Flumetasone 0.02% / Clioquinol 1% ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clioquinol; Flumetasone pivalate

Available from:

Advanz Pharma

ATC code:

S02CA02

INN (International Name):

Clioquinol; Flumetasone pivalate

Dosage:

10mg/1ml ; 200microgram/1ml

Pharmaceutical form:

Ear drops

Administration route:

Auricular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12010100; GTIN: 5060337260893 5060337260947

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor,
pharmacist or nurse.
-
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Flumetasone/Clioquinol
0.02% w/v/1 % w/v Ear Drops solution; it will be called
Flumetasone/Clioquinol Ear Drops for ease here after.
WHAT IS IN THIS LEAFLET
1.
What Flumetasone/Clioquinol Ear Drops are and
what they are used for
2.
What
y
ou
need
to
know
before
you
use
Flumetasone/Clioquinol Ear Drops
3.
How to use Flumetasone/Clioquinol Ear Drops
4.
Possible side effects
5.
How to store Flumetasone/Clioquinol Ear Drops
6.
Contents of the pack and other information
1.
WHAT FLUMETASONE/CLIOQUINOL EAR DROPS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Flumetasone/Clioquinol
Ear Drops. Flumetasone/Clioquinol Ear Drops contain the
acti
ve ingredients Flumetasone pivalate and Clioquinol.
Flumetasone/Clioquinol
Ear
Drops
are
used
to
treat
infection and inflammation of the external ear. The drops
contain an antibacterial and antifungal ingredient to combat
infection and a steroid which acts to reduce inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
FLUMETASONE/CLIOQUINOL EAR DROPS
DO NOT USE FLUMETASONE/CLIOQUINOL EAR DROPS:
•
if
you
ar
e
allergic
to
Flumetasone
pivalate,
Clioquinol, or to any of the other ingredients of this
medicine (listed in section 6). Allergic reactions
include mild symptoms such as itching and/or rash.
More severe symptoms include swelling of the face,
lips,
tongue
and/or
throat
with
difficulty
in
swallowing or breathing;
•
if you have a perforated or burst ear drum;
•
if you have an infection of

Summary of Product characteristics

OBJECT 1
FLUMETASONE/CLIOQUINOL 0.02% W/V / 1% W/V EAR
DROPS SOLUTION
Summary of Product Characteristics Updated 12-Jun-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Locorten Vioform Ear Drops
Flumetasone/Clioquinol 0.02% w/v / 1% w/v Ear Drops solution
2. Qualitative and quantitative composition
ACTIVE INGREDIENTS:
Flumetasone Pivalate 0.02% w/v
Clioquinol 1.0% w/v
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Ear drops, solution
Clear, yellowish to brownish-yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Inflammatory conditions of the external ear where a secondary
infection is suspected. Otorrhoea.
4.2 Posology and method of administration
Posology
Instill 2 or 3 drops twice daily directly into the auditory canal of
the affected ear. Treatment should be
limited to 7-10 days.
If there is little improvement after 7 days treatment with this
medicine, appropriate microbiological
investigations should be carried out and local or systemic antibiotic
treatment given.
Elderly
There is no evidence to suggest that dosage should be different in the
elderly.
Paediatric population
This medicine is contra-indicated in children below the age of two
years.
Method of administration
Auricular use
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Primary bacterial, viral or fungal infections of the outer ear.
Perforation of the tympanic membrane. Use
in children below the age of two years.
4.4 Special warnings and precautions for use
Long-term continuous topical therapy should be avoided since this can
lead to adrenal suppression.
Co-treatment with CYP3A inhibitors, including cobicistat-containing
products, is expected to increase the
risk of systemic side-effects. The combination should be avoided
unless the benefit outweighs the
increased risk of systemic corticosteroid side-effects, in which case
patients should be monitored for
systemic corticosteroid side-effects.
Topical applicati