Apo-Imipramine Tablets: Uses, Side Effects and Dosage

Serious Warnings and Precautions

To help avoid side effects and ensure proper use, before you take APO-IMIPRAMINE TABLETS, 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-IMIPRAMINE TABLETS.

• 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-IMIPRAMINE TABLETS.

APO-IMIPRAMINE TABLETS may also reveal a hidden heart problem you did not know you had, a problem called “Brugada Syndrome”. Before you start taking APO-IMIPRAMINE TABLETS, 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-IMIPRAMINE TABLETS 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-IMIPRAMINE TABLETS.

• have a history of trouble emptying your bladder (urinary retention), an enlarged prostate gland, increased pressure in the eye or glaucoma as APO-IMIPRAMINE TABLETS can make these conditions worse.
• have thyroid problems or are taking thyroid medication. Heart rhythm problems may develop when APO-IMIPRAMINE TABLETS is taken with thyroid medicines.
• have a history of seizures or fits. APO-IMIPRAMINE TABLETS can make you more likely to have seizures or fits

New or worsened emotional or behavioural problems:

• When you first start taking APO-IMIPRAMINE TABLETS or when your dose is adjusted, you may feel worse instead of better. You may feel new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
• During your treatment with APO-IMIPRAMINE TABLETS, it is important that you and your healthcare professional talk regularly about how you are feeling. They will closely monitor you for signs of new or worsened emotions or behaviours while you are taking APO-IMIPRAMINE TABLETS.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for APO-IMIPRAMINE TABLETS to work.

Self-harm or suicide:

• Antidepressants, such as APO-IMIPRAMINE TABLETS, may increase the risk of suicidal thoughts and actions.
• If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. Close observation by a healthcare professional is necessary in this situation.

What is APO-IMIPRAMINE TABLETS used for?

APO-IMIPRAMINE TABLETS is used 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-IMIPRAMINE TABLETS work?

APO-IMIPRAMINE TABLETS is an antidepressant drug that belongs to a group of medicines called tricyclic antidepressant drugs. It is not known exactly how APO-IMIPRAMINE TABLETS 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-IMIPRAMINE TABLETS?

Medicinal ingredients: imipramine hydrochloride.

Non-medicinal ingredients: carnauba wax, hydroxypropyl methylcellulose, lactose monohydrate (in only the 25 mg, 50 mg, and 75 mg tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycol, red ferric oxide, sunset yellow aluminum lake 40%, titanium dioxide, and yellow ferric oxide.

APO-IMIPRAMINE TABLETS comes in the following dosage forms:

Tablets: 10 mg, 25 mg, 50 mg, and 75 mg.

Do not use APO-IMIPRAMINE TABLETS if:

• you are allergic to imipramine hydrochloride, or any of the ingredients in APO-IMIPRAMINE TABLETS.
• you are allergic to tricyclic antidepressants that belong to the dibenzazepine group. Talk to your healthcare professional if you are not sure.
• you are taking or have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days.
• you have recently had a heart attack.
• you are in heart failure.
• you have glaucoma (increased eye pressure).
• you have liver disease.

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

• have liver problems.
• have dental problems.

• have heart problems including:

  • blood clots that form in the blood vessels or arteries of the heart,
  • angina,
  • heart failure,
  • disorders affecting heart rate, rhythm or conduction and
  • heart or blood vessel disease.
• wear contact lenses.
• have trouble urinating.
• have an enlarged prostate.
• have thoughts of harming or killing yourself.
• have bipolar depression.
• have pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine).
• suffer from epilepsy or seizures.
• are pregnant, think you might be pregnant or planning to become pregnant. APO-IMIPRAMINE TABLETS should not be used during the first trimester of pregnancy.
• are breastfeeding or are planning to breastfeed.
• are taking warfarin or similar medicines, used to thin the blood.
• are taking other anticholinergic medicines (certain medicines used to treat asthma, chronic obstructive pulmonary disease, stomach and gut problems, and Parkinson’s disease).
• 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 65 years of age or older.

• you 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-IMIPRAMINE TABLETS.

