Skip to Content

PERINAL CUTANEOUS SPRAY

Active substance(s): HYDROCORTISONE / LIDOCAINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET Information for the user

PERINAL
CUTANEOUS SPRAY
TM

hydrocortisone/lidocaine hydrochloride

Read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more
information or advice. You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.

1. WHAT Perinal Cutaneous Spray
IS AND WHAT IT IS USED FOR
• Perinal Cutaneous Spray is a treatment to
spray on and around your bottom (anus) to
relieve painful and itchy symptoms caused,
for example, by haemorrhoids (piles).
• Haemorrhoids are swollen or enlarged
blood vessels that can be either internal
(inside the anus) or external (outside the
anus). They can cause varying degrees of
pain, itch and irritation, particularly after
going to the toilet.
• Perinal Cutaneous Spray is suitable for use
by adults, the elderly and children over
the age of 14. Children under the age of
14 may also use it if recommended by their
doctor.
• The active ingredients are
hydrocortisone and lidocaine
hydrochloride. These work by:
• Reducing itching and inflammation
(hydrocortisone), and;
• Relieving pain and discomfort (lidocaine
hydrochloride).
2. BEFORE YOU USE Perinal
Cutaneous Spray
It is very important that you tell your doctor if:
• you have bleeding or persistent pain from
your bottom (anus), especially if associated
with having to go to the toilet more or less
often than you have done in the past;
• if your stomach is unusually swollen
or bloated, or;
• if you are losing weight.
Do not delay telling your doctor if
you have any of the symptoms above,
because you may need urgent treatment.

Do not use Perinal Cutaneous Spray:
• if you are allergic (hypersensitive) to
hydrocortisone, lidocaine hydrochloride
or any of the other ingredients of Perinal
Cutaneous Spray listed in Section 6;
• internally (inside the anus);
• anywhere other than over and around
the anal area;
• on broken or infected skin.
Take special care when using this spray:
• Avoid using the spray continuously for
more than 7 days, unless advised by
your doctor.
• Keep the spray away from the eyes,
nose and mouth.
• For children under the age of 14,
only use Perinal Cutaneous Spray if
recommended by a doctor.
Using other medicines
Perinal Cutaneous Spray is not known
to affect, or to be affected by, any other
medicines. However, tell your doctor or
pharmacist if you are using other medicines
containing corticosteroids because the risks
of side effects (see Section 4) may be additive.
Pregnancy and breast-feeding
It 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 Perinal Cutaneous
Spray
Use Perinal Cutaneous Spray only on and
around your bottom (anus).
Prime the pump before use by pressing
down on the top of the pump once or twice.
continued…

Prints: Pantone 3265

Flat size: 160mm x 265mm

EP4/15/1 201264

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

United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

For adults, the elderly and children over
14 years of age:
• Parting your buttocks, if necessary, spray
once over the affected area (the spray will
operate in any orientation, even upside
down).
• Repeat up to three times a day if you
need to.
• Replace the cap after use.
• Always wash your hands after use.
Stop using the spray after 7 days unless
your doctor advises you to carry on with it.

Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

If the spray gets into the eyes it may
cause irritation. If it gets into the eyes, rinse
the eyes with plenty of water. If rinsing one
eye, take care to avoid washing product
into the other eye. If irritation persists seek
medical attention.
If you occasionally forget to use Perinal
Cutaneous Spray, do not worry, just carry
on using it when you remember.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Perinal Cutaneous Spray
can cause side effects, although not
everybody gets them.
• You may feel a local tingling sensation
after initial application. This is normal and
only temporary.
• Rarely, individuals may experience more
persistent discomfort and irritation, in
which case they may be allergic to the
spray’s ingredients and should stop
using it.
• Topical 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, 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. If any of the
side effects get serious, or you notice any
other side effects not mentioned in this
leaflet, stop using this product and tell
your doctor or pharmacist.

6. FURTHER INFORMATION
What Perinal Cutaneous Spray contains:
The active ingredients are hydrocortisone
(0.2% w/w) and lidocaine hydrochloride
(1.0% w/w).The other ingredients are
macrogol cetostearyl ether (cetomacrogol
1000), citric acid monohydrate, sodium
citrate, propyl gallate, phenoxyethanol and
purified water.
What Perinal Cutaneous Spray looks like
and contents of the pack
• The spray is a colourless to pale yellow
solution.
• It is available in 30 ml collapsible tubes
fitted with metered dose spray pumps
and caps.
The Marketing Authorisation holder is
Dermal Laboratories, Hitchin, Herts,
SG4 7QR, UK.
The Manufacturer is Fleet Laboratories Ltd,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last revised in
December 2014.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only)
Please be ready to give the following
information: Perinal Cutaneous Spray,
PL 00173/0049.
This is a service provided by the Royal
National Institute of Blind People.
EP4/15/1 201264

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 (see
details below). By reporting side effects you
can help provide more information on the
safety of this medicine.

5. HOW TO STORE Perinal
Cutaneous Spray
• Keep it out of the reach and sight of
children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.
• Do not use after the expiry date shown on
the tube and carton. The expiry date refers
to the last day of that month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

Prints: Pantone 3265

Flat size: 160mm x 265mm

Expand view ⇕

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.

Hide