Hydrocortisone oceanic

Patient Information Leaflet

Hydrocortisonum Oceanic, 5 mg/g, cream
Hydrocortisoni acetas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, you should consult your doctor.

Table of Contents

1. What Hydrocortisonum Oceanic is and what it is 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 pack and other information

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

Hydrocortisonum Oceanic is a topical cream intended for application to the skin. The medicine contains
the active substance hydrocortisone acetate. When applied to the skin, the medicine exerts anti-inflammatory,
anti-pruritic (anti-itch), and vasoconstrictive effects.
The medicine suppresses the development of inflammatory symptoms, but does not affect the underlying cause.
Indications
Skin reactions following bites or stings from insects.

2. 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 simplex, chickenpox), fungi (candidiasis and other fungal infections) or bacteria (e.g. impetigo),
• on damaged skin,
• on mucous membranes,
• in acne vulgaris or rosacea,
• in perioral dermatitis,
• in or around the eyes,
• in the genital and anal areas.

Warnings and precautions
Before starting to use Hydrocortisonum Oceanic, discuss this with your doctor or
pharmacist.

• Do not use the medicine for longer than 7 days without medical advice.
• Prolonged use of the medicine, application over large areas of skin, or use under occlusive dressings (e.g. under a diaper) may lead to systemic adverse effects of hydrocortisone acetate. In children, prolonged use of corticosteroids may cause disturbances in growth and development.
• Application to the facial skin should only be carried out on a doctor's instruction.
• Do not use the medicine on large areas of skin without prior consultation with a doctor.
• If there is no improvement after 7 days of treatment or if symptoms worsen, consult your doctor.
• Pregnant women, women planning pregnancy, or women who are breastfeeding should not use the medicine without medical advice.
• If an infection develops at the site of application, appropriate antifungal and antibacterial treatment should be initiated.

Children
Do not use in children under 12 years of age without medical advice.
Hydrocortisonum Oceanic and other medicines
Inform your doctor or pharmacist about all medicines you are currently using,
have recently used, or plan to use.
No interactions have been described for topically applied hydrocortisone acetate.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become
pregnant, consult your doctor before using this medicine.
Hydrocortisonum Oceanic should not be used during pregnancy without medical advice.
If a woman becomes pregnant or suspects she is pregnant during treatment with Hydrocortisonum Oceanic,
she should contact her doctor.
Breastfeeding women should not use Hydrocortisonum Oceanic without consulting a
doctor, as it is not known whether topically applied corticosteroids pass into
breast milk.
If a doctor decides that Hydrocortisonum Oceanic may be used during breastfeeding, avoid
contact of the medicine with the skin of the breasts to prevent accidental ingestion by
the infant or accidental contact with the infant's skin.

Driving and operating machinery
Hydrocortisonum Oceanic, when applied to the skin, does not impair the ability to drive
or operate machinery.

Hydrocortisonum Oceanic contains propylene glycol (E1520), cetostearyl 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) due to the presence of cetostearyl alcohol.
• The medicine may cause allergic reactions (including delayed-type reactions) because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate. If skin reactions occur, discontinue use of Hydrocortisonum Oceanic.

3. How to use Hydrocortisonum Oceanic

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is intended for topical use on the skin.
Unless otherwise directed by a doctor, affected areas of the skin should be treated with a thin layer of the medicine twice daily. After applying the medicine, hands should be washed.
Use of the medicine without consulting a doctor should not last longer than 7 days.
Use in children
Do not use in children under 12 years of age without medical advice.
Use of a higher than recommended dose of Hydrocortisonum Oceanic
With prolonged use, application over large skin areas, on damaged skin, under occlusive dressings, or in children, enhanced systemic absorption of the active substance may occur, leading to general adverse effects of corticosteroids (e.g. suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome).
If a higher than recommended dose has been used, seek immediate advice from a doctor or pharmacist.
Missed dose of Hydrocortisonum Oceanic
If a dose has been missed, apply it as soon as possible. However, if it is almost time for the next dose, apply the next scheduled dose at the usual time. Do not increase the dose on your own initiative.
Do not use a double dose to make up for a missed dose.
Stopping Hydrocortisonum Oceanic
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone experiences them.
If hypersensitivity reactions occur, the use of the medicine should be discontinued immediately.
When the medicine is used in skin folds, on facial skin, under an occlusive dressing (e.g. diaper) or over a large skin surface, increased systemic absorption of hydrocortisone acetate may occur, leading to cutaneous atrophy, striae, superficial dilation of blood vessels, and hypersensitivity reactions. With prolonged treatment, systemic adverse effects of corticosteroids and suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur.
The occurrence of adverse effects is more likely in children, especially when occlusive dressings are used.
Changes in skin pigmentation and excessive hair growth have been reported as a result of local steroid use. During treatment, worsening of symptoms and skin reactions may occur.
If any of the above symptoms occur, consult a physician.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Hydrocortisonum oceanic

Keep this medicine out of the sight and reach of children.
Store in a tightly closed container, below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Hydrocortisonum Oceanic contains

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

What Hydrocortisonum Oceanic looks like and contents of the pack
Hydrocortisonum Oceanic is a cream.
The available pack consists of an aluminium tube containing 15 g of cream, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OCEANIC Joint Stock Company
Łokietka 58
81-736 Sopot

Manufacturer:
OCEANIC Joint Stock Company
Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
OCEANIC Joint Stock Company, Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie,
Tel.: + 48 58 692 10 00