Dicortineff

Package Leaflet: Information for the Patient

DICORTINEFF, (2 500 IU + 25 IU + 1mg)/ml, Eye and Ear Drops, Suspension
Neomycin + Gramicidin + Fludrocortisone Acetate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dicortineff and what is it used for
• 2. Important information before using Dicortineff
• 3. How to use Dicortineff
• 4. Possible side effects
• 5. How to store Dicortineff
• 6. Contents of the pack and other information

1. What is Dicortineff and what is it used for

Dicortineff is a combination medicine for local use, containing antibiotics - neomycin, gramcidin, and a corticosteroid - fludrocortisone. The medicine has antibacterial, anti-inflammatory, and antiallergic effects. It relieves itching, burning, and reduces swelling.
Dicortineff is used:
a) in ophthalmology:

• in inflammatory conditions of the eyeball, vascular membrane, conjunctiva, and eyelid margins; b) in laryngology:
• in inflammatory conditions of the outer and middle ear;
• in post-operative ear conditions;
• in post-traumatic conditions of the external auditory canal.

2. Important information before using Dicortineff

When not to use Dicortineff:

• if you are allergic to neomycin sulfate, gramcidin, fludrocortisone acetate, or any other ingredients of this medicine (listed in section 6);
• viral, tuberculosis, or fungal infections of the eye or ear;
• diseases associated with corneal or scleral thinning, if the medicine is to be used in the eye;
• glaucoma, if the medicine is to be used in the eye;
• perforation (rupture) of the eardrum, if the medicine is to be used in the ear.

Warnings and precautions

Before starting treatment with Dicortineff, discuss it with your doctor or pharmacist.

Use only for the eyes or ears.

Special caution should be exercised when using the medicine in patients suspected of having a perforated eardrum, as the medicine may cause burning pain or even damage to the auditory nerve.
During prolonged use of Dicortineff, bacterial or fungal superinfections may occur, and in predisposed individuals, an increase in intraocular pressure or even posterior subcapsular cataract may occur.
Hypersensitivity to locally applied aminoglycosides may occur in some patients, including cross-hypersensitivity to other aminoglycosides. If hypersensitivity symptoms occur, the use of the medicine should be discontinued.
Patients using eye drops containing neomycin sulfate should consult a doctor if eye pain, redness, swelling, or irritation worsens or persists.
Severe side effects, including neurotoxicity, ototoxicity, and nephrotoxicity, have occurred in patients receiving neomycin systemically or applied locally to open wounds or damaged skin. Although these effects have not been reported after local use in the eye, caution should be exercised when using systemic aminoglycoside antibiotics concurrently.
Prolonged administration of steroids to the eye may cause increased intraocular pressure and (or) glaucoma, with damage to the optic nerve, decreased visual acuity, and visual field defects, as well as posterior subcapsular cataract. In patients treated with corticosteroids for a long time, intraocular pressure should be regularly and frequently checked.
In the absence of clinical improvement, treatment with a combination product containing a corticosteroid and an antibiotic should not be continued for more than 7 days.
In diseases causing corneal or scleral thinning, due to local use of corticosteroids, perforations have occurred.
Corticosteroids may decrease resistance to infections, promote the development of bacterial, viral, or fungal infections, and mask clinical symptoms of infection, making it difficult to diagnose the lack of efficacy of the antibiotic or reduce hypersensitivity reactions to Dicortineff.
If you experience blurred vision or other visual disturbances, you should contact your doctor.

Dicortineff and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and about the medicines you plan to take, including those available without a prescription.
Interactions of individual components (neomycin, gramcidin, fludrocortisone) with various compounds have been described in the literature, but this applies to other forms of the medicine - taken orally or intravenously.
When using Dicortineff in the form of eye and ear drops, small amounts of the active substances contained in the medicine may occasionally penetrate the systemic circulation. This may happen during prolonged instillation of the suspension (if the recommended dosage is significantly exceeded).
In such cases, there is a possibility of interaction with muscle relaxants and anticoagulants. In the event of systemic absorption of fludrocortisone, it may weaken the effect of antidiabetic medicines.
Some medicines may enhance the effect of Dicortineff, and your doctor may want to closely monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine is not recommended for use in pregnant women.
The decision to stop breastfeeding or discontinue treatment with Dicortineff, taking into account the benefits of breastfeeding for the baby and the benefits of using the product for the nursing mother, should be made by the doctor.
There are no data on the effect of the medicine on fertility.

Driving and using machines

The effect of Dicortineff on the ability to drive and use machines has not been described.
As with other eye drops, temporary blurred vision or other visual disturbances may occur after instillation, affecting the ability to drive and use machines. You should not drive or operate machinery until these symptoms have resolved.

