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Tuesday 5 February 2013

RelaxHerb Coated Tablets


The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product RelaxHerb Coated Tablets (Traditional Herbal Registration number: 23056/0008). 

This product is available without prescription.

RelaxHerb coated Tablets are used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.  

The tablets’ active ingredient is dry extract from aerial parts of the passion flower, also known as Passiflora incarnata L.

One coated tablet contains 425mg of extract (as dry extract aqueous ethanolic 50% v/v) from Passion flower (Passiflora incarnata L.) (equivalent to 2125–2975mg of Passion flower).

Before you take this product

DO NOT TAKE this product if you are:

  • you are under 18 years of age
  • you are pregnant or breastfeeding
  • you are allergic to any of the ingredients (see Product description below)

Tell your doctor before using this product if you have an intolerance to some sugars (see product description below).
This product should not be taken in combination with synthetic sedatives (such as benzodiazepines).

Dosage

Adults and the elderly

Take 1 tablet daily. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.
Do not exceed the stated dose.

SIDE EFFECTS

Like all medicines, this product can have side-effects. These are listed below.

  • nausea or feeling sick
If these persist for more than a few days, or become troublesome, stop taking this product.
There has been one report of tachycardia (increased heart beat) and one report of hypersensitivity (vasculitis) in patients using Passion flower.
Tell your doctor or pharmacist if you notice any other side-effect not mentioned in this leaflet.
This product may cause drowsiness. If you are affected do not drive or operate machines.


PRODUCT DESCRIPTION

Each coated tablet of this product contains 425mg of extract (as dry extract aqueous ethanolic 50% v/v) from Passion flower (Passiflora incarnata L.) (equivalent to 2125-2975mg of Passion flower).
Tablet core: Maltodextrin, silica colloidal anhydrous, cellulose powdered, croscarmellose sodium, magnesium stearate, stearic acid, talc.
Coating: Sucrose, talc, calcium carbonate (E170), acacia, tragacanth, titanium dioxide (E171), liquid glucose spray dried, iron oxide hydrate (E172 = yellow iron oxide), hypromellose, Capol 600 T.S. containing: white beeswax, carnauba wax, shellac.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each coated tablet contains 187 mg of sucrose and 5mg of glucose. 
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