23293405 (redness, itching and soreness).
(redness, itching and soreness). Topical means • You have glaucoma (increased pressure in component can cause permanent, partial Drops time. Wash and dry your hands.
that they are used on the outside of the body and the eye) or total deafness if used on open wounds This medicine contains benzalkonium chloride Do not breathe on or touch the dropper nozzle
Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear
Patient Information Leaflet: Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal
not taken by mouth or injection. Betnesol-N •Y ou have a perforated ear drum. or damaged skin. This possibility should as a preservative which may cause skin and do not touch the eyes, ear or nose with the
Drops, solution. Betamethasone Sodium Phosphate and Neomycin Sulphate.
and Nasal Drops, solution.
Drops also contain neomycin sulphate, an If any of the above applies to you talk to your be borne in mind if high doses are given to reactions or eye irritation. dropper nozzle.
Betamethasone Sodium Phosphate and
aminoglycoside antibiotic, which prevents doctor or pharmacist. small children or infants. Avoid contact with soft contact lenses. If there is no improvement in your symptoms
Neomycin Sulphate.
bacterial infection developing. Betnesol-N If any of the above applies to you talk to your Remove contact lenses prior to application and after 7 days, stop using the drops and see your
Drops is used to treat inflammation of the eye, Check with your doctor before using doctor or pharmacist. wait at least 15 minutes before reinsertion. doctor again.
Read all of this leaflet carefully before you
ear or nose when there may also be a risk of Betnesol-N Drops if: Benzalkonium chloride is known to discolour Using your medicine
start using this medicine.
bacterial infection. • You wear soft contact lenses Taking other medicines soft contact lenses.
• Keep this leaflet. You may need to read it
• You have been treated with Betnesol-N drops Please tell your doctor if you are taking or have Eyes
again.
It is important to use this medicine to prevent or similar corticosteroid medicine recently. recently taken any other medicines, including Warnings about visual problems when using • The usual dose is 1 or 2 drops put into the
• If you have any further questions, ask your
any damage to the delicate tissues of your You should not use corticosteroids for a medicines obtained without a prescription. Betnesol-N Drops eye up to 6 times each day
doctor or pharmacist.
eyes, ear or nose and to prevent any infection long time without regular medical check-ups Contact your doctor if you experience blurred • Once the redness, itching and soreness starts
• This medicine has been prescribed for you. Some medicines may increase the effects of
developing. from your doctor vision or other visual disturbances. to feel better, apply the drops less often.
Do not pass it on to others. It may harm Betnesol-N Drops and your doctor may wish
• You have redness in your eyes for which you 1. Tilt the head back
them, even if their symptoms are the same 2. Before you use Betnesol-N Drops to monitor you carefully if you are taking 3. How to use Betnesol-N Drops
do not know the cause. Steroid treatment 2. Gently pull lower eyelid downwards and
as yours. Important: Never use this medicine in your eye these medicines (including some medicines for Important:
must not be given unless the cause of the outwards
• In this leaflet, Betnesol-N Eye, Ear & Nose without first checking with your doctor. If it is HIV: ritonavir, cobicistat) Your doctor will choose the dose that is right
redness is known 3. Place drops in the gap between the lid and
Drops will be called Betnesol-N Drops. used for the wrong condition, it could lead to for you. Your dose will be shown clearly on
• You have an infection of the lining of your Pregnancy and breast-feeding eye (squeeze bottle very gently if necessary)
blindness. nose, which is not being treated the label that your pharmacist puts on your 4. Blink a few times to spread out the drops
In this leaflet: If you are pregnant, trying to become
Do not use Betnesol-N Drops if: • You have recently had surgery on your nose medicine. If it does not, or you are not sure, 5. Repeat for the other eye if needed.
1. What Betnesol-N Drops is for pregnant or breast-feeding ask your doctor or
• You are allergic to betamethasone which has not yet healed ask your doctor or pharmacist. Medical check-ups
2. Before you use Betnesol-N Drops pharmacist for advice before using Betnesol-N
• You are allergic to any of the other ingredients • You have tuberculosis (TB) Things to remember about your dose: If you are using this medicine for your eyes
3. How to use Betnesol-N Drops Drops. If you use these drops while pregnant
of Betnesol-N Drops (listed in section 6) • You have thinning of the cornea or sclera • Always use Betnesol-N exactly as your and you use it for a number of weeks, your
4. Possible side effects there may be small risk of damage to the ear,
• You have not checked your eye condition (the tissues which cover the outer surface of doctor has told you doctor may ask you to have check-ups.
5. How to store Betnesol-N Drops cleft palate or retarded growth in the foetus.
with your doctor first. If this medicine is the eye) Using these drops could lead to a • How often you use the drops will depend These are to make sure that your medicine is
6. Further information.
used in your eye, for the wrong condition, it hole in the eyeball Driving and using machines on how your body responds to the treatment working properly and that the dose you are
1. What Betnesol-N Drops is for could lead to blindness. • You are giving this medicine to an infant. Betnesol-N Drops may cause temporary • Use as few drops as possible for the shortest taking is right for you. Your doctor will check
Betnesol-N Drops belongs to a group of • You have an infection in the eye, or it is Prolonged use in babies may cause the blurred vision and lightheadedness. If this possible time. your eyes for:
medicines called topical corticosteroids producing pus and is sticky adrenal gland to stop working properly happens to you, do not drive or use machinery Getting ready to use your medicine 1. An increase in pressure
(‘steroids’ for short). • You have an infection in the ear or nose • You are applying these drops to open until you return to normal. Check that the seal on the bottle is not broken 2. Cataracts
Betnesol-N Drops work by reducing inflammation • You have ulcers in your eye (shingles) wounds or damaged skin. The antibiotic before using Betnesol-N Drops for the first 3. Infection
Warnings about the ingredients in Betnesol-N
23293405 the nearest hospital casualty department or to irritation, itching, redness, burning or • Difficulty breathing side effects not listed in this leaflet. You can anhydrous sodium sulphate, disodium
your doctor. a stinging sensation on your skin. These • A hole or ulcers on the cartilage wall that also report side effects directly via HPRA phosphate anhydrous, sodium dihydrogen
Ears
Accidental swallowing of the contents of one symptoms may not appear until sometime separates the nostrils of the nose (nasal Pharmacovigilance, Earlsfort Terrace, IRL phosphate dihydrate, sodium hydroxide or
• The usual dose is 2 or 3 drops put into the ear
bottle (up to 10 ml) is unlikely to lead to any after you have started to use the medicine septum) - Dublin 2. Tel: +353 1 6764971. Fax: +353 phosphoric acid and water for injections.
