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KALMS DAY

Active substance(s): HOPS EXTRACT POWDER / VALERIAN ROOT DRY EXTRACT

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Job Name: Kalms Day PIL 613019 F3
Description: xxxx
Date: 23/2/11
19768-02

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: kalmsday@laneshealth.com
This leaflet was last approved February 2011

613019

THR 01074/0027
Certification Mark

Amends5.8.2009
author: SB MHRA amends

Day

Valerian Root Extract
Hops Extract

Read all of this leaflet carefully because it contains
important information for you.

Lanes
Kalms Pocket Pack
PIL

Brief Description: New size (47 x 176)
Colours:
Pantone 2748
Pantone4
2905
Pantone 285

As Cutter Guide

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 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.

The other ingredients are:
Extract Excipients: Colloidal Anhydrous Silica, Maltodextrin.
Core: Croscarmellose Sodium, Magnesium Stearate,
Microcrystalline Cellulose, Pregelatinised Starch, Stearic
Acid, Silicon Dioxide.
Coating: Polyvinyl Alcohol part hydrolysed, Titanium
Dioxide, Polyethylene Glycol 3350, Talc.
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.

6. Further Information
What Kalms Day contains
The active substances per tablet are:
Dry Extract from Valerian root....................................... 52mg
(Valeriana officinalis L.) (equivalent to 208 to 260mg of Valerian
root), Extraction solvent: Ethanol 60% V/V

Dry Extract from Hop strobile.......................................... 9mg
(Humulus lupulus L.) (equivalent to 81 to 99mg of Hop strobile),
Extraction solvent: Ethanol 45% V/V

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 effects
5. How to store Kalms Day
6. Further information
For a large print, Braille or audio version of this leaflet
please telephone: 01452 524012.

1. What Kalms Day is and what it is used for
Kalms Day is a traditional herbal medicinal product used
for the temporary relief of symptoms associated with
stress such as mild anxiety, based on traditional use only.
Kalms Day contains extracts of valerian root and hop
strobile.
2. Before you take Kalms Day
Do not take Kalms Day if you:
• are allergic to any of the ingredients
(see section 6 for a complete list of ingredients).

5. How to store Kalms Day
Keep out of the reach and sight of children.
Do not take Kalms Day 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.

4. Possible side effects
Like all medicines, Kalms Day can cause side effects,
although not everybody gets them.
Tell your doctor if you notice mild side effects such as
nausea or 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.yellowcard.gov.
uk; or get a Yellow Card form from your GP’s surgery or
pharmacy, or call freephone 0808 100 3352
(available 10am-2pm Monday – Friday).

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 Day with food and drink
Alcohol may increase the sedative effect of Kalms Day.
Therefore, excessive alcohol consumption should be
avoided whilst you are taking Kalms Day.

Pregnancy and breast-feeding
Kalms Day 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 Day may make you feel sleepy. If affected:
• 
do not drive because Kalms Day could stop you
driving safely
• do not operate any tools or machinery.

3. How to take Kalms Day
Swallow 1 tablet three times a day.
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 Day than you should
Seek medical advice in the event of an overdose.
If you forget to take Kalms Day
Do not take a double dose to make up for a
missed dose.

6. Further Information
What Kalms Day contains
The active substances per tablet are:
Dry extract from Valerian root . ............................... 52mg
(Valeriana officinalis L.) (equivalent to 208 to 260mg
of Valerian root),
Extraction solvent: Ethanol 60% v/v;
Excipients: Maltodextrin, Colloidal Anhydrous Silica
Dry extract from Hop strobile.....................................9mg
(Humulus Lupulus L.) (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: Polyvinyl Alcohol part hydrolysed, Titanium
Dioxide, Polyethylene Glycol 3350, Talc.
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: +44 (0)1452 524012
Email: kalmsday@laneshealth.com
This leaflet was last approved February 2011
THR 01074/0027
Certification Mark

613023
613023 Kalms Day PIL V5.indd 1-2

Valerian Root Extract • Hops Extract
For a large print, Braille or audio version of this leaflet
please telephone: 01452 524012.
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 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 is and what it is 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
23/02/2011 16:42

Job Name: 613023 Kalms Day PIL V5
Description: xxxx
Date: 23/2/11
Amends author: SB
Brief Description: MHRA text amends

Size: 163 x 140mm
Colours:
Pantone 2748

Black

1. What Kalms Day is and what it is used for
Kalms Day is a traditional herbal medicinal product
used for the temporary relief of symptoms associated
with stress such as mild anxiety, based on traditional
use only.
Kalms Day contains extracts of valerian root and
hop strobile.
2. Before you take Kalms Day
Do not take Kalms Day 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 Day with food and drink
Alcohol may increase the sedative effect of Kalms Day.
Therefore, excessive alcohol consumption should be
avoided whilst you are taking Kalms Day.
Pregnancy and breast-feeding
Kalms Day 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 Day may make you feel sleepy. If affected:
• do not drive because Kalms Day could stop you
driving safely
• do not operate any tools or machinery.

613023 Kalms Day PIL V5.indd 3-4

3. How to take Kalms Day
Swallow 1 tablet three times a day.
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 Day than you should
Seek medical advice in the event of an overdose.
If you forget to take Kalms Day
Do not take a double dose to make up for a
missed dose.
4. Possible side effects
Like all medicines, Kalms Day can cause side effects,
although not everybody gets them.
Tell your doctor if you notice mild side effects such as
nausea or 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.
yellowcard.gov.uk; or get a Yellow Card form from
your GP's surgery or pharmacy, or call freephone
0808 100 3352 (available 10am-2pm Monday – Friday).
5. How to store Kalms Day
Keep out of the reach and sight of children.
Do not take Kalms Day after the expiry date
which is stated on the packaging.
Do not store above 25ºC.
Do not use if cap seal is broken or foil strip is damaged.
Store in the original package.

23/02/2011 16:42

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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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