BOOTS SLEEPEAZE HERBAL

Active substance: VALERIAN EXTRACT 4:1

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P13109

With extracts of Hop Strobile, Valerian, Passion Flower

Patient Information Leaflet

Read all of this leaflet carefully before you take
this product because it contains important
information you need to know.

FRONT FACE TOP

This product is available without prescription,
however, you still need to use this product
carefully to get the best results from it.
Keep this leaflet as you may need to read it again.
Ask your doctor, pharmacist or qualified
healthcare practitioner if you need more
information or advice.

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

This medicine contains extracts of:
• hop strobile
• valerian root
• passion flower herb
These tablets are a traditional herbal medicinal
product used for the temporary relief of sleep
disturbances based on traditional use only.

2. Is this product suitable for you?

Do not take this product if you are:
• allergic to any of the ingredients
(see section 6)
• under 18 years of age
• already taking a medicine for sleep or anxiety
Pregnancy and breast feeding
Do not take this product if you are pregnant or
breast feeding, because there is no evidence that
it is safe to do so.

The effects of this product may be increased by
alcohol. Excessive use of alcohol should
therefore be avoided.
Driving and using machinery
These tablets might cause drowsiness which can
persist into the following day. If affected do not
drive or operate machinery.
Each tablet contains glucose. If you
have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking
this medicine.

3. How to take this product

For oral use. Swallow the tablets whole with
water. Do not chew.
Adults and the elderly:
2 tablets, 1 hour before you go to bed.
Not recommended for use in children or
adolescents under 18 years old.
As the effects of this product may not occur
immediately, it should be taken continuously for 2
– 4 weeks. If symptoms worsen or persist after 4
weeks consult your doctor, pharmacist or
qualified healthcare practitioner.
Do not exceed the stated dose.
What to do if too many tablets are taken
If you take too many tablets by mistake, contact
your doctor or pharmacist straight away and take
this leaflet with you.
What to do if you miss a dose
If you miss a dose just take the next dose when it
is due. Do not take a double dose to make up for
the missed dose.

REVERSE FACE TOP

4. Possible side effects

Extraction solvent: Ethanol 70% (v/v)
30.8 mg of extract (as dry extract) from
Valerian root (Valeriana officinalis L.) (4:1)
Extraction solvent: Ethanol 60% (v/v)
15.2 mg of extract (as dry extract) of Passion
Flower herb (Passiflora incarnata L.)
(5-7:1) Extraction solvent: Ethanol 50% (v/v)
The other ingredients are:
Extract excipients: Maltodextrin, colloidal
anhydrous silica, liquid glucose.
Core excipients: Calcium hydrogen
phosphate, microcrystalline cellulose, stearic
acid, magnesium stearate.
Flim-coating: Polyethylene glycol 400,
Hypromellose 4500, hydroxypropylmethyl
cellulose, iron oxides (E172),
titanium dioxide (E171).
This product is available in a pack size of 30
tablets.
This product is a tan brown, circular biconvex,
film coated tablet
Is this leaflet hard to see or read?
Contact us on:
Telephone: +44 (0)1283 228300
Email: info@bruhealth.co.uk

5. How to store this product

THR Holder & Manufacturer is: Brunel
Healthcare Manufacturing Ltd., William Nadin
Way, Swadlincote, Derbyshire, DE11 0BB,
U.K.
The Distributor is Actavis UK Ltd, Barnstaple,
EX32 8NS, UK.
Text revised: January 2014
THR: 20894/0073

Like all medicines, this product can cause side
effects, although not everybody gets them.
The frequency of the side effects is not known.
The following side effects have been reported:
• Gastrointestinal symptoms such as nausea
(feeling sick) and stomach cramps have
been reported with Valerian root
preparations
Other side effects:
One case of hypersensitivity (vasculitis) and
one case of increased heartbeat (tachycardia)
have been reported in patients using Passion
Flower herb.
If you are concerned about any side effect, if a
side effect becomes serious or if you notice a
side effect not listed in this leaflet, please tell
your doctor or qualified healthcare practitioner.
You can help to make medicines safer by
reporting any side-effects to the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
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).
Keep all medicines out of the reach and
sight of children.
Do not use these tablets after the expiry date
printed on the pack.
Do not store above 25°C. Store in the original
package.

6. Further Information

Each film coated tablet contains the active
ingredients:
34 mg of extract (as dry extract) from Hop
strobile (Humulus lupulus L.) (4-6:1)

AAAF7508

colours/plates

Sominex Herbal 30pk
item no:

1. black
AAAF7508

print proof no: 4

dimensions:

140 x 150

pharmacode:

origination date: 16.08.13

3.
4.
5.

originated by:

LW

revision date:

11-02-14

revised by:

BW

Technical Approval
date sent:

supplier:

approved for print/date

2.

Brunel

technically app. date:

6.
Non Printing Colours
1. Profile

NB. The Actavis Global Artwork Studio accept no responsibility for the accuracy of pharma/laetus codes placed on behalf of suppliers/manufacturers.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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