Proflavine 0.1% cream

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Proflavine hemisulfate

Disponibil de la:

J M Loveridge Ltd

INN (nume internaţional):

Proflavine hemisulfate

Dozare:

1mg/1gram

Forma farmaceutică:

Cutaneous cream

Calea de administrare:

Cutaneous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 13100500

Prospect

1
PATIENT INFORMATION LEAFLET
PROFLAVINE 0.1 % W/W CREAM
proflavine hemisulphate
Please read this leaflet carefully before you start to use this
product. If you have any questions or are
unsure about anything, ask your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What Proflavine Cream is and what it is used for
2.
What you need to know before you use Proflavine Cream
3.
How to use Proflavine Cream
4.
Possible side effects
5.
How to store Proflavine Cream
6.
Contents of the pack and other information
1.
WHAT PROFLAVINE CREAM IS AND WHAT IT IS USED FOR
For the treatment of infected wounds and for skin disinfection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROFLAVINE CREAM
-
Keep out of the sight and reach of children.
-
For external use only
WARNINGS AND PRECAUTIONS
Do not use if you are allergic (hypersensitive) to any of the
ingredients.
This medicine will stain clothing.
Do not smoke or go near naked flames - risk of severe burns. Fabric
(clothing, bedding, dressings etc)
that has been in contact with this product burns more easily and is a
serious fire hazard. Washing
clothing and bedding may reduce product build-up but not totally
remove it
3.
HOW TO USE PROFLAVINE CREAM
DIRECTIONS FOR USE:
Shake bottle before use.
For use by adults, the elderly, and children over 2 years old.
Apply directly onto the affected area, 2-3 times daily, or as directed
by a doctor.
If accidentally swallowed, induce vomiting (drink salty water). Seek
medical attention urgently.
If symptoms do not improve, seek medical advice. Avoid prolonged use
(over one month).
Can be used when pregnant or breast feeding.
2
4.
POSSIBLE SIDE EFFECTS
Lanolin and chlorocresol may cause local skin reactions (e.g. contact
dermatitis)
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme Website
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple A

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Proflavine Cream 0.1%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Proflavine hemisulphate BPC 0.1 % w/w
Excipient(s) with known effect
Wool Fat (Lanolin) BP 5.0 % w/w
Chlorocresol BP 0.1 % w/w
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of infected wounds and for skin disinfection
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For topical use
Adults, including the elderly and children over 2 years of age
Method of administration
To be applied to the affected part 2 - 3 times daily or as directed by
a medical
practitioner.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The bottle should be well shaken before use
Prolonged use should be avoided
The product contains Lanolin
External use only
Instruct patients not to smoke or go near naked flames – risk of
severe burns. Fabric
(clothing, bedding, dressings etc.) that has been in contact with this
product burns
more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not
totally remove it.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
FERTILITY, PREGNANCY AND LACTATION
Can be used during pregnancy and lactation
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known
4.8
UNDESIRABLE EFFECTS
None stated
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or
search for
MHRA Yellow Card in the Google Play or Apple App Store
4.9
OVERDOSE
If the product is accidentally ingested, an emetic shoul