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Relaxherb Passion Flower Tablets

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Document: leaflet HOLLAND & BARRETT_THR 23056-0008 change

LEAFLET SPEC


PATIENT INFORMATION LEAFLET


HOLLAND fr BARRETT

PASSION FLOWER STRESS RELIEF TABLETS Passion flower extract 425mg


Important notes

U Please read this leaflet carefully before you start taking these tablets; It contains some important information about Holland & Barrett Passion Flower Stress Relief tablets.

U Keep this leaflet with the tablets; you may want to read it again or show it to your doctor; pharmacist or qualified healthcare practitioner.


Taking this product with other medicines

Tell your doctor or pharmacist about any medicines you are taking including any bought without a prescription.

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.


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.


What is in this leaflet

1    What this product is and what it is used for

2    Before you take this product

3    How to take this product

4    Possible side effects

5    How to store this product

6    Further information


1 - What this product is and what it is used for

This product is a traditional herbal medicinal product containing Passion flower: It 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.


3 - How to 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:


5 - How to store this product

U Do not use your tablets after the expiry date

U 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

U Do not store above 30°C. Store in original package.

U Keep the tablets out of the reach and sight of children

U Keep your tablets in the blister pack until it is time to take them


2 - Before you take this product

Do not take this product if you are:

U Under 18 years of age U Pregnant or breastfeeding U Allergic to any of the ingredients (see section 6)

U Taking any other medicines 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).

Driving and using machines

This product may cause drowsiness. If you are affected do not drive or operate machines.


4 - Possible side-effects

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

U Nausea or feeling sick If these persist for more than a few days, or become troublesome, stop taking this product.

Other Side-Effects

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.


6 - Further information

Each coated tablet of this product contains 425mg of extract (as dry extract) from Passion flower (Passifora incarnate L.) (equivalent to 2l25-2975mg 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 (El70), acacia, tragacanth, titanium dioxide (El7l), liquid glucose spray dried, iron oxide hydrate (El72 = 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 l87 mg of sucrose and 5 mg 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 lFX

Manufactured for:

Holland & Barrett International Limited by: 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:

Holland & Barrett International Limited Regulatory Services Department Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVl0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 2l5 400 Fax: +44 (0) 2476 2l5 452 Email:

customerservices@hollandandbarrett.com This leaflet was prepared on: 08/07/20l6


HB35296 PASSION FLOWER LEAFLET

LEAFLET SIZE:

140mm x 180mm (flat)

45mm x 140mm (folded)

BLEED: N/A BULK: N/A ISSUE: 00A BARCODE: N/A

CHANGES FROM LAST PRINT: None

COLOURS:

K

P364

FONTS:

Gil Sans

Times New Roman FINISH:

LPI:

SCREEN ANGLES:

CAUTION: It is the vendors responsibility to print a scannable UPC code from either our artwork or your alternative UPC method

COLOUR MATCH: sample provided



THR"


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