Each tablet contains: Vervain 80 mg • Motherwort 100:16 concentrate dry extract (equivalent to 307 mg) 49.1 mg • Pulsatilla 3:1 concentrate dry extract (equivalent to 120 mg) 40 mg • Uva Ursi 5:2 concentrate dry extract (equivalent to 80 mg) 32 mg • Valerian 4:1 concentrate dry extract (equivalent to 160 mg) 40 mg.
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 Femmeherb Prementaid. 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 pulsatilla.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Femmeherb Prementaid. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately. A motherwort extract in soybean oil has been used with apparent safety at doses of 1200 mg daily for up to 28 days (94209) ...when administered intramuscularly, short-term. One or more intramuscular injections have been used with apparent safety in total combined doses of 40-200 mg over 48 hours or less to prevent and/or stop postpartum bleeding (94203,101890,101891,101892). Post-marketing surveillance of over 8000 females found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855) ...when administered by intrauterine injection, short-term. Post-marketing surveillance of over 1800 patients found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855).
PREGNANCY: LIKELY UNSAFE
when used orally or by injection.
Alkaloids present in motherwort have uterine stimulant effects (4,12,19).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.
PREGNANCY: LIKELY UNSAFE
when used orally.
The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.
LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19).
There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Uva ursi has been used with apparent safety in doses of up to 3600 mg daily for 3-5 days (101815).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. There is concern about the safety of long-term or high-dose use because of the hydroquinone content of uva ursi. Hydroquinone is thought to have mutagenic and carcinogenic effects (7). At high doses (around 20 grams of dried herb) it can cause convulsions, cyanosis, delirium, shortness of breath, and collapse. At very high doses (30 grams of dried herb or more) it can be fatal (4).
CHILDREN: POSSIBLY UNSAFE
when used orally by children.
Uva ursi contains hydroquinone and high tannin levels, which can cause severe liver problems in children (4,18); avoid using.
PREGNANCY: LIKELY UNSAFE
when used orally.
Uva ursi can have oxytocic effects, increasing the speed of labor (4,7,19); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately, short-term. Valerian 300-600 mg daily has been safely used in clinical studies in over 12,000 patients for up to 6 weeks (2074,3484,3485,4032,15018,17577,17578,19409,96242,103221)(104010,105718). There is insufficient reliable information available about the safety of valerian when used orally for longer than 6 weeks.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Valerian 160-320 mg has been used with apparent safety in children under 12 years of age for 4-8 weeks (14416).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Verbena has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912). There is insufficient reliable information available about the safety of verbena when used orally or topically in medicinal amounts.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of verbena in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Femmeherb Prementaid. 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, taking motherwort concomitantly with other CNS depressants may increase the risk of sedation.
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Theoretically, uva ursi may decrease the metabolism of CYP2C19 substrates.
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In vitro, uva ursi appears to inhibit cytochrome CYP2C19 (98550). This effect has not been reported in humans.
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Theoretically, uva ursi may decrease the metabolism of CYP3A4 substrates.
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In vitro, uva ursi appears to inhibit CYP3A4 (98550). This effect has not been reported in humans.
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Theoretically, uva ursi may increase levels of drugs metabolized by glucuronidation.
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In vitro, uva ursi extract appears to strongly inhibit UDP-glucuronosyltransferase (UGT) 1A1 (UGT1A1). However, uva ursi extract does not appear to inhibit UGT1A1 in animal models (98549). This effect has not been reported in humans.
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Theoretically, uva ursi may increase lithium levels, necessitating a decrease in dose.
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Uva ursi may have diuretic properties (81637). Diuretics may increase lithium reabsorption with sodium in the proximal tubule of the kidney. Theoretically, uva ursi might reduce excretion and increase levels of lithium.
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Theoretically, uva ursi may alter the levels of drugs transported by P-glycoprotein.
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In vitro, uva ursi appears to inhibit the multi-drug transporter protein, P-glycoprotein (98550). This effect has not been reported in humans.
