the amount of ACT

  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.

If you think you have taken too much ACT 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 ACT GABAPENTIN, contact your doctor or pharmacist.

Like all medications, ACT 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 ACT 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.

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

HOW TO STORE IT

• Keep all medicines out of the reach of children.
• Store at room temperature conditions, 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 ACT

  GABAPENTIN, or if you find that they have passed their expiry date, please return any left over medicine to your pharmacist.

MORE INFORMATION

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction Reporting

  (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company at: 1-866-254-6111.

Actavis Pharma Company

6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Canada

Last revised: November 30, 2017