Kalms Day
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
Date: 23/2/11
Colours:
Pantone 2748 Pantone2905 Pantone 285
Valerian Root Extract Hops Extract
Read all of this leaflet carefully because it contains important information for you.
Job Name: Kalms Day PIL 613019 F3
Description: xxxx
Amends* author: SB MHRA amends
Brief Description: New size (47 x 176)
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 m ust contact a doctor if your sym ptoms worsen or do not im prove 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: C rosea rm el lose 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% WV
Dry Extract from Hop strobile.........................................9mg
(.Humulus lupulus L.) (equivalent to 81 to 99mg of Hop strobile), Extraction solvent: Ethanol 45% WV
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 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 25°C.
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,
074/0027 ition Mark
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 201 1 THR 01
Certifica
613U23
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.
• I f 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
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
23/02/2011 16:42
613023 Kalms Day PIL V5.indd 1-2
I .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 fora 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 foruse 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 PILV5.indd 3-4
3. How to take Kalms Day
Swallow I tablet three times a day.
Not recommended for anyone under 18 years old.
As the effects ofthis 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 25°C.
Do not use if cap seal is broken or foil strip is damaged. Store in the original package.
23/02/2011 16:42