Patient Medication Information: uses, side effects, how to take - Taro-Clomipramine
Serious Warnings and Precautions
Heart Problems: Serious, and sometimes fatal, heart problems have been reported in patients taking tricyclic antidepressants, like TARO-CLOMIPRAMINE. TARO-CLOMIPRAMINE can cause a rapid heartbeat, heart rhythm problems, heart attack or stroke that can lead to death. You should talk to your healthcare professional before you take TARO-CLOMIPRAMINE if you have a history of heart problems, especially problems with your heart rhythm, or if you are elderly. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Anticholinergic Effects: TARO-CLOMIPRAMINE can have an effect on the way chemical signals are passed between cells. This can cause problems in certain areas of the body, including the eyes and urinary tract. If you have increased pressure in your eye, glaucoma, trouble passing urine or an enlarged prostate gland your healthcare professional will have to monitor you closely as TARO-CLOMIPRAMINE can make these conditions worse.
Thyroid Problems: If you have problems with your thyroid gland (hyperthyroidism) or are taking thyroid medication your healthcare professional will need to monitor you closely. Heart rhythm problems have been seen in patients taking tricyclic antidepressants, like TARO-CLOMIPRAMINE, together with thyroid medication.
Seizures: Tricyclic antidepressants, like TARO-CLOMIPRAMINE, can make you more likely to have seizures or fits. This risk is higher is patients who have a history of seizures, have had brain damage, are taking other medicines, particularly antipsychotics (used to treat mental health problems) or are suffering from alcoholism or withdrawal from alcohol. Talk to your healthcare professional about your risk of having seizures while you are taking TARO-CLOMIPRAMINE.
What is TARO-CLOMIPRAMINE used for?
TARO-CLOMIPRAMINE is not for use in children under 10 years of age for the treatment of OCD and not for use in children under 18 years of age for the treatment of depression.
TARO-CLOMIPRAMINE is used in adults to treat:
- Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain).
- obsessions and compulsions in patients (aged 10 and older) with obsessive compulsive disorder (OCD) (recurrent and intrusive thoughts, feelings, ideas, or sensations; recurrent pattern of behavior, or unwanted thoughts or actions).
How does TARO-CLOMIPRAMINE work?
TARO-CLOMIPRAMINE belongs to a group of medicines called tricyclic antidepressants. It works by increasing the levels of two naturally occurring chemicals within the brain, noradrenaline and serotonin. This helps relieve the symptoms of depression and obsessive compulsive disorder.
New or worsened emotional or behavioural problems:
- When you first start taking TARO-CLOMIPRAMINE 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 TARO-CLOMIPRAMINE, 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 TARO-CLOMIPRAMINE.
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 TARO-CLOMIPRAMINE to work.
Self-harm or Suicide:
- Antidepressants, such as TARO-CLOMIPRAMINE, may increase the risk of suicidal thoughts and actions for some patients.
- 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 are the ingredients in TARO-CLOMIPRAMINE?
Medicinal ingredients: Clomipramine hydrochloride
Non-medicinal ingredients: Colloidal silicone dioxide, corn starch and magnesium stearate.
The capsule shell for the 25 mg contains iron oxide black, D&C Yellow 10, FD&C Blue No. 2, FD&C Red No. 3, titanium dioxide, sodium lauryl sulfate, gelatin, black ink SW-9008 and black ink SW-9010.
The capsule shell for the 50 mg contains iron oxide yellow, titanium dioxide, sodium lauryl sulfate, gelatin, black ink SW-9008 and black ink SW-9010.
The black ink SW-9008 contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide.
The black ink SW-9010 contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution and black iron oxide.
TARO-CLOMIPRAMINE comes in the following dosage forms:
Capsules: 25 mg and 50 mg
Do not use TARO-CLOMIPRAMINE if:
- you are allergic to clomipramine or any of the non-medicinal ingredients in TARO-CLOMIPRAMINE (see What are the ingredients in TARO-CLOMIPRAMINE?).
- you are allergic to any other tricyclic antidepressants.
- you are taking, or have taken within the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOIs) including linezolid (an antibiotic) or methylene blue (a dye injected into a vein during surgery, x-rays or other imaging procedures).
- you have recently had a heart attack.
