PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
OXYCORT
(30 mg + 10 mg)/g, ointment
Oxytetracyclinum + Hydrocortisoni acetas
Please read this leaflet carefully 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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience 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:

What Oxycort is and what it is used for
Important information before using Oxycort
How to use Oxycort
Possible side effects
How to store Oxycort
Contents of the pack and other information

1. What Oxycort is and what it is used for

Oxycort is an ointment.
The medicine contains the active substances: oxytetracycline and hydrocortisone acetate.
Oxytetracycline is a tetracycline antibiotic active against Gram-positive and Gram-negative bacteria.
Hydrocortisone acetate is a corticosteroid with weak anti-inflammatory activity.
When applied to the skin, it exerts local anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Indications
Oxycort is used for dry and scaly lesions in the following skin diseases complicated by bacterial infection:

allergic skin diseases;
various forms of eczema;
psoriasis;
contact and seborrheic dermatitis;
chronic psoriatic lesions.

2. Important information before using Oxycort

When not to use Oxycort:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
in viral (e.g. chickenpox, cold sores), fungal or bacterial skin infections (e.g. tuberculosis skin lesions);
in acne vulgaris and rosacea;
in perioral dermatitis;
following vaccinations;
in pre-cancerous conditions and skin cancers;
on damaged skin or wounds;
in children.

Warnings and precautions
Before starting to use Oxycort, discuss this with your doctor or pharmacist.

If signs of irritation occur, discontinue use and contact your doctor. If there is no improvement after 7 days of use, contact your doctor, as the hydrocortisone acetate contained in the medicine may mask symptoms of spreading infection. Your doctor will decide whether to discontinue treatment.
Do not use the medicine continuously for longer than 2 weeks.
Do not use the medicine for longer than recommended by your doctor.
Avoid prolonged use, as long-term use may lead to the development of fungi and bacteria resistant to the antibiotic contained in the medicine. If infection symptoms worsen or do not resolve, contact your doctor.
Avoid contact of the medicine with eyes and mucous membranes.
Do not use around the eyes due to the risk of glaucoma or cataract.
Use on the facial skin, armpits and groin areas only when absolutely necessary, due to increased absorption through delicate skin and a higher risk of adverse effects (e.g. dilated blood vessels, perioral dermatitis), even after short-term use.
Use with caution in pre-existing atrophic conditions of the subcutaneous tissue, especially in elderly patients.
Do not use under occlusive dressings (airtight coverings), as this may lead to epidermal atrophy, striae or skin damage.
Avoid prolonged or extensive use over large areas of the body, as the hydrocortisone acetate (a corticosteroid) contained in the medicine may be absorbed through the skin, potentially causing systemic adverse effects typical of corticosteroids, including suppression of adrenal function (e.g. Cushing's syndrome, glycosuria, hyperglycaemia).
Patients with psoriasis should use the medicine with particular caution.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.

Children and adolescents
Do not use Oxycort in children and adolescents.

Oxycort and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
No interactions have been reported with topical use of the medicine as directed according to the recommended indications and method of administration.
Concomitant topical use of two or more medicinal products is not recommended, as this may affect the concentrations of active substances at the application site or cause skin redness.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy and breastfeeding.
The effect of hydrocortisone acetate on fertility has not been studied; however, other corticosteroids have been shown to affect fertility.

Driving and using machines
Oxycort has no effect on the ability to drive or operate machinery.

3. How to use Oxycort

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Oxycort ointment should be applied in a thin layer to the affected skin area, no more frequently than once or twice daily.
Do not use the ointment under occlusive (airtight) dressings.
Treatment should not be continued continuously for longer than 7 to 14 days.
Do not use on the face for longer than 7 days.
No more than 1 tube (10 g) of ointment should be used within one week.
Use in children and adolescents
Oxycort should not be used in children and adolescents.
Use of a higher than recommended dose of Oxycort
Prolonged use over large skin areas, in high doses, under occlusive (airtight) dressings, or on damaged skin may lead to systemic absorption of the medicine and cause systemic corticosteroid or oxytetracycline effects (see section 2: Warnings and precautions).
Missed dose of Oxycort
Do not use a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody experiences them.
Local adverse effects of unknown frequency (frequency cannot be determined from available data):
May occur: burning, itching, excessive dryness, skin atrophy, perioral dermatitis, skin maceration, acne-like changes, striae, hyperhidrosis, rash, hypertrichosis, skin discoloration, secondary skin infections and folliculitis, allergic reactions, overgrowth of yeasts or resistant bacterial strains, blurred vision.
Prolonged use on facial skin may lead to skin atrophy and dilation of blood vessels.
Irritation at the site of application may occur.

Systemic adverse effects of unknown frequency (frequency cannot be determined from available data):
With prolonged use or application over large areas of skin, hydrocortisone acetate may be absorbed into the bloodstream and cause systemic adverse effects typical of corticosteroids, such as suppression of adrenal function (see section 2: Warnings and precautions). These effects are particularly likely if the medicine is used in skin folds, in the groin area, under occlusive dressings, or if used in children.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Oxycort

Do not store above 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Oxycort contains

The active substances in this medicine are: oxytetracycline (in the form of oxytetracycline hydrochloride) and hydrocortisone acetate. Each 1 g of ointment contains 30 mg of oxytetracycline and 10 mg of hydrocortisone acetate.
Other ingredients: white soft paraffin.

What Oxycort looks like and contents of the pack
Oxycort is a homogeneous yellow ointment.
Aluminium tube containing 10 g of ointment, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, the country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaging performed at:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation number in Lithuania, the country of export: LT/1/97/0020/001
Parallel import authorisation number: 143/22