Perinal Cutaneous Spray hydrocortisone 0.2% w/w / lidocaine hydrochloride monohydrate 1.0% w/w

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Hydrocortisone; LIDOCAINE HYDROCHLORIDE

Tilgjengelig fra:

Dermal Laboratories (Ireland) Limited

ATC-kode:

C05AA; C05AA01

INN (International Name):

Hydrocortisone; LIDOCAINE HYDROCHLORIDE

Dosering :

0.2/1.0 percent weight/weight

Legemiddelform:

Cutaneous spray, solution

Terapeutisk område:

Corticosteroids; hydrocortisone

Autorisasjon status:

Marketed

Autorisasjon dato:

1992-06-05

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER:
PERINAL CUTANEOUS SPRAY
hydrocortisone 0.2% w/w / lidocaine hydrochloride monohydrate 1.0% w/w
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.
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.
Contents of the pack and other information
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 H

Preparatomtale

Health Products Regulatory Authority
11 December 2020
CRN00C18J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perinal Cutaneous Spray hydrocortisone 0.2% w/w / lidocaine
hydrochloride monohydrate 1.0% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 0.2% w/w
Lidocaine hydrochloride monohydrate 1.0% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Spray, Solution. (Cutaneous Spray)
Colourless to pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perinal is indicated for the symptomatic relief of anal and perianal
itch, irritation and pain, such as associated with
haemorrhoids.
Perinal is indicated in adults, children and adolescents.
Use in children under 14 years is recommended only under medical
supervision (see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prime the pump before initial use by depressing it once or twice.
Spray once over the affected area up to three times daily, depending
on the severity of the condition, or as recommended by
the doctor.
The same dosage schedule applies to all age groups.
_Paediatric population_
Perinal is indicated in the paediatric population however special care
should be exercised before treating children and
adolescents aged under 14 years, to exclude any other underlying
medical conditions.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
in section 6.1.
Not to be used on broken skin owing to the possibly increased risk of
systemic side effects (see section 4.9).
Not to be used on infected skin including bacterial, viral,
tuberculous or fungal lesions of the skin.
Not to be used internally (inside the anus), or anywhere other than
the anal area.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Perinal Cutaneous Spray is intended for use for limited periods and so
should not be used continuously for longer than 7 days
without medical advice. Patients should be instructed to seek medical
advice if they experience p