KALMS NIGHT

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALERIAN DRY HYDROALCOHOLIC EXTRACT

Available from:

GR Lane Health Products Ltd

ATC code:

N05CM

INN (International Name):

VALERIAN DRY HYDROALCOHOLIC EXTRACT

Pharmaceutical form:

Unknown

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other hypnotics and sedatives

Authorization status:

Authorised

Authorization date:

2013-05-03

Patient Information leaflet

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 Night 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 Night is and what it is used for
2. Before you take Kalms Night
3. How to take Kalms Night
4. Possible side effects
5. How to store Kalms Night
6. Further information
6. FURTHER INFORMATION
What Kalms Night contains
The active substance per tablet is:
Dry extract from Valerian root ...............................385 mg
(equivalent to 1.54-1.925g of Valerian root)
Extraction solvent: Ethanol 60% v/v
Excipients: Maltodextrin, Colloidal Anhydrous Silica.
The other ingredients are:
Core: Croscarmellose Sodium, Magnesium Stearate,
Silicified
Microcrystalline
Cellulose,
Talc
and
Silicon Dioxide.
Coating:
Hypromellose,
Talc,
Titanium
Dioxide,
Macrogol, Saccharin Sodium.
What Kalms Night looks like and contents of the pack
Kalms
Night
tablets
are
off-white
ovaloid
film
coated
tablets. They
are
available
in
blister
packs
containing 14, 21, 28, 42 and 56 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,
United Kingdom.
Tel: [phone]
Email: [e-mail]
This leaflet was last approved November 2017 3005-01
Film coated tablets
JOB NAME:
3005-01 KALMS NIGHT PIL
DESCRIPTION: xxxx
DATE: 30/10/17
AMENDS AUTHOR: SM
BRIEF DESCRIPTION: Reporting change
SIZE: 163 x 140mm
COLOURS:
Pantone 2593
Black
_ NIGHT_
Certification Mark
Valerian Root Extract
3005-01 Kalms Night PIL.indd 1-2
30/10/2017 14:58
1.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalms Night Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 385mg of extract (as dry extract) from_ Valeriana
officinalis_ L., radix (equivalent to 1540 mg –
1925 mg of Valerian root).
Extraction solvent: Ethanol 60% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, ovaloid film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kalms Night is a traditional herbal medicinal product used to aid
sleep 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 30-60 minutes before
bedtime.
One additional tablet can be taken earlier in the evening if necessary
As treatment effects may not be apparent immediately, Kalms Night
should be taken for 2 weeks continuously.
Duration of use:
If symptoms worsen or do not improve after 2 weeks, 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
Hypersensitivity to the active substances or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed 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 2 weeks of using the medicinal
product, a qualified healthcare professional e.g. a
doctor or pharmacist should be consulted.
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