Apo-Nortriptyline: Uses, Side Effects and Dosage

Serious Warnings and Precautions

To help avoid side effects and ensure proper use, before you take APO-NORTRIPTYLINE, talk to your healthcare professional if you:

• Are taking any other medication that may cause heart problems or affect your heart rhythm.
• Have electrolytes levels that are either too low or too high such as a low level of potassium, calcium or magnesium, or a high level of potassium in your blood. Your healthcare professional will need to treat this before you start taking APO-NORTRIPTYLINE.

• Have a history of heart problems such as

  • changes in heart rhythm,
  • a slow heartbeat (bradycardia),
  • heart disease, including a condition called heart failure (a condition where your heart cannot pump the blood in your body as well as it should)

A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG) and problems with the heart rhythm (rapid or irregular heartbeat) have been reported in people taking APO-NORTRIPTYLINE.

APO-NORTRIPTYLINE may also reveal a hidden heart problem you did not know you had, a problem called “Brugada Syndrome”. Before you start taking APO-NORTRIPTYLINE, tell your healthcare professional if you have unexplained fainting or a family history of “Brugada Syndrome” or unexplained sudden death before 45 years of age, as this could indicate you may have “Brugada Syndrome”. You should not take APO-NORTRIPTYLINE if you have or are suspected to have “Brugada Syndrome”.

These problems can be serious and cause sudden death. Get immediate medical help if you experience dizziness, fainting, a rapid heartbeat or heart palpitations while taking APO-NORTRIPTYLINE.

• have a history of trouble emptying your bladder (urinary retention), an enlarged prostate gland, increased pressure in the eye or glaucoma as APO-NORTRIPTYLINE can make these conditions worse.

What is APO-NORTRIPTYLINE used for?

APO-NORTRIPTYLINE is used in adults to relieve the symptoms of depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain).

How does APO-NORTRIPTYLINE work?

APO-NORTRIPTYLINE is a medicine that belongs to a group of medicines known as tricyclic antidepressants. It is not known exactly how APO-NORTRIPTYLINE works. It is thought to increase the concentration of certain chemicals in the brain which can help with the symptoms of depression.

What are the ingredients in APO-NORTRIPTYLINE?

Medicinal ingredients: Nortriptyline hydrochloride

Non-medicinal ingredients: Corn starch, D&C yellow #10, FD&C yellow #6, gelatin, lactose, stearic acid, talc and titanium dioxide.

APO-NORTRIPTYLINE comes in the following dosage forms:

Capsules: 10 mg and 25 mg nortriptyline (as nortriptyline hydrochloride).

Do not use APO-NORTRIPTYLINE if:

• you are allergic to nortriptyline or any of the non-medicinal ingredients in APO-NORTRIPTYLINE
• you are currently taking or have taken, within the last 14 days, medicines called monoamine oxidase inhibitors (MAOIs) such as phenelzine sulphate, moclobemide, tranylcypromine, linezolid, methylene blue or selegiline.
• you have recently experienced a heart attack or heart failure

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

• have heart problems
• have low blood pressure
• have high pressure in the eyes (glaucoma)
• have or have a history of difficulty passing urine
• have an enlarged prostate gland
• have a history of epilepsy or seizures
• have a thyroid condition or are taking thyroid medication
• have schizophrenia, bipolar disorder or any other mental health problems
• are taking other anticholinergic medicines (certain medicines used to treat asthma, chronic obstructive pulmonary disease, stomach and gut problems, and Parkinson’s disease) or sympathomimetic medicines such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine
• have ever had suicidal thoughts

• consume alcohol. Drinking alcohol while taking APO-NORTRIPTYLINE may exaggerate your response to alcohol

• are going to have electroconvulsive therapy (electric shock)
• have diabetes
• are pregnant, think you might be pregnant or are planning to become pregnant
• are breastfeeding or are planning to breastfeed
• are taking medicines used to treat high blood pressure such as guanethidine
• are 65 years of age or older
• have liver problems
• are taking medicines used to increase the amount of water released in your urine known as diuretics or “water pills”
• are dehydrated or suffer from excessive sweating, vomiting or diarrhea, or an eating disorder
• have dental problems.
• wear contact lenses.
• have a tumour (cancer) of the adrenal gland (such as pheochromocytoma or neuroblastoma).
• have or have had a blood disease such as low platelet or white blood cell counts.
• have pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine).
• are taking warfarin or similar medicines, used to thin the blood.
• have been told you have enzymes that do not work well (such as “CYP2D6 poor metabolizer” or “CYP2C19 poor metabolizer”).
• had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.

