Oxycort a

Package leaflet: Information for the patient

OXYCORT A, (10 mg + 10 mg)/g, eye ointment
(Oxytetracyclinum + Hydrocortisoni acetas)
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Oxycort A is and what it is 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 package and other information

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

Oxycort A ointment contains two active substances: oxytetracycline and hydrocortisone acetate.
Oxytetracycline is an antibiotic belonging to the group of so-called tetracyclines. It inhibits the growth and multiplication of bacteria, including Gram-negative, Gram-positive, and "atypical" bacteria ( Chlamydia and Mycoplasma).
Hydrocortisone acetate is a glucocorticosteroid with local anti-inflammatory, anti-exudative, and anti-pruritic effects.
Oxycort A is used in cases of:

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

An otorhinolaryngologist may also recommend the use of this ointment for inflammatory conditions of the external ear.

2. Information before using Oxycort A

When not to use Oxycort A:

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

Warnings and precautions
Before starting treatment with Oxycort A, consult a doctor or pharmacist.
Prolonged use of the medicine may lead to increased intraocular pressure, glaucoma, optic nerve damage, and posterior subcapsular cataract; therefore, after approximately 10 days of treatment, the doctor will check intraocular pressure and lens clarity.
Long-term local use of the medicine may lead to the development of fungi and antibiotic-resistant bacteria.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought immediately.

Oxycort A and other medicines
Inform the doctor about all medicines currently used or recently used, including those obtained without a prescription.
Some medicines may enhance the effect of Oxycort A, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
No interactions have been reported with topical administration of the medicine (see also "Note" in section 3 regarding use with other eye drops or ointments).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Oxycort A may be used during pregnancy and breastfeeding only under medical supervision, following a thorough benefit-risk assessment by the physician prior to initiating treatment.

Driving and operating machinery
Oxycort A has no effect or negligible effect on the ability to drive and operate machinery. However, bear in mind that transient visual disturbances may occur immediately after administration. Therefore, driving and operating machinery should be avoided until these symptoms have completely resolved.

3. How to use Oxycort A

This medicine should be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical ocular application.
In cases of external ear inflammation, an otolaryngologist may also recommend topical application of this ointment to the ear.

Recommended dose
Unless otherwise prescribed, apply a small amount of the squeezed ointment into the conjunctival sac or onto the eyelid margins, 1–3 times daily.

Warning! Instructions for administering the medicine:

1. Wash your hands thoroughly.
2. Unscrew the cap.
3. Hold the tube with the tip (with cannula) pointing downwards, using your thumb and index finger.
4. Tilt your head backwards.
5. When administering the medicine into the conjunctival sac, gently pull down the lower eyelid with your index finger to create a "pocket" between the eyeball and the eyelid, into which the oint游戏副本

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions:
Frequency unknown (cannot be estimated from available data):
Eye burning, tearing, redness of the conjunctiva, blurred vision which may persist for several minutes after ointment application, and unsharp vision.
With prolonged use of high doses, secondary fungal infection may occur. Increased intraocular pressure may also occur, which in rare cases may lead to glaucoma, optic nerve damage, and subcapsular cataract.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information regarding the safety of this medicine can be collected.

5. How to store Oxycort A

Store below 25°C.
Keep the medicine out of sight and reach of children.
The shelf-life after first opening the tube is 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Oxycort A contains
The active substances in the medicine are: oxytetracycline (in the form of oxytetracycline hydrochloride)
and hydrocortisone acetate.
The other ingredient in the medicine is: white vaseline.

What Oxycort A looks like and contents of the pack
Oxycort A is a homogeneous yellow ointment.
Aluminium tube, internally lacquered, with a cannula made of HDPE, secured with a cap made of HDPE+LDPE,
in a cardboard box.
3 g

Marketing Authorisation 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