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VALERINA NIGHT-TIME FILM-COATED TABLETS

Active substance(s): DRY EXTRACT OF HOPS STROBILES / LEMON BALM DRY EXTRACT / VALERIAN ROOT DRY EXTRACT / DRY EXTRACT OF HOPS STROBILES / LEMON BALM DRY EXTRACT / VALERIAN ROOT DRY EXTRACT / DRY EXTRACT OF HOPS STROBILES / LEMON BALM DRY EXTRACT / VALERIAN ROOT DRY EXTRACT

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Package
Packageleaflet:
leaflet:
Information
Informationfor
forthe
theuser
user

Valerina
ValerinaNight-Time
Night-Time
film-coated
film-coatedtablets
tablets

Extracts
Extractsofofvalerian
valerianroot,
root,hops
hopsstrobile
strobileand
and
lemon
lemonbalm
balmleaf.
leaf.

Read
Readall
allofofthis
thisleaflet
leafletcarefully
carefully
because
becauseit itcontains
containsimportant
important
information
informationfor
foryou.
you.

The
Thedose
doseforforthis
thismedicine
medicinehas
haschanged
changed– –
please
pleasesee
seesection
section3 3forfordetails.
details.This
Thismedimedicine
cineis isavailable
availablewithout
withoutprescription.
prescription.
However,
However,you
youstill
stillneed
needtototake
takeValerina
Valerina
Night-Time
Night-Timecarefully
carefullytotoget
getthethebest
bestresults
results
from
fromit.it.
• •Keep
Keepthis
thisleaflet.
leaflet.You
Youmay
mayneed
needtotoread
read
it itagain.
again.
• •Ask
Askyour
yourpharmacist
pharmacistif ifyou
youneed
needmore
more
information
informationororadvice.
advice.
• •You
Youmust
mustcontact
contacta adoctor
doctorororqualified
qualified
healthcare
healthcarepractitioner
practitionerif ifyour
yoursymptoms
symptoms
worsen
worsenorordodonot
notimprove
improveafter
after4 4weeks.
weeks.
• •If Ifany
anyofofthetheside
sideeffects
effectsgets
getsserious,
serious,oror
if ifyou
younotice
noticeany
anyside
sideeffects
effectsnot
notlisted
listedinin
this
thisleaflet,
leaflet,please
pleasetelltellyour
yourdoctor
doctororor
qualified
qualifiedhealthcare
healthcarepractitioner.
practitioner.

InInthis
thisleaflet:
leaflet:

1.1.What
WhatValerina
ValerinaNight-Time
Night-Timeis isand
andwhat
what
it itis isused
usedforfor
2.2.Before
Beforeyou
youtake
takeValerina
ValerinaNight-Time
Night-Time
3.3.How
Howtototake
takeValerina
ValerinaNight-Time
Night-Time
4.4.Possible
Possibleside
sideeffects
effects
5.5.How
Howtotostore
storeValerina
ValerinaNight-Time
Night-Time
6.6.Further
Furtherinformation
information

213
213
XXXXXXX

1.1.What
WhatValerina
ValerinaNight-Time
Night-Time
isisand
andwhat
whatititisisused
usedfor
for
Valerina
ValerinaNight-Time
Night-Timeis isa atraditional
traditionalherbal
herbal
medicinal
medicinalproduct
productused
usedforforthethetemporary
temporary
relief
reliefofofsleep
sleepdisturbances
disturbancesdue
duetoto
symptoms
symptomsofofmild
mildanxiety
anxietybased
basedonon
traditional
traditionaluse
useonly.
only.
The
Thetablets
tabletscontain
containextracts
extractsofofValerian
Valerian
root,
root,Hop
Hopstrobile
strobileand
andLemon
LemonBalm
Balmleaf.
leaf.
For
Forfullfulldetails
detailssee
seesection
section6.6.

