Relaxherb Passion Flower Tablets
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 187mg of sucrose and 5mg of glucose.
Each pack contains 30 coated tablets.
Registration holder for this product
Schwabe Pharma (UK) Ltd Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1FX
Manufacturer of this product
Wiewelhove GmbH
Gildestrasse 39, 49477 Ibbenburen, Germany
Traditional herbal registration number:
THR 23056/0008
If you would like further information about this product, please contact:
Higher Nature
Burwash Common
East Sussex, TN19 7LX
Telephone: 0870 0664478
Email: nutrition@higher-nature.co.uk
THR 23056/0008
certification mark
This leaflet was prepared in 07/2016
104
4
Patient Information Leaflet
Higher Nature Passion Flower Relax Aid
Coated tablets
Passion Flower extract 425mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about Higher Nature Passion Flower Relax Aid.
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
2: Before you take this product............................page 2
3: How to take this product...............................page 2
4: Possible side-effects..................................page 3
5: How to store this product...............................page 3
6: Further information...................................page 4
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 incamata L.) (equivalent to 2125-2975mg of Passion Flower).
Higher Nature Passion Flower Relax Aid 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.
1
15/07/2016 11:17:30
2. Before you take this product
DO NOT TAKE this product if you are:
• under 18 years of age
• pregnant or breastfeeding
• allergic to any of the ingredients (see section 6)
• taking any other medications for anxiety, or to help you sleep such as benzodiazepines
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.
Driving and using machines.
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.
3. Howto take this product
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
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.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
2
4. Possible side-effects
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.
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.
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.
5. Howto store this product
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 30°C.
Keep your tablets out of the reach and sight of children.
Keep your tablets in the blister pack until it is time to take them.
3
15/07/2016 11:18:46