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Effects of uva ursi in the urinary tract may be reduced by urinary acidifying agents.
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Uva ursi seems to work best in alkaline urine. Theoretically, taking uva ursi with medications known to acidify the urine may decrease any effects of uva ursi on the urinary tract (19).
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Valerian can have additive sedative effects when used concomitantly with alcohol.
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Valerian has sedative effects (9894). Theoretically, valerian might have an additive sedative effect when combined with alcohol. Excessive sedation has been reported in an alcohol-abusing individual who took valerian and Gingko biloba (19426). However, the potential interaction between valerian and alcohol has been disputed in other research. Limited evidence suggests that a combination of valerian 160 mg and lemon balm 80 mg (Euvegal) does not cause further deterioration in reaction ability and reaction rate when taken with alcohol as compared to the effects of alcohol alone (19427).
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Valerian can have additive sedative effects when used with alprazolam. Also, valerian in high doses might modestly increase alprazolam levels, though this is not likely to be clinically significant.
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Valerian has sedative effects (9894). Theoretically, valerian might cause additive sedation when combined with alprazolam. Also, a small pharmacokinetic study shows that taking valerian extract 1000 mg daily (providing 11 mg valerenic acid) might increase alprazolam levels by about 19%. This might be due to valerian's mild inhibition of cytochrome P450 3A4 (CYP3A4) (13014). Despite being statistically significant, this increase is not likely to be clinically significant.
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Valerian can have additive sedative effects when used concomitantly with CNS depressant drugs.
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Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP2D6.
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Although some in vitro evidence suggests that valerian affects CYP2D6, clinical pharmacokinetic (PK) studies show that valerian is unlikely to affect the CYP2D6 enzyme (13014,13536,19430,19431). In one PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days did not affect the metabolism of dextromethorphan, a CYP2D6 substrate. In another PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of debrisoquine, an accepted CYP2D6 probe-substrate (13014,13536).
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Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP3A4.
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Although some in vitro evidence suggests that valerian extract might inhibit or induce CYP3A4, clinical pharmacokinetic (PK) studies show that valerian does not have a clinically significant effect on the CYP3A4 enzyme (6450,12214,13014,13536,19431). In one PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of midazolam, an accepted CYP3A4 probe-substrate. In another PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days modestly increases levels of alprazolam, a CYP3A4 substrate, suggesting mild inhibition of CYP3A4 (13014,13536). However, this mild inhibition is unlikely to be clinically relevant.
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Valerian might weakly inhibit glucuronidation and increase concentrations of drugs metabolized by UGT1A1 and UGT2B7.
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In vitro research shows that methanolic valerian extract and valerenic acid might competitively inhibit UDP-glucuronosyltransferase (UGT) 1A1 (UGT1A1) and UGT2B7 (81685).
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In vitro research suggests that beta-myrcene, a terpene constituents of verbena, can significantly inhibit cytochrome P450 2B1 (CYP2B1) enzyme activity (82024). Theoretically, verbena might increase levels of drugs metabolized by this enzyme. However, this interaction has not been reported in humans.
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Some substrates of CYP2B1 include cyclophosphamide, ifosfamide, barbiturates, bromobenzene, and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Femmeherb Prementaid. 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 or via intramuscular or intrauterine injection, motherwort appears to be generally well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, stomach irritation.
Topically: Contact dermatitis, photosensitivity.
Intramuscular / Intrauterine: Abdominal pain, erythema, eyelid edema, fever, nausea, pruritus, rash.
Dermatologic ...Motherwort leaves can cause contact dermatitis, and the oil may cause photosensitivity reactions (4). Intramuscularly and via intrauterine injection, mild erythema, rash, and pruritus have been reported (101892,104855).
Gastrointestinal ...Orally, use of motherwort in amounts greater than 3 grams can cause diarrhea and stomach irritation (12). Intramuscularly and via intrauterine injection, abdominal pain and nausea have been reported (104855).
