April 19, 2014
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Remeron

(mirtazapine)

DIN (Drug Identification Number)

02243910 REMERON 30MG TABLET

What side effects are possible with Remeron?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • increased appetite
  • muscle pain
  • nausea
  • weakness
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal dreams
  • aggressive behaviour
  • agitation
  • anxiety
  • decreased sexual ability
  • difficulty urinating
  • dizziness when standing from a sitting or lying position
  • fainting
  • hallucinations (hearing, seeing, or feeling things that are not there)
  • joint or muscle pain
  • mood changes (undesirable)
  • mood swings
  • rash
  • restless legs
  • signs of worsening depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (such as sore throat, chills, and fever, mouth sores)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • swelling of feet and hands due to fluid retention
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • uncontrolled sudden movement
  • unusual bruising or bleeding
  • unusual excitement
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • confusion or changes in thought patterns
  • mania, or feeling "high"
  • seizures
  • signs of an allergic reaction (e.g., difficulty breathing, hives, swelling of the face or throat)
  • signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)
  • signs of serotonin syndrome (e.g., delirium, agitation, muscle rigidity, movement difficulty)signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • swelling of the hands or feet with shortness of breath
  • tremors

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Remeron?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

March 28, 2014

Health Canada has issued new restrictions concerning the use of Remeron and Remeron RD (mirtazapine). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Blood disorders: Mirtazapine can affect the production of blood cells in your body. It may cause a reduced number of white blood cells to be available to fight infection. If you notice any signs of infection, such as sore throat or flu-like symptoms, contact your doctor as soon as possible.

Diabetes: Mirtazapine may cause a loss of control of diabetes by increasing blood glucose (sugar). If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Mirtazapine may cause drowsiness. People taking mirtazapine should avoid operating hazardous machinery (including cars) until they are certain that the medication does not impair their mental alertness, judgment, or physical coordination.

Medical conditions: Mirtazapine may worsen a number of medical conditions. If you have glaucoma, low blood pressure (especially low blood pressure upon standing up (orthostatic hypotension), prostate problems, or urinary retention, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If symptoms of any of these conditions worsen, contact your doctor as soon as possible.

Kidney disease: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Liver disease: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Neuroleptic malignant syndrome (NMS): Mirtazapine, like other medications that affect serotonin, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin Syndrome: Severe reactions are possible when mirtazapine is combined with other medications that act on serotonin, such as antipsychotics, "triptan " migraine medications and other medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking any of these groups of medications, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may cause side effects such as dizziness, agitation, confusion, headache, sweating and others. A gradual reduction in dose over a period of time is recommended. If you are thinking of stopping the medication, check with your doctor first.

Suicidal or agitated behaviour: Adults and children taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.

Mirtazapine may cause symptoms of mania to worsen or to return. People with a history of manic symptoms or bipolar disorder should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. It has been reported that babies born to women who have taken mirtazapine during the last trimester of pregnancy may experience complications that result in an increase in the length of their hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if mirtazapine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of this medication have not been established for children and adolescents under 18 years of age. There have been reports that the use of this medication by children and adolescents younger than 18 years may cause behavioural and emotional changes, such as suicidal thoughts and behaviour. Children and adolescents who take this medication should be closely monitored and encouraged to report all changes in feelings to their doctor and caregiver.

Seniors: Seniors often have decreased kidney or liver function. For this reason, they often have this medication build up in the body and experience more side effects than younger people. A lower dose may be needed for older people.

What other drugs could interact with Remeron?

There may be an interaction between mirtazapine and any of the following:

  • alcohol
  • amiodarone
  • anti-HIV medications (e.g., indinavir, lopinavir, ritonavir, saquinavir)
  • antipsychotics (e.g., chlorpromazine, haloperidol, olanzapine, perphenazine, prochlorperazine, quetiapine, risperidone)
  • aprepitant
  • azelastine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • benzodiazepines (e.g., clobazam, diazepam, lorazepam, oxazepam)
  • bosentan
  • buprenorphine
  • bupropion
  • busulfan
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • celecoxib
  • certain antihistamines (e.g., dimenhydrinate, diphenhydramine)
  • certain seizure medications (e.g., carbamazepine, phenytoin, primidone)
  • chloroquine
  • clonidine
  • cyclosporine
  • cyproterone
  • dapsone
  • deferasirox
  • delavirdine
  • dexamethasone
  • dexmedetomidine
  • dextroamphetamine
  • disopyramide
  • doxorubicin
  • estrogen
  • etoposide
  • fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • gemfibrozil
  • imatinib
  • isoniazid
  • isosorbide
  • lidocaine
  • linezolid
  • lithium
  • macrolide antiobiotics (e.g., clarithromycin, erythromycin)
  • magnesium sulfate
  • MAO inhibitors (e.g., phenelzine, selegiline, tranylcypromine, moclobamide)
  • medroxyprogesterone
  • metoclopramide
  • metronidazole
  • mexilitine
  • methyldopa
  • montelukast
  • nilotinib
  • opioid pain relievers (e.g., codeine, fentanyl, meperidine, methadone, morphine, oxycodone)
  • pramipexole
  • primaquine
  • progesterone
  • quinidine
  • quininerifabutin
  • rifampin
  • ropinirole
  • St. John's wort
  • sibutramine
  • sildenafil
  • sirolimus
  • SSRI antidepressants (e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • "statin" cholesterol-lowering medications (e.g., atorvastatin, pravastatin)
  • tacrolimus
  • tamoxifen
  • tamsulosin
  • ticlopidine
  • tizanidine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
  • "triptan" medications for migraine (e.g, rizatriptan, sumatriptan)
  • vinblastine
  • vincristine
  • warfarin
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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Depression Symptom Checker Tool

The Depression Symptom Checker tool can help you learn about depression. Use this tool to create a list of your symptoms and rate how much the symptoms impact your life on a daily basis. The checklist is divided into 6 symptom categories that are associated with depression. You can also learn more about symptoms of depression here.

For each statement choose a number from 0 to 4 that describes the impact on your daily life, where 4 has the highest impact and 0 has no impact:

  • 0 = no impact on daily life/no symptoms
  • 1 = mild impact on daily life
  • 2 = moderate impact on daily life
  • 3 = severe impact on daily life
  • 4 = debilitating impact on daily life

It is important to remember that this is not a “score” but a way to help you communicate how much you feel the symptom impacts your daily life. When you finish you will be able to print out your symptoms and share this information with your doctor. Use the Doctor Discussion Guide to prepare for your doctor’s visit.

Rate how much the following symptoms apply to you.

1. Emotions

Depression can affect anyone at any age, although it most commonly appears between 15 and 45 years of age.

0 1 2 3 4
0 1 2 3 4
0 1 2 3 4
0 1 2 3 4

Visit your doctor with these results, when booking your appointment inform your doctor that you may need extra time to discuss these matters. Getting help for your depression can change your life. Don’t wait- depression is an illness that can, and should be treated.

Thoughts about death or suicide are common in depression, and it’s important to take such thoughts seriously. If you feel like giving up or as if you might hurt yourself, get help immediately: call your doctor, go to the emergency room or call 911.

This tool is adapted with permission from similar content found on www.depressionhurts.ca.


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