- you are in heart failure.
- you have any serious liver or kidney problems.
- you have or have had a blood disorder.
- you have glaucoma (increased eye pressure).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TARO-CLOMIPRAMINE. Talk about any health conditions or problems you may have, including if you:
- suffer from epilepsy (fits) or seizures.
- have suffered brain damage.
- are going to have electroconvulsive therapy (ECT).
- are elderly.
- have been told you have a low level of potassium in your blood (hypokalemia). Your healthcare professional will need to treat this before you start taking TARO-CLOMIPRAMINE.
- have an overactive thyroid gland or are taking thyroid medication.
- have low levels of sodium in your blood.
- have trouble passing urine.
- have an enlarged prostate gland.
- have paralytic ileus (blocked intestine).
- have a tumour (cancer) of the adrenal gland (such as phaeochromocytoma or neuroblastoma).
- have schizophrenia or any other mental health problems.
- have low blood pressure or other problems with your blood circulation.
- have dental problems.
- wear contact lenses.
- have or have had breast cancer.
- are taking medicines for depression called selective-serotonin reuptake inhibitors (SSRIs).
- are taking diuretics or “water pills”, used to treat high blood pressure.
- 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 TARO-CLOMIPRAMINE.
Other warnings you should know about:
Withdrawal symptoms: Do not stop taking TARO-CLOMIPRAMINE without talking to your healthcare professional. You may need to lower your dose gradually and careful monitoring by your healthcare professional is required. Stopping TARO-CLOMIPRAMINE suddenly may cause withdrawal symptoms including dizziness, nausea, vomiting, headache, malaise (general discomfort), sleep disturbance, increased body temperature, irritability and changes in behavior.
Bone Fracture: Taking TARO-CLOMIPRAMINE 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.
TARO-CLOMIPRAMINE can cause serious side effects, including:
Angle-closure glaucoma: TARO-CLOMIPRAMINE can cause angle-closure glaucoma (sudden eye pain). Having your eyes examined before you take TARO-CLOMIPRAMINE 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.
Serotonin toxicity (also known as Serotonin syndrome): TARO-CLOMIPRAMINE can cause serotonin toxicity, rare but potentially life-threatening conditions. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take TARO-CLOMIPRAMINE with certain anti-depressants or migraine medications
Symptoms of serotonin toxicity 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.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects
Pregnancy and Breastfeeding:
- You should not take TARO-CLOMIPRAMINE if you are pregnant or thinking of becoming pregnant.
Babies born to mothers that took medicines similar to TARO-CLOMIPRAMINE while they were pregnant have experienced withdrawal symptoms after birth. Get immediate medical help for your baby if you took TARO-CLOMIPRAMINE while you were pregnant and if 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
- Do not breastfeed while you are taking TARO-CLOMIPRAMINE. TARO-CLOMIPRAMINE passes into breastmilk.
Blood tests and monitoring: TARO-CLOMIPRAMINE 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 TARO-CLOMIPRAMINE.
Driving and using machines: TARO-CLOMIPRAMINE can cause you to feel relaxed and sleepy, especially when you first start taking it. Give yourself time after taking TARO-CLOMIPRAMINE to see how you feel before driving a vehicle or using machinery.
Surgery: If you have a planned surgery, talk to your healthcare professional as soon as possible. They may ask you to stop taking TARO-CLOMIPRAMINE.
Episodes of mania: Some patients with manic-depressive illness may enter into a manic phase. This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your healthcare professional who probably will change your medication.
Drug reaction with eosinophilia and systemic symptoms (DRESS): TARO-CLOMIPRAMINE may cause a serious skin reaction that can lead to death and may affect one or more organs. DRESS is characterized by some or all of the following:
- 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.
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 TARO-CLOMIPRAMINE 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.
- Do not start TARO-CLOMIPRAMINE if you are taking monoamine oxidase inhibitors such as the antibiotic linezolid and the intravenous dye methylene blue.
- Taking TARO-CLOMIPRAMINE and thyroid medication can cause heart rhythm problems.
The following may interact with TARO-CLOMIPRAMINE:
- Alcohol.
- Medicines used to treat anxiety and help you sleep called barbiturates, and benzodiazepines, such as diazepam, alprazolam.
