Consumer Information for: IPG-AMITRIPTYLINE

IPG-AMITRIPTYLINE is used in adults to treat depression.

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

Medicinal ingredients: amitriptyline hydrochloride

Non-medicinal ingredients: colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, microcrystalline cellulose, dried maize starch, magnesium stearate, polethylene glycol, talc, and titanium dioxide.

In addition to the above ingredients, the tablets also contain the following non-medicinal ingredients:

10 mg tablets: Lake of Brilliant Blue (FD & C Blue No.1)

25 mg tablets: Colour Quinoline Yellow (D & C Yellow No. 10)

50 mg tablets: Aluminum Lake (FD & C Yellow No. 6) and Indigo Carmine (FD & C Blue No. 2) 75 mg tablets: Aluminum Lake (FD & C Yellow No. 6)

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

• have liver problems.

• have dental problems.

• wear contact lenses.

• have a tumour (cancer) of the adrenal gland (such as pheochromocytoma or neuroblastoma).

• have bipolar disorder.

• have schizophrenia.

• 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).

• have diabetes as you might need an adjustment of your antidiabetic medicine.

• are dehydrated or suffer from excessive sweating, vomiting or diarrhea, or an eating disorder.

• are undergoing electroconvulsive therapy (ECT) to treat mental health problems.

• 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.

Pregnancy: Before taking IPG-AMITRIPTYLINE, tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. You should not take IPG-AMITRIPTYLINE 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 IPG-AMITRIPTYLINE.

Babies born to mothers that took medicines similar to IPG-AMITRIPTYLINE while they were pregnant have experienced withdrawal symptoms after birth. Get immediate medical help for your baby if you took IPG-AMITRIPTYLINE 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

Breastfeeding: Tell your healthcare professional if you are breastfeeding or planning to breastfeed. IPG-AMITRIPTYLINE 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 IPG-AMITRIPTYLINE. You should not do both.

Cavities: Long term use of IPG-AMITRIPTYLINE can cause dental cavities.

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

Bone Fracture: Taking IPG-AMITRIPTYLINE 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.

IPG-AMITRIPTYLINE can cause serious side effects, including:

• Angle-closure glaucoma: IPG-AMITRIPTYLINE can cause angle-closure glaucoma (sudden eye pain). Having your eyes examined before you take IPG-AMITRIPTYLINE could help identify if you are at risk of having angle-closure glaucoma. Talk to your healthcare professional right away if you have:

  • eye pain;

  • changes in vision;

  • swelling or redness in or around the eye.

• Serious skin reactions: Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can be serious or life-threatening, have been reported with IPG-AMITRIPTYLINE. 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

• Serotonin toxicity (also known as Serotonin syndrome) or Neuroleptic malignant syndrome: IPG-AMITRIPTYLINE 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 IPG-AMITRIPTYLINE 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, changes in reflexes, loss of coordination;

  • fast heartbeat, changes in blood pressure;

  • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

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: IPG-AMITRIPTYLINE can affect your ability to drive and operate machinery. Do not drive or operate machinery until you know how IPG-AMITRIPTYLINE affects you.

Blood tests and monitoring: IPG-AMITRIPTYLINE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results. Your healthcare professional will also monitor your blood pressure and the health of your heart while you are taking IPG-AMITRIPTYLINE.

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

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

• alcohol. You should avoid drinking alcohol while taking IPG-AMITRIPTYLINE.

• 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 and selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, fluvoxamine, sertraline, and paroxetine.

• bupropion, used to treat depression or for smoking cessation.

• ozanimod, used to treat multiple sclerosis or ulcerative colitis.

• triptans, used to treat migraine.

• anticholinergic drugs such as certain medicines used to treat asthma, chronic obstructive pulmonary disease, Parkinson’s disease and stomach and gut problems, like atropine and hyoscyamine*.

• cimetidine, used to treat stomach ulcers.

• sedatives used to treat anxiety and sleep disorders.

• pitolisant, used to treat excessive daytime sleepiness.

• modafinil, used to treat excessive sleepiness.

• disulfiram*, used to treat alcoholism.

• medicines used to treat schizophrenia and other mental health problems, such as pimozide, sertindole*, fluphenazine, thioridazine* and haloperidol.

• high blood pressure medications such as calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine*, betanidine*, reserpine*, clonidine and methyldopa.

• medicines used to treat irregular heartbeat such as quinidine*, propafenone, flecainide, disopyramide, amiodarone, procainamide and sotalol.

• astemizole* and terfenadine*, used to treat allergies and hayfever.

• diuretics or “water pills” such as furosemide.

• 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.

• opioids such as morphine, tramadol, buprenorphine, 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.

• methylphenidate, used to treat ADHD.

• protease inhibitors such as ritonavir, used to treat HIV and COVID-19.

• oral contraceptives, used to prevent pregnancy.

• St. John´s Wort (hypericum perforatum) – a herbal remedy used for depression.

• grapefruit juice.

* Product is not or no longer marketed in Canada.

• Always take IPG-AMITRIPTYLINE exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• IPG-AMITRIPTYLINE can be taken with or without food.

• Swallow the tablets whole with water. Do not chew them.

Even if you feel better, do not stop taking IPG-AMITRIPTYLINE without first talking to your healthcare professional. Stopping IPG-AMITRIPTYLINE suddenly can cause serious withdrawal symptoms.

Adults: The recommended initial dose is 25 mg three times a day.

Depending on your response to IPG-AMITRIPTYLINE, your healthcare professional may gradually increase your dose to 150 mg per day divided in two doses.

The usual maintenance dose is 50 to 100 mg per day.

Signs of an overdose may include:

• temporary confusion

• drowsiness

• low body temperature (hypothermia)

• heart rhythm problems such as an irregular heartbeat

• heart failure

• abnormal eye movement

• convulsions

• severe low blood pressure

• constipation

• coma

If you forget to take IPG-AMITRIPTYLINE, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do NOT take two doses at the same time to make up for a missed dose.

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

Side effects may include:

• nausea, vomiting

• stomach pain

• constipation

• diarrhea

• drowsiness

• dizziness

• fatigue

• restlessness

• headache

• dry mouth, sore mouth

• unpleasant taste in the mouth

• black tongue

• itching

• changes in weight (loss or gain)

• weakness

• increased sweating

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.

Store at room temperature (15°C to 30°C). Keep in a tightly closed container. Keep out of reach and sight of children.

• 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; on the manufacturer’s website www.marcanpharma.com, or by calling 1-855-627-2261.

This leaflet was prepared by Marcan Pharmaceuticals Inc.

Last Revised: November 28, 2023