Dicortineff contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride in each ml of suspension. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove contact lenses before instillation and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, you should contact your doctor.
Wearing contact lenses is not recommended during eye infection treatment.

3. How to use Dicortineff

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor.
Note: shake before use.
Treatment duration: up to 2 days after symptoms have resolved, but no longer than 7 days.
Usual doses of Dicortineff:
Adults, adolescents, and children over 2 years

Administration to the eye

1-2 drops into the conjunctival sac 2 to 5 times a day.
Method of administration

• 1. Before instilling the medicine, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine falls into the eye. Do not touch the dropper tip to the eye or eyelids.

Failure to follow this instruction may lead to infection of the drops. Using infected drops can lead to serious complications, even vision loss.

• 5. If the drop did not get into the eye, instill another one.
• 6. After instillation, gently press the inner corner of the eye for about 2 minutes. This will help prevent the medicine from entering the body.
• 7. If your doctor has instructed you to instill the medicine into the other eye as well, repeat the actions from points 3, 4, and 5.
• 8. The dropper is designed to measure the drops accurately, so do not enlarge the opening of the dropper.
• 9. After instillation, replace the cap on the bottle. Do not tighten it too much.

Administration to the ear

2-4 drops into the ear canal on the dressing 2-4 times a day.
Method of administration

• 1. Before instilling the medicine, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Lie on your side so that the treated ear is facing up.
• 4. Gently pull the earlobe (the lower part of the auricle) away from the neck.
• 5. Invert the bottle and gently press the thumb or index finger on the wall until 2-4 drops of the medicine fall into the treated ear.
• 6. After instillation, remain in a lying position for about 15 minutes so that the drops can flow into the ear canal.
• 7. Wipe off any excess drops with a clean cloth.
• 8. After instillation, replace the cap on the bottle. Do not tighten it too much.

Additional tips for administering the medicine

• 1. Having someone else help you with ear drop administration or using a mirror can make it easier to administer the medicine.
• 2. Be careful not to get water into the ear that has been treated with the medicine.
• 3. For hygiene reasons, the medicine packaging should only be used by one patient.

Using more than the recommended dose of Dicortineff

Overdose after administration to the conjunctival sac, as well as after accidental oral ingestion, is unlikely due to the small amount of active substance.
Accidental ingestion of the suspension does not cause severe side effects.
It is recommended to administer fluids to dilute the ingested medicine.

Missing a dose of Dicortineff

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Dicortineff can cause side effects, although not everybody gets them.
Dicortineff is usually well tolerated and does not usually cause significant side effects.
In case of severe hypersensitivity reactions after using the medicine, such as: rash, redness, and swelling of the skin, facial or throat swelling, chest tightness, or difficulty breathing stop using Dicortineff and contact your doctor or go to the nearest hospital immediately.
Rarely (less than 1 in 1000 patients) may occur:

• non-specific conjunctivitis or allergic reactions. See below.

Frequency not known (frequency cannot be estimated from the available data):

• itching or burning of the conjunctiva, blurred vision,
• hypersensitivity reactions, usually of a delayed type, leading to irritation, burning, stinging, itching, and skin inflammation. If you experience any of these symptoms, you should contact your doctor.

Due to the steroid content in Dicortineff, in diseases causing corneal or scleral thinning, there is a higher risk of perforation, especially after prolonged treatment (see section Warnings and precautions).
Locally applied steroids to the eye may cause increased intraocular pressure with damage to the optic nerve and visual field defects.
Intensive or prolonged local administration of corticosteroids may lead to the development of posterior subcapsular cataract.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dicortineff

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Shelf life after first opening the bottle: 4 weeks.

Shake before use.

Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dicortineff contains

• The active substances of the medicine are: neomycin, gramcidin, and fludrocortisone acetate. Each ml of suspension contains 2,500 IU of neomycin (as neomycin sulfate), 25 IU of gramcidin, and 1 mg of fludrocortisone acetate.
• Other ingredients are: tromethamine; hydrochloric acid diluted (to adjust pH); benzalkonium chloride solution; sodium chloride; ethanol 96%; purified water.

What Dicortineff looks like and contents of the pack

Dicortineff is a white or almost white suspension, which may form a sediment at the bottom after standing for a longer time; after gentle shaking, the mixture becomes uniform.
A 5 ml polyethylene bottle with a dropper and a cap with a tamper-evident ring, in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Rompharm Company SRL
1A Eroilor Street, 075100 Otopeni, Ilfov
Romania

Date of last revision of the leaflet: