Each perle contains: Proprietary Blend 348 mg: Flaxseed Oil , Bovine Liver fat extract, Flaxseed Oil extract, Bovine Orchic Extract • Vitamin B6 (pyridoxine hydrochloride) 2 mg. Other Ingredients: Gelatin, Glycerin, Beeswax, Water, Carob.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Cataplex F Perles. 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
There is insufficient reliable information available about the effectiveness of orchic extract.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Cataplex F Perles. 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 and appropriately for medicinal purposes, short-term. Flaxseed oil has been used safely in doses up to 2 grams daily for up to 6 months. Higher doses of up to 24 grams daily has been safely used for up to 7 weeks (845,3912,5898,14443,16789,16791,16794,16795,17523,101951,101952,101955).
POSSIBLY SAFE ...when used topically for medicinal purposes, short-term. Flaxseed oil has been used safely on the wrist for up to 4 weeks (25691). ...when used in eye drops twice daily for up to 90 days (101953).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Some evidence suggests that flaxseed oil, providing 200 mg of alpha-linolenic acid, can be safely used in children for up to 3 months (14443).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately for medicinal purposes, short-term.
Although flaxseed oil has been used with apparent safety in clinical research in doses of 1-2 grams daily for up to 6 weeks (96432,101957), some population research has found that consuming flaxseed oil during the second and third trimesters of pregnancy is associated with a four-fold increased risk of premature birth (16797).
LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of orchic extract. However, since orchic extract preparations are derived from animals, there is concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of orchic extract.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately in doses that do not exceed the tolerable upper intake level (UL) of 100 mg daily for adults (15). ...when used parenterally and appropriately. Injectable vitamin B6 (pyridoxine) is an FDA-approved prescription product (15).
POSSIBLY SAFE ...when used orally and appropriately in doses of 101-200 mg daily (6243,8558).
POSSIBLY UNSAFE ...when used orally in doses at or above 500 mg daily. High doses, especially those exceeding 1000 mg daily or total doses of 1000 grams or more, pose the most risk. However, neuropathy can occur with lower daily or total doses (6243,8195). ...when used intramuscularly in high doses and frequency due to potential for rhabdomyolysis (90795).
CHILDREN: LIKELY SAFE
when used orally and appropriately (3094).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in amounts exceeding the recommended dietary allowance (5049,8579,107124,107125,107135).
CHILDREN: POSSIBLY UNSAFE
when used orally in excessive doses, long-term (3094).
PREGNANCY: LIKELY SAFE
when used orally and appropriately.
A special sustained-release product providing vitamin B6 (pyridoxine) 75 mg daily is FDA-approved for use in pregnancy. Vitamin B6 (pyridoxine) is also considered a first-line treatment for nausea and vomiting in pregnancy by the American College of Obstetrics and Gynecology (111601). However, it should not be used long-term or without medical supervision and close monitoring.
PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive doses.
There is some concern that high-dose maternal vitamin B6 (pyridoxine) can cause neonatal seizures (4609,6397,8197).
LACTATION: LIKELY SAFE
when used orally in doses not exceeding the recommended dietary allowance (RDA) (3094).
The RDA in lactating women is 2 mg daily. There is insufficient reliable information available about the safety of vitamin B6 when used in higher doses in breast-feeding women.
Below is general information about the interactions of the known ingredients contained in the product Cataplex F Perles. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, using flaxseed oil in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.
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Theoretically, combining flaxseed oil with other antihypertensive drugs might have additive effects and increase the risk of hypotension.
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Concomitant use of flaxseed oil and ezetimibe reduces the absorption of alpha-linolenic acid from flaxseed oil.
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In one clinical study, concomitant consumption of ezetimibe 10 mg daily with flaxseed oil 2 grams providing 1 gram of alpha-linolenic acid daily blocked the absorption of alpha-linolenic acid, resulting in an overall reduction in alpha-linolenic plasma levels from baseline (96433).
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Theoretically, vitamin B6 might increase the photosensitivity caused by amiodarone.
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Theoretically, vitamin B6 may have additive effects when used with antihypertensive drugs.
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Research in hypertensive rats shows that vitamin B6 can decrease systolic blood pressure (30859,82959,83093). Similarly, clinical research in patients with hypertension shows that taking high doses of vitamin B6 may reduce systolic and diastolic blood pressure, possibly by reducing plasma levels of epinephrine and norepinephrine (83091).
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Vitamin B6 may increase the metabolism of levodopa when taken alone, but not when taken in conjunction with carbidopa.
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Vitamin B6 (pyridoxine) enhances the metabolism of levodopa, reducing its clinical effects. However, this interaction does not occur when carbidopa is used concurrently with levodopa (Sinemet). Therefore, it is not likely to be a problem in most people (3046).
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High doses of vitamin B6 may reduce the levels and clinical effects of phenobarbital.
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High doses of vitamin B6 may reduce the levels and clinical effects of phenytoin.
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Below is general information about the adverse effects of the known ingredients contained in the product Cataplex F Perles. 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, flaxseed oil is generally well tolerated.
Topically, flaxseed oil seems to be well-tolerated.
Most Common Adverse Effects:
Topically: Itching, redness.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as anaphylaxis.
Endocrine ...Orally, flaxseed oil might cause gynecomastia. In a case report, a 70-year-old male developed gynecomastia after taking flaxseed oil daily for 3 months. Discontinuing flaxseed oil lead to resolution of gynecomastia (105478).
