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BETACAP SCALP APPLICATION

Active substance(s): BETAMETHASONE VALERATE

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PACKAGE LEAFLET Information for the user
TM

0.1% w/w cutaneous solution
betamethasone (as betamethasone valerate)
Read all of this leaflet carefully before you start using this product.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor
or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT BETACAP SCALP APPLICATION IS
AND WHAT IT IS USED FOR
s "ETACAP3CALP!PPLICATIONISFORUSEONTHE
scalp to treat skin diseases including psoriasis
(scaly, pink patches of thickened skin) and
seborrhoeic dermatitis (scaly, itchy patches
of skin).
s "ETACAP3CALP!PPLICATIONISSUITABLEFORUSE
by adults, the elderly and children over the
age of one year.
s 4HEactive ingredient in this product is
BETAMETHASONE4HISISONEOFAGROUPOF
medicines called corticosteroids (which should
not be confused with ‘anabolic steroid’ tablets
or injections misused by some athletes).
s "ETAMETHASONEISASTRONGANDFASTACTING
corticosteroid and is intended for use on the
scalp which tends not to respond very well
to weaker medicines of this type.
s "ETAMETHASONEWORKSBYREDUCING
inflammation and calming down your immune
system.
s 4HEPRODUCTALSOWORKSASANANTISEPTIC AND
includes an emollient (moisturiser) to help make
the scalp feel more comfortable.
2. BEFORE YOU USE BETACAP SCALP
APPLICATION
Do not use Betacap Scalp Application:
s IFYOUAREallergic (hypersensitive) to
betamethasone or any of the other ingredients
of Betacap Scalp Application listed in Section 6;
s TOTREATANYOTHERSKINPROBLEMS especially
skin infections, as it may make them worse;
s TOTREATANYSCALPPROBLEMOTHERTHANTHEONE
your doctor prescribed it for;
s ONCHILDRENunder one year of age.
Take special care when using this product:
s 4ELLYOURDOCTORIFATANYSTAGEYOUTHINKYOUR
scalp has become infected. Your doctor may
advise you to stop using Betacap for a while
and start using an alternative anti-microbial
treatment instead.
s +EEPTHEPRODUCTaway from your eyes
and mouth.
s "ETACAPIShighly flammable. Do not use it
near flames or ignition sources (e.g. burning
cigarettes or anything else that might ignite it).

s )FYOUARETREATINGscalp psoriasis, it is
important that your doctor checks your
progress regularly to avoid a possible
complication that can occur (see Section 4).
s Do not use this product excessively:
– avoid using this product continuously
or frequently for long periods (weeks or
months on end);
– this is especially important for infants and
young children, because long term use
increases the chance of local and
generalised side effects (see Section 4);
– for children with scalp seborrhoeic
dermatitis, treatment should normally be
limited to no more than 7 days.
Using other medicines
Betacap Scalp Application is not known to affect,
or to be affected by, any other medicines.
Pregnancy and breast-feeding
)TISUNCLEARWHETHERTHISPRODUCTISSAFEFORUSE
during pregnancy and breast-feeding. Animal
birth defects have occurred with similar medicines
containing corticosteroids, so there may be a
very small risk of these problems in humans. You
should therefore not normally use this product if
you are pregnant or breast-feeding unless your
doctor has recommended you to do so.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.
3. HOW TO USE BETACAP SCALP
APPLICATION
Use Betacap Scalp Application only on psoriasis
and seborrhoeic dermatitis affecting the scalp.
Before using this bottle of Betacap Scalp
Application for the first time, turn the bottle cap
anti-clockwise to break the seal.
For adults and the elderly:
Repeat the following twice a day, morning and
evening, until you notice an improvement in your
scalp condition. On days when you shampoo your
hair, apply Betacap Scalp Application after drying
the hair:
s #
AREFULLYTURNTHEBOTTLEUPSIDE DOWNOVERYOUR
head, holding the nozzle against the part of the
scalp to be treated.
s 'ENTLYSQUEEZETHEBOTTLEUNTILTHEAFFECTEDAREA
is coated with a thin layer of the preparation.
s 'ENTLYMASSAGETHEAPPLICATIONINTOTHESCALP
to prevent it from running off.
s !LLOWTHETREATEDSCALPTODRYNATURALLY
Do not use a hair drier.
continued…

VP5/15/1 201314

In this leaflet:
1. What Betacap Scalp Application is and
what it is used for
2. Before you use Betacap Scalp Application
3. How to use Betacap Scalp Application
4. Possible side effects
5. How to store Betacap Scalp Application
6. Further information