Other warnings you should know about:

Angle-closure Glaucoma: APO-IMIPRAMINE TABLETS can cause an acute attack of glaucoma. Having your eyes examined before you take APO-IMIPRAMINE TABLETS 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.

Bone Fracture: Taking APO-IMIPRAMINE TABLETS 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.

Breastfeeding: Tell your healthcare professional if you are breastfeeding or planning to breastfeed. APO-IMIPRAMINE TABLETS is released into breast milk. It is not known if this is safe for your baby. You and your healthcare professional should decide if you should breastfeed or take APO-IMIPRAMINE TABLETS. You should not do both.

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

Laboratory Tests: Tell your healthcare professional if you develop a fever and sore throat while taking APO-IMIPRAMINE TABLETS. Your healthcare professional will do blood tests. These tests will monitor your white blood cell count.

Pregnancy: Before taking APO-IMIPRAMINE TABLETS, tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. You should not take APO-IMIPRAMINE TABLETS 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-IMIPRAMINE TABLETS. Babies born to mothers that took medicines similar to APO-IMIPRAMINE TABLETS while they were pregnant have experienced withdrawal symptoms after birth. Get immediate medical help for your baby if you took APO-IMIPRAMINE TABLETS while you were pregnant, and they have any of the following symptoms:

• breathing problems, bluish skin
• seizures or fits
• body temperature changes
• stiff or floppy muscles
• jitteriness, irritability, lethargy
• drowsiness
• constant crying

Serotonin toxicity (also known as Serotonin syndrome) or Neuroleptic malignant syndrome (NMS): APO-IMIPRAMINE TABLETS can cause Serotonin toxicity or neuroleptic malignant syndrome, rare but potentially life-threatening conditions. They can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin toxicity or neuroleptic malignant syndrome if you take APO-IMIPRAMINE TABLETS with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.

Symptoms of serotonin toxicity or neuroleptic malignant syndrome 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.

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-IMIPRAMINE TABLETS. 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

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

Driving and Using Machines: APO-IMIPRAMINE TABLETS can affect your ability to drive and operate machinery. Do not drive or operate machinery until you know how APO-IMIPRAMINE TABLETS affects you.

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

Withdrawal symptoms: Do NOT stop taking APO-IMIPRAMINE TABLETS without talking to your healthcare professional. You may need to lower your dose gradually and careful monitoring by your healthcare professional is required. Stopping APO-IMIPRAMINE TABLETS suddenly may cause withdrawal symptoms including restlessness, nausea, headache, malaise (general discomfort), sleep disturbance, irritability and changes in behavior.

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

Serious Drug Interactions

Do not take APO-IMIPRAMINE TABLETS if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last 14 days as this can cause serious side effects.

Taking APO-IMIPRAMINE TABLETS and thyroid medication can cause heart rhythm problems.

The following may interact with APO-IMIPRAMINE TABLETS:

• alcohol beverages.

• medicines such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine which may be found in cough and cold medication and anesthetics used in surgery.
• other medicines used to treat depression such as other tricyclic antidepressants such as imipramine, guanethidine, betanidine, reserpine, clonidine and methyldopa, phenothiazines [fluphenazine, thioridazinea], butyrophenones [haloperidol]).
• anticholinergic agents, used to relieve stomach cramps, spasms and travel sickness.

• drugs that inhibit CYP2D

  • cimetidine used to treat stomach ulcers.
  • quinidine, used to treat certain type of irregular heartbeats.
  • bupropion, used to treat depression or for smoking cessation.
  • duloxetine, used to manage depression and anxiety, fibromyalgia, diabetic neuropathy and chronic musculoskeletal pain.
  • fluoxetine, used for depression, obsessive-compulsive disorder, panic disorder, bulimia.
  • paroxetine, used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, generalized anxiety disorder (GAD), social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD).
  • terbinafine, fungus infections of the scalp, body, groin (jock itch), feet (athlete's foot), fingernails, and toenails.
• nitroglycerine, used for relief of chest pain (angina)

• drugs such as cytochrome P450 inducers

  • oral contraceptives
  • rifampicin, used to treat infections.
  • carbamazepine, used to manager and treat epilepsy.

