Lamberts Valerian Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALERIAN EXTRACT

Available from:

Lamberts Healthcare Limited

ATC code:

N05CM; N05CM09

INN (International Name):

VALERIAN EXTRACT

Dosage:

.

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other hypnotics and sedatives; Valerianae radix

Authorization status:

Not marketed

Authorization date:

2016-12-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamberts Valerian Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dry extract of_ Valeriana officinalis_ radix
(valerian root) 300 mg, equivalent to 1500 -1800 mg of
valerian root.
Extraction solvent: ethanol 70 % v/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Brown speckled, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of symptoms
of mild mental stress and to aid sleep,
exclusively based upon long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short term use only.
Adults and the elderly.
For the relief of symptoms of mild mental stress:
Take one tablet twice a day.
To aid sleep:
Take 1 tablet half to one hour before bedtime with an earlier dose
during the evening if necessary to aid
sleep
Do not exceed the stated dose (4 tablets per day).
Not recommended for children or adolescents under 18 years (see
Section 4.4. Special warnings and precautions for
use).
Tablets should be swallowed whole with some water or other liquid. The
tablets should not be chewed.
As treatment effects may not be apparent immediately, tablets should
be taken for at least 2 weeks continuously.
Maximum dose: 4 tablets per day.
DURATION OF USE:
If symptoms worsen or do not improve after 2 weeks a doctor or
qualified healthcare professional e.g. a doctor or
pharmacist should be consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to valerian root or any of the excipients listed in
section 6.1.
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