SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Kalms Day

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 52 mg of extract (as dry extract) from Valeriana officinalis L., radix (equivalent to 208 mg - 260 mg of Valerian root).

Extraction solvent: Ethanol 60% V/V.

Each tablet contains 9 mg of extract (as dry extract) from Humulus lupulus L., strobiles (equivalent to 81 mg - 99 mg of Hop strobile).

Extraction solvent: Ethanol 45% V/V

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film coated tablet

White, circular, biconvex film coated tablet

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Adults and the elderly: One tablet to be taken 3 times a day.

As treatment effects may not be apparent immediately, Kalms Day should be taken for 2-4 weeks continuously.

Duration of use:

If symptoms worsen or do not improve after 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions of use).

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

If symptoms persist or worsen after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway have not been observed.

Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

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

4.6 Pregnancy and lactation

Safety during pregnancy and lactation has not been established. As a precautionary measure, because of lack of data, use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. The frequency is not known.

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

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 8 to 13 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 10 g of the drug) withdrawal symptoms (delirium) have been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extracts Excipients Maltodextrin

Colloidal Anhydrous Silica Tablet Core

Croscarmellose Sodium Microcrystalline Cellulose Magnesium Stearate Pregelatinised Starch Silicon Dioxide Stearic Acid

Tablet Coating

Opadry II White (Polyvinyl Alcohol part hydrolysed, Titanium Dioxide, Polyethylene Glycol 3350, Talc)

Incompatibilities

Not applicable.

6.3 Shelf life

30 months

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5    Nature and contents of container

21 or 42 tablets stored in PVC/Aclar®-aluminium/polyethylene laminate blister packs - pocketpack format with sliding blisters attached to the carton.

21, 42 or 84 tablets stored in PVC/Aclar®-aluminium/polyethylene laminate blister packs.

100 tablets stored in 60ml amber glass bottles (Ph. Eur. type III glass) fitted with white HDPE tamper evident caps.

100 tablets stored in 60ml white HDPE bottles fitted with white HDPE tamper evident caps.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: info@laneshealth.com

8    MARKETING AUTHORISATION NUMBER(S)

THR 01074/0027

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/03/2011

10 DATE OF REVISION OF THE TEXT

01/04/2016