Oxicort

LEAFLET INCLUDED IN THE PACKAGE: 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
Oxytetracycline + Hydrocortisone acetate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Oxycort and what is it used for
• 2. Important information before using Oxycort
• 3. How to use Oxycort
• 4. Possible side effects
• 5. How to store Oxycort
• 6. Package contents 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 from the tetracycline group, it acts on Gram-positive and Gram-negative bacteria.
Hydrocortisone acetate is a medicine from the corticosteroid group with mild anti-inflammatory action.
Applied to the skin, it acts locally anti-inflammatory, anti-itching, and vasoconstrictive.

Indications for use

Oxycort is used for scaly and dry changes in the following bacterial infection-complicated skin diseases:

• skin diseases of allergic origin;
• various forms of eczema;
• pruritus;
• 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, common herpes), fungal, or bacterial skin infections (e.g., on tuberculous lesions);
• in common and rosacea acne;
• in dermatitis around the mouth;
• after protective vaccinations;
• in cases of pre-cancerous and skin cancer conditions;
• on damaged skin and wounds;
• in children.

Warnings and precautions

Before starting to use Oxycort, you should discuss it with your doctor or pharmacist.

• If irritation symptoms occur, you should stop using the medicine and contact your doctor. If after 7 days of use there is no improvement, you should contact your doctor, as the hydrocortisone acetate contained in the medicine may mask the symptoms of an expanding infection. The doctor will decide whether to stop using the medicine.
• Do not use the medicine without interruption for more than 2 weeks.
• Do not use the medicine for longer than prescribed by your doctor.
• Avoid using the medicine for a long time, as prolonged use of the medicine may cause the development of fungi and bacteria resistant to the antibiotic contained in the medicine. If the symptoms of the infection worsen or do not subside, you should contact your doctor.
• Avoid contact of the medicine with the eyes and mucous membranes.
• Do not use around the eyes, due to the risk of glaucoma or cataracts.
• On facial skin and in the armpits and groin, use only in absolutely necessary cases, due to increased absorption of the medicine through delicate skin and a higher risk of side effects (vasodilation, dermatitis around the mouth), even after short use.
• Use with caution in existing atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Do not use under occlusive dressings (sealing), as it may lead to epidermal atrophy, stretch marks, and superinfections.
• Avoid using the medicine for a long time or on a large surface of the body, as the hydrocortisone acetate contained in the medicine (from the corticosteroid group) is absorbed through the skin, resulting in systemic side effects characteristic of corticosteroids, including adrenal gland suppression (e.g., Cushing's syndrome, glucosuria, excessive blood sugar levels).
• Patients with psoriasis should use the medicine with special caution.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children and adolescents

Do not use the medicine in children and adolescents.

Oxycort and other medicines

You should tell your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
No interactions have been found during local use of the medicine in accordance with the recommended indications and method of use.
It is not recommended to use two or more medicines locally at the same time, 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 or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine should not be used during pregnancy and breastfeeding.
The effect of hydrocortisone acetate on fertility has not been studied, but other corticosteroids have been shown to affect fertility.

Driving and using machines

Oxycort does not affect the ability to drive and use machines.

3. How to use Oxycort

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Oxycort ointment is applied in a thin layer to the affected skin surface, no more than once or twice a day.
The ointment should not be used under an occlusive dressing (sealing).
Treatment should not be continued without interruption for more than 7 to 14 days.
On facial skin, do not use for more than 7 days.
Within one week, no more than 1 tube (10 g) of ointment can be used.

Use in children and adolescents

Do not use the medicine in children and adolescents.

Using a higher dose of Oxycort than recommended

After prolonged use on large skin surfaces, in large doses, under an occlusive dressing (sealing), or on damaged skin, the medicine may be absorbed into the blood and cause systemic corticosteroid or oxytetracycline action (see section 2: Warnings and precautions).

Missing a dose of Oxycort

Do not use a double dose to make up for a missed dose. In case of any further doubts about using this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Oxycort can cause side effects, although not everybody gets them.
Local side effects of unknown frequency (frequency cannot be determined from available data):
May occur: burning, itching, excessive drying, atrophic skin changes, dermatitis around the mouth, skin maceration, acne-like changes, stretch marks, diaper rash, rash, excessive hair growth, skin discoloration, secondary skin infections, and folliculitis, allergic reactions, yeast or resistant bacterial strains, blurred vision.
Prolonged use on facial skin may cause skin atrophy and vasodilation.
Irritation may occur at the site of application of the medicine.
Systemic side effects of unknown frequency (frequency cannot be determined from available data):
During prolonged use of the medicine or use on large skin surfaces, hydrocortisone acetate may be absorbed into the blood and cause systemic side effects characteristic of corticosteroids, such as adrenal gland suppression (see section 2: Warnings and precautions). These effects may occur especially if the patient uses the medicine in skin folds, groin, under an occlusive dressing (sealing), or in children.
If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of 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 Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Oxycort

Do not store above 25°C.
The medicine should be stored out of sight and 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 should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Oxycort contains

• The active substances of the medicine are: oxytetracycline (in the form of oxytetracycline hydrochloride) and hydrocortisone acetate. 1 g of ointment contains 30 mg of oxytetracycline and 10 mg of hydrocortisone acetate.
• The other ingredients are: white petrolatum.

What Oxycort looks like and what the package contains

Oxycort is a uniform yellow ointment.
An aluminum tube containing 10 g of ointment, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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

Repackaged by:

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 authorization number in Lithuania, the country of export: LT/1/97/0020/001

Parallel import authorization number: 143/22 Date of leaflet approval: 28.03.2022

[Information about the trademark]