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Relaxherb Passion Flower Tablets

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6. Further information

Each coated tablet of this product contains 425mg of extract (as dry extract aqueous ethanolic 50% v/v) from Passionflower (Passiflora incarnata L.) (equivalent to 2125-2975mg of Passionflower).

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

This leaflet was revised in 03/2014

certification mark


Patient Information Leaflet

Higher Nature Passionflower Relax Aid

Coated tablets Passionflower extract 425mg

Please read this leaflet carefully before you start taking these tablets.

It contains some important information about Higher Nature Passionflower 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 Passionflower. Each coated tablet of this product contains 425mg of extract (as dry extract aqueous ethanolic 50% v/v) from Passionflower (Passiflora incamata L.) (equivalent to 2125-2975mg of Passionflower).

Higher Nature Passionflower Relax Aid is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as mild anxiety. This usage is based on traditional use only.

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)

Tell your doctor before taking this product if you have an intolerance to some sugars (see section 6).

This product should not be taken in combination with synthetic sedatives (such as benzodiazepines).

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.

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 Passionflower. 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.

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.


You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am-2pm Monday - Friday).


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 the product in a cool dry place.

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.

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