Betnesol 0.1% w/v Eye, Ear and Nasal Drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAMETHASONE SODIUM PHOSPHATE

Available from:

RPH Pharmaceuticals AB

ATC code:

S02BA; S02BA07

INN (International Name):

BETAMETHASONE SODIUM PHOSPHATE

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Ear/eye/nasal drops, solution

Prescription type:

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

Therapeutic area:

Corticosteroids; betamethasone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET: BETNESOL 0.1% W/V
EYE, EAR & NASAL DROPS, SOLUTION (BETAMETHASONE SODIUM PHOSPHATE)
BETNESOL 0.1% W/V EYE, EAR & NASAL DROPS, SOLUTION
(BETAMETHASONE SODIUM PHOSPHATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
• In this leaflet, Betnesol Eye, Ear & Nose Drops will be called
Betnesol Drops.
IN THIS LEAFLET:
1. What Betnesol Drops are for
2. Before you use Betnesol Drops
3. How to use Betnesol Drops
4. Possible side effects
5. How to store Betnesol Drops
6. Further information.
1. WHAT BETNESOL DROPS ARE FOR
Betnesol Drops belong to a group of medicines called corticosteroids
(‘steroids’ for short).
Betnesol Drops work by reducing inflammation (redness, itching and
soreness). Betnesol Drops are
used to treat inflammation of the eye, ear or nose where there is no
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. BEFORE YOU USE BETNESOL 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 DROPS IF:

You are allergic to betamethasone

You are allergic to any of the other ingredients of Betnesol Drops
(listed in section 6)

You have not checked your eye condition with your doctor first. If
this medicine is used in your eye,
for the wrong condition, it could lead to blindness.

You have an infection in the eye, or it is producing pus and is sticky

You have ulcers in your eye (shingles)

You have glaucoma (increased pressure in the eye)

You have a perforated ear drum

You wear soft contact lenses.
If any of the above applies to you ta

Summary of Product characteristics

Health Products Regulatory Authority
04 May 2022
CRN00CTVX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnesol 0.1% w/v Eye, Ear and Nasal Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.1% w/v betamethasone sodium phosphate.
Excipients with known effect
Each ml contains 0.2 mg benzalkonium chloride and 1.6 mg phosphates
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye, ear and nasal drops, solution (eye, ear and nasal drops).
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical short-term treatment of corticosteroid responsive inflammation
of the eye, ear and nose in the absence of local
infection.
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. After more prolonged treatment (over 6 to 8
weeks), the drops should be withdrawn slowly to avoid relapse.
Eyes
1 or 2 drops instilled into the eye every one or two hours until
control is achieved, when the frequency may be reduced.
Ears
2 or 3 drops instilled into the ear every two or three hours until
control is achieved, when the frequency may be reduced.
Nose
2 or 3 drops instilled into each nostril two or three times daily.
4.3 CONTRAINDICATIONS
Untreated bacterial, fungal, and viral infections. Use is
contraindicated if glaucoma is present or herpetic keratitis (e.g.
dendritic
ulcer) is considered a possibility.
Use in the ear in the presence of a known or suspected perforated ear
drum.
Hypersensitivity to any component at the preparation.
Health Products Regulatory Authority
04 May 2022
CRN00CTVX
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A patient information leaflet should be supplied with this product.
Steroids should not be administered to “red eyes” until a
definitive diagnosis has been made.
Topical corti