2.2.Before
Beforeyou
youtake
takeValerina
Valerina
Night-Time
Night-Time
Do
Donot
nottake
takeValerina
ValerinaNight-Time
Night-Time
ififyou
youare:
are:
• •allergic
allergic(hypersensitive)
(hypersensitive)totoValerian,
Valerian,
Hops,
Hops,Lemon
LemonBalm
Balmororany
anyofofthetheother
other
ingredients
ingredientsofofValerina
ValerinaNight-Time.
Night-Time.
• •already
alreadytaking
takingother
othermedicines
medicinesforfor
anxiety
anxietyororsleep.
sleep.
• •under
under1818years
yearsofofage.
age.
• •pregnant
pregnantororbreast
breastfeeding.
feeding.

This
Thisproduct
productcontains
containslactose
lactosemonohydrate.
monohydrate.
If Ifyou
youhave
havebeen
beentold
toldbybyyour
yourdoctor
doctorthat
that
you
youhave
haveananintolerance
intolerancetotosome
somesugars
sugarsdodo
not
nottake
takeValerina
ValerinaNight-Time.
Night-Time.

Taking
Takingother
othermedicines
medicines

Please
Pleasetelltellyour
yourdoctor
doctorororqualified
qualifiedhealthhealthcare
carepractitioner
practitionerif ifyou
youare
aretaking
takingany
any
other
othermedicines.
medicines.

Alcohol
Alcohol

The
Theeffects
effectsofofValerina
ValerinaNight-Time
Night-Timemay
maybebe
increased
increasedbybyalcohol.
alcohol.Therefore,
Therefore,you
you
should
shouldnot
notdrink
drinkexcessive
excessiveamounts
amountsofof
alcohol.
alcohol.

Driving
Drivingand
andusing
usingmachines
machines

Valerina
ValerinaNight-Time
Night-Timemay
maycause
causedrowsiness.
drowsiness.
If Ifafter
aftertaking
takingValerina
ValerinaNight-Time
Night-Timeyou
youfeel
feel
drowsy,
drowsy,dodonot
notdrive,
drive,use
usetools
toolsororoperate
operate
machinery.
machinery.

3.3.How
Howtototake
takeValerina
Valerina
Night-Time
Night-Time
For
Fororal
oralshort
shortterm
termuse
useonly.
only.
Take
TakeValerina
ValerinaNight-Time
Night-Timeasasadvised
advisedininthis
this
leaflet.
leaflet.You
Youshould
shouldcheck
checkwith
withyour
yourdoctor
doctor
ororqualified
qualifiedhealthcare
healthcarepractitioner
practitionerif ifyou
you
are
arenot
notsure.
sure.
DoDonot
notexceed
exceedthethestated
stateddose.
dose.

Adults
Adultsand
andthe
theelderly
elderly
Take
Take2 2tablets
tabletshalf
halfananhour
hourtoto1 1hour
hour
before
beforebed
bedtime.
time.
If Ifnecessary,
necessary,you
youcan
cantake
take1–2
1–2additional
additional
tablets
tabletsearlier
earlierininthetheevening.
evening.
Swallow
Swallowthethetablets
tabletswhole
wholewith
withwater.
water.
You
Youmay
mayneed
needtototake
takethethetablets
tabletsforfor2 2toto4 4
weeks
weekscontinuously
continuouslytotoget
getthetheeffect
effectfrom
from
thethetreatment.
treatment.
Stop
Stoptaking
takingValerina
ValerinaNight-Time
Night-Timeand
and
contact
contactyour
yourdoctor
doctorororqualified
qualifiedhealthcare
healthcare
practitioner
practitionerif ifyour
yoursymptoms
symptomsworsen
worsenorordodo
not
notimprove
improveafter
after4 4weeks.
weeks.

Children
Childrenand
andadolescents
adolescents

DoDonot
notuse
useininchildren
childrenand
andadolescents
adolescents
under
under1818years
yearsofofage.
age.

