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Clomipramine

Warning

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Precautions

See also Warning section.

Before taking clomipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as imipramine, nortriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood problems (such as purpura, thrombocytopenia), breathing problems (such as asthma, chronic bronchitis), personal or family history of glaucoma (angle-closure type), eating disorders (such as bulimia), heart problems (such as arrhythmias, coronary artery disease, recent heart attack), intestinal problems (such as chronic constipation, ileus), liver problems, kidney problems, personal or family history of other mental/mood conditions (such as bipolar disorder, schizophrenia), history of hospitalization for a very serious reaction to certain medications (neuroleptic malignant syndrome), heartburn/stomach acid in the esophagus (such as due to hiatal hernia), seizures, overactive thyroid (hyperthyroidism), trouble urinating (urinary retention, enlarged prostate), any condition that may increase your risk of seizures (such as alcohol/sedative dependency, use of electroconvulsive therapy, brain injury/disease), certain types of tumors (such as pheochromocytoma, neuroblastoma).

Clomipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using clomipramine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using clomipramine safely.

This drug may make you dizzy or drowsy or temporarily blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially bleeding, confusion, dizziness, and QT prolongation (see above). Dizziness and confusion can increase the risk of falling. Older adults may also be more likely to develop low sodium in the blood, especially if they are taking "water pills" (diuretics).

During pregnancy, this medication should be used only when clearly needed. Newborns exposed to clomipramine during pregnancy may experience withdrawal symptoms or side effects. Discuss the risks and benefits with your doctor. Tell your doctor right away if you notice jitteriness, shaking, feeding problems, fast breathing, or seizures in your newborn.

Since untreated mental/mood problems (such as obsessive compulsive disorder, depression, panic attack) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Dizziness, drowsiness, dry mouth, constipation, stomach upset, nausea, vomiting, changes in appetite/weight, flushing, sweating, tiredness and blurred vision may occur. Anxiety symptoms may temporarily worsen when you first start taking clomipramine. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, memory problems), enlarged/painful breasts, unwanted breast milk production, irregular/painful menstrual periods, muscle stiffness, ringing in the ears, sexual problems (such as decreased sexual ability, changes in desire), shakiness (tremors), numbness/tingling of the hands/feet, trouble urinating, easy bleeding/bruising, unusual/uncontrolled movements (especially of the tongue/face/lips), severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Get medical help right away if you have any very serious side effects, including: black stools, chest pain, fainting, slow/fast/irregular heartbeat, seizures, vomit that looks like coffee grounds, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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