EBENOL

EBENOL 0.25% Cream

Important notes (mandatory information)

Ebenol 0.25% cream. Active ingredient: Hydrocortisone. Areas of application: used to relieve mild inflammatory skin conditions.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebenol 0.25% cream for use in adults and children aged 6 years and over
Active ingredient: Hydrocortisone

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS EBENOL 0.25% CREAM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE IT
3. HOW TO USE EBENOL 0.25% CREAM
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE EBENOL 0.25% CREAM
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EBENOL 0.25% CREAM AND WHAT IS IT USED FOR?

Ebenol 0.25% cream contains a synthetically produced hormone from the adrenal cortex, a so-called glucocorticoid. It is intended for use on the skin. Ebenol 0.25% cream is used to relieve mild inflammatory skin conditions.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE IT

Do not use - You must not use Ebenol 0.25% cream if:

• specific skin conditions (syphilis, tuberculosis).
• Viral infections (e.g. chickenpox, herpes simplex, herpes zoster).
• Vaccination reactions.
• Fungal infections (mycoses).
• bacterial skin infections, acne vulgaris, steroid acne.
• Skin inflammation around the mouth (perioral dermatitis).
• inflammatory redness of the face (rosacea) You must not use Ebenol 0.25% cream if you are allergic to hydrocortisone or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Special care is required when using:

• on the face (especially around the eyes, if you are predisposed to increased intraocular pressure).
• on sore areas of skin, especially in skin folds (intertriginous areas).
• around skin ulcers.
• in the genital and anal area.

Do not apply to open wounds. Do not apply the cream to an area larger than 1/10 of the body surface.

What should be considered in children?
Special care is required in children because children have a larger body surface area in relation to their body weight. Children under the age of 6 years (under 6 years) should only be treated with this medicine on doctor's orders. Here, once-daily application is usually sufficient. The duration of treatment should be limited to a maximum of three weeks.

What should you consider during pregnancy and breastfeeding?
Ask your doctor or pharmacist for advice before taking or using any medicine.

• You should only use Ebenol 0.25% cream during pregnancy and breastfeeding if your doctor has strictly indicated it.
• During pregnancy, especially in the first three months of pregnancy, and during breastfeeding, you should not use the medicine over a large area (more than 1/10 of the body surface) or for a long period of time (longer than four weeks).
• With long-term use, growth disorders within the womb cannot be ruled out.
• If treatment is given towards the end of pregnancy, there is a risk of the foetus's adrenal cortex becoming smaller (atrophy).
• Glucocorticoids pass into breast milk. If use is essential, breastfeeding should be discontinued.
• Newborns whose mothers were treated with corticosteroids for a long period of time and/or over a large area during pregnancy or breastfeeding should be closely monitored for possible adverse effects.
• Do not apply the cream to the breast area during breastfeeding to avoid unintended oral ingestion by the infant.

What should be considered in the elderly?
Special care is required in the elderly because the barrier function of the outer skin layer (horny layer) is weaker in old age.

Driving and using machines

No effects are known.

Interactions

Medicines can affect each other, so that their effect is then stronger or weaker than usual. Please inform your doctor or pharmacist if you are taking or have recently taken or intend to take any other medicines.

What should you consider if you are taking other medicines at the same time?
Interactions are not to be expected with intended external use.

Information on other ingredients

Ebenol 0.25% cream contains, among other things, cetyl stearyl alcohol and potassium sorbate. These can cause localised skin irritation (e.g. contact dermatitis).

3. HOW TO USE EBENOL 0.25% CREAM

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

For adults and children aged 6 years and over

At the start of treatment, you generally apply the cream 1-2 times a day. Once the clinical picture improves, once-daily application is usually sufficient.

Children under 6 years of age

Children under the age of 6 years should only be treated with this cream on doctor's orders. Here, once-daily application is usually sufficient. The duration of treatment should be limited to a maximum of 3 weeks.

The cream is applied to the skin. The skin area should not be larger than 1/10 of the body surface. Do not apply the cream to open wounds. Please talk to your doctor if you have the impression that the effect of Ebenol 0.25% cream is too strong or too weak.

How long should you use Ebenol 0.25% cream?
The duration of treatment depends on the type, severity and course of the disease. In general, a treatment period of 4 weeks should not be exceeded.

If you have applied too much Ebenol 0.25% cream, remove the excess with a soft cloth. If you have used the medicine for a long period of time (longer than 4 weeks) and in high doses, reduce the dose or - if possible - stop taking the medicine. With long-term (longer than 4 weeks) large-area (more than 1/10 of the body surface) use, especially under occlusive dressings or on severely damaged skin, the active ingredient may be absorbed into the body and thus lead to side effects, such as inhibition of the adrenal gland or Cushing's syndrome (truncal obesity, moon face). Consult your doctor.

If you forget to use it once, do not use double the dose the next time. Continue using it as prescribed by your doctor or as described in these dosage instructions.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The list includes all known side effects under treatment with hydrocortisone, including those under higher dosage or long-term therapy in adults and children aged 6 years and over.

Rare (1 to 10 in 10,000 treated)

Allergic skin reactions occur.

The following side effects are known with long-term use (longer than four weeks)

Thinning of the skin, change in skin pigmentation, visible capillary dilation on the skin (telangiectasias), stretch marks on the skin (striae), steroid acne, skin inflammation around the mouth (perioral dermatitis), pathological increased body hair (hypertrichosis).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE EBENOL 0.25% CREAM

Storage conditions: Keep out of reach of children. Do not store above 25°C. Shelf life: Do not use the medicine after the expiry date stated. This date is printed on the folding box and tube after (). The expiry date refers to the last day of the month. Shelf life after opening: The cream can be stored for 3 months after opening. Do not dispose of the medicine in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ebenol 0.25%

Cream contains

The active ingredient is hydrocortisone. 100 g of cream contain 0.25 g of hydrocortisone. Other ingredients: Carbomer (40,000-60,000 cP), Dimethicone (350 cSt), Emulsifying cetyl stearyl alcohol (Type A) (Ph.Eur.), Purified water, Glycerol 85%, Glycerol monostearate, Potassium sorbate (Ph.Eur.), Medium-chain triglycerides, Sodium edetate (Ph.Eur.), Octyldodecanol (Ph.Eur.), Trometamol, [(Z)-Octadec-9-en- 1-yl]oleate.

What Ebenol 0.25%

Cream looks like and contents of the pack

The cream is white. It is filled into aluminium tubes which are inserted into folding boxes. Ebenol 0.25% cream is available in packs of 10 g, 20 g, 25 g, 40 g and 50 g cream. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Strathmann GmbH & Co. KG
Postfach 610425
22424 Hamburg
Tel.: 040-55 90 5-0
Fax: 040-55 90 5-100
E-mail: info@strathmann.de

Manufacturer

Biokirch GmbH
Bei den Kämpen 11
21220 Seevetal

This package leaflet was last revised in April 2014.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Hydrocortisone. Areas of application: used to relieve mild inflammatory skin conditions.