clomipramine 25 mg capsule

Generic name:
Clomipramine - oral

Pronunciation
(klo-MIP-ruh-meen)

Brand name(s)
Anafranil

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.

This medication is used to treat obsessive compulsive disorder (OCD). Clomipramine belongs to a class of drugs known as tricyclic antidepressants. It works by helping to restore the balance of certain natural substances in the brain.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for depression, panic attacks, or ongoing pain.

Read the Medication Guide provided by your pharmacist before you start taking clomipramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. To lessen side effects such as stomach upset, clomipramine may be started at a low dose, given in several doses during the day with meals, and slowly increased as your body gets used to it. After you have reached the best dose for you, the total dose can be taken once daily as directed by your doctor, usually at bedtime to prevent daytime drowsiness.

Follow your doctor's instructions carefully. Do not take more or less medication or take it more often than prescribed. Your condition will not improve any faster and your risk of side effects such as seizures may be increased. The dosage is based on your medical condition and response to treatment.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly in order to get the most benefit from it. Keep taking it even if you feel well. To help you remember, use it at the same time(s) each day.

Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. You may experience sweating, dizziness, nausea, vomiting, headache, or irritability if you suddenly stop taking this drug. Your dose may need to be gradually decreased.

It may take 2 to 3 weeks or longer before you notice the full effects of this medication. Tell your doctor if your condition lasts or gets worse.

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.

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.

See also the How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• certain drugs for high blood pressure (such as clonidine, guanethidine)
• digoxin
• thyroid supplements
• valproic acid
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin)

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Many drugs besides clomipramine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, quinidine, sotalol, pimozide, procainamide, macrolide antibiotics (such as erythromycin), among others. Before using clomipramine, report all medications you are currently using to your doctor or pharmacist.

Other medications can affect the removal of clomipramine from your body, which may affect how clomipramine works. Examples include artemether/lumefantrine, barbiturates (such as phenobarbital), cimetidine, haloperidol, certain drugs for heart rhythm (such as flecainide/propafenone), certain HIV protease inhibitors (such as fosamprenavir), phenothiazines (such as thioridazine), certain anti-seizure drugs (such as phenytoin).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting, delirium, seizures, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as EKG, liver function, blood counts) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.