Kalms Sleep
PACKAGE LEAFLET
Kalms Sleep tablets
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescripti on. However you still need to take Kalms Sleep tablets 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 if your symptoms worsen or do not improve after 4 weeks.
• If any of the side effects become serious, or if you notice any si de effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Kalms Sleep tablets are and what they are used for
2. Before you take Kalms Sleep tablets
3. How to take Kalms Sleep tablets
4. Possible side effects
5. How to store Kalms Sleep tablets
6. Further information
1. What Kalms Sleep is and what it is used for
Kalms Sleep contains a combination of herbs. It is a traditional herbal
medicinal product used for the temporary relief of sleep disturbances, based on traditional use
only..
2. Before you take Kalms Sleep tablets Do not take Kalms Sleep if you:
• are allergic to any of the ingredients (see Section 6 for a complete list of ingredients).
• are pregnant or breast feeding
• are under 18
• are already taking a medicine for sleep and anxiety Taking other medicines
Please tell your doctor or pharm acist if you are taking or have recently taken any other medicines, including:
• medicines obtained without a prescription.
Important information about some if the ingredients:
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this product.
Driving and using machines: If you feel sleepy, do not drive or operate machines.
Additional information: The effects of this medicine may be increased by alcohol.
Therefore alcohol should be avoided whist taking this medicine.
3. How to take Kalms Sleep tablets
For the temporary relief of sleep disturbances
Adults and the elderly : Take 3 to 4 tablets 60 minutes before bedtime.
The tablets should be swallowed whole with some water or other liquid.
The use in children and adolescents under 18 years of age is not recommended
As the effects of this product may not occur immediately, the tablets should be taken continuously for 2-4 weeks.
If symptoms worsen or do not improve after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.
If you take more Kalms Sleep tablets than you should
If you take too many tablets, consult your doctor or qualified healthcare practitioner as soon as possible. Take this leaflet to show them.
If you forget to take Kalms Sleep tablets
Do not take a double dose to make up for a missed dose.
If you are unsure about anything, consult your doctor or qualified healthcare practitioner for advice.
4. Possible side effects
Like all m edicines, Kalms Sleep tablets can cause side effects, although not everybody gets them.
Gastrointestinal effects such as nausea, stomach cramps have been reported with Valerian root preparations. The frequency is not known.
One case of hypersensitivity (v asculitis) and one case of increas ed heart beat (tach ycardia) have been reported in patients using Passion flower herb. The frequency is not known.
If any of the side effects becom e serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
You can help 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 GP's surgery or pharmacy or call freephone 0808 100 3352
5. How to store Kalms Sleep tablets
Keep out of the reach and sight of children.
Do not tak e these tablets after the expiry date which is stated on the outer carton and container.
Do not store above 25°C.
Store in the original package.
6. Further Information
What Kalms Sleep tablets contains
The active substance per tablet is:
Verbena Herb (Verbena officinalis L.)..............................................................................60mg
Hop strobiles (Humulus lupulus L.)..................................................................................30mg
Dry extract from Passion Flower herb (Passiflora incarnata L.)
(equivalent to 90 mg of Passion Flower herb).
Extraction solvent: Ethanol 60% v/v............................................................................. 16.82mg
Dry extract from Wild Lettuce (Lactuca virosa L.)
(equivalent to 29 mg of Wild Lettuce leaf)
Extraction solvent: Water...............................................................................................22.5mg
Dry extract from Valerian root (Valeriana officinalis L.)
(equivalent to 139 to 173 mg of Valerian root)
Extraction solvent: Ethanol 60%V/V........................................................................... 34.65mg
The other ingredients are:
Extract: Maltodextrin, Colloidal anhydrous silica, Cellulose, Gum Arabic.
Core: Acacia, Calcium Hydrogen Phosphate, Croscarmellose Sodium, Icing Sugar, Magnesium Stearate, Stearic Acid
Coating: Acacia, Calcium Carbonate (Light), Mastercote Grey SP0933, Opaglos 6000 Talc, Shellac Varnish, Sucrose, Titanium Dioxide
What Kalms Sleep tablets looks like and contents of the pack
Kalms Sleep tablets are dark grey round sugar co ated tablets. They are available in am ber glass bottles containing 50 or 84 tablets.
Certification Mark
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: info@laneshealth.com
This leaflet was last revised 03 /2013
For a large print, Braille or audio versions of this leaflet please telephone: 01452 524012.