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

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
BETAMETHASONE SODIUM PHOSPHATE; Neomycin sulfate
Available from:
RPH Pharmaceuticals AB
ATC code:
S03CA; S03CA06
INN (International Name):
BETAMETHASONE SODIUM PHOSPHATE; Neomycin sulfate
Dosage:
0.1% w/v 3500  international unit(s)/millilitre
Pharmaceutical form:
Ear/eye drops, solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Corticosteroids and antiinfectives in combination; betamethasone and antiinfectives
Authorization status:
Marketed
Authorization number:
PA1638/002/001
Authorization date:
1993-08-13

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.

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-N Eye, Ear & Nose

Drops will be called Betnesol-N Drops.

In this leaflet:

1. What Betnesol-N Drops is for

2. 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. Further information.

1. What Betnesol-N Drops is for

Betnesol-N

Drops

belongs

group

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. 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 betamethasone

You are allergic to any of the other ingredients

of Betnesol-N 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 an infection in the ear or nose

You have ulcers in your eye (shingles)

You have glaucoma (increased pressure in

the eye)

You have a perforated ear drum.

If any of the above applies to you talk to your

doctor or pharmacist.

Check

with

your

doctor

before

using

Betnesol-N Drops if:

You wear soft contact lenses

You have been treated with Betnesol-N drops

or similar corticosteroid medicine recently.

You should not use corticosteroids for a

long time without regular medical check-ups

from your doctor

You have redness in your eyes for which you

do not know the cause. Steroid treatment

must not be given unless the cause of the

redness is known

You have an infection of the lining of your

nose, which is not being treated

You have recently had surgery on your nose

which has not yet healed

You have tuberculosis (TB)

You have thinning of the cornea or sclera

(the tissues which cover the outer surface of

the eye) Using these drops could lead to a

hole in the eyeball

You are giving this medicine to an infant.

Prolonged

babies

cause

adrenal gland to stop working properly

You

applying

these

drops

open

wounds or damaged skin. The antibiotic

component

cause

permanent,

partial

or total deafness if used on open wounds

or damaged skin. This possibility should

be borne in mind if high doses are given to

small children or infants.

If any of the above applies to you talk to your

doctor or pharmacist.

Taking other medicines

Please tell your doctor if you are taking or have

recently taken any other medicines, including

medicines obtained without a prescription.

Some medicines may increase the effects of

Betnesol-N Drops and your doctor may wish

to monitor you carefully if you are taking

these medicines (including some medicines for

HIV: ritonavir, cobicistat)

Pregnancy and breast-feeding

pregnant,

trying

become

pregnant or breast-feeding ask your doctor or

pharmacist for advice before using Betnesol-N

Drops. If you use these drops while pregnant

there may be small risk of damage to the ear,

cleft palate or retarded growth in the foetus.

Driving and using machines

Betnesol-N

Drops

cause

temporary

blurred

vision

lightheadedness.

this

happens to you, do not drive or use machinery

until you return to normal.

Warnings about the ingredients in Betnesol-N

Drops

This medicine contains benzalkonium chloride

preservative

which

cause

skin

reactions or eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses prior to application and

wait at least 15 minutes before reinsertion.

Benzalkonium chloride is known to discolour

soft contact lenses.

Warnings about visual problems when using

Betnesol-N Drops

Contact your doctor if you experience blurred

vision or other visual disturbances.

3. How to use Betnesol-N Drops

Important:

Your doctor will choose the dose that is right

for you. Your dose will be shown clearly on

the label that your pharmacist puts on your

medicine. If it does not, or you are not sure,

ask your doctor or pharmacist.

Things to remember about your dose:

Always

Betnesol-N

exactly

your

doctor has told you

How often you use the drops will depend

on how your body responds to the treatment

Use as few drops as possible for the shortest

possible time.

Getting ready to use your medicine

Check that the seal on the bottle is not broken

before using Betnesol-N Drops for the first

time. Wash and dry your hands.

Do not breathe on or touch the dropper nozzle

and do not touch the eyes, ear or nose with the

dropper nozzle.

If there is no improvement in your symptoms

after 7 days, stop using the drops and see your

doctor again.

Using your medicine

Eyes

The usual dose is 1 or 2 drops put into the

eye up to 6 times each day

Once the redness, itching and soreness starts

to feel better, apply the drops less often.

1. Tilt the head back

2. Gently pull lower eyelid downwards and

outwards

3. Place drops in the gap between the lid and

eye (squeeze bottle very gently if necessary)

4. Blink a few times to spread out the drops

5. Repeat for the other eye if needed.

Medical check-ups

If you are using this medicine for your eyes

and you use it for a number of weeks, your

doctor may ask you to have check-ups.

These are to make sure that your medicine is

working properly and that the dose you are

taking is right for you. Your doctor will check

your eyes for:

1. An increase in pressure

2. Cataracts

3. Infection

Patient Information Leaflet: Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal

Drops, solution. Betamethasone Sodium Phosphate and Neomycin Sulphate.