Genitourinary ...Orally, use of motherwort in amounts greater than 3 grams can cause uterine bleeding (12).
Immunologic ...Motherwort can also cause allergic reactions in sensitive individuals (4). Intramuscularly and via intrauterine injection, transient fever and chills lasting less than 24 hours have been reported (104855).
Ocular/Otic ...Intramuscularly and via intrauterine injection, transient eyelid edema lasting less than 24 hours has been reported (104855).
General
...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).
Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).
Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).
Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).
Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).
Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).
Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).
General
...Uva ursi is generally well tolerated in low doses, short-term.
Most Common Adverse Effects:
Orally: Diarrhea, nausea, stomach upset, and vomiting.
Serious Adverse Effects (Rare):
Orally: At high doses (20 grams of dried herb), uva ursi has been reported to cause collapse, convulsions, cyanosis, delirium, shortness of breath, and tinnitus. Very high doses of 30 grams or more may be fatal.
Gastrointestinal ...Orally, uva ursi may cause nausea, vomiting, diarrhea, and stomach upset (92148). It can also irritate the gastrointestinal tract (19).
Genitourinary ...Orally, uva ursi may cause the urine to be greenish-brown. It may also cause irritation and inflammation of the urinary tract mucous membranes (18).
Hepatic ...Uva ursi may be hepatotoxic. Theoretically, chronic use, especially in children, can cause liver impairment due its hydroquinone and high tannin content (4,18).
Neurologic/CNS ...Orally, around 20 grams of uva ursi is reported to supply up to one gram of hydroquinone, which can theoretically cause convulsions and delirium (4).
Ocular/Otic
...Orally, uva ursi may potentially cause retinal toxicity due to its hydroquinone content, which reduces melanin synthesis.
A 56-year-old female developed bilateral bull's-eye maculopathy, paracentral scotomas, and retinal thinning after 3 years of uva ursi tea ingestion (16900).
Taking around 20 grams of uva ursi orally is reported to supply up to one gram of hydroquinone, which can theoretically cause tinnitus (4).
Pulmonary/Respiratory ...Orally, around 20 grams of uva ursi is reported to supply up to one gram of hydroquinone, which can theoretically cause shortness of breath and cyanosis (4).
General
...Orally, valerian is generally well-tolerated.
Most Common Adverse Effects:
Orally: Dizziness, drowsiness, and mental slowness. Other reported side effects include headache, gastrointestinal upset, excitability, and vivid dreams. When used chronically and abruptly stopped, symptoms of withdrawal such as tachycardia, anxiety, irritability, and insomnia might occur. Advise patients to taper doses slowly after extended use.
Serious Adverse Effects (Rare):
Orally: Several case reports raise concerns about hepatotoxicity after the use of valerian and valerian-containing multi-ingredient dietary supplements. Withdrawal from chronic valerian use has been associated with cases of cardiac failure and hallucinations.
Cardiovascular ...When used orally in high doses for an extended period of time, valerian withdrawal has been associated with tachycardia and high output cardiac failure in one patient with a history of coronary artery disease (3487). Chest tightness has been reported for an 18-year-old female who took 40-50 capsules containing valerian 470 mg/capsule (659). A case of severe hypotension, suspected to be due to vasodilation, hypocalcemia, and hypokalemia, has been reported for a patient who injected an unknown quantity of a crude tap water extract of raw valerian root (81734).
Dermatologic ...Orally, valerian might rarely cause a rash. A case of valerian-related rash that resolved after valerian root discontinuation was reported in clinical research (19422).
Gastrointestinal ...Orally, valerian has been associated with increased incidence of gastrointestinal problems including diarrhea, nausea, vomiting, and stomach pain (15046,19406,19407,19422,110712). In one individual, taking 20 times the normal dose caused abdominal cramping (659).
