Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
OXYCORT, (30 mg + 10 mg)/g, ointment
Oxytetracyclinum + Hydrocortisoni acetas
Please read the entire 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 doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What is Oxycort and what is it 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 is Oxycort and what is it used for

Oxycort is an ointment.
The medicine contains the active substances: oxytetracycline and hydrocortisone acetate.
Oxytetracycline is an antibiotic belonging to the tetracycline group and acts 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, and vasoconstrictive effects.
Indications
Oxycort is used for dry, scaly lesions in the following skin diseases complicated by bacterial infection:

skin diseases of allergic origin;
various forms of eczema;
lichen;
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 to any of the other ingredients of this medicine (listed in section 6);
in viral (e.g. chickenpox, herpes simplex), fungal or bacterial skin infections (e.g. tuberculosis skin lesions);
in acne vulgaris and rosacea;
in perioral dermatitis;
following vaccinations;
in precancerous conditions and skin cancers;
on damaged skin or wounds;
in children.

Warnings and precautions
Before starting to use Oxycort, discuss it 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 treatment should be discontinued.
Do not use the medicine continuously for longer than 2 weeks.
Do not use the medicine for longer than prescribed by your doctor.
Avoid prolonged use, as long-term use may lead to the development of antibiotic-resistant fungi and bacteria. 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 developing glaucoma or cataracts.
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 existing atrophic conditions of subcutaneous tissue, especially in elderly patients.
Do not use under occlusive dressings (airtight coverings), as this may lead to epidermal atrophy, striae and skin damage.
Avoid prolonged use or application over large body surface areas, as the hydrocortisone acetate contained in the medicine (a corticosteroid) may be absorbed through the skin, potentially leading to 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 blurred vision or other visual disturbances occur, contact your doctor.

Children and adolescents
Do not use Oxycort in children and adolescents.
Oxycort and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions have been reported during topical use according to the recommended indications and method of administration.
Concomitant topical use of two or more medicines is not recommended, as this may affect the concentration of active substances at the site of application or cause skin redness.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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 or breastfeeding.
The effect of hydrocortisone acetate on fertility has not been studied; however, effects of other corticosteroids on fertility have been demonstrated.
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 prescribed by your doctor. In case of doubt, consult
your doctor or pharmacist.
Oxycort ointment should be applied thinly to the affected skin area, no more than once or twice daily.
Do not use the oint游戏副本

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Local adverse effects with unknown frequency (frequency cannot be determined from available data):
May occur: burning sensation, itching, excessive dryness, skin atrophy, perioral dermatitis, skin maceration, acne-like changes, striae, increased sweating, rash, hypertrichosis, skin discoloration, secondary skin infections and folliculitis, allergic reactions, proliferation 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 with 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 may be particularly likely if the medicine is used in skin folds, in the groin area, under occlusive dressings, or in children.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse effects
If any adverse effects occur, including adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
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 stated month.
Medicines must not be disposed of via sewage systems 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 package and other information

What Oxycort contains

The active substances in the 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 petrolatum.

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.
Responsible party in Lithuania, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Lithuania, country of export: LT/1/97/0020/001
Parallel import authorisation number: 81/22