23293405

Ears

The usual dose is 2 or 3 drops put into the ear

three or four times each day

Once the redness, itching and soreness starts

to feel better, apply the drops less often.

1. Tilt the head to one side

2. Place drops in the ear canal (squeeze bottle

gently if necessary)

3. Keep head tilted for a minute or two to let the

drops soak in

4. Repeat for other ear if needed.

Nose

The usual dose is 2 or 3 drops put into each

nostril two or three times each day.

1. Tilt head backwards

2. Place drops in nostril (squeeze bottle gently

if necessary)

3. Keep head tilted and sniff gently to let the

drops soak in

4. Repeat for other nostril if needed.

Medical check-ups

Your doctor will regularly check the growth

of children who are taking Betnesol-N by nose

over a long period of time.

If you use more Betnesol-N Drops than you

should

If you accidentally use too much Betnesol-N

Drops it is unlikely to lead to any serious side

effects. However, if you are concerned, contact

the nearest hospital casualty department or

your doctor.

Accidental swallowing of the contents of one

bottle (up to 10 ml) is unlikely to lead to any

serious adverse events.

It is important that you take your dose as stated

on the pharmacist’s label or advised by your

doctor. You should use only as much as your

doctor recommends; using more or less may

make your symptoms worse.

If you forget to use Betnesol-N

Do not use a double dose to make up for

a missed dose. Simply use the next dose as

planned.

How to stop using Betnesol-N Drops

Do not stop using Betnesol-N Drops without

first talking to your doctor.

If you have been using Betnesol-N Drops for a

long period of time (around 6 to 8 weeks), then

you should stop using it gradually, to avoid

the inflammation coming back. It is important

to only use the drops for as long as they are

needed.

If you have any further questions about the use

of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Betnesol-N Drops can cause

side effects, although not everybody gets them.

These may include:

Hypersensitivity reactions may occur leading

irritation,

itching,

redness,

burning

stinging

sensation

your

skin.

These

symptoms may not appear until sometime

after you have started to use the medicine

Ulcers on the surface of the eye (cornea).Tell

your doctor if your eye becomes painful and

if you have blurred vision which does not

improve after a few minutes

Increased

pressure

(glaucoma)

which can lead to problems with your sight

A hole in the eyeball (if you have a disease which

causes thinning of the surface of the eye)

Cataracts (clouding of the lens of the eye)

Enlarged pupils

Drooping of the eyelid

Swelling and redness of the outer surface of

the eye

Blurred vision and other alterations to your

sight

In very rare cases, some patients with severe

damage to the clear layer at the front of

the eye (the cornea) have developed cloudy

patches on the cornea due to calcium build-

up during treatment.

Microorganisms may become resistant to the

anti-biotic if using the drops for a long time.

If you are using Betnesol-N Drops for your

nose, you may also experience some of the

following side effects:

If you are a child, Betnesol-N Drops may slow

your growth

Difficulty breathing

A hole or ulcers on the cartilage wall that

separates

nostrils

nose

(nasal

septum)

Irritation and dryness in the nose

Sneezing

Headache

Light-headedness

Itching

Feeling sick

Nosebleeds

Blocked nose

Changes in the senses of smell and taste

Blurred vision.

Using too much of this medicine for a long time

could cause side effects in the rest of the body,

and stop your adrenal glands making the body’s

own steroids. This means that when you stop

using Betnesol-N Drops, you could experience

the following effects:

Low blood pressure which may make you feel

faint

Fever

A runny nose

Painful itchy skin

Redness of the eye (conjunctivitis)

Muscle and joint pain

Weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor

pharmacist.

This

includes

possible

side effects not listed in this leaflet. You can

also

report

side

effects

directly

HPRA

Pharmacovigilance,

Earlsfort

Terrace,

- Dublin 2. Tel: +353 1 6764971. Fax: +353

6762517.

Website:

www.hpra.ie,

e-mail:

medsafety@hpra.ie. By reporting side effects

you can help provide more information on the

safety of this medicine.

5. How to store Betnesol-N Drops

Keep this medicine out of the sight and reach of

children. Do not use Betnesol-N Drops after the

expiry date on the label. The expiry date refers

to the last day of that month.

The bottle should be disposed of 28 days after

first opening, even if there is solution remaining.

Do not store above 25°C. Do not refrigerate or

freeze. Keep the bottle in the outer carton to

protect it from light.

Medicines

should

disposed

wastewater

household

waste.

Return

medicine

longer

need

your

pharmacist.

6. Further information

What Betnesol-N Drops contains

Betnesol-N

Drops

contains

0.1%w/v

betamethasone sodium phosphate and 3500IU/ml

neomycin sulphate.

other

ingredients

Benzalkonium

Chloride

(anhydrous

equivalent),

disodium

edetate,

macrogol

300,

sodium

formate,

anhydrous

sodium

sulphate,

disodium

phosphate anhydrous, sodium dihydrogen

phosphate

dihydrate,

sodium

hydroxide

phosphoric acid and water for injections.

What Betnesol-N Drops looks like

Betnesol-N Drops is an eye, ear and nose drops

solution. It is colourless to pale yellow liquid.

