ANAFRONIL 25 MG ( CLOMIPRAMINE ) 30 TABLETS

WHAT IS CLOMIPRAMINE (ANAFRANIL)?
Clomipramine is a tricyclic antidepressant that is used to treat symptoms of obsessive-compulsive disorder (OCD), such as recurrent thoughts or feelings and repetitive actions.

Clomipramine is for use in adults and children at least 10 years old.

Clomipramine may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF CLOMIPRAMINE (ANAFRANIL)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
confusion, extreme fear, thoughts of hurting yourself;
pain or burning when you urinate; or
a seizure (convulsions).
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

feeling dizzy, drowsy, tired, or nervous;
tremors, jerking muscle movements;
sweating;
changes in appetite or weight;
urination problems;
vision changes; or
decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CLOMIPRAMINE (ANAFRANIL)?
You should not use this medicine if you have recently had a heart attack.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Anafranil Patient Information including How Should I Take

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING CLOMIPRAMINE (ANAFRANIL)?
You should not use clomipramine if you are allergic to it, or if you have:

you have recently had a heart attack; or
you are allergic to antidepressants such as amitriptyline, amoxapine, trimipramine, desipramine, doxepin, imipramine, nortriptyline, or protriptyline.
Do not use clomipramine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

liver disease;
kidney disease;
bipolar disorder (manic-depression), schizophrenia or other mental illness;
alcoholism;
a seizure or a head injury;
heart disease;
low blood pressure;
narrow-angle glaucoma;
overactive thyroid or adrenal gland tumor (pheochromocytoma or neuroblastoma); or
urination problems.
Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with clomipramine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or plan to get pregnant. Taking this medicine during late pregnancy may cause withdrawal symptoms in the newborn.

You should not breastfeed while using clomipramine.

HOW SHOULD I TAKE CLOMIPRAMINE (ANAFRANIL)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Call your doctor if your symptoms do not improve, or if they get worse.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Do not stop using clomipramine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Anafranil Patient Information including If I Miss a Dose

WHAT HAPPENS IF I MISS A DOSE (ANAFRANIL)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

WHAT HAPPENS IF I OVERDOSE (ANAFRANIL)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clomipramine can be fatal.

Overdose symptoms may include irregular heartbeats, feeling restless or agitated, confusion, severe sweating, slow or jerky muscle movements, extreme drowsiness, slow breathing, feeling like you might pass out, seizure, or coma.

WHAT SHOULD I AVOID WHILE TAKING CLOMIPRAMINE (ANAFRANIL)?
Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

WHAT OTHER DRUGS WILL AFFECT CLOMIPRAMINE (ANAFRANIL)?
Using clomipramine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect clomipramine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION (ANAFRANIL)?
Your pharmacist can provide more information about clomipramine.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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