Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Neomycin sulfate; BETAMETHASONE SODIUM PHOSPHATE

Διαθέσιμο από:

RPH Pharmaceuticals AB

Φαρμακολογική κατηγορία (ATC):

S03CA; S03CA06

INN (Διεθνής Όνομα):

Neomycin sulfate; BETAMETHASONE SODIUM PHOSPHATE

Δοσολογία:

0.1% w/v 3500  international unit(s)/millilitre

Φαρμακοτεχνική μορφή:

Ear/eye/nasal drops, solution

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Corticosteroids and antiinfectives in combination; betamethasone and antiinfectives

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1993-08-13

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET: BETNESOL-N 0.1% W/V, 3500 IU/ML EYE, EAR
AND NASAL
DROPS, SOLUTION. BETAMETHASONE SODIUM PHOSPHATE AND NEOMYCIN SULPHATE.
BETNESOL-N 0.1% W/V, 3500 IU/ML EYE, EAR AND NASAL DROPS, SOLUTION.
BETAMETHASONE SODIUM PHOSPHATE AND NEOMYCIN SULPHATE.
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 or pharmacist.
• 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.
• In this leaflet, Betnesol-N Eye, Ear & Nose Drops will be called
Betnesol-N Drops.
WHAT IS IN THIS LEAFLET:
1. What Betnesol-N Drops is and what it is used for
2. What you need to know before you use Betnesol-N Drops
3. How to use Betnesol-N Drops
4. Possible side effects
5. How to store Betnesol-N Drops
6. Contents of the pack and other information.
1. WHAT BETNESOL-N DROPS IS AND WHAT IT IS USED FOR
Betnesol-N Drops belongs to a group of medicines called topical
corticosteroids (‘steroids’ for short).
Betnesol-N Drops work by reducing inflammation (redness, itching and
soreness). Topical means that
they are used on the outside of the body and not taken by mouth or
injection. Betnesol-N Drops also
contain neomycin sulphate, an aminoglycoside antibiotic, which
prevents bacterial infection
developing. Betnesol-N Drops is used to treat inflammation of the eye,
ear or nose when there may
also be a risk of bacterial infection.
It is important to use this medicine to prevent any damage to the
delicate tissues of your eyes, ear or
nose and to prevent any infection developing.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETNESOL-N DROPS
IMPORTANT: NEVER USE THIS MEDICINE IN YOUR EYE WITHOUT FIRST CHECKING
WITH YOUR DOCTOR. IF IT IS
USED FOR THE WRONG CONDITION, IT COULD LEAD TO BLINDNESS.
DO NOT USE BETNESOL-N DROPS IF:
• You are allergic to betamethason

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 January 2021
CRN00C33W
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.1% w/v betamethasone sodium phosphate and 3500 IU/ml
Neomycin sulphate.
Excipients with known effect
Benzalkonium chloride – 0.01% w/v
Disodium Phosphate Anhydrous – 0.2% w/v
Sodium Dihydrogen Phosphate Dihydrate – 0.03% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye, ear and nasal drops, solution (ear, eye and nasal drops)
A colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eye
Short-term treatment of steroid responsive inflammatory conditions of
the eye when prophylactic antibiotic treatment is also
required, after excluding the presence of viral and fungal disease.
Ear
Otitis externa or other steroid responsive conditions where
prophylactic antibiotic treatment is also required.
Nose
Steroid responsive inflammatory conditions where prophylactic
antibiotic treatment is also required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The frequency of dosing depends on the clinical response. If there is
no clinical response within 7 days of treatment, the drops
should be discontinued.
Treatment should be the lowest effective dose for the shortest
possible time. Normally, Betnesol-N Drops should not be given
for more than 7 days, unless under expert supervision. After more
prolonged treatment (over 6 to 8 weeks), the drops should
be withdrawn slowly to avoid relapse.
Eyes
1 or 2 drops applied to each affected eye up to six times daily
depending on clinical response.
Ears
2 or 3 drops instilled into the ear three or four times daily.
Nose
2 or 3 drops instilled into each nostril two or three times daily.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
27 January 2021
CRN00C33W
Page 2 of 5
Viral, fungal, tuberculous or purulent conditions of the eye. Fungal
infections of the nose