Mylan-Mirtazapine: Uses, Side Effects and Dosage

What is MYLAN-MIRTAZAPINE used for?

• MYLAN-MIRTAZAPINE is used in adults to relieve symptoms of depression.

How does MYLAN-MIRTAZAPINE work?

MYLAN-MIRTAZAPINE belongs to a group of medicines called anti-depressants. The way MYLAN-MIRTAZAPINE works to treat depression is unknown. MYLAN-MIRTAZAPINE is thought to have an effect in the brain on chemicals called serotonin and norepinephrine.

What are the ingredients in MYLAN-MIRTAZAPINE?

Medicinal ingredients: Mirtazapine

Non-medicinal ingredients: Colloidal anhydrous silica, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, and titanium dioxide.

15 mg: Triacetin and yellow iron oxide

30 mg: Yellow, red and black iron oxides

MYLAN-MIRTAZAPINE comes in the following dosage forms:

Tablets: 15 mg, 30 mg and 45 mg.

Do not use MYLAN-MIRTAZAPINE if you are:

• allergic to mirtazapine or any of the other ingredients in the medication;
• currently taking or have recently taken monoamine oxidase (MAO) inhibitors (including some types of anti-depressant and anti-Parkinson treatments) in the past 14 days.

MYLAN-MIRTAZAPINE is not for use in patients under 18 years of age.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MYLAN-MIRTAZAPINE. Talk about any health conditions or problems you may have, including if you:

• have ever shown unusual sensitivity (rash or any other signs of allergy) to any medication;
• have heart problems;
• have had a heart attack or stroke;
• have liver or kidney problems;
• are taking a medicine to lower your blood pressure;
• have a history of drug abuse;
• have a history of mania;
• have a history of seizures or fits;
• have diabetes;
• have prostate problems;
• have glaucoma or increased pressure in your eyes;
• have a history of suicidal behaviour or other mental health problems, such as schizophrenia and bipolar disorder (alternating periods of elation/overactivity and depressed mood);
• have a history of high cholesterol and/or high triglycerides (fats in the blood);
• are 65 years of age or older;

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in MYLAN-MIRTAZAPINE.

Other warnings you should know about:

MYLAN-MIRTAZAPINE can cause serious side effects, including:

• Changes in Feelings, Thoughts and Behaviour: It is important that you have good communication with your healthcare professional about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful. Some patients may feel worse when they first start taking MYLAN-MIRTAZAPINE or when their dose is changed. You may have thoughts of hurting yourself or others. This can be more likely to happen if you have a history of suicidal thoughts or attempts and if you are aged 18 to 24 years old.
• Agranulocytosis: Severely low numbers of white blood cells that can lead to death.
• Heart Problems: MYLAN-MIRTAZAPINE can cause serious heart problems that can lead to death. There is a greater risk for these heart problems if you have or have a family history of heart rhythm problems (QT Prolongation).
• Serotonin Syndrome and Neuroleptic Malignant Syndrome: These are life-threatening conditions that affect your muscle tone and temperature control.
• Serious Skin Problems: MYLAN-MIRTAZAPINE can cause serious skin problems such as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) that can be life-threatening.

See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.

Pregnancy: If you are pregnant, think you might be pregnant, or are thinking of becoming pregnant talk to your healthcare professional. If you get pregnant while taking MYLAN-MIRTAZAPINE you should discuss the risks and benefits of continuing your treatment with

MYLAN-MIRTAZAPINE with your healthcare professional. Some newborns whose mothers took an SSRI or other newer antidepressants during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing and feeding difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. If your baby experiences any of these symptoms, contact your doctor as soon as you can.

Breastfeeding: If you are breastfeeding or thinking of breastfeeding discuss the risks and benefits of continuing your treatment with MYLAN-MIRTAZAPINE with your healthcare professional. MYLAN-MIRTAZAPINE passes into breastmilk. It is very important that you do NOT stop taking MYLAN-MIRTAZAPINE without first talking to your doctor.

Discontinuation Symptoms: Do not stop taking MYLAN-MIRTAZAPINE or change your dose without speaking to your healthcare professional. This can cause serious side effects. If you experience symptoms such as dizziness, abnormal dreams, numbness and tingling or electric shock sensations, agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting or sweating when your dose has been lowered or changed, talk to you healthcare professional. These symptoms can also occur if you miss a dose.

Driving and using machines: Before you do tasks that require special attention, wait until you know how you respond to MYLAN-MIRTAZAPINE, it may affect your ability to be alert.

Blood tests: MYLAN-MIRTAZAPINE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MYLAN-MIRTAZAPINE:

• other antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs, i.e. paroxetine), venlafaxine, certain tricyclics antidepressants (i.e. amitriptyline), nefazodone, tryptophan
• ketoconazole; used to treat fungal infections
• cimetidine; used to treat reflux and stomach ulcers
• antibiotics used to treat bacterial infections, such as erythromycin and linezolid
• antiviral medicines used to treat Human Immunodeficiency Virus (HIV), such as a combination of fosamprenavir and ritonavir
• medicines used to treat epilepsy, such as carbamazepine and phenytoin
• rifampicin; an antibiotic used to treat tuberculosis
• warfarin; used to prevent blood clotting
• benzodiazepines; such as midazolam, oxazepam and diazepam
• medicines that may affect the heart’s rhythm
• medicines used to treat mental health problems such as risperidone and lithium
• triptans; used to treat migraines
• opioids such as tramadol; used to treat moderate to severe pain
• St. John’s Wort, an herbal product used to treat depression

• alcohol; you should not drink alcohol with you are taking MYLAN-MIRTAZAPINE

How to take MYLAN-MIRTAZAPINE:

• Take MYLAN-MIRTAZAPINE exactly as your healthcare professional tells you.
• Do not stop taking MYLAN-MIRTAZAPINE or change your dose without speaking to your healthcare professional.
• Take your tablet(s) at the same time each day, preferably in the evening before sleep.
• Swallow the tablets with water. Do not chew the tablets.

Usual adult dose:

15 mg – 45 mg once a day.

Overdose:

Signs that you have taken too much MYLAN-MIRTAZAPINE include; drowsiness, disorientation, increased heart rate. The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes.

Missed Dose:

If you forget to take your evening dose, do not take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with your normal dose. Do not take a double dose to make up for forgotten doses.

What are possible side effects from using MYLAN-MIRTAZAPINE?

These are not all the possible side effects you may feel when taking MYLAN-MIRTAZAPINE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• sleepiness, drowsiness
• weakness
• dry mouth
• increased appetite
• constipation
• weight gain
• dizziness
• headache
• muscle pain, back pain
• abnormal dreams, trouble sleeping, nightmares
• frequent urination
• itchiness, rash
• faintness (especially when you get up quickly from a lying or sitting position)
• urinary tract infections
• abnormal sensation in the skin (e.g., burning, stinging, tickling or tingly

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Store at controlled room temperature, 15°C - 30°C. Protect from light, in the tight, light-resistant container given to you by the pharmacist.
• Keep MYLAN-MIRTAZAPINE out of the reach and sight of children.
• Do not use MYLAN-MIRTAZAPINE after the expiry date indicated on the package.

If you want more information about MYLAN-MIRTAZAPINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.mylan.ca, or by calling 1-800-596-9526.

Last Revised: October 27, 2022