• 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 APO-NORTRIPTYLINE.

Other warnings you should know about:

Withdrawal symptoms: Do NOT stop taking APO-NORTRIPTYLINE without talking to your healthcare professional first. You may need to lower your dose gradually and careful monitoring by your healthcare professional is required. Stopping APO-NORTRIPTYLINE suddenly may cause withdrawal symptoms including flu-like symptoms, dizziness, nausea, headache, malaise (general discomfort), agitation and stomach cramps.

Driving and using machines: APO-NORTRIPTYLINE can cause you to feel drowsy, dizzy, and confused. Do not drive or operate machinery until you know how APO-NORTRIPTYLINE affects you.

Pregnancy: APO-NORTRIPTYLINE can cross the placenta barrier. It is not known if this is safe for your unborn baby. You should not take APO-NORTRIPTYLINE if you are pregnant unless you and your healthcare professional have discussed the risks and decided that you should. Tell your healthcare professional right away if you become pregnant while taking APO-NORTRIPTYLINE.

Breastfeeding: APO-NORTRIPTYLINE is released into breast milk. It is not known if this is safe for your baby. You should not take APO-NORTRIPTYLINE if you are pregnant unless you and your healthcare professional have discussed the risks and decided that you should.

Serotonin toxicity (also known as Serotonin Syndrome): APO-NORTRIPTYLINE can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take APO-NORTRIPTYLINE with certain anti-depressants or migraine medications. Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Angle-Closure Glaucoma: APO-NORTRIPTYLINE can cause angle-closure glaucoma (sudden eye pain). Having your eyes examined before you take APO-NORTRIPTYLINE 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.

Brugada syndrome (serious heart problem): APO-NORTRIPTYLINE may reveal a hidden heart problem you did not know you had, a problem called Brugada syndrome. Brugada syndrome can be serious and cause sudden death. Get immediate medical help if you experience fainting, dizziness, heart palpitations or abnormal heartbeat during your treatment.

Before you start taking APO-NORTRIPTYLINE, tell your healthcare professional if you:

• have Brugada syndrome.
• have unexplained fainting, or a family history of Brugada syndrome or unexplained sudden death before 45 years of age. This could mean you may have Brugada syndrome.

Surgery: If you have a planned surgery, talk to your healthcare professional as soon as possible. They may ask you to stop taking APO-NORTRIPTYLINE.

Check-ups and testing: Your healthcare professional may do tests to monitor your health while you are taking APO-NORTIPTYLINE. This may include tests to monitor your blood pressure and check for problems with your heart.

Bone Fracture: Taking APO-NORTRIPTYLINE may increase your risk of breaking a bone if you are elderly, have osteoporosis, or have other major risk factors for breaking a bone. You should take extra care to avoid falls, especially if you get dizzy or have low blood pressure.

Cavities: Long term use of APO-NORTRIPTYLINE can cause dental cavities.

Serious skin reactions: Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can be serious or life-threatening, have been reported with APO-NORTRIPTYLINE. Get immediate medical help if you experience:

• fever
• severe rash
• peeling skin
• swelling of the face
• swollen lymph glands
• flu-like feeling
• yellow skin or eyes
• shortness of breath
• swelling of the legs
• dry cough
• chest pain or discomfort
• feeling thirsty
• urinating less often, less urine or dark urine

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

The following may also interact with APO-NORTRIPTYLINE:

