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Home » Antidepressants, MAOIs

PARNATE®

Submitted by on November 26, 2016 – 2:40 pm | 33 views
parnate-tranylcypromine

PrPARNATE®

Tranylcypromine Tablets USP

CONSUMER INFORMATION

This leaflet is part III of a three-part “Product Monograph” published for PARNATE®, approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about PARNATE®. Contact your doctor or pharmacist if you have any questions about the drug.

Please read this information before you start to take your medication, even if you have taken this drug before. Keep this information with your medicine in case you need to read it again.

ABOUT THIS MEDICATION

What the medication is used for:

PARNATE® has been prescribed to you by your doctor to relieve your symptoms of depression.

What it does:

PARNATE® belongs to the family of medicines called monoamine oxidase inhibitors (MAOIs). PARNATE® increases the levels of naturally occurring chemicals in the brain called epinephrine, norepinephrine, and serotonin, thus relieving the symptoms of depression.

When it should not be used:

PARNATE® should not be used:

  • if you are allergic to the active ingredient, tranylcypromine or any of the components of its formulation (See What the medicinal ingredient is and What the nonmedicinal ingredients are section)
  • if you have high blood pressure or heart disease
  • if you have ever had a stroke, or any other kind of
  • if you have liver disease or blood dyscrasias (i.e. blood disorders)
  • if you have a history of severe or frequent headaches.
  • if you have a pheochromocytoma (a tumor of the adrenal gland)
  • if you are receiving any other antidepressant medication

What the medicinal ingredient is:

The medical ingredient in PARNATE® is tranylcypromine sulfate.

What the nonmedicinal ingredients are:

PARNATE® contains the following nonmedicinal ingredients: carnauba wax, citric acid, croscarmellose sodium, gelatine, hydroxyl propylmethyl cellulose, lactose, magnesium stearate, propylene glycol, talc and .

What dosage forms it comes in:

PARNATE® is available as a round, film-coated tablet. Each tablet contains 10 mg tranylcypromine sulfate.

WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions

• New or Worsened Emotional or Behavioral Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

• Hypertensive crisis: Certain foods and drinks must be avoided during treatment with PARNATE® and for two weeks after stopping treatment. This hypertensive reaction can be life-threatening, depending on the amount of tyramine that has been taken (See INTERACTIONS WITH THIS MEDICATION).

BEFORE you use PARNATE®, tell your doctor or pharmacist:

  • all your medical conditions, including a history of stroke, liver disease, blood disorders, kidney disease, heart problems, diabetes, , or overactive thyroid gland
  • if you have or have ever had recurrent or frequent headaches
  • any medications (prescription or non prescription) which you are taking or have recently taken, especially any other antidepressants
  • if you are pregnant, plan to become pregnant, or are breastfeeding
  • if you are beyond the age of sixty
  • your habits of alcohol and /or street drug consumption
  • if you had any type of surgery or are planning to have surgery

Effects on Pregnancy and Newborns:

As stated above, ask your doctor or pharmacist for advice before taking any medicine including PARNATE®. If you are already taking/using PARNATE® and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Children and adolescents (less than 18 years of age): Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviour in children and adolescents with depression.

Angle-Closure Glaucoma:

PARNATE® may cause an acute attack of glaucoma. Having your eyes examined before you take this drug could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye.

INTERACTIONS WITH THIS MEDICATION

Check with your doctor or pharmacist before taking any other medicines, including prescription and non-prescription medicines. Some medicines may cause serious unwanted effects if you take them at the same time as PARNATE®. This also applies even in the first weeks after you stop taking PARNATE®.

Drugs that may interact with PARNATE® include:

  • other antidepressants, such as other MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitor (SNRI) and certain
  • appetite suppressants such as amphetamines
  • cold or any hay fever medicines (including nose drops or sprays)
  • cough suppressant such as dextromethorphan
  • levodopa and other treatments for Parkinson’s disease
  • herbal preparations
  • other drugs that affect serotonin such as pethidine and tryptophan
  • medications which lower blood pressure, including , reserpine, methyldopa
  • narcotics and barbiturates

Certain foods and drinks must be avoided during treatment with PARNATE® and for two weeks after stopping treatment. PARNATE® reacts with a chemical, tyramine, found in various foods, which can cause dangerously (See Serious Warnings and Precautions). This reaction can be life-threatening, depending on the amount of tyramine that has been taken. You should avoid foods in which aging or breakdown is used to increase flavour, including:

  • matured or aged cheeses
  • aged, cured or fermented meat, fish or poultry
  • fermented soybean products, such as soy sauce
  • sauerkraut
  • fava or broad bean pods
  • banana peel (but not the pulp)
  • concentrated yeast extracts
  • all tap/draught beers
  • in general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking PARNATE®.

