Sanorex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SANOREX^® is used as short-term (e.g. a few weeks) management of obesity in addition to continuing a weight reduction plan outlined by a healthcare professional. SANOREX^® is normally prescribed to people that have not responded to an appropriate weight reducing plan alone and who have a Body Mass Index of at least 27 to 30 kg/m² as decided by your doctor. SANOREX is given as part of a long-term weight loss and weight management approach under the care of a doctor. This approach should include diet and behaviour modification as well as increased physical activity. The change in lifestyle initiated before you started taking SANOREX must be continued once you no longer take SANOREX or you may regain the weight you have lost during treatment with SANOREX.

What it does:.

It is thought that SANOREX^® helps you lose weight by reducing your appetite.

When it should not be used:

You should not take SANOREX^® if you:

• Have an eye disorder called narrow-angle glaucoma.
• Have uncontrolled high blood pressure.
• Have pulmonary artery hypertension.
• Have now or have a history of stroke or mini-strokes (called trans-ischemic attacks or TIAs).
• Have now or a history of heart disease including coronary artery disease, irregular heart beats, a prior heart attack, and/or a diagnosis of congestive heart failure (including a type known as cardiac decompensation).
• Have severe kidney or liver disease.
• Have now or have a history of a diagnosis of uraemia (kidney failure).
• Have now or have a history of or a tendency towards drug or alcohol dependence or abuse.
• Have a diagnosis or a history of psychiatric disorders including an eating disorder, depression, hyperexcitability, states of agitation, schizophrenia or any other psychiatric illness or are taking prescription medicines called monoamine oxidase inhibitors (MAOIs) for depression, Parkinson’s Disease, or any other disorder (for example: Eldepryl^®, Parnate^®, Nardil^®, Manerix^®) or taking other centrally acting medications for the treatment of psychiatric disorders (for example: Prozac^®, Zoloft^TM, Effexor^®, Cymbalta, Luvox^®, or Paxil^®), including herbal remedies (such as St. John’s Wort).
• Are taking other weight loss medications that act on the brain. This includes prescription medications, over-the-counter medications and herbal products.

• Are pregnant or trying to become pregnant.

• Are breastfeeding a baby.

Children under 12 years of age should not take SANOREX^®.

Do not take SANOREX^® if you are allergic to mazindol or any of the ingredients in SANOREX^®, (see, “What the non-medicinal ingredients are”).

What the medicinal ingredient is:

mazindol

What the nonmedicinal ingredients are:

The 1 mg tablet contains the non-medicinal ingredients calcium sulphate, lactose, magnesium stearate, povidone, starch and talc.

The 2 mg tablet contains the non-medicinal ingredient dyes (D&C Yellow #10 Lake HS and D&C Red #21 Aluminum Lake), iron oxide red, lactose, magnesium stearate, povidone and starch.

What dosage forms it comes in:

1 mg and 2 mg Tablets

WARNINGS AND PRECAUTIONS

When used for more than 3 months, certain weight loss medications that act on your whole body have been associated with dysfunction of heart valves as well as a rare but sometimes deadly disease known as primary pulmonary hypertension (PPH).

BEFORE you use SANOREX^® talk to your doctor or pharmacist if:

$ You are not on a weight reducing diet and exercise plan.

$ You have high blood pressure.

$ You have epilepsy or seizures

$ You have taken weight loss drugs in the past.

$ You have current medical problems.

$ You have now or have a history of bleeding disorders or you are predisposed to bleeding disorders or you take medication that affects bleeding.

$ You have been diagnosed with the hereditary problem of galactose intolerance or glucose-galactose malabsorption.

$ You are taking any prescription medications, over the counter medications or herbal/natural products or remedies.

$ You have a prior allergy to a medication.

$ You have a heart murmur or an abnormality with your heart valves.

$ You have an abnormal heartbeat (e.g. fast, slow, or irregular).

$ You have a history of drug or alcohol abuse or dependence.

$ You are pregnant, trying to become pregnant or breastfeeding.

$ You are diabetic and take insulin.

You should not engage in activities requiring rapid or precise response, such as driving a car or operating machinery until you are certain that SANOREX^® does not impede your ability to do so safely.