For children (over one year old):
s &OLLOWTHESAMEINSTRUCTIONSASFORADULTSSEE
above), but use the product more sparingly.
s .EVERAPPLYMORETHANISNEEDEDTOCOVERTHE
affected area.
s Do not cover the treated scalp with an airtight
dressing.
s 7HENTREATINGSEBORRHOEICDERMATITISINCHILDREN
do not use the product for longer than 7 days.
If Betacap Scalp Application gets into the
eyes ITMAYCAUSEDAMAGE)FITGETSINTOTHEEYES
RINSEIMMEDIATELYWITHPLENTYOFWATER)FRINSING
one eye, take care to avoid washing product into
THEOTHEREYE)FIRRITATIONPERSISTSTELLYOURDOCTOR
or pharmacist.
Betacap Scalp Application is dangerous if
swallowed.
If someone swallows this product by mistake,
take the following emergency action: if they
are drowsy or unconscious, give nothing by mouth.
)FTHEYARECONSCIOUS ENCOURAGETHEMTODRINK
or 2 cups of milk or water (one cup in the case of
a child), but do not carry on if they are vomiting.
)NALLCASES TAKETHEMTOADOCTORORHOSPITAL
STRAIGHTAWAY4AKETHISLEAFLETANDTHECONTAINER
of Betacap Scalp Application with you.
If you apply too much Betacap Scalp
Application, use a tissue to mop up any excess
and stop it spreading onto uninvolved skin areas.
If you occasionally forget to use Betacap
Scalp Application, do not worry, just carry on
using it when you remember.
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betacap Scalp Application can
cause side effects, although not everybody gets
them:
s )NRARECASESSKINIRRITATIONMAYOCCUR)FTHIS
happens stop using the product.
s )NRARECASES TREATINGPSORIASISWITHTHISTYPE
of product may cause the development of the
pustular form of the disease (blisters filled with
PUS 4HISEXPLAINSWHYCAREFULSUPERVISION
by your doctor is required if you are treating
scalp psoriasis.
s 4OPICALCORTICOSTEROIDSAREUSUALLYWELLTOLERATED
when used in the right amount and for the
correct length of time. However, prolonged,
excessive use, particularly in children or
on skin that is bandaged or wrapped up,
can cause local skin thinning (making the skin
damage easily), and adrenal suppression
(a type of hormone imbalance that causes
generalised effects on the body). Stopping
treatment normally corrects these side effects.
)FYOUAREINANYDOUBTABOUTTHETREATMENT OR
experience any of the above side effects or any
other side effect not mentioned in this leaflet,

stop using this product and tell your doctor
or pharmacist.
Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE
side effects not listed in this leaflet. You can also
report side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
9ELLOW#ARD3CHEMEAT
www.mhra.gov.uk/yellowcard
Ireland
(02!0HARMACOVIGILANCE %ARLSFORT4ERRACE
)2, $UBLIN4EL 
&AX 7EBSITEWWWHPRAIE
E-mail: medsafety@hpra.ie.
5. HOW TO STORE BETACAP
SCALP APPLICATION
s +EEPOUTOFTHEREACHANDSIGHTOFCHILDREN
s $ONOTUSE"ETACAP3CALP!PPLICATIONAFTERTHE
EXPIRYDATESHOWNONTHEBOTTLEANDCARTON4HE
expiry date refers to the last day of that month.
s $ONOTSTOREABOVEª#
s !LWAYSREPLACETHECAPTIGHTLYANDRETURNTHE
bottle to the carton after use (to protect the
contents from light).
s Betacap Scalp Application is highly
flammable. Do not use it near flames or
ignition sources.
s EDICINESSHOULDNOTBEDISPOSEDOFVIA
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
LONGERREQUIRED4HESEMEASURESWILLHELPTO
protect the environment.
6. FURTHER INFORMATION ABOUT
BETACAP SCALP APPLICATION
What Betacap Scalp Application contains:
4HEactive ingredient is betamethasone
(as betamethasone valerate) 0.1% w/w.
4HEother ingredients are macrogol 7 glycerol
cocoate, isopropyl alcohol, carbomer, sodium
hydroxide and purified water.
What Betacap Scalp Application looks like
and contents of the pack
s "
ETACAP3CALP!PPLICATIONISACLEAR COLOURLESS
slightly thickened liquid.
s 4
HEPRODUCTISAVAILABLEINPLASTICBOTTLES
containing 100 ml, incorporating a specially
designed nozzle applicator for convenient direct
application to the scalp.
The Marketing Authorisation holder is:
$ERMAL,ABORATORIES 4ATMORE0LACE 'OSMORE
(ITCHIN (ERTFORDSHIRE 3'12 5+
The Manufacturer is: Fleet Laboratories Ltd,
2ICKMANSWORTH2D 7ATFORD (ERTFORDSHIRE
7$** 5+
This Patient Information Leaflet was last
revised in-ARCH
4OLISTENTOORREQUESTACOPYOFTHISLEAFLETIN
Braille, large print or audio, please call free of
CHARGE5+ONLY 
Please be ready to give the following information:
"ETACAP 
4HISISASERVICEPROVIDEDBYTHE2OYAL.ATIONAL
)NSTITUTEOF"LIND0EOPLE2.)" 

VP5/15/1 201314

s 9OURSCALPWILLFEELCOOLUNTILTHELIQUIDHASDRIED
4HEACTIVEINGREDIENTISTHENLEFTONYOURSCALP
s !LWAYSWASHYOURHANDSAFTERUSE
When you can see that your scalp condition is
getting better, you can start to apply Betacap
Scalp Application less often, only once a day or
EVENLESS4HEFREQUENCYOFAPPLICATIONSHOULDBE
reduced to the minimum necessary to keep your
scalp condition under control.

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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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