Nytol Herbal Simply Sleep One-A-Night Tablets
rHR‘
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 25°C.
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 61 3026
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.
• 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 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
613026 Kalms Night One-A-Night PIL V5.indd 1-2
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 I additional tablet earlier during the evening.
Not recommended for anyone under I 8 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 I0am-2pm Monday - Friday)
21/09/2012 11:49