OXYCORT 5 mg /1.67 Mg Aerosol

Contents of the leaflet

1. Checked in terms of TERRITORIAL
2. What is Oxycort and what is it used for
   1. Indications for use
3. Important information before using Oxycort
4. How to use Oxycort
5. Possible side effects
6. How to store Oxycort
7. Contents of the packaging and other information
   1. Warnings and precautions
   2. Other medicines and Oxycort
   3. Pregnancy and breastfeeding
   4. Driving and using machines
   5. Dosage and administration Always use the medicine as recommended by the doctor or pharmacist.
   6. Side effects
   7. Storage
   8. Adults
   9. Children and adolescents
   10. Treatment duration
   11. Application
   12. In case of a missed dose of Oxycort
8. Possible side effects
9. How to store Oxycort
10. Contents of the packaging and additional information
11. Storage of Oxycort
12. Contents of Oxycort and other information
    1. What Oxycort looks like and what the packaging contains
    2. Responsible entity Pharmaceutical Works Polpharma S.A.
    3. Date of the last update of the leaflet

Checked in terms of TERRITORIAL

Leaflet attached to the packaging: patient information
Should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
Should keep this leaflet, so that it can be read again if necessary.
In case of any doubts, should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Should not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, should tell the 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. Contents of the packaging and other information

1. What is Oxycort and what is it used for

Oxycort – skin spray, suspension - contains two active substances: oxytetracycline and hydrocortisone.
Oxytetracycline is an antibiotic belonging to the tetracycline group. It has a bacteriostatic effect on many Gram-positive and Gram-negative bacteria.
Hydrocortisone is a corticosteroid. It has anti-inflammatory, anti-itching, and vasoconstrictive effects.
Oxycort acts on tetracycline-sensitive bacteria in skin inflammation foci and limits local inflammatory processes, reduces redness and itching.

Indications for use

Oxycort is used for local treatment of skin inflammatory conditions complicated by bacterial infection, in the course of the following skin diseases: seborrheic, atopic, contact, urticarial – with pustular rash, eczema, lichen planus, ingrown nails.

2. Important information before using Oxycort

Do not use Oxycort

1. If the patient is allergic to oxytetracycline, hydrocortisone, or any other component of this medicine.
2. If the patient has a fungal skin infection.
3. If the patient has a viral skin infection (e.g., herpes, chickenpox).
4. If the patient has rosacea.

Use Oxycort with caution
Before starting to use Oxycort, should inform the doctor in case of:

• pregnancy or breastfeeding
• presence of other diseases, especially diabetes, glaucoma, cataract
• use of other medicines, including topical ones

Using Oxycort with other medicines
Should inform the doctor about all medicines being taken, including those available without a prescription.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, should consult a doctor before using Oxycort.

3. How to use Oxycort

Oxycort should be used as recommended by the doctor.
Usually, a thin layer of the spray is applied 2-3 times a day to the affected skin areas.
Should not use Oxycort for more than 7 days without consulting a doctor.
In case of no improvement or worsening of symptoms, should stop using the medicine and consult a doctor.

4. Possible side effects

Like all medicines, Oxycort can cause side effects, although not everybody gets them.
Common side effects (may occur in less than 1 in 10 patients):

• skin irritation at the application site
• itching
• redness of the skin

Uncommon side effects (may occur in less than 1 in 100 patients):

• rash
• hives
• swelling

Rare side effects (may occur in less than 1 in 1000 patients):

• allergic reactions
• secondary infections

In case of any side effects, should stop using the medicine and consult a doctor.

5. How to store Oxycort

Store in a room temperature (up to 25°C). Protect from light and moisture.
Store in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging.

6. Contents of the packaging and other information

1 spray contains 0.5 g oxytetracycline and 0.1 g hydrocortisone.
Other ingredients: isopropanol, propylene glycol, purified water.
Manufacturer: Polpharma S.A.

Warnings and precautions

Before starting to use the medicine, should discuss it with a doctor or pharmacist.

• Oxycort in the form of a spray is intended only for topical use on the skin.
• Should protect the eyes from the sprayed substance. In case of the suspension getting into the eyes, should rinse them thoroughly with warm water.
• If skin irritation occurs at the site of application, should stop using the medicine and consult a doctor.
• If after 7 days of use there is no improvement, should consult a doctor, as hydrocortisone may mask the symptoms of a spreading infection. The doctor will decide whether to stop using the medicine.
• Corticosteroids are absorbed through the skin. Should avoid using the medicine for a long time or on a large surface of the body. Should not use the medicine under occlusive dressings (sealing), as it may lead to skin atrophy, stretch marks, and superinfections. Systemic side effects characteristic of corticosteroids may also occur, including adrenal gland suppression (e.g., Cushing's syndrome, glucosuria, high blood sugar levels).
• During treatment, should avoid sunbathing or exposure to artificial ultraviolet radiation (e.g., solarium). Due to the presence of oxytetracycline in the medicine, skin symptoms of hypersensitivity (photodermatitis) may occur.
• Should not use the medicine for longer than recommended by the doctor. Long-term use of the medicine may lead to the development of antibiotic-resistant fungi and bacteria. If the symptoms of the infection worsen or do not improve, should consult a doctor.

