
SUMMARY OF PRODUCT CHARACTERISTICS
- PRODUCT NAME
Anti-Stress Labofarm, tablets
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 170 mg of Valeriana officinalis L., radix (valerian root), 50 mg of Humulus lupulus L., flos (hop strobile), 50 mg of Melissa officinalis L., folium (melissa leaf), 50 mg of Leonurus cardiaca L., herba (motherwort herb).
1 tablet contains at least 0.15 mg of valerenic acids.
See below for full list of excipients.
- PHARMACEUTICAL FORM
Tablet
- CLINICAL PARTICULARS
Traditional herbal medicinal product with stated indications, derived solely from long-term use.
- Indications
Traditionally used to relieve temporary mild nervous tension and periodic difficulties in falling asleep.
- Posology and method of administration
Posology:
Adults, adolescents over 12 years: 2 tablets 3 times a day. In difficulties in sleeping – 2 tablets half an hour or 1 hour before bedtime, or if necessary 2 more tablets in the evening. Wash down with plenty of water.
Children:
Use in children under 12 years has not been determined due to insufficient data.
Method of administration:
Oral.
Duration of use:
If symptoms persist after 2-4 weeks or worsen during use, consult a doctor.
- Contraindications
Hypersensitivity to any active substance or any excipient listed in 6.1.
- Special warnings and precautions for use
Does not cause dependency. Alcohol may intensify the effect of valerian root. Due to motherwort content, hypersensitivity to UV radiation may occur, and given its anticoagulant properties, use of the product should be ceased at least 2 weeks before scheduled surgery.
- Drug interactions and other interactions
May intensify activity of CNS depressants and exhibit interactions wtih anticoagulants.
- Impact on fertility, pregnancy and lactation
Do not use during pregnancy and lactation. No data regarding impact on fertility.
- Impact on ability to drive vehicles and operate machinery
May affect the ability to drive vehicles and operate machinery. Not recommended up to 2 hours before driving vehicles during night hours or in case of fatigue, given the product's effect of promoting sleep.
- Adverse effects
None observed. Due to valerian root content, gastrointestinal symptoms may occur (nausea, cramps).
Reporting suspected adverse effects
After a medicinal product receives marketing authorisation, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
- Overdose
No overdose symptoms observed.
- PHARMACOLOGICAL PROPERTIES
- Pharmacodynamics
- Sedative and sleep-promoting effect has been proven for both the raw material and isolated ingredients and fractions (valepotriates, sesquiterpenes, oil).
- Valepotriates (valtrate, acevaltrate and dihydrovaltrate) have sedative activity and provide valerian extracts with their diastolic effect. The strongest sedative and motility-reducing effect among sesquiterpenes was exhibited by valerenal and valerenic acid, as well as the root-derived oil. Valerenal showed such effect at a dose of 50 mg/kg.
- In animal trials, valerian root extracts prolonged sleep induced by hexobarbital.
- Aforementioned sesquiterpene compounds exhibited a stimulating effect on GABAergic conductance of the CNS.
- Clinical trials on valerian root found its extracts to significantly improve sleep quality and help fall asleep.
- Hop strobiles (Lupuli flos) are used for nervous hyperactivity and insomnia. Such properties are attributed to components of the oil, especially methylbutan 2-ol, which is also created in the body from hop bitter acids contained in the raw material. Terpene alcohols found in melissa oil (citronellal, citral, linalool) show sedative and spasmolytic activity (animal trials). Recent trials confirm sedative and hypnotic effects of lyophilised extracts of melissa leaf.
- Clinical trials found that Anti-Stress Labofarm improves sleep latency and quality.
- Pharmacokinetics
No data for individual ingredients and the medicinal product.
- Preclinical safety data
- Acute toxicity for valeranone is 460-3160 mg/kg for mice and 1000-3160 mg/kg for rats. LD50 for both species exceeded 3160 mg/kg. Toxicity of valepotriates and oil is unknown. Previous reports of estrogenic activity of Lupuli strobili have not been verified.
It has been reported that purified aqueous fraction causes a slight decrease in ovary weight in mice. The fraction may decrease the sensitivity of ovaries to gonadotropin.
- PHARMACEUTICAL PARTICULARS
- List of excipients
Colloidal anhydrous silica
Potato starch
- Incompatibilities
No data
- Expiry date
2 years
- Special precautions for storage
Store closed in max. 25° C, keep away from children.
- Box type and contents
Glass containers with polytethylene caps, polyethylene or polypropylene containers with polyethylene caps, with 20, 60, 90 or 150 tablets.
Direct packaging – blister made with PVC foil bonded with aluminum foil, containing 10 tablets.
Outer packaging – box containing 10 tablets (1 blister) or 20 tablets
(2 blisters) or 30 tablets (3 blisters) or 40 tablets (4 blisters) or 50 tablets (5 blisters) or 60 tablets (6 blisters) or 70 tablets (7 blisters) or 80 tablets (8 blisters) or 90 tablets (9 blisters) or 100 tablets (10 blisters).
Not all types of packaging need to be marketed.
- Special precautions for disposal and preparation of medicinal product for use
No special requirements.
- MARKETING AUTHORISATION HOLDER
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
fax 58 561 20 16
e-mail: poczta@labofarm.com.pl
- MARKETING AUTHORISATION NUMBER
R/2168
- FIRST MARKETING AUTHORISATION ISSUE DATE / RENEWAL DATE
First marketing authorisation issue date: 20.03.1992
Last marketing authorisation renewal date: 28.03.2011
- DATE OF APPROVAL OR PARTIAL CHANGE OF SUMMARY OF PRODUCT CHARACTERISTICS