- General anesthetics, used during surgery to put you to sleep.
- Atropine, used as eye drops to dilate the pupil.
- Antihistamines, used to treat allergies.
- Medicines used to treat Parkinson’s Disease, such as biperiden, levodopa.
- Medicines used to treat heart rhythm problems, such as quinidine, propafenone and flecainide.
- Medicines used to treat high blood pressure, such as guanethidine, bethanidine, clonidine, reserpine, alpha-methyldopa.
- Diuretics or “water pills”, used to treat high blood pressure.
- Noradrenaline, used to treat low blood pressure.
- Adrenaline, used to treat serious allergic reactions.
- Nasal drops, used to relieve nasal congestion, and local anesthetics, used to numb the skin, such as isoprenaline, ephedrine, phenylephrine.
- Other medicines used to treat depression called selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine and fluvoxamine, sertraline, paroxetine.
- Cimetidine, used to treat stomach ulcers or heartburn.
- Medicines used to treat attention-deficit/hyperactivity disorder (ADHD), such as methylphenidate, amphetamine.
- Medicines used to prevent seizures, such as carbamazepine, phenytoin, phenobarbital.
- Nicotine, this includes if you smoke or are using nicotine replacement therapy.
- Medicines used to treat mental health problems, like schizophrenia, such as phenothiazines, butyrophenones (e.g., haloperidol), lithium.
- Disulfiram, used to help you stop drinking alcohol.
- Coumarin, and other similar medicines, used to thin the blood (e.g., warfarin).
- Digoxin, used to treat heart failure.
- Medicines that contain estrogens, such as birth control pills or hormone replacement therapy.
- Opioids such as morphine, tramadol, buprenorphine.
- St. John´s Wort (hypericum perforatum) – a herbal remedy used for depression.
- Grapefruit juice.
How to take TARO-CLOMIPRAMINE:
- Always take TARO-CLOMIPRAMINE exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Swallow TARO-CLOMIPRAMINE capsules whole with water.
TARO-CLOMIPRAMINE can be taken with or without food. To reduce stomach upset, take TARO-CLOMIPRAMINE with food.
- Do not stop taking TARO-CLOMIPRAMINE or change your dose without talking to your healthcare professional.
Usual dose:
Depression
Adults:
The recommended starting dose is 25 mg daily. Your healthcare professional may increase your dose by 25 mg increments up to 150 mg to 200 mg daily over a period of several weeks depending on your condition.
Elderly:
Lower doses are recommended for elderly patients. The recommended starting dose is 20 mg to 30 mg daily in divided doses.
Obsessive Compulsive Disorder
Adults:
The recommended starting dose is 25 mg daily. Your healthcare professional may increase your dose by 25 mg increments up to 100 mg to 200 mg daily by the end of 2 weeks depending on your condition.
Children and Adolescents (10 to 17 years of age):
Limited information is available for the use of TARO-CLOMIPRAMINE in children aged 10 to 17 years, therefore, TARO-CLOMIPRAMINE is not recommended for use in this population. For this age group the recommended starting dose may be 25 mg daily. The dose may be increased by 25 mg increments, up to 100 mg to 150 mg per day or 3 mg/kg of their body weight, whichever is lower.
Elderly:
Lower doses are recommended for elderly patients. The recommended starting dose is 20 mg to 30 mg daily in divided doses.
Overdose:
You may have the following symptoms if you take more TARO-CLOMIPRAMINE than you should:
- drowsiness,
- stupor (when you are unable to move but still conscious),
- irregular muscle contractions,
- vomiting,
- blue skin,
- restlessness,
- agitation,
- enhanced reflexes,
- muscle stiffness,
- twisting and writhing movements of the hands and feet, convulsions (fits).
Other signs include fever, abnormally dilated pupil, a decrease or absence of urine production, constipation, shortness of breath, changes in blood pressure, rapid or irregular heartbeat, changes in electrocardiogram (ECG), heart attack and coma.
Missed Dose:
If you forget to take TARO-CLOMIPRAMINE, 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.
What are possible side effects from using TARO-CLOMIPRAMINE?
