Relaxherb Passion Flower Tablets
RelaxHerb PIL 07-2016 (6011-01) 11/07/2016 11:28 Page 1
6: Further information
Each coated tablet of this product contains 425mg of extract (as dry extract) from Passion flower (Passiflora incarnata L.) (equivalent to 2125-2975mg of Passion flower). The extraction solvent is ethanol 50% v/v.
This product also contains the following ingredients:
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 5 mg of glucose.
Each pack contains 14 or 30 coated tablets.
Not all pack sizes may be marketed.
Registration holder for this product
Schwabe Pharma (UK) Ltd
Alexander Elouse, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX
Manufacturer of this product
Wiewelhove GmbH,
Gildestrasse 39, 49477 Ibbenbiiren, Germany Traditional herbal registration number:
THR 23056/0008
If you would like further information about this product, please contact: Schwabe Pharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX Telephone: 01628 401980 Email: info@schwabepharma.co.uk Leaflet last revised 07/2016.
For a large print, Braille or audio version of this leaflet, call 01628 401980
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Patient Information Leaflet
s
RelaxHerb® Passion Flower
Tablets
Passion flower extract 425mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about RelaxHerb Passion Flower tablets.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.
1: What this product is and what it is used for..............................................page 1
1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing Passion flower. Each coated tablet of this product contains 425mg of extract (as dry extract) from Passion flower (Passiflora incarnata L.) (equivalent to 2125-2975mg of Passion flower).
RelaxHerb Passion Flower 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.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
DO NOT TAKE this product if you are:
• under 18 years of age
• pregnant or breast-feeding
• taking any other medicines for anxiety, or to help you sleep such as benzodiazepines
• allergic to any of the ingredients (see section 6)
Tell your doctor before taking this product if you have an intolerance to some sugars (see section 6).
Taking this product with other medicines
Tell your doctor or pharmacist about any medicines you are taking including any bought without a prescription.
Like all medicines, this product can have side-effects. These are listed below.
Side-effects
• nausea or feeling sick
If these persist for more than a few days, or become troublesome, stop taking this product.
Other side-effects
Driving and using machine
This product may cause drowsiness. If you are affected do not drive or operate machines.
You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if side-effects not mentioned in this leaflet occur.
Adults and the elderly
Take 1 tablet daily if required. Swallow the tablet whole with a little liquid. Do not chew the tablet.
Do not exceed the stated dose.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side-effects not listed in this leaflet.
You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.
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5: How to store this product | |
If you take too much of this product (overdose)
If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.
If you forget to take this product
Continue to take your usual dose at the usual time; it does not matter if you have missed a dose.
Do not use your tablets after the expiry date.
Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.
Store in the original packaging.
Do not store the tablets in a place where the temperature goes above 30oC. Keep the tablets out of the reach and sight of children.
Keep your tablets in the blister pack until it is time to take them.