Betnesol-N Drops comes in 5 ml or 10 ml

plastic bottles with a built-in nozzle and a

tamper-evident plastic cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

RPH Pharmaceuticals AB, Lagervagen 7, 136

50 Haninge, Sweden.

Manufacturer

Excelvision, 27, rue de la Lombardière, ZI La

Lombardière, 07100 Annonay.

This leaflet was last updated in 05/2018.

If this leaflet is difficult to see or read or you

would

like

different

format,

please

contact RPH Pharmaceuticals AB, Lagervagen

7, 136 50 Haninge, Sweden.

23293405

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: contains 0.01%w/v benzalkonium chloride.

For a 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

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.

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.

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4.3 Contraindications

Viral, fungal, tuberculous or purulent conditions of the eye. Fungal infections of the nose or ear. Use is contraindicated

if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the

latter condition can lead to an extension of the ulcer and marked visual deterioration.

Otitis externa should not be treated when the eardrum is perforated because of the risk of ototoxicity.

Corticosteroids should not be used in patients with a perforated tympanic membrane.

Hypersensitivity to any component of the preparation.

4.4 Special warnings and precautions for use

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of

any clinical improvement, since prolonged use may lead to occult extension of infection due to the masking effect of

the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Prolonged use may lead to the risk of adrenal suppression in infants.

Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular

review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied

topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment.

Although this effect has not been reported following topical ocular use, the possibility should be considered when high

dose topical treatment is given to small children or infants.

Nasal administration of corticosteroids is not advised if an untreated nasal infection is present or if the patient has

pulmonary tuberculosis or following nasal surgery (until healing has occurred).

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods.

These

effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between

different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features,

adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of

psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or

aggression (particularly in children).

Betnesol-N Drops contain benzalkonium chloride as a preservative and therefore, should not be used as eye drops to

treat patients who wear soft contact lenses.

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.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.Betnesol Drops contain benzalkonium chloride as a preservative and

therefore, should not be used to treat patients who wear soft contact lenses.Co-treatment with CYP3A

inhibitors,including cobicistat-containing products,is expected to increase the risk ofsystemic 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.

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4.6 Fertility, pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human

pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development

including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the

human foetus.

There is a risk of foetal ototoxicity if aminoglycoside antibiotic preparations are administered during pregnancy.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Patients should be warned not to drive or operate hazardous

machinery unless vision is clear.

4.8 Undesirable effects

Hypersensitivity reactions,

usually of the delayed type,

may occur leading to irritation,

burning,

stinging,

itching and

dermatitis.

Topical corticosteroid use may result

in corneal ulceration increased intraocular pressure leading to optic nerve

damage, reduced visual acuity and visual field defects.

Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts.

In those diseases causing thinning of the cornea or sclera,

corticosteroid therapy may result in thinning of the globe

leading to perforation.

Mydriasis,

ptosis,

epithelial punctate keratitis and glaucoma have also been reported following ophthalmic use of

corticosteroids.

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye

drops in some patients with significantly damaged corneas.

Following nasal administration, the most common effects are nasal irritation and dryness, although sneezing, headache,

lightheadedness,

urticaria,

nausea,

epistaxis,

rebound congestion,

bronchial

asthma,

perforation of the nasal septum ,

ulceration of the nasal septum, anosmia, parosmia and disturbance to sense of taste have also been reported.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth

retardation has been reported in children receiving nasal corticosteroids at licensed doses.

is recommended that

the height

of children receiving prolonged treatment

with nasal

corticosteroids is regularly

monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroids,

if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should

also be given to referring the patient to a paediatric specialist.

Vision, blurred (see also section 4.4)

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Tel: +353 1 6764971.

Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

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4.9 Overdose

Long-term intensive topical use may lead to systemic effects.

Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is

evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be

considered during periods of stress or elective surgery.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: S03C A

Betamethasone has topical corticosteroid activity. The presence of neomycin should prevent the development of

bacterial infection.

5.2 Pharmacokinetic properties

Not applicable as the drops are applied topically.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium Chloride (anhydrous equivalent)

Disodium Edetate

Macrogol 300

Sodium Formate

Sodium Sulphate, Anhydrous

Disodium Phosphate Anhydrous

Sodium Dihydrogen Phosphate Dihydrate

Sodium Hydroxide (for pH adjustment)

Phosphoric Acid (for pH adjustment)

Water for Injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened: 18 months

Once opened: Discard 28 days after first opening

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze. Keep the bottle in the outer carton to protect from light.

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6.5 Nature and contents of container

5 ml and 10 ml opaque bottles with nozzle insert moulded in natural low density polyethylene closed with a tamper

evident high density polyethylene cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

RPH Pharmaceuticals AB

Lagervägen 7

136 50 Haninge

Sweden

8 MARKETING AUTHORISATION NUMBER

PA1638/002/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13 August 1993

Date of last renewal: 13 August 2008

10 DATE OF REVISION OF THE TEXT

December 2017

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