three or four times each day
serious adverse events. • Ulcers on the surface of the eye (cornea).Tell • Irritation and dryness in the nose 1 6762517. Website: www.hpra.ie, e-mail:
• Once the redness, itching and soreness starts What Betnesol-N Drops looks like
It is important that you take your dose as stated your doctor if your eye becomes painful and • Sneezing medsafety@hpra.ie. By reporting side effects
to feel better, apply the drops less often. Betnesol-N Drops is an eye, ear and nose drops
on the pharmacist’s label or advised by your if you have blurred vision which does not • Headache you can help provide more information on the
1. Tilt the head to one side solution. It is colourless to pale yellow liquid.
doctor. You should use only as much as your improve after a few minutes • Light-headedness safety of this medicine.
2. Place drops in the ear canal (squeeze bottle Betnesol-N Drops comes in 5 ml or 10 ml
doctor recommends; using more or less may • Increased pressure in the eye (glaucoma) • Itching
gently if necessary) 5. How to store Betnesol-N Drops plastic bottles with a built-in nozzle and a
make your symptoms worse. which can lead to problems with your sight • Feeling sick
3. Keep head tilted for a minute or two to let the Keep this medicine out of the sight and reach of tamper-evident plastic cap.
If you forget to use Betnesol-N • A hole in the eyeball (if you have a disease which • Nosebleeds
drops soak in children. Do not use Betnesol-N Drops after the Not all pack sizes may be marketed.
Do not use a double dose to make up for causes thinning of the surface of the eye) • Blocked nose
4. Repeat for other ear if needed. expiry date on the label. The expiry date refers
a missed dose. Simply use the next dose as • Cataracts (clouding of the lens of the eye) • Changes in the senses of smell and taste Marketing Authorisation Holder
planned. • Enlarged pupils • Blurred vision. to the last day of that month.
Nose RPH Pharmaceuticals AB, Lagervagen 7, 136
How to stop using Betnesol-N Drops • Drooping of the eyelid Using too much of this medicine for a long time The bottle should be disposed of 28 days after
The usual dose is 2 or 3 drops put into each 50 Haninge, Sweden.
Do not stop using Betnesol-N Drops without • Swelling and redness of the outer surface of could cause side effects in the rest of the body, first opening, even if there is solution remaining.
nostril two or three times each day.
first talking to your doctor. the eye and stop your adrenal glands making the body’s Do not store above 25°C. Do not refrigerate or Manufacturer
1. Tilt head backwards
If you have been using Betnesol-N Drops for a • Blurred vision and other alterations to your own steroids. This means that when you stop freeze. Keep the bottle in the outer carton to Excelvision, 27, rue de la Lombardière, ZI La
2. Place drops in nostril (squeeze bottle gently
long period of time (around 6 to 8 weeks), then sight using Betnesol-N Drops, you could experience protect it from light. Lombardière, 07100 Annonay.
if necessary)
you should stop using it gradually, to avoid • In very rare cases, some patients with severe the following effects: Medicines should not be disposed of via
3. Keep head tilted and sniff gently to let the This leaflet was last updated in 05/2018.
the inflammation coming back. It is important damage to the clear layer at the front of • Low blood pressure which may make you feel wastewater or household waste. Return
drops soak in If this leaflet is difficult to see or read or you
to only use the drops for as long as they are the eye (the cornea) have developed cloudy faint any medicine you no longer need to your
4. Repeat for other nostril if needed. would like it in a different format, please
needed. patches on the cornea due to calcium build- • Fever pharmacist.
Medical check-ups contact RPH Pharmaceuticals AB, Lagervagen
Your doctor will regularly check the growth up during treatment. • A runny nose 6. Further information 7, 136 50 Haninge, Sweden.
If you have any further questions about the use • Microorganisms may become resistant to the • Painful itchy skin
of children who are taking Betnesol-N by nose What Betnesol-N Drops contains
of this medicine, ask your doctor or pharmacist. anti-biotic if using the drops for a long time. • Redness of the eye (conjunctivitis)
over a long period of time. Betnesol-N Drops contains 0.1%w/v
If you use more Betnesol-N Drops than you 4. Possible side effects If you are using Betnesol-N Drops for your • Muscle and joint pain betamethasone sodium phosphate and 3500IU/ml
should Like all medicines Betnesol-N Drops can cause nose, you may also experience some of the • Weight loss. neomycin sulphate.
If you accidentally use too much Betnesol-N side effects, although not everybody gets them. following side effects: The other ingredients are Benzalkonium
• If you are a child, Betnesol-N Drops may slow Reporting of side effects
Drops it is unlikely to lead to any serious side These may include: Chloride (anhydrous equivalent), disodium
your growth If you get any side effects, talk to your doctor
effects. However, if you are concerned, contact • Hypersensitivity reactions may occur leading edetate, macrogol 300, sodium formate,
or pharmacist. This includes any possible
