Germoloids HC spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine hydrochloride; Hydrocortisone

Available from:

Bayer Plc

ATC code:

C05AX03

INN (International Name):

Lidocaine hydrochloride; Hydrocortisone

Dosage:

10mg/1gram ; 2mg/1gram

Pharmaceutical form:

Spray

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070200; GTIN: 5010605829857

Patient Information leaflet

PATIENT INFORMATION LEAFLET
HYDROCORTISONE
PLUS
LOCAL
ANAESTHETIC
Germoloids HC Spray BayerCross
Hydrocortisone and Lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Germoloids HC
Spray carefully to get the best results from it. Keep this leaflet.
You may need to read it again.
Ask your pharmacist if you need more information or advice. You must
contact a doctor if your
symptoms worsen or do not improve. If you have any unusual effects
after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What is Germoloids HC Spray and what is it used for?
2.
Before you use Germoloids HC Spray
3.
How to use Germoloids HC Spray
4.
Possible side effects
5.
How to store Germoloids HC Spray
6.
Further information
1.
WHAT IS GERMOLOIDS
® HC SPRAY AND WHAT IS IT USED FOR?
Haemorrhoids (also known as piles) are swollen or enlarged blood
vessels, which can cause
discomfort, itching and irritation, particularly after a bowel
movement. They may be either
internal (inside the anus) or external (outside the anus). Germoloids
HC Spray is used to relieve
the symptoms of external haemorrhoids, which include pain, itching and
irritation immediately
around the anus.
The Spray contains two active substances:
•
Hydrocortisone - a steroid that occurs naturally in the body. When
applied to the skin,
steroids have been shown to reduce itching, redness and inflammation
associated with
certain skin problems.
•
Lidocaine hydrochloride - a local anaesthetic that relieves pain.
2. BEFORE YOU USE GERMOLOIDS
® HC SPRAY
This medicine should only be sprayed outside the anal area (not inside
the anus).
DO NOT USE GERMOLOIDS HC SPRAY:
•
If you are allergic (hypersensitive) to hydrocortisone or lidocaine
hydrochloride, or any of
the other ingredients in the product (see section 6, Further
Information).
•
On broken or infected skin.
•
If you are pregnant or breast-feeding.
•
If you are under 16 years o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germoloids
®
HC Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 0.2% w/w
Lidocaine Hydrochloride 1.0% w/w
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray solution.
Colourless to pale yellow.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the symptomatic relief of anal and perianal itch, irritation and
pain,
associated with external haemorrhoids.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The product is for cutaneous use.
Prime pump before initial use by depressing its top once or twice.
Adults
The product is applied by parting the buttocks if necessary, spraying
once over
the affected area, up to three times daily depending on the severity
of the
condition. The spray will operate in any orientation.
Wash hands and replace cap after use.
Elderly
The same dose applies to the elderly.
Children
The spray should not be used in children under 16 years.
4.3.
CONTRA-INDICATIONS
Not to be used if sensitive to lidocaine or any of the other
ingredients. Not to
be used on broken or infected skin. Not to be used internally (inside
the anus),
or anywhere other than the anal area.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Germoloids HC Spray is intended for use for limited periods and should
not
be used continuously for longer than 7 days. Patients should be
instructed
to seek medical advice if they experience persistent pain or bleeding
from
the anus, especially where associated with a change in bowel habit,
abdominal pain, if the stomach is distended or if they are losing
weight.
Prompt medical treatment may be very important under such
circumstances. Germoloids HC Spray should be kept away from the eyes,
nose and mouth.
VISUAL DISTURBANCE:
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient presents with symptoms such as
blurred
vision or other visual disturbances, the patient should be considered
for
referral to an ophthalmologist for evaluation of possible causes which