KALMS DAY

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALERIAN DRY HYDROALCOHOLIC EXTRACT; HOPS DRY EXTRACT

Available from:

GR Lane Health Products Ltd

ATC code:

N05CM

INN (International Name):

VALERIAN DRY HYDROALCOHOLIC EXTRACT; HOPS DRY EXTRACT

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other hypnotics and sedatives

Authorization status:

Authorised

Authorization date:

2013-05-10

Patient Information leaflet

_ _
_VALERIAN ROOT EXTRACT • HOPS EXTRACT_
_FILM-COATED TABLETS_
6. FURTHER INFORMATION
What Kalms Day contains
The active substances per tablet are:
Dry extract from _Valeriana officinalis _L. . ...............52mg
(equivalent to 208 to 260mg of Valerian root),
Extraction solvent: Ethanol 60% V/V;
Excipients: Maltodextrin, Colloidal Anhydrous Silica
Dry extract from _Humulus Lupulus _L. ......................9mg
(equivalent to 81 to 99mg of Hop strobile),
Extraction solvent: Ethanol 45% V/V;
Excipient: Maltodextrin
The other ingredients are:
Extract
Excipients:
Colloidal
Anhydrous
Silica,
Maltodextrin.
Core: Croscarmellose Sodium, Magnesium Stearate,
Microcrystalline
Cellulose,
Pregelatinised
Starch,
Stearic Acid and Silicon Dioxide.
Coating:
Hypromellose,
Talc,
Titanium
Dioxide,
Macrogol, Saccharin Sodium.
What Kalms Day looks like and contents of the pack
Kalms
Day
tablets
are
white
circular
biconvex
film-coated tablets. They are available in blister packs of
21, 42 or 84 tablets and bottles containing 100 tablets.
Not all pack sizes may be marketed.
Traditional Herbal Registration Holder and Manufacturer
G. R. Lane Health Products Limited,
Sisson Road, Gloucester, GL2 0GR, U.K.
Tel: [phone]
Email: [e-mail]
This leaflet was last approved March 2013
TR 257/2/1
XXXXXX
Certification Mark
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This
medicine
is
available
without
prescription.
However you still need to take Kalms Day carefully to
get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor if your symptoms worsen
or do not improve after 2 weeks.
• If any of the side effects become serious, or if you
notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Kalms Day is and what it is used for
2. Before you take Kalms Day
3. How to take Kalms Day
4. Possible side effect

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalms Day film-coated tablets
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
Off-white, circular, biconvex film-coated tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kalms Day is a traditional herbal medicinal product for the relief of
symptoms of mild mental stress exclusively based
on long standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3 CONTRAINDICATIONS
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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None.
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