Oxicort A

Leaflet attached to the packaging: patient information

OXYCORT A, (10 mg + 10 mg)/g, eye ointment

(Oxytetracycline + 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 or pharmacist.
• -This medicine has been prescribed to you by a doctor. 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Oxycort A and what is it used for

Oxycort A ointment contains two active ingredients: oxytetracycline and hydrocortisone acetate.
Oxytetracycline is an antibiotic belonging to the group of so-called tetracyclines. It inhibits the growth and multiplication of bacteria known as Gram-negative, Gram-positive, and "atypical" bacteria (Chlamydia and Mycoplasma).
Hydrocortisone acetate is a glucocorticosteroid that acts locally anti-inflammatory, anti-edematous, and antipruritic.
Oxycort A is used in the case of:

• acute and chronic bacterial infections of the eyelid margins
• inflammatory conditions of the cornea and iris.

An ear, nose, and throat specialist may also recommend using this ointment in cases of external ear inflammation.

2. Important information before using Oxycort A

When not to use Oxycort A:

• if you are allergic to the active substances (oxytetracycline, hydrocortisone), other antibiotics from the tetracycline group, or any of the other ingredients of this medicine (listed in section 6);
• if you have acute conjunctivitis, primary glaucoma, corneal diseases associated with epithelial defects;
• in the case of viral diseases: herpes, chickenpox, viral keratitis;
• in the case of fungal or tuberculosis infections.

Warnings and precautions

Before starting to use Oxycort A, discuss it with your doctor or pharmacist.
Prolonged use of the medicine may lead to increased intraocular pressure, glaucoma, damage to the optic nerve, and posterior subcapsular cataract, so after about 10 days of treatment, the doctor will check the intraocular pressure and the so-called lens transparency.
Long-term local use of the medicine may lead to the development of fungi and bacteria resistant to the antibiotic contained in the ointment.
If you experience blurred vision or other vision disturbances, contact your doctor.

Oxycort A and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, including those that are available without a prescription.
Some medicines may enhance the effect of Oxycort A, and your doctor may want to closely monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
No interactions have been found with local use of the medicine (see also "Note" in section 3 regarding the use of the medicine with other eye drops or ointments).

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.
Oxycort A may be used during pregnancy and breastfeeding only on the advice of a doctor, who will assess the benefit-risk ratio before starting treatment.

Driving and using machines

Oxycort A has no influence or negligible influence on the ability to drive and use machines.
However, remember that immediately after administration of the medicine, temporary vision disturbances may occur, so do not drive or operate machines until these symptoms have completely resolved.

3. How to use Oxycort A

Use this medicine as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The medicine is intended for local use in the eye.
In the case of external ear inflammation, an ear, nose, and throat specialist may also recommend using this ointment locally in the ear.
Recommended dose
If not otherwise prescribed, apply a small amount of ointment to the conjunctival sac or eyelid margins, 1-3 times a day.

Important! Instructions for administering the medicine:

• 1. Wash your hands thoroughly.
• 2. Unscrew the cap.
• 3. Hold the tube with the nozzle (with the cannula) downwards, using your thumb and index finger.
• 4. Tilt your head back.
• 5. If the medicine is to be administered to the conjunctival sac, gently pull down the lower eyelid with your index finger to form a "pocket" between the eye and the eyelid, into which the ointment will be inserted.

• 6. Bring the nozzle close to the eye, without touching the nozzle to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze out the ointment onto the eyelid margins or, in the case of administration to the conjunctival sac, looking up, insert a small amount of ointment directly into the formed "pocket". If the medicine does not get into the eye, repeat the procedure.
• 8. Gently close the eyelid.
• 9. If administering to the conjunctival sac, press the inner corner of the eye at the base of the nose with your finger. This will help minimize the risk of the medicine getting into the entire body.
• 10. If the ointment is to be administered to both eyes, repeat the above steps for the second eye.
• 11. Immediately after use, screw the tube cap back on carefully.

Having someone assist you or using a mirror may make it easier to administer the medicine.
Oxycort A is a sterile medicine. To avoid contamination, do not touch the nozzle with your fingers or touch it to the eye surface or any other surface. Using contaminated ointments can lead to serious eye damage, including vision loss.
If you feel that the effect of Oxycort A is too strong or too weak, talk to your doctor or pharmacist.
Important:
If Oxycort A is used at the same time as other eye drops or ointments, keep a 15-minute interval between administering the medicines, and apply Oxycort A last.

Using a higher dose of Oxycort A than recommended

With prolonged incorrect use of the medicine, posterior glaucoma may occur.
In such a case, the doctor will decide on further treatment.

Missing a dose of Oxycort A

Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose. If you have missed several doses, inform your doctor and follow their advice.

Stopping the use of Oxycort A

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxycort A can cause side effects, although not everybody gets them.
Possible side effects:
Frequency not known (cannot be estimated from the available data):
Burning sensation in the eye area, tearing, conjunctival redness, and blurred vision, which may last for a few minutes after applying the ointment, blurred vision.
With long-term use of high doses, secondary infection (infection) with fungi may occur. Increased intraocular pressure may also occur, which in rare cases can lead to glaucoma, optic nerve damage, and posterior subcapsular cataract.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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 this medicine.

5. How to store Oxycort A

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Shelf life after first opening the tube – 28 days.
Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.
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. Contents of the pack and other information

What Oxycort A contains

The active substances of the medicine are: oxytetracycline (in the form of oxytetracycline hydrochloride) and hydrocortisone acetate.
The other ingredient of the medicine is: white petrolatum.

What Oxycort A looks like and contents of the pack

Oxycort A is a homogeneous ointment of yellow color.
Aluminum tube, internally lacquered, with an HDPE nozzle, protected with an HDPE+LDPE cap in a cardboard box.
3 g

Marketing authorization holder

Bausch Health 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: