LAMBERTS VALERIAN

Lamberts Valerian Tablets

Each tablet contains dry extract of Valeriana officinalis radix (valerian root) 300 mg, equivalent to 1500 -1800 mg of valerian root.

Extraction solvent: ethanol70 % v/v

For a full list of excipients, see section 6.1.

Film-coated tablet

Brown speckled, film-coated tablet.

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.

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.

Hypersensitivity to valerian root or any of the excipients listed in section 6.1.

Do not exceed the stated dose.

If the condition worsens during the use of the product consult a doctor or qualified healthcare professional.

The use of this product is not recommended in children and adolescents below the age of 18years because data are not sufficient and medical advice should be sought.

Only limited data on pharmacological interactions with other medicinal products are available. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

May impair the ability to drive and use machines. If affected, do not drive or operate machines.

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; Email: medsafety@hpra.ie.

Valerian root at a dose of approximately 20 g (equivalent to 11 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

Herbal Preparation

Maltodextrin

Colloidal anhydrous silica

Tablet Core

Maltodextrin

Microcrystalline cellulose

Sodium croscarmellose

Stearic acid

Colloidal anhydrous silica

Magnesium stearate

Tablet Coating

Hypromellose

Glycerol

Not applicable.

3years

Do not store above 25°C. Store in the original packaging.

Tablets are packed into a PVC/PVDC blister strip and packed into a carton in the following pack sizes: 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

TR2029/001/001

No special requirements.