It is important to let your doctor know if you have had or have now a history of heart disease of any kind, high blood pressure, migraine headaches, glaucoma, seizures, depression, any psychiatric illness (including anorexia nervosa or bulimia nervosa), prior strokes, prior transient ischemic attacks (TIAs), thyroid disorders, gallstones, liver disease, kidney disease, or any other medical problem.

If you develop depression, become delirious or anxious, inform your doctor right away.

Weight loss can cause gall stones or make the formation of them worse.

INTERACTIONS WITH THIS MEDICATION

Serious Interactions with this Medication

Do not use SANOREX^® if you are taking or have taken within the last 2 weeks:

• Diet or weight loss products
• monoamine oxidase inhibitors (MAOIs)
• drugs or herbal remedies for the treatment of mental disorders (for example depression or psychosis).
• Do not use SANOREX® if you are taking or have taken fluoxetine within the last 5 weeks.

Tell your doctor or pharmacist if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

• drugs for depression
• drugs that affect serotonin such as, lithium, linezolid, tramadol, tryptophan, St. John’s Wort, or triptans (used to treat migraines)
• CNS stimulants (e.g., methylphenidate, dextroamphertamine, mixed salts amphetamine)
• thyroid hormones (e.g., levothyroxine, liothyronine))
• amantadine
• antihypertensive drugs such as clonidine, gueanethidine, methyldopa, and rauwolfia alkaloids
• Drugs used to put you to sleep for surgery (anaesthetics)
• dihydroergotamine (Migranal^®, DHE; used to treat migraines)
• certain pain medications such as Demerol^® (meperidine), Duragesic™ (fentanyl), and Talwin^® (pentazocine);
• cough suppressant (dextromethorphan)

Many over-the-counter decongestants, cough, cold and allergy remedies, containing medicines such as phenylpropanolamine (no longer available in Canada), ephedrine, or pseudoephedrine, as well as certain anti-inflammatory drugs (e.g. NSAIDs) may increase blood pressure or heart rate. Before taking these medications on your own, you should check with your doctor to make sure it is all right to take these medicines while you are taking SANOREX^®. Your doctor may advise you to take a certain type of cough, cold, decongestant or allergy medicine that will not interact with SANOREX^®.

PROPER USE OF THIS MEDICATION

Be sure to discuss a weight reduction plan with your doctor, and do your best to abide by that plan while you are taking SANOREX^®.

Speak with your doctor if you feel that the effect SANOREX^® is having on reducing your appetite is noticeably less than it was when you started taking SANOREX^®.

Usual dose:

From 1 mg once a day up to 1 mg 3 times a day to be determined by your doctor. SANOREX^® should be taken 1 hour before a meal. Take SANOREX at the beginning of the time you plan to be awake. Taking it before going to sleep can cause nervousness and problems sleeping. Always follow your doctor’s instructions. Treatment is for a maximum of 6 weeks.

Overdose:

If you have taken more medication than you should have, contact either your doctor, the regional poison control centre or hospital emergency department immediately.

Missed Dose:

If you miss a dose, take it as soon as possible and continue with your regular schedule. If you are approaching the

time of your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects with SANOREX^® are nervousness, agitation, dizziness, drowsiness, depression, vertigo, and problems sleeping.

During controlled medical testing, the following side effects were reported: Headache, tremors, tingling, anxiety, restlessness, overstimulation, dry mouth, nausea, vomiting, unpleasant taste, diarrhea, constipation, abdominal discomfort, rash, itchiness, paleness, clamminess, sexual dysfunction, menstrual disorder, excessive sweating and flushing, dilated pupils, blurred vision and weakness.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking SANOREX^®, contact your doctor or pharmacist.

HOW TO STORE IT

Store bottles of SANOREX^® at 15-30˚C. Protect from exposure to moisture.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects

information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or 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: ---------------------------------------------------------------------------------------------------------------------------------------

• 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 0701C

    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.

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MORE INFORMATION

This document plus the full product monograph, prepared for health professionals by contacting the sponsor, HEXIM Pharmaceuticals Inc. at:

(201) 552-2289

Last revised: July 7, 2015