Terra-Cortril ointment

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Oxytetracycline hydrochloride; Hydrocortisone

Tersedia dari:

Pfizer Ltd

Kode ATC:

D07CA01

INN (Nama Internasional):

Oxytetracycline hydrochloride; Hydrocortisone

Dosis:

30mg/1gram ; 10mg/1gram

Bentuk farmasi:

Cutaneous ointment

Rute administrasi :

Cutaneous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 13040000

Selebaran informasi

PATIENT INFORMATION LEAFLET
TERRA-CORTRIL
® OINTMENT (OXYTETRACYCLINE, HYDROCORTISONE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
Keep this leaflet as 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
as it may harm them, even if
their symptoms are the same as yours.
If any side effect becomes serious, or if you notice a side effect
that is not listed in this leaflet
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Terra-Cortril Ointment is and what it
is used for
2.
Before you use Terra-Cortril Ointment
3.
How to use Terra-Cortril Ointment
4.
Possible side effects
5.
How to store Terra-Cortril Ointment
6.
Further information
1.
WHAT TERRA-CORTRIL OINTMENT IS AND WHAT
IT IS USED FOR
Terra-Cortril Ointment contains two different
medicines: oxytetracycline and hydrocortisone.
Oxytetracycline is one of a group of
medicines called tetracycline antibiotics. It is
used to treat infections caused by bacteria
and certain other micro-organisms.
Hydrocortisone is a corticosteroid used to
reduce inflamed skin which has resulted
from allergy, infection or injury.
Terra-Cortril Ointment has been prescribed for
you to treat:
inflamed skin conditions (such as eczema).
allergic skin conditions (such as after contact
with certain cosmetics, plants or drugs).
infected insect bites.
2.
BEFORE YOU USE TERRA-CORTRIL OINTMENT
DO NOT USE TERRA-CORTRIL OINTMENT IF:
You have ever had an allergic reaction to
any of the ingredients of the ointment. This
may be itching, reddening of the skin or
difficulty in breathing.
You have an infection of the skin causing
blisters or yellow crusting (a primary
bacterial infection) e.g. impetigo, boils
(furunculosis).
You are pregnant, planning to become
pregnant or breast feeding.
The patient is an infant or young child whose
permanent teeth are growing.
If any of the above applies to you talk to your
doctor.
CHECK WITH YOUR DOCTOR OR PHARMAC

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TERRA-CORTRIL
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
gram
of
Terra-Cortril
Ointment
contains
30mg
oxytetracycline
as
oxytetracycline hydrochloride Ph Eur and 10mg hydrocortisone Ph. Eur
3
PHARMACEUTICAL FORM
Ointment for topical administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Terra-Cortril Ointment is indicated in the following disorders:
exudative and
secondarily
infected
eczema
including
atopic
eczema,
primary
irritant
dermatitis, allergic and seborrhoeic dermatitis. Secondarily infected
insect
bite reactions.
In exudative flexural intertrigo Terra-Cortril Ointment can be used
for up to
seven days.
Like other tetracyclines, oxytetracycline is generally ineffective
against Pseudomonas
and Proteus species. Because these are recognised secondary infecting
organisms in
exudative dermatoses, preliminary identification of the organism and
determination of
antibiotic sensitivity is important.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
After thorough cleansing of the affected skin areas, a small amount of
the
ointment should be applied gently. Applications should be made two to
four
times daily.
Terra-Cortril Ointment is for topical administration only.
_Use in the elderly_ No special precautions.
_Use in children _ Not recommended. (See ‘Contra-indications’).
_Use in renal or hepatic impairment _No special precautions.
4.3
CONTRAINDICATIONS
Hypersensitivity to one of the components of the preparation.
Primary bacterial infections eg impetigo, pyoderma, furunculosis.
Pregnancy, lactation and in infants and small children because of the
theoretical risk
of damage to permanent dentition
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Terra-Cortril Ointment should not be continued for more than seven
days in the
absence of any clinical improvement, since in this situation occult
extension of
infection may occur due to the masking effect of the steroid.
Extended or recurrent application may increase the risk of contact
sensiti