OXYCORT 30 mg + 10 Mg Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. OXYCORT, (30 mg + 10 mg)/g, ointment
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Oxycort and what is it used for
   1. Indications for use
5. Important information before using Oxycort
   1. When not to use Oxycort:
   2. Warnings and precautions
   3. Children and adolescents
   4. Oxycort and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
6. How to use Oxycort
   1. Use in children and adolescents
   2. Using more than the recommended dose of Oxycort
   3. Missing a dose of Oxycort
7. Possible side effects
   1. Reporting side effects
8. How to store Oxycort
9. Package contents and other information
   1. What Oxycort contains
   2. What Oxycort looks like and what the pack contains
   3. Marketing authorization holder in Lithuania, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 81/22 Date of approval of the leaflet: 15.02.2022

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

OXYCORT, (30 mg + 10 mg)/g, ointment

Oxytetracycline + Hydrocortisone acetate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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, effective against Gram-positive and Gram-negative bacteria.
Hydrocortisone acetate is a medicine from the corticosteroid group with mild anti-inflammatory effects.
When applied to the skin, it acts locally as an anti-inflammatory, anti-itch, and vasoconstrictive agent.

Indications for use

Oxycort is used for scaly and dry changes in the following skin diseases, complicated by bacterial infections:

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

2. Important information before using Oxycort

When not to use Oxycort:

• in viral (e.g., chickenpox, herpes simplex), fungal, or bacterial skin infections (e.g., on tuberculous lesions);
• in common and rosacea acne;
• in perioral dermatitis;
• after protective vaccinations;
• in cases of precancerous and cancerous skin conditions;
• on damaged skin and wounds;
• in children.

Warnings and precautions

Before starting to use Oxycort, consult a doctor or pharmacist.

• If irritation symptoms occur, stop using the medicine and contact a doctor.
• If there is no improvement after 7 days of use, contact a doctor, as the hydrocortisone acetate in the medicine may mask the symptoms of a spreading infection. The doctor will decide whether to stop using the medicine.
• Do not use the medicine continuously for more than 2 weeks.
• Do not use the medicine for longer than prescribed by the doctor.
• Avoid long-term use of the medicine, as it may cause the development of fungi and bacteria resistant to the antibiotic in the medicine. If the symptoms of infection worsen or do not improve, contact a 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 axillary and groin areas, use only when absolutely necessary, due to increased absorption of the medicine through delicate skin and a higher risk of side effects (vasodilation, perioral dermatitis), even after short-term 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 long-term use or use on large areas of the body, as the hydrocortisone acetate in the medicine (from the corticosteroid group) is absorbed through the skin, which may cause systemic side effects characteristic of corticosteroids, including adrenal suppression (e.g., Cushing's syndrome, diabetes, excessive blood sugar levels).
• Patients with psoriasis should use the medicine with particular caution.
• If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.

Children and adolescents

Do not use the medicine in children and adolescents.

Oxycort and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 site of application or cause skin redness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.
Do not use the medicine 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

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Apply a thin layer of Oxycort ointment to the affected skin area, no more than once or twice a day.
Do not use the ointment 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, do not use more than 1 tube (10 g) of ointment.

Use in children and adolescents

Do not use the medicine in children and adolescents.

Using more than the recommended dose of Oxycort

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

Missing a dose of Oxycort

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, 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 estimated from the available data):
May include: burning, itching, excessive dryness, atrophic skin changes, perioral dermatitis, skin maceration, acne-like changes, stretch marks, folliculitis, rash, excessive hair growth, skin discoloration, secondary skin infections and folliculitis, allergic reactions, growth of 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.
Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):
During prolonged use of the medicine or use on large areas of skin, hydrocortisone acetate may be absorbed into the bloodstream and cause systemic side effects characteristic of corticosteroids, such as adrenal suppression (see section 2: Warnings and precautions). These effects may occur especially if the patient uses the medicine in skin folds, axillae, under an occlusive dressing (sealing), or in children.
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 provide more information on the safety of this medicine.

5. How to store Oxycort

Do not store above 25°C.
Keep the medicine out of the 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 month stated.
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. Package contents and other information

What Oxycort contains

• The active substances are: oxytetracycline (as 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 pack contains

Oxycort is a uniform yellow ointment.
An aluminum tube containing 10 g of ointment, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, the country of export, marketing authorization number: LT/1/97/0020/001

Parallel import authorization number: 81/22 Date of approval of the leaflet: 15.02.2022

[Information about the trademark]