IfIfyou
youtake
takemore
moreValerina
Valerina
Night-Time
Night-Timethan
thanyou
youshould
should

If Ifyou
youtake
takemore
morethan
thanthetherecommended
recommended
dose,
dose,speak
speaktotoa adoctor,
doctor,pharmacist
pharmacistoror
qualified
qualifiedhealthcare
healthcarepractitioner
practitionerand
andtake
take
this
thisleaflet
leafletwith
withyou.
you.
If Ifyou
youhave
haveany
anyfurther
furtherquestions
questionsononthethe
use
useofofthis
thisproduct,
product,ask
askyour
yourdoctor
doctororor
qualified
qualifiedhealthcare
healthcarepractitioner.
practitioner.

4.4.Possible
Possibleside
sideeffects
effects
Like
Likeallallmedicines,
medicines,Valerina
ValerinaNight-Time
Night-Timecan
can
cause
causeside
sideeffects,
effects,although
althoughnot
noteverybody
everybody
gets
getsthem.
them.
Side
Sideeffects
effectsinclude
includefeeling
feelingsick
sick
and
andstomach
stomachcramps.
cramps.The
Thefrequency
frequencyis is
not
notknown.
known.

Reporting
Reportingofofside
sideeffects
effects

If Ifyou
youget
getany
anyside
sideeffects,
effects,talk
talktotoyour
your
doctor,
doctor,pharmacist
pharmacistorornurse.
nurse.This
Thisincludes
includes
any
anypossible
possibleside
sideeffects
effectsnot
notlisted
listedininthis
this
leaflet.
leaflet.You
Youcan
canalso
alsoreport
reportside
sideeffects
effects
directly
directlyvia
viathetheYellow
YellowCard
CardScheme
Schemeat:at:
www.mhra.gov.uk/yellowcard.
www.mhra.gov.uk/yellowcard.
ByByreporting
reportingside
sideeffects
effectsyou
youcan
canhelp
help
provide
providemore
moreinformation
informationononthethesafety
safetyofof
this
thismedicine.
medicine.

422604029
422604029
UK-A
UK-A

5. How to store Valerina
5. How
to store Valerina
Night-Time
Night-Time
Do
store above
25°C.Valerina
Keep in original
5.not
How
to store
Do not store
above the
25°C.
Keep
in original
package
to
protect
tablets
from
light
Night-Time
package
to protect the tablets from light
and moisture.
Do not
store above 25°C. Keep in original
and
moisture.
Keep
out to
of protect
the reach
sight
of light
package
theand
tablets
from
Keep
out
of the reach
and
sight
of
children.
and
moisture.
children.
Do
not useofValerina
Night-Time
Keep
the reach
and sight after
of the
Do notout
use Valerina
after
the
expiry
date
which is Night-Time
stated on the
carton.
children.
expiry
datedate
which
is stated
theday
carton.
The expiry
refers
to theon
last
of
Do
use date
Valerina
Night-Time
The
expiry
refers
to the lastafter
day the
of
thatnot
month.
expiry
date which is stated on the carton.
that
month.
Medicines
not be
of via
The
expiry should
date refers
to disposed
the last day
of
Medicines
should
not be
disposed
of via
wastewater
or
household
waste.
Take
the
that
month.
wastewater
household
waste.
Take the
medicines noorlonger
required
to your
Medicines
should
notdispose
be disposed
of via
medicines
longer
required
your
pharmacistno
who
will
oftothem.
wastewater
or household
waste.
Take
pharmacist
who
will help
dispose
of them.
These
measures
will
to
protect
thethe
medicines
no
longer
required
to
your
These
measures
will
help
to
protect
the
environment.
pharmacist who will dispose of them.
environment.
These measures will help to protect the
environment.