Gastrointestinal ...Orally, flaxseed oil may cause a change in bowel habits, dry mouth, and dyspepsia when taken at a dose of about 5 grams daily. However, these effects have been reported by only a small number of patients (approximately 3%) (16794). High doses of flaxseed oil (30 grams per day and higher) have been associated with loose stools and diarrhea (5898,11025).
Immunologic ...Severe allergic reactions such as anaphylaxis have been reported with flaxseed oil ingestion and also in workers processing flaxseed products (6809).
Ocular/Otic ...Topically, eye drops containing flaxseed oil may cause redness and itching (101953).
Oncologic ...Flaxseed oil has not been linked to increased prostate cancer risk. Although epidemiologic research has found that high dietary intake of alpha-linolenic acid (ALA) is associated with increased prostate cancer risk (1337,2558,7147,7823,12978), this risk does not seem to apply to ALA from plant sources, like flaxseed (12909).
General
...No adverse effects reported; however, a thorough evaluation of safety outcomes has not been conducted.
Other ...Orchic extract is derived from raw bovine testes gathered from slaughterhouses, which may include sick or diseased animals (1319). Products made from contaminated or diseased organs might present a human health hazard. There is also concern that orchic extracts produced from cows in countries where bovine spongiform encephalitis (BSE) has been reported might be contaminated with diseased tissue (1825). However, there have been no reports of BSE transfer to humans from contaminated orchic extract products.
General
...Orally or by injection, vitamin B6 is well tolerated in doses less than 100 mg daily.
Most Common Adverse Effects:
Orally or by injection: Abdominal pain, allergic reactions, headache, heartburn, loss of appetite, nausea, somnolence, vomiting.
Serious Adverse Effects (Rare):
Orally or by injection: Sensory neuropathy (high doses).
Dermatologic ...Orally, vitamin B6 (pyridoxine) has been linked to reports of skin and other allergic reactions and photosensitivity (8195,9479,90375). High-dose vitamin B6 (80 mg daily as pyridoxine) and vitamin B12 (20 mcg daily) have been associated with cases of rosacea fulminans characterized by intense erythema with nodules, papules, and pustules. Symptoms may persist for up to 4 months after the supplement is stopped, and may require treatment with systemic corticosteroids and topical therapy (10998).
Gastrointestinal ...Orally or by injection, vitamin B6 (pyridoxine) can cause nausea, vomiting, heartburn, abdominal pain, mild diarrhea, and loss of appetite (8195,9479,16306,83064,83103,107124,107127,107135). In a clinical trial, one patient experienced infectious gastroenteritis that was deemed possibly related to taking vitamin B6 (pyridoxine) orally up to 20 mg/kg daily (90796). One small case-control study has raised concern that long-term dietary vitamin B6 intake in amounts ranging from 3.56-6.59 mg daily can increase the risk of ulcerative colitis (3350).
Hematologic ...Orally or by injection, vitamin B6 (pyridoxine) can cause decreased serum folic acid concentrations (8195,9479). One case of persistent bleeding of unknown origin has been reported in a clinical trial for a patient who used vitamin B6 (pyridoxine) 100 mg twice daily on days 16 to 35 of the menstrual cycle (83103). It is unclear if this effect was due to vitamin B6 intake.
Musculoskeletal ...Orally or by injection, vitamin B6 (pyridoxine) can cause breast soreness or enlargement (8195).
Neurologic/CNS ...Orally or by injection, vitamin B6 (pyridoxine) can cause headache, paresthesia, and somnolence (8195,9479,16306). Vitamin B6 (pyridoxine) can also cause sensory neuropathy, which is related to daily dose and duration of intake. Doses exceeding 1000 mg daily or total doses of 1000 grams or more pose the most risk, although neuropathy can occur with lower daily or total doses as well (8195). The mechanism of the neurotoxicity is unknown, but is thought to occur when the liver's capacity to phosphorylate pyridoxine via the active coenzyme pyridoxal phosphate is exceeded (8204). Some researchers recommend taking vitamin B6 as pyridoxal phosphate to avoid pyridoxine neuropathy, but its safety is unknown (8204). Vitamin B6 (pyridoxine) neuropathy is characterized by numbness and impairment of the sense of position and vibration of the distal limbs, and a gradual progressive sensory ataxia (8196,10439). The syndrome is usually reversible with discontinuation of pyridoxine at the first appearance of neurologic symptoms. Residual symptoms have been reported in patients taking more than 2 grams daily for extended periods (8195,8196). Tell patients daily doses of 100 mg or less are unlikely to cause problems (3094).
Oncologic ...In females, population research has found that a median intake of vitamin B6 1. 63 mg daily is associated with a 3.6-fold increased risk of rectal cancer when compared with a median intake of 1.05 mg daily (83024). A post-hoc subgroup analysis of results from clinical research in adults with a history of recent stroke or ischemic attack suggests that taking folic acid, vitamin B12, and vitamin B6 does not increase cancer risk overall, although it was associated with an increased risk of cancer in patients who also had diabetes (90378). Also, in patients with nasopharyngeal carcinoma, population research has found that consuming at least 8.6 mg daily of supplemental vitamin B6 during treatment was associated with a lower overall survival rate over 5 years, as well as a reduced progression-free survival, when compared with non-users and those with intakes of up to 8.6 mg daily (107134).
