Oxicort

Package Leaflet: Information for the Patient

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

(Oxytetracycline + Hydrocortisone Acetate)

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

• Keep this leaflet, you may need to read it again.
• In case of 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. 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 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;
• neurodermatitis;
• contact and seborrheic dermatitis;
• chronic psoriatic changes.

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, herpes simplex), fungal, or bacterial skin infections (e.g., on tuberculous changes);
• in common and rosacea acne;
• in perioral dermatitis;
• after protective vaccinations;
• in pre-cancerous 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, discontinue use and consult a doctor.
• If there is no improvement after 7 days of use, consult a doctor, as the hydrocortisone acetate contained in the medicine may mask the symptoms of a spreading infection. The doctor will decide whether to discontinue the medicine.
• Do not use the medicine without interruption 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 prolonged use may lead to the development of fungi and bacteria resistant to the antibiotic contained in the medicine. If the symptoms of infection worsen or do not improve, consult 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 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, 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 of the medicine 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, which may cause systemic side effects characteristic of corticosteroids, including adrenal suppression (e.g., Cushing's syndrome, glucosuria, 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 consult a doctor.

Children and adolescents

Do not use the medicine in children and adolescents.

Oxycort and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans 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, thinks they may be pregnant, or plans to have a child, they should 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 has no effect on the ability to drive and use machines.

3. How to use Oxycort

Always use this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.
Oxycort ointment is applied in a thin layer to the affected skin surface, 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, no more than 1 tube (10 g) of ointment should be used.

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 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 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 occur: burning, itching, excessive drying, atrophic changes of the skin, perioral dermatitis, maceration of the skin, acne-like changes, stretch marks, diaper rash, 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 of the medicine.
Systemic side effects of unknown frequency (frequency cannot be estimated from the 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 suppression (see section 2: Warnings and precautions). These effects may occur especially if the patient uses the medicine in skin folds, armpits, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxycort

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use Oxycort after the expiry date stated on the tube and carton. The expiry date refers to the last day of that month.
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. Contents of the pack 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 contents of the pack

Oxycort is a uniform yellow ointment.
An aluminum tube containing 10 g of ointment, in a cardboard box.

Marketing authorization 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
tel.: (075) 643 31 02
fax: (075) 752 44 55
e-mail: [email protected]

Date of last revision of the leaflet: