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KALMS NIGHT

Active substance(s): VALERIAN ROOT DRY EXTRACT

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5. How to store Kalms Night One-A-Night
Keep out of the reach and sight 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: +44 (0)1452 524012
Email: kalmsnight@laneshealth.com Certification Mark
This leaflet was last revised 09/2012 613026
613026 Kalms Night One-A-Night PIL V5.indd 1-2

Night
Valerian Root Extract 385 mg
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

21/09/2012 11:49

Job Name:
Description: xxxx
Date: 19/9/12
Amends author:
Brief Description:
Size: 163 x 140mm
Colours:
Pantone 2593

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1. What Kalms Night One-A-Night is and
what it is used for
Kalms Night One-A-Night is a traditional herbal
medicinal product containing valerian root, used for
the temporary relief of sleep disturbances, based on
traditional use only.
2. Before you take Kalms Night One-A-Night
Do not take Kalms Night One-A-Night if you:
• are allergic to any of the ingredients (see Section 6
for a complete list of ingredients).
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including:
• medicines which make you drowsy
• medicines obtained without a prescription.
Taking Kalms Night One-A-Night with food and drink
Alcohol may increase the sedative effect of
Kalms Night One-A-Night. Therefore, excessive alcohol
consumption should be avoided whilst you are taking
Kalms Night One-A-Night.
Pregnancy and breast-feeding
Kalms Night One-A-Night is not recommended for
use during pregnancy or when breast-feeding. Ask
your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Kalms Night One-A-Night is used traditionally to
help you sleep. This could affect your ability to drive or
operate machinery. If affected:
• do not drive because Kalms Night One-A-Night
could stop you driving safely
• do not operate any tools or machinery.

613026 Kalms Night One-A-Night PIL V5.indd 3-4

3. How to take Kalms Night One-A-Night
The recommended dose is one tablet 30 to 60 minutes
before bedtime. If necessary, on subsequent evenings,
swallow 1 additional tablet earlier during the evening.
Not recommended for anyone under 18 years old.
As the effects of this product may not occur immediately,
the tablets should be taken continuously for 2-4 weeks.
If you take more Kalms Night One-A-Night than
you should
Seek medical advice in the event of an overdose.
If you forget to take Kalms Night One-A-Night
Do not take a double dose to make up for a
missed dose.
4. Possible side effects
Like all medicines, Kalms Night One-A-Night can cause
side effects, although not everybody gets them.
Tell your doctor if you notice any of the following mild
side effects:
• nausea
• abdominal cramps.
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.
You can help to make medicines safer by reporting
any side-effects to the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. Alternatively you can
get a paper Yellow Card form from your surgery or
pharmacy, or call freephone 0808 100 3352 (available
10am-2pm Monday – Friday)

21/09/2012 11:49

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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