Summary of product characteristics
- PRODUCT NAME
OPTIMUM Anti-Stress Labofarm, coated tablets
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 170 mg of Valeriana officinalis L., radix (powdered valerian root), 50 mg of Humulus lupulus L., flos (powdered hop strobile), 50 mg of Melissa officinalis L. folium (powdered melissa leaf), 50 mg of Leonurus cardiaca L., herba (powdered motherwort herb).
1 tablet contains at least 0.15 mg of valerenic acids.
See 6.1 for full list of excipients.
- PHARMACEUTICAL FORM
Coated 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.
Method of administration:
Oral.
- Contraindications
Hypersensitivity to any active substance or any excipient listed in 6.1.
- Special warnings and precautions for use
Use in children under 12 years has not been determined due to lack of relevant data. If symptoms persist after 2-4 weeks or worsen during use, consult a doctor. 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 adverse effects:
In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301,
fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.
- Overdose
No overdose symptoms observed.
- PHARMACOLOGICAL PROPERTIES
- Pharmacodynamics
Use for stated indications is based on traditional use.
- Sedative and sleep-promoting effect has been proven for both the raw material (herbal drug) – valerian root and isolated ingredients and fractions (sesquiterpenes, oil).
- Pharmacological trials found valerenal and valerenic acid, as well as the root-derived oil, to possess the strongest sedative and motility-reducing activity among sesquiterpenes. Valerenal and valerenic acid showed such effect at a dose of 50 mg/kg.
- Aforementioned sesquiterpene compounds exhibited a stimulating effect on GABAergic conductance of the CNS.
- Hop strobiles – Lupuli strobili, are used for nervous hyperactivity and insomnia. Relevant properties are exhibited by oil components, especially methylobutan 2-ol, created also in the body from hop bitter acids contained in the raw material.
- Terpene alcohols found in melissa oil (citronellal, citral, linalool) exhibit sedative and spasmolytic activity (animal trials).
- Doublie-blind clinical trials found that Anti-Stress Labofarm improves sleep latency and quality.
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- 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
Polyethylene glycol
(Hydroxypropyl) methylcellulose
- 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
Direct packaging – polypropylene container with polytethylene cap, with 20, 60 or 90 tablets, or blister made of PVC foil bound with aluminum foil, with 10 tablets.
Outer packaging – box containing 10 tablets (1 blister) or 20 tablets
(2 blisters or container) or 30 tablets (3 blisters) or 40 tablets (4 blisters) or 50 tablets (5 blisters) or 60 tablets (6 blisters or container) or 70 tablets (7 blisters) or 80 tablets (8 blisters) or 90 tablets (9 blisters or container) 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
19897
- FIRST MARKETING AUTHORISATION ISSUE DATE / RENEWAL DATE
First marketing authorisation issue date: 22.03.2012
Last marketing authorisation renewal date: –
- DATE OF APPROVAL OR PARTIAL CHANGE OF SUMMARY OF PRODUCT CHARACTERISTICS
09.02.2017
PL