• cimetidine, used to treat stomach ulcers
• anticholinergic medications such as certain medicines used to treat asthma, chronic obstructive pulmonary disease, stomach and gut problems, and Parkinson’s disease
• medicines called sympathomimetics such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine
• dextromethorphan used to treat cough
• other antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, and serotonin and norepinephrine reuptake inhibitors (SNRIs)
• medicines used to treat mental and emotional problems called phenothiazines, such as chlorpromazine, thioridazine, trifluoperazine
• medicines used to treat seizures such as carbamazepine and valproic acid
• medicines used to treat irregular heartbeats such as propafenone, flecainide, encainide and quinidine
• medicines used to treat thyroid problems such as levothyroxine
• medicines used to treat high blood pressure such as guanethidine, reserpine, debrisoquine, betanidine, methyldopa, and clonidine
• medicines used to treat pain called opioids, such as tramadol and fentanyl
• lithium, used to treat bipolar disorder
• buspirone, used to treat generalized anxiety disorder
• medicines called triptans, used to treat migraines or headaches
• alcohol
• herbal medicines such as goldenseal, garcinia cambogia, ashwagandha, and St. John's wort
• medicines used to treat schizophrenia and other mental health problems, such as pimozide, sertindole*, fluphenazine, thioridazine* and haloperidol.
• medicines used to treat bacterial infections such as erythromycin, clarithromycin, tacrolimus, rifampicin* and ciprofloxacin.
• medicines used to treat malaria such as quinine, halofantrine* and chloroquine.
• medicines used to treat fungal infections such as ketoconazole, itraconazole, fluconazole and terbinafine.
• domperidone used to treat nausea and vomiting and increase milk supply in breastfeeding mothers.
• medicines used to treat nausea and vomiting in cancer patients such as ondansetron.
• medicines used to treat cancer such as sunitinib and vorinostat.
• medicines used to treat breathing problems like asthma and COPD such as salmeterol.
• warfarin or similar medicines, used to thin the blood.
• baclofen, used to treat muscle spasms.
• nitrates, used to treat angina (chest pain).
• oral contraceptives, used to prevent pregnancy.

* Product is not or no longer marketed in Canada.

How to take APO-NORTRIPTYLINE:

• Always take APO-NORTRIPTYLINE exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• You should continue to take your medicine even if you do not feel better. It may take a number of weeks for your medicine to start working.
• Do not stop taking or change your dose without talking to your healthcare professional. If you are stopping this medication you may need to lower the dose gradually. Stopping APO-NORTRIPTYLINE suddenly can cause withdrawal symptoms.

Usual dose:

Your healthcare professional will determine the dose that is right for you. Take APO-NORTRIPTYLINE exactly as directed. Based on how you respond to APO-NORTRIPTYLINE and your tolerability, your healthcare professional may change your dose. If you are elderly or have other health problems such as problems with your liver, your healthcare professional may prescribe a lower dose.

Overdose:

Signs of overdose may include blurred vision, confusion, restlessness, changes in body temperature, agitation, vomiting, uncontrolled movements, dilated pupils, fever, rapid heartbeats, constipation, dry mouth, difficulties passing water, fits, difficulty breathing, renal failure, repetitive, uncontrolled eye movements, impaired coordination, slurred speech, involuntary twitching or writhing movements, coma, low blood pressure, and abnormal heart rhythms

Missed Dose:

If you forget to take APO-NORTRIPTYLINE, skip the missed dose and take the next dose as scheduled.

What are possible side effects from using APO-NORTRIPTYLINE?

These are not all the possible side effects you may have when taking APO-NORTRIPTYLINE. If you experience any side effects not listed here, tell your healthcare professional.

The side effects may include:

• restlessness
• constipation
• nausea and vomiting
• decrease appetite
• stomach pain
• diarrhea
• changes in taste
• black tongue
• changes in weight (gain or loss)
• increased sweating
• drowsiness
• dizziness
• weakness
• tiredness
• headache
• hair loss
• trouble sleeping
• fatigue
• itching
• dry mouth, sore mouth

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

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

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, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store at room temperature (15°C - 30°C). Keep in a tightly closed container.

• Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures
• Keep out of reach and sight of children.

If you want more information about APO-NORTRIPTYLINE:

• 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 (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: APR 09, 2025