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BETACAP SCALP APPLICATION

Active substance(s): BETAMETHASONE VALERATE / BETAMETHASONE VALERATE / 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 "ETACAP 3CALP !PPLICATION IS FOR USE ON THE
scalp to treat skin diseases including psoriasis
(scaly, pink patches of thickened skin) and
seborrhoeic dermatitis (scaly, itchy patches
of skin).
s "ETACAP 3CALP !PPLICATION IS SUITABLE FOR USE
by adults, the elderly and children over the
age of one year.
s 4HE active ingredient in this product is
BETAMETHASONE 4HIS IS ONE OF A GROUP OF
medicines called corticosteroids (which should
not be confused with ‘anabolic steroid’ tablets
or injections misused by some athletes).
s "ETAMETHASONE IS A STRONG AND FAST ACTING
corticosteroid and is intended for use on the
scalp which tends not to respond very well
to weaker medicines of this type.
s "ETAMETHASONE WORKS BY REDUCING
inflammation and calming down your immune
system.
s 4HE PRODUCT ALSO WORKS AS AN ANTISEPTIC 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 IF YOU ARE allergic (hypersensitive) to
betamethasone or any of the other ingredients
of Betacap Scalp Application listed in Section 6;
s TO TREAT ANY OTHER SKIN PROBLEMS especially
skin infections, as it may make them worse;
s TO TREAT ANY SCALP PROBLEM OTHER THAN THE ONE
your doctor prescribed it for;
s ON CHILDREN under one year of age.
Take special care when using this product:
s 4ELL YOUR DOCTOR IF AT ANY STAGE YOU THINK YOUR
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 +EEP THE PRODUCT away from your eyes
and mouth.
s "ETACAP IS highly flammable. Do not use it
near flames or ignition sources (e.g. burning
cigarettes or anything else that might ignite it).

s )F YOU ARE TREATING scalp 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
)T IS UNCLEAR WHETHER THIS PRODUCT IS SAFE FOR USE
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 #AREFULLY TURN THE BOTTLE UPSIDE DOWN OVER YOUR
head, holding the nozzle against the part of the
scalp to be treated.
s 'ENTLY SQUEEZE THE BOTTLE UNTIL THE AFFECTED AREA
is coated with a thin layer of the preparation.
s 'ENTLY MASSAGE THE APPLICATION INTO THE SCALP
to prevent it from running off.
s !LLOW THE TREATED SCALP TO DRY NATURALLY
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 &OLLOW THE SAME INSTRUCTIONS AS FOR ADULTS SEE
above), but use the product more sparingly.
s .EVER APPLY MORE THAN IS NEEDED TO COVER THE
affected area.
s Do not cover the treated scalp with an airtight
dressing.
s 7HEN TREATING SEBORRHOEIC DERMATITIS IN CHILDREN
do not use the product for longer than 7 days.
If Betacap Scalp Application gets into the
eyes IT MAY CAUSE DAMAGE )F IT GETS INTO THE EYES
RINSE IMMEDIATELY WITH PLENTY OF WATER )F RINSING
one eye, take care to avoid washing product into
THE OTHER EYE )F IRRITATION PERSISTS TELL YOUR DOCTOR
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.
)F THEY ARE CONSCIOUS ENCOURAGE THEM TO DRINK 
or 2 cups of milk or water (one cup in the case of
a child), but do not carry on if they are vomiting.
)N ALL CASES TAKE THEM TO A DOCTOR OR HOSPITAL
STRAIGHT AWAY 4AKE THIS LEAFLET AND THE CONTAINER
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.
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS
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 )N RARE CASES SKIN IRRITATION MAY OCCUR )F THIS
happens stop using the product.
s )N RARE CASES TREATING PSORIASIS WITH THIS TYPE
of product may cause the development of the
pustular form of the disease (blisters filled with
PUS  4HIS EXPLAINS WHY CAREFUL SUPERVISION
by your doctor is required if you are treating
scalp psoriasis.
s 4OPICAL CORTICOSTEROIDS ARE USUALLY WELL TOLERATED
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.
)F YOU ARE IN ANY DOUBT ABOUT THE TREATMENT 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
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR
PHARMACIST OR NURSE 4HIS INCLUDES ANY POSSIBLE
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 #ARD 3CHEME AT
www.mhra.gov.uk/yellowcard
Ireland
(02! 0HARMACOVIGILANCE %ARLSFORT 4ERRACE
)2, $UBLIN  4EL   
&AX    7EBSITE WWWHPRAIE
E-mail: medsafety@hpra.ie.
5. HOW TO STORE BETACAP
SCALP APPLICATION
s +EEP OUT OF THE REACH AND SIGHT OF CHILDREN
s $O NOT USE "ETACAP 3CALP !PPLICATION AFTER THE
EXPIRY DATE SHOWN ON THE BOTTLE AND CARTON 4HE
expiry date refers to the last day of that month.
s $O NOT STORE ABOVE ª#
s !LWAYS REPLACE THE CAP TIGHTLY AND RETURN THE
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 -EDICINES SHOULD NOT BE DISPOSED OF VIA
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
LONGER REQUIRED 4HESE MEASURES WILL HELP TO
protect the environment.
6. FURTHER INFORMATION ABOUT
BETACAP SCALP APPLICATION
What Betacap Scalp Application contains:
4HE active ingredient is betamethasone
(as betamethasone valerate) 0.1% w/w.
4HE other 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 "ETACAP 3CALP !PPLICATION IS A CLEAR COLOURLESS
slightly thickened liquid.
s 4HE PRODUCT IS AVAILABLE IN PLASTIC BOTTLES
containing 100 ml, incorporating a specially
designed nozzle applicator for convenient direct
application to the scalp.
The Marketing Authorisation holder is:
$ERMAL ,ABORATORIES 4ATMORE 0LACE 'OSMORE
(ITCHIN (ERTFORDSHIRE 3' 12 5+
The Manufacturer is: Fleet Laboratories Ltd,
 2ICKMANSWORTH 2D 7ATFORD (ERTFORDSHIRE
7$ ** 5+
This Patient Information Leaflet was last
revised in -ARCH 
4O LISTEN TO OR REQUEST A COPY OF THIS LEAFLET IN
Braille, large print or audio, please call free of
CHARGE    5+ ONLY 
Please be ready to give the following information:
"ETACAP 
4HIS IS A SERVICE PROVIDED BY THE 2OYAL .ATIONAL
)NSTITUTE OF "LIND 0EOPLE 2.)" 

VP5/15/1 201314

s 9OUR SCALP WILL FEEL COOL UNTIL THE LIQUID HAS DRIED
4HE ACTIVE INGREDIENT IS THEN LEFT ON YOUR SCALP
s !LWAYS WASH YOUR HANDS AFTER USE
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
EVEN LESS 4HE FREQUENCY OF APPLICATION SHOULD BE
reduced to the minimum necessary to keep your
scalp condition under control.

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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