Gabapentin (Sorres Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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 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:

Capsules: corn starch, gelatin, lactose, talc, titanium dioxide, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg).

Tablets: carnauba wax, copovidone, dehydrated alcohol, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and talc.

What dosage forms it comes in:

Capsules: 100 mg, 300 mg or 400 mg

Tablets: 600 mg and 800 mg

WARNINGS AND PRECAUTIONS

BEFORE you use GABAPENTIN, 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.
• 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 GABAPENTIN in your blood. If you experience increased side effects such as drowsiness or slowed breathing while taking these drugs together, the dose of GABAPENTIN or morphine may need to be adjusted.

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:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

• 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 GABAPENTIN 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 GABAPENTIN.

• The following side effects have been reported since gabapentin

  has been marketed. At this time it is unknown whether or not 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.

• 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.

• If you have suicidal thoughts while taking GABAPENTIN, you

  should seek immediate medical assistance.

• 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 GABAPENTIN, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medicines out of the reach of children.
• Store capsules and tablets 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 GABAPENTIN, or if you find that they have passed their expiry data, please return any left over medicine to you pharmacist.

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:

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• 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, Ontario

    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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Sorres Pharma Inc. at 1-888-550-6060.

Sorres Pharma Inc.

Montreal Quebec

H4P 2T4

Last revised: January 14, 2013