(Hypericum perforatum) - ORAL
(Hypericum perforatum) - ORAL
(Hypericum perforatum) - ORAL
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
J. Iverson Riddle Developmental Center<br />
Patient Education Monograph<br />
IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE<br />
EXPERTISE AND JUDGEMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTHCARE PROFESSIONAL. IT<br />
SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR<br />
YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS DRUG.<br />
ST. JOHN’S WORT (<strong>Hypericum</strong> <strong>perforatum</strong>) - <strong>ORAL</strong><br />
USES: St. John’s wort has been used for depression.<br />
• Some herbal/dietary supplement products have been found to contain possibly harmful impurities/additives.<br />
Check with your pharmacist for more details about the brand you use.<br />
• The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist<br />
for more details.<br />
HOW TO USE: Take this product by mouth as directed. Follow all directions on the product package. If you are<br />
uncertain about any of the information, consult your doctor or pharmacist. Do not take more than the recommended<br />
amount. It may take about 3 weeks of regular use before you notice the benefits of this product.<br />
• Do not suddenly stop taking this product. Some conditions may become worse when this product is<br />
abruptly stopped. You may need to gradually reduce your dose. Consult your doctor or pharmacist for<br />
details.<br />
• If your condition persists or worsens, or if you think you may have a serious medical problem, seek<br />
immediate medical attention.<br />
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<br />
missed dose and resume your usual dosing schedule. Do not double the dose to catch up.<br />
STORAGE: Refer to storage information printed on the package. If you have any questions about storage, ask your<br />
pharmacist. Keep all medications and herbal products away from children and pets.<br />
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly<br />
discard this product when it is expired or no longer needed. Consult your pharmacist or local waste<br />
disposal company for more details about how to safely discard your product.<br />
SIDE EFFECTS: Trouble sleeping, restlessness, upset stomach, dizziness, headache, or numbness/tingling of the<br />
hands/feet may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.<br />
• Tell your doctor immediately if this unlikely but serious side effect occurs: a sunburn-like skin reaction<br />
(increased sun sensitivity).<br />
• Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody/tarry<br />
stools, vomit that looks like coffee grounds, easy bruising/bleeding.<br />
• This product may rarely cause a very serious condition called serotonin syndrome. The risk increases<br />
when this product is used with certain drugs such as ”triptans” used to treat migraine headaches<br />
(e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, paroxetine)<br />
and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity<br />
(sibutramine). See also Drug Interactions section. Before taking this product, tell your doctor if you<br />
take any of these medications. Serotonin syndrome may be more likely when you start or increase the<br />
dose of any of these medications. Seek immediate medical attention if you develop any of the following<br />
symptoms: unusual mental/mood changes (e.g., strange thoughts, unusual excitement, extreme anxiety,<br />
confusion), severe dizziness, severe headache, fast heartbeat, unexplained fever, sweating, severe<br />
nausea/vomiting/diarrhea, twitching muscles.<br />
• A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you<br />
notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of<br />
the face/tongue/throat), severe dizziness, trouble breathing.<br />
• This is not a complete list of possible side effects. If you notice other effects not listed above, contact<br />
your doctor or pharmacist.<br />
• In the US -<br />
1
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-<br />
FDA-1088.<br />
• In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health<br />
Canada at 1-866-234-2345.<br />
PRECAUTIONS: Before taking St. John’s wort, tell your doctor or pharmacist if you are allergic to it; or if you have<br />
any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.<br />
Talk to your pharmacist for more details.<br />
• If you have any of the following health problems, consult your doctor or pharmacist before using this<br />
product: personal or family history of bipolar/manic-depressive disorder.<br />
• This product may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths,<br />
and sunlamps. Use a sunscreen and wear protective clothing when outdoors.<br />
• Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes,<br />
alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.<br />
• Before having surgery, tell your doctor or dentist that you are using this product.<br />
• St. John’s wort is not recommended for use during pregnancy. Consult your doctor before using this<br />
product.<br />
• It is not known if St. John’s wort passes into breast milk. Consult your doctor before breast-feeding.<br />
DRUG INTERACTIONS: Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide,<br />
phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after using St.<br />
John’s wort. In some cases a serious (possibly fatal) drug interaction may occur.<br />
• St. John’s wort interacts with many medications and products. The following drugs are just some of<br />
the products that may interact with St. John’s wort.<br />
• Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal<br />
products you may use, especially of: drugs used to prevent organ rejection (e.g., cyclosporine, sirolimus,<br />
tacrolimus), drugs used to treat cancer (e.g., cyclophosphamide, etoposide, irinotecan, paclitaxel, tamoxifen),<br />
heart medications (e.g., digoxin, beta blockers such as metoprolol, calcium channel blockers such<br />
as diltiazem), anti-seizure drugs (e.g., carbamazepine, phenytoin, phenobarbital), tricyclic antidepressants<br />
(e.g., amitriptyline, nortriptyline), sympathomimetic drugs (e.g., albuterol, phenylephrine), drugs<br />
used to treat HIV infection such as protease inhibitors (e.g., indinavir), non-nucleoside reverse transcriptase<br />
inhibitors (NNRTIs such as delavirdine, efavirenz, nevirapine, etravirine), and entry inhibitors (e.g.,<br />
maraviroc), drugs that can cause bleeding/bruising (e.g., antiplatelet drugs such as clopidogrel, ”blood<br />
thinners” such as warfarin and heparin, NSAIDs such as ibuprofen).<br />
• Also tell your doctor if you take any other products/drugs that increase serotonin, such as bromocriptine,<br />
buspirone, dextromethorphan, meperidine, propoxyphene, phentermine, ergots such as dihydroergotamine,<br />
street drugs such as MDMA/”ecstasy,” amphetamine. (See also Side Effects section.)<br />
• Aspirin can increase the risk of bleeding when used with this product. If your doctor has directed you<br />
to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams<br />
a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and<br />
benefits with your doctor.<br />
• This product may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This<br />
could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable<br />
birth control methods while using this product. Also tell your doctor if you have any new spotting or<br />
breakthrough bleeding, because these may be signs that your birth control is not working well.<br />
• The interactions listed above are not a complete listing of all possible drug interactions. St. John’s wort<br />
may also interact with many other drugs by affecting how they are absorbed by your body or removed<br />
from your body. These effects may change how well these other drugs work. Therefore, before using St.<br />
John’s wort, talk with your doctor or pharmacist about all medications and products you take.<br />
• Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist<br />
first.<br />
• This document does not contain all possible interactions. Therefore, before using this product, tell your<br />
doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share<br />
the list with your doctor and pharmacist.<br />
NOTES: Keep all regular medical and laboratory appointments.<br />
2
• Check the product labeling carefully to make sure you have the correct product. St. John’s wort is a<br />
species called <strong>Hypericum</strong> <strong>perforatum</strong> and should not be confused with other <strong>Hypericum</strong> species.<br />
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US<br />
residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison<br />
control center.<br />
3