Summary of product characteristics
1. NAME OF MEDICINAL PRODUCT
VALDIX FORTE, 355 mg, coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 355 mg of valerian root dry hydroalcoholic extract (Valeriana officinalis L., radix) (3-4:1).
Extraction solvent: ethanol 60% (V/V).
See 6.1 for full list of excipients.
3. PHARMACEUTICAL FORM
Coated tablet
4. CLINICAL PARTICULARS
4.1. Indications for use
To relieve mild symptoms of nervous tension and difficulty falling asleep.
4.2. Posology and method of administration
Posology
Adolescents over 12 years, adults, elderly persons:
- moderate nervous tension – 2 tablets up to 3 times a day,
- sleep disorders – 2 tablets half an hour up to 1 hour before bedtime, or if necessary 2 additional tablets in the evening.
Maximum daily dose: 8 tablets.
Method of administration
Oral.
Duration of use
Recommended duration of use: 2-4 weeks. Patients should be informed it is necessary to consult a doctor if symptoms persist or worsen after 2 weeks.
4.3. Contraindications:
Hypersensitivity to valerian root products or any of the excipients listed in 6.1.
4.4. Special warnings and precautions for use
Not recommended for children under 12 years.
If symptoms worsen during use, consult a doctor or pharmacist.
4.5. Drug interactions and other interactions
Little data on pharmacological interactions is available. No clinically significant interactions with medication metabolised by
CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 have been observed. Concomitant use with synthetic sedatives requires medical diagnosis and supervision.
4.6. Impact on fertility, pregnancy and lactation
Safety of use during pregnancy and lactation has not been determined. Due to lack of data, such use is not recommended. No data on impact on fertility.
4.7. Impact on ability to drive vehicles and operate machinery
May impede the ability to drive vehicles and operate machinery, therefore not recommended for use by persons performing above actions.
4.8. Adverse effects
Mild gastrointestinal symptoms (nausea, cramps) may occur. Frequency of occurrence is unknown.
If other adverse effects, not mentioned above, occur, consult a doctor or pharmacist.
Reporting suspected adverse effects
After a medicinal product receives marketing authorization, 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
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
4.9. Overdose
Valerian root in doses of 20 g may cause mild symptoms: fatigue, painful abdominal cramps, tightness in chest, dizziness, trembling hands, pupil dilation, which should subside within 24 hours. If symptoms persist, adjunct treatment should be applied. 20 g of valerian root corresponds to 14-19 tablets of Valdix Forte.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamics
Pharmacotherapeutic group: Hypnotics and sedatives
ATC: N05C M09
- Long-observed sedative activity of valerian root products was confirmed in preclinical trials and controlled clinical trials. Oral use of valerian root dry extracts, prepared with ethanol-water combination (ethanol, max. 70% (v/v)), in recommended dosage improve sleep onset and quality. These properties cannot be definitely attributed to any known ingredient. A few mechanisms responsible for the clinical effect of various valerian root components (sesquiterpenes, lignans, flavonoids), including impact on the GABA system, adenosine A1 receptor agonism and 5-HT1A receptor affinity.
5.2. Pharmacokinetics
No pharmacokinetic studies have been performed.
5.3. Preclinical safety data
Ethanol extracts and essential oil of valerian root showed low toxicity in rats, both in acute toxicity tests, as well as during 4-8 weeks of administering toxic doses. Reproductive toxicity and carcinogenicity studies have not been conducted.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Core tablet excipients:
Microcrystalline cellulose (type 102)
Microcrystalline cellulose (type 12)
Magnesium stearate
Colloidal anhydrous silica
Opadry 03B90571 Blue coating excipients:
Polyethylene glycol
Titanium dioxide (E171)
Hydroxypropyl methylcellulose
Indigotine aluminum pigment
6.2. Incompatibilities
No data.
6.3. Expiry date
3 years
6.4. Special precautions for storage
Store closed in max. 25° C
6.5. Box type and contents
Direct packaging:
Polypropylene container with polyethylene cap or polyethylene container and cap, with label or booklet label, with 30, 60 or 90 tablets, or PVC/aluminum blister with 10 tablets.
Outer packaging – cardboard box containing 10 tablets (1 blister) or 20 tablets (2 blisters) or 30 tablets (3 blisters or container) 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).
Containers may be labelled and packaged in cardboard boxes, or have booklet labels.
Not all types of packaging need to be marketed.
6.6. Special precautions for disposal and preparation for use
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
Laboratorium Farmaceutyczne Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: poczta@labofarm.com.pl
- MARKETING AUTHORIZATION NUMBER
22757
- FIRST MARKETING AUTHORIZATION ISSUE DATE / RENEWAL DATE
First marketing authorization issue date: 30.10.2015
Marketing authorization renewal date: 26.10.2020
- DATE OF APPROVAL OR PARTIAL CHANGE OF SUMMARY OF PRODUCT CHARACTERISTICS
PL