Bio-Gabapentin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

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

When it should not be used:

Do not use Bio-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:

Bio-GABAPENTIN Capsules:

Capsules contain: copovidone, magnesium stearate, maize starch, and poloxamer. Capsule shells contain: Gelatin, sodium lauryl sulfate, titanium dioxide (all three strengths), yellow iron oxide (300 mg & 400 mg) and red iron oxide (400 mg).

Bio-GABAPENTIN Tablets contain: copovidone, hydroxypropylcellulose, magnesium stearate, maize starch poloxamer 407, and purified talc.

What dosage forms it comes in:

Gabapentin are 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 Bio-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.
• 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 Bio-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. If you experience increased side effects such as drowsiness or slowed breathing while taking these drugs together, the dose of Bio-GABAPENTIN or opioids may need to be adjusted.

Avoid alcoholic drinks while taking Gabapentin Capsules USP and Gabapentin Tablets USP.

PROPER USE OF THIS MEDICATION

Usual dose

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

• Bio-GABAPENTIN may be taken with or without food.

• You should not increase or decrease the amount of Bio-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 tablets or 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 Bio-GABAPENTIN, contact your doctor or pharmacist.

Like all medications, Bio-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 Bio-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.
• The following side effects have been reported when Bio-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 Bio-GABAPENTIN, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medicines out of the reach of children.
• Store at room temperature (15° - 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 Bio-GABAPENTIN, or if you find that they have passed their expiry date, please return any left over medicine to you pharmacist.

MORE INFORMATION

REPORTING SUSPECTED SIDE EFFECTS

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Biomed Pharma.

Biomed Pharma

100-5950, Ch. de la Côte de Liesse

Mont-Royal, QC, H4T 1E2

Phone# (514) 731-2003; Fax: (514) 731-2004

Date of Preparation: July 19, 2016