Hidrocortisonum oceanic

Leaflet attached to the packaging: patient information

Hydrocortisonum Oceanic, 5 mg/g, cream

Hydrocortisone acetate

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

This medicine should always be used exactly as described in this patient leaflet or according to the doctor's, pharmacist's, or nurse's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• 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.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Hydrocortisonum Oceanic and what is it used for
• 2. Important information before using Hydrocortisonum Oceanic
• 3. How to use Hydrocortisonum Oceanic
• 4. Possible side effects
• 5. How to store Hydrocortisonum Oceanic
• 6. Contents of the packaging and other information

1. What is Hydrocortisonum Oceanic and what is it used for

Hydrocortisonum Oceanic is a cream for topical use on the skin. The medicine contains the active substance hydrocortisone acetate. After application to the skin, the medicine has anti-inflammatory, anti-itching, and vasoconstrictive effects. The medicine suppresses the development of inflammation symptoms without affecting their cause.

Indications for use

Skin reactions after insect bites or stings.

2. Important information before using Hydrocortisonum Oceanic

When not to use Hydrocortisonum Oceanic:

• if the patient is allergic to hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6),
• in skin infections caused by viruses (e.g., herpes, chickenpox), fungi (candidiasis and other mycoses), or bacteria (e.g., impetigo),
• on damaged skin,
• on mucous membranes,
• in common or rosacea acne,
• in perioral dermatitis,
• in the eyes or around the eyes,
• in the genital or anal area.

Warnings and precautions

Before starting to use Hydrocortisonum Oceanic, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be used for more than 7 days without a doctor's recommendation.
• Long-term use of the medicine or use on large skin areas, or under occlusive dressings (e.g., under a diaper), may cause systemic side effects of hydrocortisone acetate. In children, long-term use of corticosteroids may cause growth and development disorders.
• Use on the face should only be done on a doctor's recommendation.
• The medicine should not be used on a large skin area without prior consultation with a doctor.
• If there is no improvement after 7 days of using the medicine or the symptoms worsen, the patient should contact their doctor.
• Pregnant or breastfeeding women should not use the medicine without a doctor's recommendation.
• If an infection occurs at the site of application, appropriate antifungal and antibacterial treatment should be used.

Children

The medicine should not be used in children under 12 years of age without a doctor's recommendation.

Hydrocortisonum Oceanic and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use. No interactions have been described for topical hydrocortisone acetate.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Hydrocortisonum Oceanic should not be used during pregnancy without a doctor's recommendation. If the patient becomes pregnant or thinks they may be pregnant while using Hydrocortisonum Oceanic, they should contact their doctor. Breastfeeding women should not use Hydrocortisonum Oceanic without consulting their doctor, as it is not known whether topical corticosteroids pass into breast milk. If the doctor decides to use Hydrocortisonum Oceanic during breastfeeding, the medicine should not come into contact with the breast skin to avoid accidental ingestion by the infant or accidental contact with the infant's skin.

Driving and using machines

Hydrocortisonum Oceanic used on the skin does not affect the ability to drive or use machines.

Hydrocortisonum Oceanic contains propylene glycol (E1520), cetearyl alcohol, methyl parahydroxybenzoate (E218), and propyl parahydroxybenzoate (E216).

• The medicine contains 80 mg of propylene glycol in each gram of cream.
• The medicine may cause skin irritation due to the presence of propylene glycol.
• The medicine may cause local skin reactions (e.g., contact dermatitis) because it contains cetearyl alcohol.
• The medicine may cause allergic reactions (possible late reactions) because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate. If skin reactions occur, the use of Hydrocortisonum Oceanic should be discontinued.

3. How to use Hydrocortisonum Oceanic

This medicine should always be used exactly as described in this patient leaflet or according to the doctor's, pharmacist's, or nurse's instructions. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. The medicine is intended for use on the skin. Unless the doctor recommends otherwise, the affected areas of the skin should be thinly coated with the medicine 2 times a day. After using the medicine, the hands should be washed. The medicine should not be used without consulting a doctor for more than 7 days.

Use in children

The medicine should not be used in children under 12 years of age without a doctor's recommendation.

Using a higher dose of Hydrocortisonum Oceanic than recommended

During long-term use of the medicine, use on large skin areas, or on damaged skin or under occlusive dressings, and in children, due to increased absorption of hydrocortisone acetate into the bloodstream, systemic side effects of corticosteroids may occur (e.g., suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome). If a higher dose of the medicine is used than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Hydrocortisonum Oceanic

If a dose of the medicine is missed, it should be used as soon as possible. However, if it is almost time for the next dose, the next scheduled dose should be used. The dose of the medicine should not be increased without consulting a doctor. A double dose should not be used to make up for a missed dose.

Stopping the use of Hydrocortisonum Oceanic

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Hydrocortisonum Oceanic can cause side effects, although not everybody gets them. If an allergic reaction occurs, the use of the medicine should be stopped immediately. When using the medicine in skin folds, on the face, under occlusive dressings, or on large skin areas, due to increased absorption of hydrocortisone acetate into the body, atrophic changes in the skin, striae, superficial vasodilation, or allergic reactions may occur. After long-term treatment, systemic side effects of corticosteroids and suppression of the hypothalamic-pituitary-adrenal axis may occur. The occurrence of side effects is more likely in children, especially when using occlusive dressings. Changes in skin pigmentation and excessive hair growth have been reported with the use of topical steroids. During treatment, worsening of symptoms or skin reactions may occur. If any of the above symptoms occur, the patient should consult their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Hydrocortisonum Oceanic

The medicine should be stored out of sight and reach of children. The medicine should be stored in a tightly closed packaging, at a temperature below 25°C. The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Hydrocortisonum Oceanic contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of cream contains 5 mg of hydrocortisone acetate.
• The other ingredients are: propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), sorbitan stearate, macrogol cetostearyl ether, liquid paraffin, white petrolatum, cetearyl alcohol, propylene glycol (E1520), purified water.

What Hydrocortisonum Oceanic looks like and what the packaging contains

Hydrocortisonum Oceanic is a cream. The available packaging of the medicine is an aluminum tube containing 15 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OCEANIC Spółka Akcyjna
ul. Łokietka 58
81-736 Sopot

Manufacturer:

OCEANIC Spółka Akcyjna
ul. Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
OCEANIC Spółka Akcyjna, ul. Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie,
Tel.: +48 58 692 10 00

Date of the last update of the leaflet: