KALMS DAY

Kalms Day film-coated tablets

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.

Film coated tablet

Off-white, circular, biconvex film-coated tablet

For oral short term use only

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 weeks continuously.

Duration of use:

If symptoms persist, worsen or do not improve after 2 weeks use of Kalms Day a qualified healthcare professional e.g. a doctor or pharmacist should be consulted.

Not recommended for children or adolescents under 18 years.

Patients with known hypersensitivity to Valerian root, Hop Strobile or to any of the other ingredients of this product should not use Kalms Day.

Kalms Day should not be used in children and adolescents under 18 years.

None.

Interaction with other medicinal products and other forms of interactions

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 increased by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

The safety of Kalms Day during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Kalms Day may impair ability to drive and use machines.

Patients who are affected should not drive or operate machinery.

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

If other adverse reactions not mentioned above occur, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted.

Valerian root at a dose of approximately 20 g (equivalent to 77 to 96 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.

No case of overdose has been reported for Hops Strobile.

Pharmacotherapeutic group: Other hypnotics and sedatives, ATC code: N05CM

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.

Extracts Excipients

Maltodextrin

Colloidal Anhydrous Silica

Tablet Core

Croscarmellose Sodium

Microcrystalline Cellulose

Magnesium Stearate

Pregelatinised Starch

Silicon Dioxide

Stearic Acid

Tablet Coating

Not applicable.

30 months

Do not store above 25°C.

Store in the original package in order to protect from moisture and light.

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.

Not all pack sizes may be marketed.

No special requirements.

TR 257/2/1

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

Date of first registration: 10^th May 2013