Aplenzin

• Valeant Pharmaceuticals North America LLC

Tell your doctor about your other medical conditions including if you:

• are allergic to Aplenzin or to any of its ingredients. 
• have ever had depression, suicidal thoughts or actions, or other mental health problems.
• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
• have an eating disorder, such as anorexia nervosa or bulimia.
• have had a head injury.
• have had a seizure (convulsion, fit).
• have a tumor in your nervous system (brain or spine).
• have had a heart attack, heart problems, or high blood pressure.
• have diabetes and use insulin or other medicines to control your blood sugar.
• drink alcohol.
• abuse prescription medicines or street drugs.
• are pregnant or plan to become pregnant. It is not known if Aplenzin can harm your unborn baby.
• are breastfeeding. Aplenzin passes through your milk. It is not known if Aplenzin can harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using Aplenzin.

Tell your doctor if you are breastfeeding or plan to breastfeed. Aplenzin passes through your milk. It is not known if Aplenzin can harm your baby.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how you respond to this medication
• your kidney function
• your liver  function

The recommended starting dose of Aplenzin (bupropion hydrochloride) for major depressive disorder and seasonal affective disorder 348 mg once daily.  

Your doctor will start you on a low dose and increase the dose if needed. 

For those whose liver or kidneys are not working as well as they should, the recommended dose will be lower. 

Get emergency medical help if you have signs of an allergic reaction: hives, rash or itching; fever, swollen glands, joint pain, general ill feeling; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have:

• a seizure (convulsions);

• unusual changes in mood or behavior;

• a manic episode--racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• fast heartbeats; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dry mouth, stuffy nose;

• nausea, constipation;

• sleep problems (insomnia);

• feeling anxious;

• dizziness; or

• joint pain.

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.

You may have a higher risk of seizures if you use certain other medicines while taking bupropion.

Many drugs can interact with bupropion. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with bupropion. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• dry mouth
• hyperventilation
• irregular heartbeats
• irritability
• restlessness
• shaking
• trouble sleeping

• Buzzing or ringing in the ears
• headache (severe)
• skin rash, hives, or itching

• Confusion
• fainting
• false beliefs that cannot be changed by facts
• having extreme distrust of people
• seeing, hearing, or feeling things that are not there
• seizures
• trouble concentrating

• Actions that are out of control
• anger
• assaulting or attacking others
• being aggressive or impulsive
• chest pain or discomfort
• fast or pounding heartbeat
• force
• inability to sit still
• need to keep moving
• sweating
• talking, feeling, or acting with excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

• Lightheadedness, dizziness, or fainting
• loss of consciousness
• slow or irregular heartbeat
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decrease in appetite
• dizziness
• increased sweating
• stomach pain
• trembling
• unusual weight loss

• Blurred vision
• change in sense of taste
• drowsiness
• frequent need to urinate
• sore throat
• unusual feeling of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to bupropion or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had seizures.
• If you drink a lot of alcohol and you stop drinking all of a sudden.
• If you use certain other drugs like drugs for seizures or anxiety and you stop using them all of a sudden.
• If you have ever had an eating problem like anorexia or bulimia.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Aplenzin within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aplenzin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Aplenzin affects you.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Do not stop taking Aplenzin all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• High blood pressure has happened with Aplenzin. Have your blood pressure checked as you have been told by your doctor.
• This medicine may raise the chance of seizures. The chance may be higher in people who have certain health problems, use certain other drugs, or drink a lot of alcohol. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
• Avoid drinking alcohol while taking Aplenzin.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• It may take several weeks to see the full effects.
• Some people may have a higher chance of eye problems with this medicine. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• This medicine is not approved for use in children. Talk with the doctor.
• If you are 65 or older, use Aplenzin (bupropion extended-release tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you smoke:

• Not all products are approved for use to help stop smoking. Talk with the doctor to make sure that you have the right product.
• New or worse mental, mood, or behavior problems have happened when bupropion has been used to stop smoking. These problems include thoughts of suicide or killing someone else, depression, forceful actions, fury, anxiety, and anger. These problems have happened in people with and without a history of mental or mood problems. Talk with the doctor.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day bupropion hydrochloride, respectively. These doses are approximately 7 and 2 times the maximum recommended human dose (MRHD), respectively, on a mg/m2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day of bupropion hydrochloride (approximately 2 to 7 times the MRHD on a mg/m2 basis); lower doses were not tested. The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study.

Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in one Ames bacterial mutagenicity assay, but was negative in another. Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies.

A fertility study in rats at doses up to 300 mg/kg/day revealed no evidence of impaired fertility.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

You may have a higher risk of seizures if you use certain other medicines while taking Aplenzin.

Many drugs can interact with bupropion. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aplenzin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Common side effects of Aplenzin include: dizziness, insomnia, nausea, pharyngitis, weight loss, and xerostomia. Other side effects include: agitation, arthralgia, migraine, palpitations, skin rash, tinnitus, tremor, anxiety, asthenia, chest pain, confusion, hostility, hypertension, myalgia, pruritus, urinary frequency, vomiting, anorexia, diaphoresis, dysgeusia, and flushing. See below for a comprehensive list of adverse effects.