Atecortin

Package Leaflet: Information for the Patient

ATECORTIN, (5 mg + 10,000 IU + 15 mg)/ml, eye and ear drops, suspension
(Oxytetracycline + Polymyxin B sulfate + Hydrocortisone acetate)

Read the 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, pharmacist, or nurse.
• -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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Atecortin and what is it used for
• 2. Important information before using Atecortin
• 3. How to use Atecortin
• 4. Possible side effects
• 5. How to store Atecortin
• 6. Package contents and other information

1. What is Atecortin and what is it used for

Atecortin is a three-component medicine used locally in ophthalmology and laryngology.
Oxytetracycline is an antibiotic from the tetracycline group. It acts bacteriostatically on both Gram-positive and Gram-negative bacteria.
Polymyxin B is a polypeptide antibiotic. It acts bactericidally mainly on Gram-negative microorganisms, with the exception of the Proteus species. It does not act on staphylococci and streptococci.
Hydrocortisone acetate is a glucocorticosteroid with mild anti-inflammatory, antiallergic, and anti-edematous effects.
The action of Atecortin is the result of the combined action of its components.

Indications for use

In ophthalmology:

• bacterial conjunctivitis and blepharitis, dacryocystitis, keratitis;
• after surgical procedures on the eyeball (after complete healing of the wound, i.e., after about 8 to 10 days after the procedure). In otology:
• otitis externa.

2. Important information before using Atecortin

When not to use Atecortin:

• -if the patient is allergic to the active substances or any of the other components of this medicine (listed in section 6);
• if the patient has fungal conjunctivitis, viral diseases (herpes, chickenpox, viral keratitis or retinitis);
• in primary glaucoma;
• in ocular tuberculosis.

Warnings and precautions

Before starting to use Atecortin, discuss it with your doctor or pharmacist.
Before using this medicine, tell your doctor if you currently have or have had a damaged eardrum. The patient should consult a doctor if they experience hearing or balance disorders.

• if the patient currently has or has had a perforated eardrum. The patient should consult a doctor if they experience hearing or balance disorders.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
The medicine should be used under the control of an ophthalmologist or laryngologist and cannot be used for diseases other than those prescribed by the doctor.
The medicine is used for about 7 days, unless the doctor recommends otherwise.
Do not use in the absence of inflammation, do not instill into the ears in case of a perforated eardrum.

Children and adolescents

In children, the medicine can only be used in case of absolute necessity.

Atecortin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take.
Some medicines may enhance the effect of Atecortin, and your doctor may want to closely monitor your condition while taking such medicines (including some HIV medicines: ritonavir, cobicistat).
No interactions with other medicines have been reported during the use of this form of the medicine.
However, if other eye drops are used, a 5-10 minute interval should be maintained between the medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use of the medicine during pregnancy is only allowed when absolutely necessary, and the use of a safer medicine is impossible or contraindicated.
Use of the medicine during pregnancy may only be carried out on the prescription of a specialist doctor.
Breastfeeding
Use of the medicine during breastfeeding is not recommended.

Driving and using machines

Atecortin does not affect the ability to drive and use machines. However, keep in mind that immediately after administration, temporary vision disturbances may occur.

3. How to use Atecortin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
In ophthalmology
1 to 2 drops are instilled into the conjunctival sac, 2 to 3 times a day.
The medicine is used for about 7 days, unless the doctor recommends otherwise.
In otology
2 to 4 drops are instilled into the ear, 3 times a day. The medicine is used for about 7 days, unless the doctor recommends otherwise.
Before use, the suspension should be gently shaken.

Do not touch the tip of the tube to the eye, ear, or surrounding area. This may cause bacterial contamination, which can lead to infection and serious eye damage, even vision loss. To avoid contamination of the suspension, avoid contact between the tip of the tube and any surface.

How to use the medicine in the eye:
1. Wash your hands before administration.
2. Unscrew the tube cap.
3. Make sure the tip of the tube does not touch anything.
4. Hold the tube with your thumb and index finger.
5. Tilt your head back and pull the lower eyelid down with your index finger.
6. Bring the dropper tip close to the eye - without touching the surface or eyelids - and gently squeeze the tube to release one drop of the suspension into the eye.

• 7. Then, close your eyes and gently press the inner corner of the eye with your index finger for 1 minute.
• 8. If the doctor has prescribed instillation into the second eye, repeat the steps from 4 to 7.
• 9. After use, screw the tube cap back on.

How to use the medicine in the ear:

• 1. Unscrew the tube cap.
• 2. Lie on your side, with the ear to be treated facing up.
• 3. Instill the drops into the ear canal and remain in the lying position for about 15 minutes.
• 4. If the doctor has prescribed instillation into the second ear, repeat steps 2 and 3.
• 5. After use, screw the tube cap back on.

Use the medicine as directed by your doctor. Do not extend the treatment period beyond the time specified by your doctor. It is not recommended to use the medicine for more than about 7 days.

Missing a dose of Atecortin

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Atecortin can cause side effects, although not everybody gets them.
If you experience allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing, stop using Atecortin and contact your doctor immediately.
Side effects may occur with the following frequency:
very common: more than 1 in 10 people
common: between 1 in 10 and 1 in 100 people
uncommon: between 1 in 100 and 1 in 1,000 people
rare: between 1 in 1,000 and 1 in 10,000 people
very rare: less than 1 in 10,000 people
frequency not known: cannot be estimated from available data
Eye disorders:
rare - allergic reactions (redness, itching);
frequency not known - conjunctival irritation, burning, and itching of the eye area after administration, blurred vision.
Prolonged use (more than 3 to 6 weeks) may cause secondary fungal infection, increased intraocular pressure, and lead to the development of steroid cataracts.
Hearing disorders:
frequency not known - hearing disorders (hearing loss, deafness, ringing, or buzzing in the ears) or dizziness caused by ear canal blockage (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atecortin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Shelf life:
28 days after first opening.
Do not use this medicine after the expiry date stated on the tube. The expiry date is the last day of the given month.
After each use, the tube should be tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atecortin contains

• The active substances of the medicine are oxytetracycline (as oxytetracycline hydrochloride), polymyxin B sulfate, and hydrocortisone acetate. 1 ml of the suspension contains: oxytetracycline (as oxytetracycline hydrochloride) 5 mg, polymyxin B sulfate 10,000 IU, hydrocortisone acetate 15 mg
• The other ingredients of the medicine are aluminum stearate, liquid paraffin.

What Atecortin looks like and contents of the package

Atecortin is a yellow, oily suspension.
An aluminum tube, internally lacquered, with an HDPE nozzle, protected with a cap made of 90% HDPE + 10% LDPE, in a cardboard box.
5 ml

Marketing authorization holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21
Date of last revision of the leaflet: 07/2025