Other medicines and Oxycort

Should tell the doctor or pharmacist about all medicines being taken currently or recently, as well as about medicines that the patient plans to use.
During treatment, should not use other topical medicines at the same time, as it may affect the concentration of the active substances at the application site, harming the patient.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, should use the medicine with caution and only if the benefit to the mother outweighs the potential risk to the child. Should avoid using the medicine on a large surface of the body.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Dosage and administration Always use the medicine as recommended by the doctor or pharmacist.

Adults and children over 12 years of age:

1. Usually, apply a thin layer of the medicine 2-3 times a day to the affected skin area.
2. The treatment duration should not exceed 7 days without consulting a doctor.

In case of a missed dose, should use the medicine according to the next schedule.

Side effects

Like all medicines, Oxycort can cause side effects, although not everybody gets them.

• Common side effects: skin irritation at the application site, burning, itching.
• Rare side effects: allergic reactions, skin atrophy, stretch marks, bacterial or fungal superinfections, skin pigmentation changes.
• Very rare side effects: systemic symptoms characteristic of corticosteroids (e.g., Cushing's syndrome, glucosuria).

In case of side effects, should stop using the medicine and consult a doctor.

Storage

Store in a room temperature (up to 25°C). Protect from light. Store in a place inaccessible to children.

Adults

Should spray the affected skin areas with a stream of suspension, holding the can vertically, with the spray head up, at a distance of 15-20 cm, for 1 to 3 seconds. Should use from 2 to 4 times a day at equal time intervals.
Note: Should protect the eyes from the sprayed substance.
Should not inhale the sprayed substance.
After each application of the medicine, should wash hands thoroughly with soap and water.
Before each use, should shake the can vigorously.

Children and adolescents

There is no data on the safety of use.

Treatment duration

The doctor will determine the appropriate treatment duration. Usually, the treatment duration is 7 to 14 days.
In case of a feeling that the effect of the medicine is too strong or too weak, should consult a doctor.

Application

For long-term use at the recommended dose of Oxycort.
After long-term use on large skin surfaces, in high doses, under occlusive dressings (sealing), or on damaged skin, the medicine may be absorbed into the blood and cause systemic corticosteroid effects or substitution (see section 2: When to be cautious when using Oxycort).
Should immediately consult a doctor in case of accidental ingestion of the medicine.
Oxycort is intended only for use on the skin, not for oral use. In case of accidental ingestion of the medicine, the doctor may recommend the use of an appropriate method of stomach emptying.

In case of a missed dose of Oxycort

In case of missing a dose at a fixed, specified time, should use the medicine as soon as possible, and then continue the regular use of the medicine.
Should not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Oxycort can cause side effects, although not everybody gets them.

• Hydrocortisone, used topically, may cause local side effects, especially with long-term use, in high doses, under occlusive dressings, or on large skin surfaces.
• Common (occurring in 1 to 10 out of 100 patients):

1. Itching, burning, or irritation at the application site.
2. Skin changes, such as: acne, dilated blood vessels, skin pigmentation changes, skin maceration.

• Rare (occurring in 1 to 10 out of 1000 patients):

1. Skin atrophy (reduced skin thickness).
2. Skin infections.

• Very rare (occurring less frequently than 1 in 10,000 patients):

1. Allergic reactions (rash, itching, swelling).
2. Excessive hair growth.
3. Perioral dermatitis.

In case of side effects, should stop using the medicine and consult a doctor.

5. How to store Oxycort

Store in a room temperature, in a dry place.
Protect from light.
Store in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging.

6. Contents of the packaging and additional information

Oxycort, solution for skin use
Packaging: 20 ml
Responsible entity: Galderma Polska Sp. z o.o., ul. Żelazna 59/61, 00-807 Warszawa
To obtain additional information, should contact the responsible entity.

5. Storage of Oxycort

Should store the medicine in a place invisible and inaccessible to children.
Store in a temperature below 25°C.
Do not use the medicine after the expiry date (EXP) stated on the packaging.
The expiry date means the last day of the specified month.

• Highly flammable aerosol
• Pressurized container. Limited explosion risk.
• Store away from heat sources/ignition sources, open flames/hot surfaces. Smoking prohibited.
• Do not spray near open flames or other ignition sources.
• Pressurized container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.

Medicines should not be disposed of via wastewater or household waste. Should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of Oxycort and other information

The active substance of the medicine is oxytetracycline hydrochloride and hydrocortisone.
1 g of suspension contains 9.30 mg of oxytetracycline hydrochloride and 13.0 mg of hydrocortisone.
Other ingredients of the medicine are: sorbitan trioleate, isopropanol mixture, myristate, propane, butane, isobutane.

What Oxycort looks like and what the packaging contains

Appearance: Brown suspension in a pressurized container.
Packaging: Aerosol container 50 ml.

Responsible entity Pharmaceutical Works Polpharma S.A.

ul. Pełczyńska 5, 05-850 Starachowice
tel.: +48 24 221 31 31
e-mail: [email protected]

Date of the last update of the leaflet

2023-11