6. Further information
6. Further information

What Valerina Night-Time
What
Valerina
Night-Time
contains
6. Further
information
contains

Each film-coated
contains:
What
Valerina tablet
Night-Time
• Each film-coated tablet contains:
60 mg of extract (as dry extract)
contains

60 mg of extract
(as drymg
extract)
equivalent
to 420–600
of Valerian
• Each
film-coated
tablet contains:
equivalent
to 420–600
root
(Valeriana
officinalismg
L.).of Valerian
60
mg
of extract
(as
dry extract)
root
(Valeriana
officinalis
L.).
Extraction
solvent:
Ethanol
60% V/V.
equivalent solvent:
to 420–600
mg60%
of Valerian
Extraction
Ethanol
V/V.
65
mg
of
extract
(as
dry
extract)
root
(Valeriana
officinalis
L.).
65 mg of extract
(as drymg
extract)
equivalent
to 293–553
of Hops
Extraction solvent:
Ethanol 60%
V/V.
equivalent
to 293–553
Hops
strobile (Humulus
lupulusmg
L.).ofExtraction
65
mg of
extract70
(as
extract)
strobile
(Humulus
lupulus
L.).
Extraction
solvent:
Ethanol
%dry
V/V.
equivalent
to 293–553
mg of Hops
solvent: Ethanol
70 % V/V.
strobile (Humulus lupulus L.). Extraction
solvent: Ethanol 70 % V/V.

17.5 mg of extract (as dry extract)
17.5
mg oftoextract
(as dry
equivalent
124–200
mg extract)
of Lemon
equivalent
to 124–200
mg ofL.).
Lemon
Balm
leaf (Melissa
officinalis
17.5
extract Ethanol
(as dry 60%
extract)
Balm mg
leafof
(Melissa
officinalis
L.). V/V.
Extraction
solvent:
equivalent solvent:
to 124–200
mg60%
of Lemon
Extraction
Ethanol
V/V.
• The
other
ingredients
are L.).
278 mg
Balm
leaf
(Melissa
officinalis
• of
Thelactose
othermonohydrate,
ingredients cellulose,
are 278 mg
Extraction
solvent: Ethanol
60% V/V.
of
lactoseanhydrous
monohydrate,
cellulose,
colloidal
silica,
potato
• colloidal
The
other
ingredients
278 mg
anhydrous
silica,are
potato
starch,
magnesium
stearate,
hyproof
lactose
monohydrate,
cellulose,
starch,
magnesium
stearate,
hypromellose, macrogol 6000, titanium
colloidal
anhydrous
silica,
potato
mellose, (E171)
macrogol
titanium
dioxide
and6000,
paraffin.
starch,
magnesium
stearate,
dioxide (E171) and paraffin.hypromellose, macrogol 6000, titanium
What
Valerina Night-Time looks
dioxide
(E171) and
paraffin.
What
Valerina
Night-Time
looks

like and contents of the pack
like
and contents
of off-white
the pack
The film-coated
tablets are
and
What
Valerina
Night-Time
looks
The
film-coated
tablets
are
off-white
and
round.
like
round.and contents of the pack
Pack
sizes: 40, tablets
60, 80 tablets
in blisters.
The
off-white
and
Packfilm-coated
sizes: 40, 60, 80are
tablets
in blisters.
Not
all pack sizes may be marketed.
round.
Not all pack sizes may be marketed.
Pack sizes: 40, 60, 80 tablets in blisters.

Traditional Herbal Registration
Not
all pack sizes
may be
marketed.
Traditional
Herbal
Registration
Holder
Holder
Pharbio Medical International AB,
Traditional
Herbal
Registration
Pharbio
Box 715,Medical
SE-194International
27 UpplandsAB,
Väsby,
Holder
Box
715,
SE-194
27
Upplands
Väsby,
Sweden.

Pharbio
AB,
Sweden.Medical
Telephone:
+46 8International
590 963 00 AB
1336,
171
26
Solna,
Sweden
Box
715,
SE-194
27
Upplands
Väsby,
Telephone:
+46
8
590
963
00
E-mail: regulatory@cederroth.com
Telephone:
+46 10 2183700
Sweden.
E-mail:
regulatory@cederroth.com
Telephone: +46 8 590 963 00
Manufacturer
E-mail:
regulatory@cederroth.com
Manufacturer
Cederroth International Production
Cederroth
Production3-7,
Orkla
CareInternational
A/S,
Paramedical
A/S,Vassingerødvej
Vassingerødvej
3-7,
Manufacturer
Paramedical
A/S,
Vassingerødvej 3-7,
DK-3540
Lynge,
Danmark
Denmark.
CederrothLynge,
International
Production
DK-3540
Denmark.
Paramedical
A/S,
Vassingerødvej
3-7,
This leaflet was last revised in
DK-3540
Lynge,
Denmark.
This leaflet
was
last
revised in
November
2016
.
November 2016.
This leaflet was last revised in
November 2016.