Pre-prepared foods such as pizzas, casseroles, meals with sauces, and some restaurant foods may contain these prohibited foods or drink. It is therefore important that you check the ingredients of foods or drink that you have not prepared yourself.

All foods that you eat must be fresh, or properly frozen. Tyramine levels of many foods also increase naturally as they get older, even if they are refrigerated. It is very important that you buy and eat only fresh foods or those which have been properly frozen.

The amounts of tyramine may vary in different brands or even batches of food. A person may absorb different amounts of tyramine from a particular food at different times. Therefore, if you have accidentally taken a prohibited food or drink on one occasion and not had a reaction, you can still have a serious reaction if you take it again.

Your doctor has more information on foods to be careful with or avoid while taking PARNATE®. Ask your doctor for advice if you have any questions about this.

PROPER USE OF THIS MEDICATION

Usual dose:

  • It is important that you take PARNATE® exactly as your doctor has instructed. The usual starting dose of PARNATE® is one 10 mg tablet taken twice a day.
  • PARNATE® tablets are usually taken in the morning and again mid-afternoon. It is better if you take your tablets at the same times each day.
  • You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.
  • Keep taking your tablets, as instructed, until the doctor tells you to stop.
  • Talk to your doctor before you stop taking your medication on your own.

Remember: 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.

Overdose:

If you have taken a large number of tablets all at once, go to the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your pack of tablets.

Missed Dose:

If you forget to take a PARNATE® tablet, do not try to make up for the dose that you missed by taking more than one dose at a time. Wait until the next dose and take your normal dose then.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, PARNATE® 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. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and go to the nearest hospital emergency department immediately.

The most common side effects of PARNATE® are:

  • sleep disturbances (insomnia)
  • nausea
  • dry mouth
  • drowsiness
  • weakness
  • dizziness
  • loss of appetite
  • diarrhea

PARNATE ® does not usually affect people’s normal activities. However, some people feel drowsiness, dizziness or light headedness while taking it, in which case they should not drive or operate machinery.

Tell your doctor immediately if you notice any of the following:

Stop taking PARNATE® and contact your doctor or go to the emergency department of your nearest hospital if the following happens:

  • severe or frequent headaches, chest pain, fast or slow heartbeat, neck stiffness or soreness, sweating with initial paleness followed by flushing of the skin, enlarged pupils, nausea and vomiting.

Other rare side effects that have been reported include disorders of the liver and blood.

New or Worsened Emotional or Behavioral Problems

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also the WARNINGS and PRECAUTIONS sections.

Drug Dependence and Discontinuation Symptoms

It is possible to become dependent on PARNATE®. You may experience unwanted effects when you stop taking PARNATE®. Withdrawal symptoms such as sleep disturbances, depression, confusion, agitation, hallucinations and other symptoms have been reported after stopping treatment of PARNATE®. Tell your doctor as soon as possible if you have these or any other symptoms. Contact your doctor before stopping or reducing your dosage of PARNATE®.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect

 

Talk with your doctor or pharmacist

 

Seek immediate medical emergency assistance.
Rare

 

Allergic reactions including but not limited to red and lumpy skin rash, hives, swelling in the mouth, tongue, face and throat, itching, rash, trouble breathing check
See Warnings & Precautions

 

New or Worsened Emotional or Behavioral Problems

 

Hypertensive crisis [severe or frequent headaches, chest pain, fast or slow heartbeat, neck stiffness or soreness, sweating with initial paleness followed by flushing of the skin, enlarged pupils, nausea and vomiting]

check  

 

 

check

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

HOW TO STORE IT

PARNATE® should be stored between 15 and 30°C. Keep PARNATE® out of the sight and reach of children.

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.

 

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.gsk.ca or by contacting the sponsor,

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

This leaflet was prepared by GlaxoSmithKline Inc.

Last revised: April 6, 2016

© 2016 GlaxoSmithKline Inc. All Rights Reserved

PARNATE is a registered trademark of SmithKline Beecham Animal Health Company, used under license by GlaxoSmithKline Inc.

A previous article entitled KHEDEZLA (key-DEZ-luh) (desvenlafaxine) provides information... abnormal dreams, Aggressive ve Antidepressant medicines

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