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Gerard House Somnus Sleep Aid

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Document: document 6 change

Herbal TABLETS

With extracts of Hop Strobile, Valerian and Passion Flower


Read all of this leaflet carefi contains important informal

This product is available withou this product carefully to get th Keep this leaflet as you may n Ask your doctor, pharmacist o more information or advice

In this leaflet:

1.    What this product is and wh

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.


ully before you take this produc ion you need to know.

it prescription; however, you still n< e best results from it. eed to read it again. qualified healthcare practitioner if


at it is used for.


2. Before

Q Doo


you take this product

ot take this product if you


are:


•    allergic to any

•    under 18 year:

•    already taking


of the ingredients (see section 6) of age

a medicine for sleep or anxiety


:t because it

eed to use


you need


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

This medicine contains extracts of:

   hop strobile

   valerian root

   passion flower herb.


A traditional herbal medicinal disturbances based on tradition


product used for the temporary rel al use only.


ef of sleep


Pregnancy and breast feeding


Do not take

because there The effects of alcohol should


is product if you are pregnant or bre s no evidence that it is safe to do so this product may be increased by alco therefore be avoided.


th


ast feeding,

hol. Excessive use of


Driving and using machinery


   These tablets might day. If affectec

•    Each tablet cc i

you have an in this medicine

3. How to


cause drowsiness which can persist into the following do not drive or operate machinery, ntains glucose. If you have been to d by your doctor that tolerance to some sugars, contact your doctor before taking


For ora Swallow Do not


take this product

use.

w the tablets whole with water. chew.


Adults and the elderly: 2 tablets 1 hour be Not recommended for use in children or years old.


fore you go to bed. adolescents under 18


P13112


O)



As the effects of this product continuously for 2 - 4 weeks. consult your doctor, pharmaci

Do not exceed the stated dose.

)lets are taken

by mistake, contact your doctor or p flet with you


may not occur immediately, it should be taken If symptoms worsen or persist after 4 weeks or qualified healthcare practitioner.


ist


What to do if too many tabl

If you take too many tablets straight away and take this


leafl


4. Possible side e

Like all medicines, this product gets them. The frequency of The following side effects have • Gastrointestinal symptoms si have been reported with Val

Other side effects:

One case of hypersensitivity (va (tachycardia) have been repori

If you are concerned about an if you notice a side effect not qualified healthcare practitione

You can help to make medicinr Yellow Card Scheme at ww can get a paper Yellow Card f freephone 0808 100 3352 (avai


ffects

can cause side effects, although n e side effects is not known. been reported: uch as nausea (feeling sick) and sto lerian root preparations.


harmacist

ot everybody mach cramps


sculitis) and one case of increased heartbeat in patients using Passion Flower herb.

side effect, if a side effect become listed in this leaflet, please tell your


ted


s serious or doctor or


es safer by reporting any side-effects to the .mhra.gov.uk/yellowcard. Alternatively you rm from your GP's surgery or pharmacy or call lable 10am-2pm Monday - Friday).


th


5. How to store

Keep out of the reach and

Do not use these tablets after Do not store above 25°C. Stor


is product

sight of children.

the expiry date printed on the pack in the original package.


6. Further

Each film coated

34 mg of extract


information


tablet contains the active ingredi

(as dry extract) from Hop strobile (Hu Extraction solvent: Ethanol 70% (v/v),


ents:

umulus lupulus L.) (4-6:1).


30.8 mg of extract Extraction solvent: 15.2 mg of extract

(5-7:1).

Extraction solvent:


(as dry extract) from Valerian root (Va. Ethanol 60% (v/v),

(as dry extract) of Passion Flower her


leriana officinalis L.) (4:1). b (Passiflora incarnata L.)


Ethanol 50% (v/v)

The other ingredients are:

Extract excipients: Maltodextrin, colloidal anhydrous Core excipients Calcium hydrogen phosphate, micro stearic acid, magnesium stearate.

Film-coating: Polyethylene glycol 400, hypromellose hydroxypropylmethyl cellulose, iron oxides (E172), tita

This product is available in pack sizes of 6, 30, 50, 60. all pack sizes are marketed. This product is a tan brow coated tablet.


silica, liquid glucose. crystalline cellulose,

4500,

inium dioxide (E171).

90 and 120 tablets. Not n, circular biconvex, film


Is this leaflet

Contact us on: Telephone: +44 Email: info@bruh


hard to see or read?


(0)1283 228300 ealth.co.uk


THR Holder & M

William Nadin

Text revised: Ju THR: 20894/007


Wa


lanufacturer is: Brunel Healthcare iy, Swadlincote, Derbyshire, DE11 0E

y 2013.


Manufacturing Ltd., B, U.K.


THR


P13112

L636004/06