| Ingredients | Each tablet contains: |
|---|---|
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(S-Adenosyl-L-Methionine disulfate tosylate)
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200 mg |
Cellulose, Mannitol, Sodium Starch Glycolate, Silica, Glycerol Behenate, Magnesium Stearate, Methacrylic Acid Copolymer, Glycerol Palmitostearate, Medium-Chain Triglycerides, Titanium Dioxide, Talc, Triethyl Citrate, yellow tartrazine
In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
Below is general information about the effectiveness of the known ingredients contained in the product SAM-e iSO Active Enteric-Coated 200 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product SAM-e iSO Active Enteric-Coated 200 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally, intravenously, or intramuscularly and appropriately. Serious adverse effects have not been reported in multiple clinical studies involving more than 22,000 patients and lasting from a few days to 2 years (5189,5201,5202,5219,5231,5232,12231,17490,95075,95076).
PREGNANCY: POSSIBLY SAFE
when used intravenously short-term during the third trimester of pregnancy.
In two small-scale trials, SAMe 800 mg daily was used intravenously for 14-20 days during the third trimester of pregnancy for cholestasis. No adverse effects were observed (5219,5231,5240). However, use of SAMe in pregnancy should only be considered when benefits clearly outweigh the potential risks. There is insufficient reliable information available about the use of SAMe at higher doses, for extended periods of time, or during the earlier trimesters of pregnancy.
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product SAM-e iSO Active Enteric-Coated 200 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
SAMe might reduce the effectiveness of levodopa.
 Details
SAMe methylates levodopa, which might reduce its effectiveness for treating Parkinson disease (10466).
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Taking SAMe with serotonergic drugs might increase the risk of serotonin syndrome and other serotonergic side effects.
Details
SAMe has serotonergic effects (3521,5196,5232,5193). Theoretically, combining serotonergic drugs with SAMe might increase the risk of serotonergic side effects, including serotonin syndrome and cerebral vasoconstrictive disorders (8056). In one case report, SAMe 100 mg intramuscularly was given daily with clomipramine (Anafranil) 25 mg per day. When the clomipramine dose was increased to 75 mg per day the patient experienced serotonin syndrome about 48-72 hours later, requiring hospitalization (3521).
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Below is general information about the adverse effects of the known ingredients contained in the product SAM-e iSO Active Enteric-Coated 200 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, SAMe is generally well tolerated when used in typical doses.
Side effects are more common with higher doses.
Most Common Adverse Effects:
Orally: Anorexia, constipation, diarrhea, dizziness, dry mouth, flatulence, headache, insomnia, nausea, nervousness, sweating, vomiting.
Cardiovascular
...There has been some concern that SAMe might increase homocysteine levels.
SAMe is metabolized to s-adenosylhomocysteine, which can be metabolized to homocysteine (5232). Elevated levels of homocysteine have been linked to cardiovascular and kidney disease (1698). However, in a study lasting 4 weeks, administration of SAMe orally in doses titrated up to 1600 mg daily was not associated with a significant increase in homocysteine levels (12231). In another study, there also was no difference in cardiovascular mortality in people with cirrhosis taking SAMe 1200 mg daily for 2 years (1712).
Intravenously, SAMe infusions may cause phlebitis (20204). Also, a case of tachycardia has been reported in a patient treated with intravenous SAMe (72988).
Dermatologic
...Orally, SAMe may cause rash and itching, transient hair loss, sweating, and night sweats (5196,5199,5203,20202,20230,73035).
Intravenously, SAMe may cause rash and sweating (20204,72996,73038).
Gastrointestinal ...When taken orally or given intravenously, SAMe may cause increased salivation, bloating, flatulence, nausea, vomiting, diarrhea, stomach ache, heartburn, constipation, hunger, thirst, anorexia, blood in the stool, and dry mouth (1712,5188,5196,5200,5203,5208,5221,5241,9113,9981,12054,20202,20218,73035,95075,95076).
Genitourinary ...Orally, rare adverse effects associated with SAMe include increased urinary frequency (5196).
Neurologic/CNS
...Orally, SAMe may cause vertigo, headache, insomnia, fatigue, tremors, agitation, dizziness, vivid dreams, and anxiety (5188,5195,5196,5203,5241,9981,12054,17123,20203,20218,20225,20230,20468,20471,72942,73001,95076).
Intramuscularly, SAMe may cause insomnia , anxiety, hostility, dizziness and drowsiness, and headache, although these events are rare (5188,20218,73002).
Intravenously, side effects rarely associated with SAMe include insomnia, anxiety, and psychomotor agitation (20204,72978,72988,73038).
Ocular/Otic ...Orally, rare side effects associated with SAMe include blurred vision, and a hot sensation and itchiness of the ear (5195,5196,9981,20225).
Psychiatric
...Orally, anxiety and tiredness have been reported in patients with depression (5231,14841).
Rare adverse effects associated with SAMe include hypermania (5196). Hypomania has occurred with a combination of intramuscular and oral SAMe (20218). Cases of mania with suicidal ideation have also been reported in otherwise healthy patients (5195,12231). A crawling sensation on the skin has been reported in a clinical trial (5195). In a case report, a patient with depression self-medicated with oral SAMe and attempted suicide four days later (72965).
When used as an injection, rarely SAMe has caused both hypermania and hypomania in people with bipolar disorder or depression (5216,5231,17122,72978). Two suicide attempts occurred in a clinical trial of intramuscular SAMe in patients with major depression (20222).
Pulmonary/Respiratory ...Orally, congestion has occurred rarely in clinical trials of SAMe (5196,20225,72981).