These are not all the possible side effects you may have when taking TARO-CLOMIPRAMINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- headache
- dry mouth
- constipation
- diarrhea
- nausea, vomiting
- indigestion
- stomach pain, stomach cramps
- change in appetite
- weight gain
- sleepiness, fatigue
- trouble sleeping, nightmares
- shaking
- muscle spasms, muscle weakness
| If you think you, or a person you are caring for, have taken too much TARO-CLOMIPRAMINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
- dizziness
- nervousness
- sweating
- hot flashes
- increased sensitivity of the skin to sunlight
- yawning
- vision changes, blurred vision
- change in libido
- inability to have or maintain an erection
- inability to ejaculate or delay in ejaculation
- hair loss
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
Low blood pressure: dizziness, fainting, lightheadedness. May occur with you go from lying down or sitting to standing up. | ✓ | ||
| COMMON | |||
| Peripheral neuropathy: numbness or tingling sensation in the hands or feet | ✓ | ||
Changes in feelings and behaviors: confusion, hallucinations (seeing or hearing things that are not there), anxiety, agitation, restlessness, worsening of depression, thoughts of suicide, extremely elevated and excitable mood memory problems, feeling of unreality, changes in your perception of reality, disorientation, thoughts or speech that do not make sense | ✓ | ||
| Heart rhythm problems: irregular heartbeat, fast heartbeat, palpitations, shortness of breath, fainting, loss of consciousness | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Mania: elevated or irritated mood, decreased need for sleep, racing thoughts, uneasiness, excessive physical activity. | ✓ | ||
| RARE | |||
Seizures or fits: uncontrollable shaking with or without loss of consciousness | ✓ | ||
| VERY RARE | |||
Movement disorders: continuous muscle spasms and contractions, rigid muscles, restlessness, slowness of movement, tremor, jerky or irregular movements | ✓ | ||
Angle-closure Glaucoma: increased pressure in the eye, pupil dilation, blurred vision, eye pain | ✓ | ||
| Heart attack: chest pain or discomfort, lightheadedness, shortness of breath, pain in the jaw, neck or back, pain in the arm or shoulder, cold sweat, nausea, vomiting | ✓ | ||
Stroke: sudden numbness or weakness in the face, arm or leg, especially on one side of the body, confusion, trouble speaking, vision problems, weakness, dizziness, loss of coordination | ✓ | ||
| Liver problems: abdominal pain, nausea, vomiting, loss of appetite, yellowing of skin and eyes, dark urine, pale stool | ✓ | ||
Bronchospasm: coughing, tightness in the chest, wheezing, shortness of breath, difficulty breathing | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Hormonal changes: breast enlargement in men, breast enlargement and abnormal milk production in women, testicular swelling, irregular menstrual periods | ✓ | ||
Allergic reaction: rash, hives, tiny purple, red, or brown spots on the skin, itching, swelling of the face, lips and tongue, trouble swallowing or breathing, fever | ✓ | ||
Withdrawal symptoms: nausea, vomiting, abdominal pain, diarrhea, sleeplessness, nervousness, anxiety, headache, generally feeling unwell, increased body temperature, irritability, behavioural changes | ✓ | ||
| Bone marrow depression: easy bruising, bleeding, nose bleeds, bleeding gums, red spots on the skin, fever and chills, rash, extreme fatigue, pale skin and lips | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Hyponatremia (low level of sodium in your blood): loss of energy, tiredness, muscle weakness or cramps, seizures | ✓ | ||
| Self-harm or suicide: thoughts or actions about hurting or killing yourself or other people | ✓ | ||
| Serotonin Toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38 °C), or rigid muscles. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): concentrated urine (dark in colour), feel or are sick, muscle cramps, confusion and fits (seizures) which may be due to inappropriate secretion of ADH (antidiuretic hormone) | ✓ | ||
Drug reaction with eosinophilia and systemic symptoms (DRESS) (a serious skin reaction that can lead to death, it that may affect one or more organs): fever, severe rash, peeling skin, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine. | ✓ | ||
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/service/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:
Protect from heat (store between 15°C and 30°C).
Keep out of reach and sight of children.
If you want more information about TARO-CLOMIPRAMINE:
- 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.taro.ca or by calling 1-800-268-1975.
130 East Drive, Brampton, Ontario, L6T 1C1