Hepatic
...There have been several case reports of hepatotoxicity associated with the use of multi-ingredient oral preparations containing valerian (8243,96241).
In one case report, a 57-year-old man presented with acute hepatitis after consuming a cold and flu remedy containing valerian 2 grams for 3 days; the remedy also contained white willow, elderberry, and horseradish. Although the use of the cold and flu remedy was discontinued one month prior to symptom presentation, the acute hepatitis was attributed to valerian root and treated with steroids (96241). It is possible, however, that some of these preparations may have been adulterated with hepatotoxic agents (8243).
Hepatotoxicity involving long-term use of single-ingredient valerian preparations has also been reported (3484,17578). Also, a case of a 38-year-old female with liver insufficiency and cirrhosis of a vascular parenchymal nature who developed hepatotoxic symptoms following valerian and ethyl-alcohol abuse has been reported (81697). Symptoms resolved and laboratory values normalized following intense plasmapheresis treatment. Another case of acute hepatitis characterized by elevated aminotransferases, mild fibrosis, and liver inflammation has been reported for a 50-year-old female who consumed valerian root extract 5 mL three times weekly along with 10 tablets of viamine, a product containing dry valerian extract 125 mg/tablet, for 2 months (81696). Because a variety of doses were used in these cases, and many people have used higher doses safely, these hepatotoxic reactions might have been idiosyncratic. Tell patients the long-term effect of valerian on liver function is unknown.
Musculoskeletal ...In a case report, combined intake of valerian and passionflower caused throbbing and muscular fatigue when taken concomitantly with lorazepam (19429).
Neurologic/CNS ...Orally, valerian might cause dizziness, headaches, fatigue, sleepiness, and mental dullness (3484,17578,19411,19422,81723,89407). The severity of adverse effects appears to increase with higher doses (19411). However, taking valerian extracts in doses up to 1800 mg does not appear to significantly affect mood or psychomotor performance (10424,15044). Valerian does not usually have a negative impact on reaction time, alertness, and concentration the morning after intake (2074,8296). Clinical research shows that a single dose of valerian root 1600 mg is not associated with any changes in sleepiness, reaction time, or driving performance within 1-4 hours after intake (96240). More serious side effects may occur when valerian is taken at higher doses. In one individual, 20 times the normal dose caused tremor of the hand and foot and lightheadedness (659). In a case report, combined intake of valerian and passionflower caused shaking of the hands and dizziness when taken concomitantly with lorazepam (19429).
Psychiatric ...Orally, valerian has been associate with reports of restlessness, excitability, uneasiness, agitation, and vivid dreams (3484,17578,19411,19422). Chronic use and rapid cessation can lead to withdrawal syndrome with symptoms of agitation, insomnia, and hallucinations (104003). There appears to be a trend towards increased severity of adverse effects with higher doses (19411). A case of acute hypomania has been reported for a 21-year-old female patient who took a valerian decoction in water each night for one month to treat subclinical anxiety. Symptoms included euphoric mood, rapid speech, and increased sociability and sexual interest. Following cessation of valerian use and treatment with quetiapine 100 mg daily for two weeks, the patient recovered (89405). In another case report, an 85-year-old male with mild cognitive impairment, major depression, anxiety, and chronic kidney disease presented to the emergency department with hallucinations, confusion, and agitation thought to be due to abrupt cessation after taking valerian 600 mg daily for about 6 months. The symptoms resolved in about 5 days (104003).
General
...Orally, verbena is well tolerated when used orally in amounts commonly found in foods (4912).
When used in medicinal amounts and in combination with other herbs, adverse effects have included gastrointestinal adverse effects and allergic skin reactions (374,379).
Topically, verbena can cause contact dermatitis (13431).
Gastrointestinal ...Orally, verbena in combination with other herbs can cause gastrointestinal adverse effects (374,379).
Immunologic ...Orally, verbena in combination with other herbs can cause allergic skin reactions (374,379). Topically, verbena can cause contact dermatitis (13431).