• drugs that prolong the QT interval of the heat (QT-prolonging drugs)

  • quinidine, procainamide, disopyramide, amiodarone, flecainide and propafenone used to treat certain types of irregular and abnormal heartbeats
  • pimozide and haloperidol, used as an antipsychotic.
  • methadone, used as an opiod.
  • erythromycin, clarithromycin, tacrolimus, and ciprofloxacin, used as antibiotics.
  • quinine and chloroquine), used as antimalarials.
  • ketoconazole, used as antifungals.
  • domperidone used to increases the movements or contractions of the stomach and bowel.
  • ondansetron, used to prevent nausea and vomiting.
  • sunitinib and vorinostat, used to treat certain types of cancers.
  • asalmeterol, used to manage and treat asthma and COPD.
• medicines used to treat high blood pressure such as guanethidine.
• norepinephrine used to treat low blood pressure.
• epinephrine used to treat anaphylaxis, cardiac arrest, and severe asthma attacks.
• methylphenidate used to treat attention-deficit/hyperactivity disorder (ADHD).
• anticholinergic drugs such as certain medicines used to treat asthma, chronic obstructive pulmonary disease, Parkinson’s disease and stomach and gut problems (stomach cramps, spasms and travel sickness), drugs like atropine and hyoscyamine*.
• cimetidine, used to treat stomach ulcers.
• pitolisant, used to treat excessive daytime sleepiness.
• high blood pressure medications such as calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine*, betanidine*, reserpine*, clonidine and methyldopa.
• medicines used to treat fungal infections such as ketoconazole, itraconazole, fluconazole and terbinafine.
• opioids such as morphine, tramadol, buprenorphine, tramadol, and methadone, used to treat pain and opioid drug dependence.
• warfarin or similar medicines, used to thin the blood.
• baclofen, used to treat muscle spasms.
• nitrates, used to treat angina (chest pain).
• phenytoin, carbamazepine, topiramate, valproic acid, used to treat seizures or fits.
• St. John´s Wort (hypericum perforatum) – a herbal remedy used for depression.
• grapefruit juice.
• pitolisant, used to treat weak or paralyzed muscles or excessive daytime sleepiness (EDS) in patients with narcolepsy.

Talk to your healthcare professional as there might be newly added drugs that may interact with APO-IMIPRAMINE TABLETS.

How to take APO-IMIPRAMINE TABLETS:

• Take APO-IMIPRAMINE TABLETS exactly as your healthcare professional tells you to. Talk to your healthcare professional if you are not sure.
• Swallow the tablets whole with a glass of water.

Usual dose:

Your healthcare professional will determine the dose that is right for you and how often you should take it. Your dose will depend on your age and if you have any heart problems. Based on how you respond to APO-IMIPRAMINE TABLETS and your tolerability, your healthcare professional may change your dose.

Overdose:

Signs of an overdose may include:

• confusion
• disturbed concentration
• visual hallucinations
• restlessness
• overactive reflexes
• muscle rigidity
• vomiting
• high fever
• drowsiness
• hypothermia
• heart rhythm problems

If you think you, or a person you are caring for, have taken too much APO-IMIPRAMINE TABLETS, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of APO-IMIPRAMINE TABLETS, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time to make up for the missed dose.

What are possible side effects from using APO-IMIPRAMINE TABLETS?

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

Side effects may include:

• dry mouth
• swelling of salivary glands
• constipation
• diarrhea
• nausea, vomiting
• stomach pain, stomach cramps
• unpleasant taste in the mouth
• sore mouth
• black tongue
• change in appetite
• weight gain or loss
• fever
• weakness
• tiredness
• headache
• falls
• impaired coordination
• shaking
• drowsiness
• dizziness
• dilated pupils
• change in libido
• inability to have or maintain an erection
• swelling of testicles
• problem emptying your bladder
• frequent urination
• itching
• sweating more than usual
• flushing

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15°C-30°C).

Keep out of reach and sight of children.

If you want more information about APO-IMIPRAMINE TABLETS:

•

• 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: JUL 25, 2025