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Saturday, 16 February 2013

Kalms Night Sleeping Tablets


The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product Kalms Night Tablets (Traditional Herbal Registration number: 01074/0002). 

This product is available without prescription.

Kalms Night Tablets are used for the temporary relief sleep disturbances, based on traditional use only.

The tablets’ active ingredient comes from the roots of the valerian plant, which is also known as Valeriana officinalis L.. 


Before you take this product

Do NOT take this product if:
  • you are under 18 years of age
  • you are allergic to any of the ingredients (see Product description below)
Taking other medicines
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 With Food and Drink
Alcohol may increase the sedative effects of Kalms Night. Therefore, excessive alcohol consumption should be avoided whilst you are taking Kalms Night.

Pregnancy and breast-feeding
Kalms Night is not recommended for use during pregnancy or when breast-feeding.Ask your  doctor or your pharmacist for advice before taking any medicine.

Driving and using machines
Kalms Night may make you feel sleepy. If affected:
  • do not drive because Kalms Night could stop you driving safely
  • do not operate any tools or machinery.


      Dosage

      Swallow 1 tablet 30 to 60 minutes before bedtime. If necessary, on subsequent evenings, swallow 1 additional tablet earlier during the evening.  

      As the effect of this product may not occur immediately, the tablets should be taken continuously for 2-4 weeks.

      Side effects

      Like all medicines, Kalm Nights 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
      • digestive upsets such as wind, bloating or diarrhoea
      • headache
      If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


      Product Description

      Each tablet contains dry extract from Valerian root  500mg (Valeriana officinalis L.) (equivalent to 1.5-2.5g of Valerian root).

      Extraction solvent: Ethanol 60% v/v 

      This product also contains the following ingredients:
      Tablet core: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose, talc and silicone dioxide. 
      Film-coating: Polyvinyl alcohol part hydrolysed, titanium dioxide, polyethylene glycol 3350, talc. 

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