Nytol Herbal tablet

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Passion flower extract; Wild lettuce dry extract; Jamaica dogwood powder; Lupulus; Pulsatilla dry extract

Available from:

Haleon UK Ltd

ATC code:

n/a

INN (International Name):

Passion flower extract; Wild lettuce dry extract; Jamaica dogwood powder; Lupulus; Pulsatilla dry extract

Dosage:

36mg ; 54mg ; 90mg ; 30mg ; 15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

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
One-A-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 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 Night One-A-Night is and what it is
used for
2. Before you take Kalms Night One-A-Night
3. How to take Kalms Night One-A-Night
4. Possible side effects
5. How to store Kalms Night One-A-Night
6. Further information
5. HOW TO STORE KALMS NIGHT ONE-A-NIGHT
Keep out of the sight and reach of children.
Do not take Kalms Night One-A-Night after the
expiry date which is stated on the packaging.
Do not store above 25ºC.
Do not use if foil strip is damaged.
Store in the original package.
6. FURTHER INFORMATION
What Kalms Night One-A-Night contains
The active substance per tablet is:
Dry extract from Valerian root ...............................385 mg
(_Valeriana officinalis_ L.) (equivalent to 1.54-1.93g 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, Saccharine Sodium.
What Kalms Night One-A-Night looks like and contents
of the pack
Kalms Night One-A-Night tablets are 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: +4

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kalms Night One-A-Night
Nytol Herbal Simply Sleep One-A-Night Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 385 mg of extract (as dry extract) from
_Valeriana officinalis_
L., radix (equivalent to 1.54 – 1.93 g 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
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the temporary relief
of sleep
disturbances, based on traditional use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Adults and the elderly: One tablet to be taken 30-60 minutes before
bedtime.
One additional tablet can be taken earlier during the evening if
necessary.
As treatment effects may not be apparent immediately, Kalms Night
One-a-Night
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 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 worsen, or do not improve after 4 weeks, 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
c