Mar-Gabapentin Tabs: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

Mar-GABAPENTIN TABS has been prescribed for you by your doctor to reduce your number of seizures.

When it should not be used:

Do not use Mar- GABAPENTIN TABS 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:

Hydroxypropyl cellulose, Low-substituted Hydroxypropyl cellulose, Magnesium Stearate and Talc.

What dosage forms it comes in:

Mar- GABAPENTIN TABS is available in tablets (containing 600 mg or 800 mg of gabapentin).

WARNINGS AND PRECAUTIONS

BEFORE you use Mar- GABAPENTIN TABS, tell your doctor or pharmacist:

• All your medical conditions, especially if you have any kidney disease.

• 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.
• 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.

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 Mar- GABAPENTIN TABS in your blood. If you experience increased side effects such as drowsiness or slowed breathing while taking these drugs together, the dose of Mar-

GABAPENTIN TABS or opioid may need to be adjusted.

PROPER USE OF THIS MEDICATION

Usual dose

It is very important that you take Mar- GABAPENTIN TABS exactly as your doctor has instructed.

Mar- GABAPENTIN TABS may be taken with or without food.

You should not increase or decrease the amount of Mar- GABAPENTIN TABS 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 Mar-GABAPENTIN TABS contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Show the doctor your bottle of medication when you seek medical attention.

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 Mar-GABAPENTIN TABS contact your doctor or pharmacist.

Like all medications, Mar- GABAPENTIN TABS 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 Mar-

  GABAPENTIN TABS you may experience some side effects such as 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.

• Avoid alcoholic drinks while taking Mar-

  GABAPENTIN TABS.

• The following side effects have been

  reported since Mar-GABAPENTIN TABS has been marketed. At this time it is unknown whether or not these side effects were caused by the use of Mar-GABAPENTIN TABS. If you develop

  any of the following side effects tell your

  doctor immediately: skin rash or redness, hypoglycemia, hyperglycemia, blood glucose fluctuations for patients suffering from diabetes, chest pain, shortness of breath, hallucinations, unusual muscle movement or tone, heart palpitations, unexplained muscle pain or tenderness or weakness, ringing or whistling in the ear, unusual changes in mood, confusion, sleeplessness, loss of consciousness, jaundice (yellowing of skin), dark urine, nausea and/or vomiting, swelling of legs, ankles or feet, and inability to control urination.

  • Please see your doctor immediately if you develop fever, rash, swollen lymph nodes, hives, sore mouth, sore eyes or swelling of lips or tongue, particularly in the first six weeks of therapy.
  • The following side effects have been reported when Mar-GABAPENTIN TABS 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 Mar- GABAPENTIN TABS, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medicines out of the sight and

  reach of children.

• Store tablets at controlled room

  temperature (15° 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

  Mar- GABAPENTIN TABS, or if you find that they have passed their expiry data, please return any left over medicine

  to you pharmacist.

  •

MORE INFORMATION

REPORTING SUSPECTED 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

  www.healthcanada.gc.ca/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 0701E Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/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.

This document plus the full monograph, prepared for health professionals by Marcan Pharmaceuticals Inc.

Date of Preparation: October 24, 2014.