Kalms tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lupulus; Valerian root extract; Gentian

Available from:

G.R. Lane Health Products Ltd

ATC code:

n/a

INN (International Name):

Lupulus; Valerian root extract; Gentian

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09120000; GTIN: 5000477939082 5000477000201 5000477070501 5000477967092

Patient Information leaflet

FOR A LARGE PRINT, BRAILLE OR AUDIO VERSIONS OF
THIS LEAFLET PLEASE TELEPHONE: [phone].
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 them.
• 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
or
qualified
healthcare
practitioner if your symptoms worsen, or do not improve
after 4 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 are and what they are used for
2. Before you take Kalms Day
3. How to take Kalms Day
4. Possible side effects
5. How to store Kalms Day
6. Further information
5. HOW TO STORE KALMS DAY
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take Kalms Day after the expiry date which is stated
on the packaging. Do not store above 25ºC. Store in the
original package.
6. FURTHER INFORMATION
What Kalms Day contain:
The active substance per coated tablet is:
• 33.75mg of extract (as dry extract) from Valerian root
(_Valeriana officinalis_ L.) (equivalent to 135 to 167mg of
Valerian root) Extraction solvent: Ethanol 60%v/v
The other ingredients are:
• Extract: Maltodextrin, Colloidal Anhydrous Silica.
• Core:
Hops
Extract, Acacia
(Spray-dried),
Icing
Sugar,
Magnesium Stearate, Maize Starch, Colloidal Anhydrous
Silica, Sodium Starch Glycolate, Stearic Acid.
• Coating: Acacia (Spray-dried), Calcium Carbonate (Light),
Carnauba Wax, Mastercote White SP0950G, Talc, Sucrose,
Titanium Dioxide E171, Yellow Beeswax.
What Kalms Day look like and contents of the pack
Kalms Day are white, circular, sugar coated tablets. They
are available in amber glass bottles containing 100 or 200
tablets. Kalms Day are also available in blister packs containing
84 tablets. Not all pack sizes may be marketed.
Tradit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kalms Day
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
33.75 mg of extract (as dry extract) from Valerian root (_Valeriana
officinalis_
L.) (equivalent to 135 to 167mg of Valerian root)
Extraction solvent: Ethanol 60%v/v
Each coated tablet contains 271 mg sucrose. (See Section 4.4.
‘Special
warnings and precautions for use’.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sugar coated tablet
White, circular, biconvex sugar 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: Two tablets 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.
A