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SUPERDRUG BECALM TABLETS

Active substance(s): HOPS EXTRACT POWDER / PASSIFLORA DRY EXTRACT / VALERIAN EXTRACT 4:1 / DRY EXTRACT OF HOPS STROBILES / PASSIFLORA DRY EXTRACT / VALERIAN EXTRACT 4:1 / DRY EXTRACT OF HOPS STROBILES / PASSIFLORA DRY EXTRACT / VALERIAN EXTRACT 4:1

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P CODE:
VERSION:
CUSTOMER:
PRODUCT:
PL or THR No.:
PHARMACODE:
SIZE:

Brunel Healthcare Manufacturing Ltd, William Nadin Way
Swadlincote, Derbyshire, DE11 0BB
Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228328

P17857
BRU001
Generic
Stress Relief Tablet Leaflet
THR 20894/0074

460
140mm x 150mm
(fold to 39x140mm with minimum 2mm lip size)

DATE: 25/08/2016
PRINTER:
PAGE: 1 of 2

140mm

P17857

Stress Relief Tablet
Extracts of Hop Strobile, Valerian, Passion Flower

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.
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

150mm

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 product used
for temporary relief of symptoms associated
with stress, such as mild anxiety based on
traditional use only.

2. Before you take this product
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

COLOUR LIST:

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.

3. How to take this product

Direction of Travel

Patient Information Leaflet
Read all of this leaflet carefully before
you take this product because it contains
important information you need to know.
This product is available without prescription;
however, you still need to use this product
carefully to get the best results from it.

1st bar

last bar

For oral use. Swallow the tablet whole with
water. Do not chew.
Adults and the elderly: 1 tablet, 3 times a day.
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 take more medicine than the leaflet
tells you too.
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.

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minimum Font size used
Helvetica - used: 7.8pt - x (1.438mm high)

Please check this proof on size, claims, text & spelling, layout,
design issue, positioning & colour. Please check BBE/BN/EXP
positioning, Component code, Barcode number & that Barcode
scans correct number.
Please mark clear necessary amends, modification needed.
Brunel Healthcare Manufacturing Ltd cannot be held
responsible for errors that have been overlooked once
this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS
ORIGINATION SOFTWARE: CORELDRAW X4

P CODE:
VERSION:
CUSTOMER:
PRODUCT:
PL or THR No.:
PHARMACODE:
SIZE:

Brunel Healthcare Manufacturing Ltd, William Nadin Way
Swadlincote, Derbyshire, DE11 0BB
Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228328

P17857
BRU001
Generic
Stress Relief Tablet Leaflet
THR 20894/0074

460
140mm x 150mm
(fold to 39x140mm with minimum 2mm lip size)

DATE: 25/08/2016
PRINTER:
PAGE: 2 of 2

140mm

4. Possible side effects

6. Further Information

Like all medicines, this product can
cause side effects, although not
everybody gets them.

Each film coated tablet contains
the active ingredients:
34 mg of extract (as dry extract) from
Hop strobile (Humulus lupulus L.) (4-6:1)
Extraction solvent: Methanol 30% (v/v)
30.8 mg of extract (as dry extract) from
Valerian root (Valeriana officinalis L.) (4:1)
Extraction solvent: Ethanol 60% (v/v)
18.2 mg of extract (as dry extract) of
Passion Flower herb (Passiflora incarnata L.)
(3-7:1) Extraction solvent: Ethanol 70% (v/v)

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.

150mm

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.

5. How to store this product
Keep out of sight and reach
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.

COLOUR LIST:

The other ingredients are:
Extract excipients: Maltodextrin,
colloidal anhydrous silica.
Core excipients: Calcium hydrogen phosphate,
microcrystalline cellulose, stearic acid,
magnesium stearate.
Film-coating: Polyethylene glycol 400,
hypromellose 4500, hydroxypropylmethyl
cellulose, iron oxides (E172), titanium
dioxide (E171).
This product is available in pack sizes
of 24, 30, 48, 60 and 120 tablets.
Not all pack sizes are marketed.
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
THR Holder & Manufacturer is:
Brunel Healthcare Manufacturing Ltd.,
William Nadin Way, Swadlincote, Derbyshire,
DE11 0BB, U.K.
Text revised: September 2016
THR: 20894/0074
Certification Mark

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FONT Information
Times New Roman font - size used: 7pt - x (1.105mm high)

minimum Font size used
Helvetica - used: 7.8pt - x (1.438mm high)

SUBSTRATE
PRODUCT COLOUR

Please check this proof on size, claims, text & spelling, layout,
design issue, positioning & colour. Please check BBE/BN/EXP
positioning, Component code, Barcode number & that Barcode
scans correct number.
Please mark clear necessary amends, modification needed.
Brunel Healthcare Manufacturing Ltd cannot be held
responsible for errors that have been overlooked once
this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS
ORIGINATION SOFTWARE: CORELDRAW X4

Expand Transcript

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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