Self-Help Health Education to
Self-Help
Health Education
to
Promote Natural
Sleep
Promote
Natural
Sleep
• Exercise: gentle exercise can help the
Self-Help
Health
Education
tothe
• Exercise:
gentle
exercise
can help
body burn up
excess
energy.
Promote
Natural
Sleep
body burn up excess energy.

























Healthy
eating:
a variedcan
well
Exercise:
gentle exercise
help the
Healthy
eating:
a varied
well
balanced
diet
will
help
ensure
the body
body
burn
up
excess
energy.
balanced
diet
will help
ensure and
the body
receives the
essential
vitamins
Healthy
varied
well
receives the
essential
vitamins
minerals
iteating:
needs
toafunction
atand
its best.
balanced
willtohelp
ensure
the
body
minerals
itdiet
needs
function
its best.
Try
to avoid
excess
intake
of at
coffee,
tea
receives
the
essential
vitamins
and
Try
to
avoid
excess
intake
of
coffee,
tea
or alcohol from late afternoon.
minerals
needslate
to function
at its best.
or
alcoholit from
afternoon.
Daylight:
to arrange
exposure
Try to avoidtry
excess
intake some
of coffee,
tea
Daylight:
try
to arrange
some
exposure
to
daylight
at
least
once
a
day
to
help
or
alcohol
from
late
afternoon.
to daylight
least clock
once maintain
a day to its
help
your
naturalatbody
Daylight:
try
to
arrange
some
exposure
your
natural
body
clock
maintain
its
balance. Turn out lights before going
to daylight
at least
oncebefore
a day going
to help
balance.
out lights
to
sleep. Turn
your
natural
body
clock
maintain
its
to sleep.
Daytime
naps:
try to before
avoid having
balance.
Turn
out
lights
going
Daytime
try since
to avoid
naps
duringnaps:
the day
this having
will affect
to
sleep.
naps
during the
day since this will affect
your
evening
pattern.
Daytime
naps:
try to avoid having
your
evening
pattern.
Unwind:
construct
asince
relaxed
naps
during
the
day
this pre-bed
will affect
Unwind:
construct
a relaxed
pre-bed
routine
so
that
you
stop
all
stressful
your
evening
pattern.
routine soan
that
youand
stopa all
activities
hour
halfstressful
before you
Unwind:
aa
relaxed
pre-bed
activities
half relaxation
before
you
plan to goanconstruct
tohour
bed.and
Try
some
routine
so
that
you
stop
all
stressful
plan
to
go
to
bed.
Try
some
relaxation
techniques such as yoga or other forms
activities
ansuch
hourasand
a half
before
you
techniques
yoga
or other
forms
of meditation.
plan
to go to bed. Try some relaxation
of meditation.
Organising
time:
can or
help
youforms
take
techniques
such
as yoga
other
Organising
time:
can
help
you
take
control
of
your
life,
set
priorities
and
of
meditation.
control
of
your
life,
set
priorities
and
plan ahead allowing time for relaxation.
Organising
time: can
you take
plan ahead allowing
timehelp
for relaxation.
In
bed:ofdon’t
read
or priorities
watch television
control
your
life,
set
and
In
bed:these
don’tare
read
or watch
television
in
bed,
waking
activities.
plan
ahead
allowing
time
for
relaxation.
in bed, these are waking activities.
Getting
up: rise
morning
at a
In
bed: don’t
readeach
or watch
television
Getting
up: rise
each
morning
at a
regular,
convenient
hour.
in
bed, these
are waking
regular,
convenient
hour. activities.
Getting up: rise each morning at a
regular, convenient hour.

CERTIFICATION MARK
CERTIFICATION MARK
CERTIFICATION MARK

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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