Alterra oral

St. John's wort has been used for depression.

Some herbal/dietary supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Alterra Tablet, Extended Release

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. Do not take more than the recommended amount. It may take about 3 weeks of regular use before you notice the benefits of this product.

Do not suddenly stop taking this product. Some conditions may become worse when this product is abruptly stopped. You may need to gradually reduce your dose. Consult your doctor or pharmacist for details.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Trouble sleeping, restlessness, upset stomach, dizziness, headache, or numbness/tingling of the hands/feet may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Tell your doctor right away if any of these rare but very serious side effects occur: black/bloody/tarry stools, vomit that looks like coffee grounds, easy bruising/bleeding.

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 (see Drug Interactions section). 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.

A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

Before taking St. John's wort, tell your doctor or pharmacist if you are allergic to it; 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.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: personal or family history of bipolar/manic-depressive disorder.

This product may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist that you are using this product.

St. John's wort is not recommended for use during pregnancy. Consult your doctor before using this product.

It is not known if St. John's wort passes into breast milk. Consult your doctor before breast-feeding.

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 product include: drugs used to prevent organ rejection (such as cyclosporine, sirolimus, tacrolimus), drugs used to treat cancer (such as cyclophosphamide, irinotecan, tamoxifen), heart medications (including digoxin, beta blockers such as metoprolol, calcium channel blockers such as diltiazem), anti-seizure drugs (such as carbamazepine, phenytoin, phenobarbital), tricyclic antidepressants (such as amitriptyline, nortriptyline), sympathomimetic drugs (such as albuterol, phenylephrine), drugs used to treat HIV infection (including cobicistat, elvitegravir, protease inhibitors such as indinavir/nelfinavir/ritonavir, certain NNRTIs such as delavirdine/nevirapine/etravirine, entry inhibitors such as maraviroc), drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin and heparin, NSAIDs such as ibuprofen).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, 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 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," 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.

Aspirin can increase the risk of bleeding when used with this product. If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and benefits with your doctor.

This product may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this product. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

The interactions listed above are not a complete listing of all possible drug interactions. St. John's wort can interact with many medications and products. It may also speed up the removal of other medications from your body, which may affect how they work.

Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Keep all regular medical and laboratory appointments.

Check the product labeling carefully to make sure you have the correct product. St. John's wort is a species called Hypericum perforatum and should not be confused with other Hypericum species.

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 themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all medications and herbal products 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 for more details about how to safely discard your product.Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.