Clomipramine 50mg Capsule

Product Summary

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• PRESCRIPTION REQUIRED

IMPORTANT: 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. CLOMIPRAMINE - ORAL (klo-MIP-ruh-meen) COMMON BRAND NAME(S): Anafranil

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. Therefore, 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 immediately 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.

USES: Clomipramine is used to treat obsessive compulsive disorder (OCD). It helps decrease persistent/unwanted thoughts (obsessions), and it helps reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. This medication belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (serotonin, among others) in the brain.

OTHER USES: 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 medication has also been used to treat depression, panic attacks, and ongoing pain.

HOW TO USE: Read the Medication Guide available from your pharmacist. Consult your doctor or pharmacist if you have any questions. 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, usually at bedtime to prevent daytime drowsiness or as directed by your doctor. Usually, the daily dose will not be more than 250 milligrams for adults and 200 milligrams for children and teenagers. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects such as seizures may be increased. Dosage is based on your medical condition and response to therapy. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Use this medication regularly in order to get the most benefit from it. Continue to take 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 the full effects of this medication are noticed. Inform your doctor if your condition persists or if it worsens.

SIDE EFFECTS: See also the 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 persist or worsen, notify your doctor or pharmacist promptly. 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, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, depression, hallucinations, memory problems), enlarged/painful breasts, unwanted breast milk production, irregular/painful menstrual periods, muscle stiffness/twitching, feelings of restlessness, ringing in the ears, sexual problems (e.g., decreased sexual ability, changes in desire), shakiness (tremors), numbness/tingling of the hands/feet, trouble urinating, severe vomiting. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unusual/uncontrolled movements (especially of the tongue/face/lips), severe stomach/abdominal pain, dark urine, yellowing of eyes/skin. Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, chest pain, fainting, high fever, slow/fast/irregular heartbeat, seizures, vomit that looks like coffee grounds. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking clomipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., 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. This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have had: a recent heart attack. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., purpura, thrombocytopenia), breathing problems (e.g., asthma, chronic bronchitis), certain eye problems (e.g., glaucoma, increased intraocular pressure), eating disorders (e.g., bulimia), heart problems (e.g., arrhythmias, coronary artery disease), intestinal problems (e.g., chronic constipation, ileus), liver problems, kidney problems, personal or family history of other mental/mood conditions (e.g., bipolar disorder, schizophrenia), history of hospitalization for a very serious reaction to certain medications (neuroleptic malignant syndrome), heartburn/stomach acid in the esophagus (e.g., due to hiatal hernia), seizures, overactive thyroid (hyperthyroidism), trouble urinating (urinary retention, enlarged prostate), any condition that may increase your risk of seizures (e.g., alcohol/sedative dependency, use of electroconvulsive therapy, brain injury/disease), certain types of tumors (e.g., pheochromocytoma, neuroblastoma). Clomipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using clomipramine, tell your doctor or pharmacist 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 cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. To decrease dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Before having surgery, tell your doctor or dentist that you are taking this medication. Caution is advised when using this drug in children who participate in active sports because it may increase the risk of heart problems. (See also the Warning section.) Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug (e.g., bleeding, confusion, dizziness). This medication should be used only when clearly needed during pregnancy. Newborns exposed to clomipramine during pregnancy may experience withdrawal symptoms or side effects. Tell your doctor immediately if you notice jitteriness, shaking, feeding problems, fast breathing, or seizures in your newborn. Discuss the risks and benefits with your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. (See also the How to Use section.) This drug should not be used with the following medications because very serious interactions may occur: arbutamine, cisapride, sibutramine. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur. If you are currently using any of the medications listed above, tell your doctor or pharmacist before starting clomipramine. 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. Therefore, before using clomipramine, report all medications you are currently using to your doctor or pharmacist. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine, belladonna alkaloids, scopolamine), inhaled bronchodilators (e.g., albuterol, salmeterol), certain drugs for high blood pressure (e.g., clonidine, guanethidine, reserpine), digoxin, nasal decongestants (e.g., epinephrine, phenylephrine), levodopa, lithium, stimulants (e.g., amphetamine, epinephrine, methylphenidate), thyroid supplements, valproic acid, drugs that can cause bleeding/bruising (e.g., "blood thinners" such as warfarin/heparin, anti-platelet drugs including aspirin or NSAIDs such as ibuprofen), drugs affecting liver enzymes that remove clomipramine from your body (e.g., alcohol, barbiturates such as phenobarbital, cimetidine, haloperidol, certain drugs for heart rhythm such as flecainide/propafenone, certain HIV protease inhibitors such as amprenavir/fosamprenavir, phenothiazines such as thioridazine, certain anti-seizure drugs such as carbamazepine/phenytoin, antidepressants such as fluoxetine/fluvoxamine/paroxetine, St. John's wort, terbinafine), drugs that may increase serotonin levels/activity (e.g., alprazolam, bromocriptine, buspirone, dextromethorphan, certain narcotic pain relievers such as fentanyl/meperidine/pentazocine, antidepressants such as amitriptyline/trazodone/venlafaxine, certain stimulants, S-adenosylmethionine, street drugs such as MDMA/"ecstasy," tramadol, "triptans" such as sumatriptan, tryptophan). Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with this medication such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., desipramine), among others. Consult your doctor or pharmacist for details. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., levetiracetam), drugs for motion sickness (e.g., meclizine). Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that, if taken together with this drug, may increase your risk for bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-containing ingredients or decongestants that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting, delirium, seizures, loss of consciousness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., EKG, liver function tests, blood counts) may be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at controlled temperature away from light and moisture. Ask your pharmacist for more instructions. Do not store in the bathroom. Keep all medicines out of reach of 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 for more details about how to safely discard your product. MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.