Anginovag

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEQUALINIUM CHLORIDE, TYROTHRICIN, HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE

Available from:

Ferrer Internacional S.A. Gran Vía Carlos III, 94 08028 Barcelona, Spain

ATC code:

R02AA20

INN (International Name):

TYROTHRICIN 0.4 % (W/V) DEQUALINIUM CHLORIDE 0.1 % (W/V) HYDROCORTISONE ACETATE 0.06 % (W/V) LIDOCAINE HYDROCHLORIDE 0.1 % (W/V)

Pharmaceutical form:

OROMUCOSAL SPRAY

Composition:

TYROTHRICIN 0.4 % (W/V) DEQUALINIUM CHLORIDE 0.1 % (W/V) HYDROCORTISONE ACETATE 0.06 % (W/V) LIDOCAINE HYDROCHLORIDE 0.1 % (W/V)

Prescription type:

POM

Therapeutic area:

THROAT PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-05-26

Patient Information leaflet

1
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
Anginovag 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
after 3 days
-- If any of side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET:
1. What ANGINOVAG is and what it is used for
2. Before you use ANGINOVAG
3. How to use ANGINOVAG.
4. Possible side effects.
5. How to store ANGINOVAG
6. Further information
1. WHAT ANGINOVAG IS AND WHAT IT IS USED FOR:
Anginovag is an oromucosal spray
Anginovag is supplied in a white polyethylene flask containing a
solution and closed by
an spray dosing valve.
Anginovag is used to alleviate the symptoms of buccopharyngeal
affections (pain,
inflammation, etc)
2. BEFORE YOU USE ANGINOVAG:
DO NOT USE ANGINOVAG:
-
If you are allergic (hypersensitive) to active substances or any of
the other
ingredients of Anginovag.
TAKE SPECIAL CARE WITH ANGINOVAG
Do not spray on the eyes
Contact your doctor if you experience blurred vision or other visual
disturbances
TAKING OTHER MEDICINES:
You can take other medication by oral or injection route.
It is advisable do not use Anginovag with other topical medication
USING ANGINOVAG WITH FOOD AND DRINK
It is possible to use Anginovag after the meals.
It is not advisable to take foods or to drink after to use Anginovag
PREGNANCY AND BREAST-FEEDING
Anginovag can be used during pregnancy or breast-feeding.
DRIVING AND USING MACHINES
2
Anginovag, does not produce any effect over the ability to drive and
use of machines
IMPORTANT INFORMATION ON SOME OF THE INGREDIENTS OF ANGINOVAG
This medicine contains ethanol and sodium saccharin.
3. HOW TO USE ANGINOVAG
The usual dose is:
The first 3 days, 1-2 applications each 2-3 hours

Summary of Product characteristics

Page 1 of 3
SUMMARY PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ANGINOVAG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mL contains:
_ACTIVE INGREDIENT: _
Dequalinium chloride 0.100g; Tyrothricin 0.400g; Hydrocortisone
acetate 0.060g;
Lidocaine hydrochloride 0.100 g; beta-Glycyrrhetinic acid 0.060 g
3. PHARMACEUTICAL FORM
Oromucosal spray
Is supplied in bottles containing 10 mL of solution
4. CLINICAL PARTICULARS
:
4.1 THERAPEUTIC INDICATIONS
:
-Preventive and curative therapy of buccopharyngeal affections:
ulcers, aphthae,
stomatitis, laryngitis, glossitis, amygdalitis, pharyngitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY:
Attack dose: 1-2 applications each 2-3 hours.
Maintenance or preventive therapy: 1 application each 6 hours.
METHOD OF ADMINISTRATION:
It is recommended to place the flask in upright position with the
cannula
pointing towards the place of application, but without introducing it
completely
in the mouth.
Press the upper part of the cap.
4.3 CONTRAINDICATIONS
It must not be administered to patients with known allergy to any
ingredient.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
:
It is advisable not to administer Anginovag in conjunction with other
topical
Treatments
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 may include cataract, glaucoma or rare diseases such as central
serous
chorioretinopathy (CSCR) which have been reported after use of
systemic and topical
corticosteroids.
Page 2 of 3
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Can be interacted by other oral topical products.
4.6 PREGNANCY AND LACTATION
Controlled studies in woman or in the animal are not available.
Nevertheless Anginovag is marketed in a flask provided with a dosing
valve that
permits the application of the