Ebenol HCA 0.25% cream, 25 g

Instructions for use for Ebenol HCA 0.25% cream, 25 g

Important notes (compulsory information):

Ebenol HCA 0.25% cream. Active ingredient: hydrocortisone acetate. Areas of application: For the treatment of very weakly pronounced inflammatory or allergic skin diseases, where low concentrated, weakly effective, topically applied glucocorticoids are displayed.

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


LEAFLET: INFORMATION FOR THE USER

Ebenol HCA 0.25% cream, for application in adults and children from the age of 6 years
Active ingredient: hydrocortisone acetate

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If your complaints worse or get no improvement after 4 weeks, you must definitely visit a doctor.

What is in this leaflet:

1. What is level HCA 0.25% cream and what is it used for?
2. What should you consider before use?
3. How to use Local HCA 0.25% cream?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Eight HCA 0.25% cream?
6. Content of the pack and more information

1. What is level HCA 0.25% cream and what is it used for?

What is Ebenol HCA 0.25% cream?
Ebenol HCA 0.25% cream is intended for use on the skin. The active ingredient, hydrocortisone acetate (HCA) is a synthetically produced hormone from the adrenal bark, a so-called glucocorticoid. It is included in a proportion of 0.25% in the cream.

What is the cream used for?
Ebenol HCA 0.25% cream is alcoholic. It is used to treat very weak inflammatory or allergic skin diseases in which low concentrated, weakly effective, topically applied glucocorticoids are displayed.

2. What should you consider before use?

You are allowed Ebenol Do not apply HCA 0.25% cream:

• if they are allergic to hydrocortic acetate or one of the other ingredients of this medicinal product referred to in section 6.
• for specific skin diseases (syphilis, tuberculosis),
• for viral infections (eg chickenpox, herpes simplex, herpes zoster),
• for vaccine reactions of the skin,
• for fungal diseases (mycoses),
• with bacterial skin infections, acne vulgaris, steroidakne,
• for skin inflammation in the mouth (perioral dermatitis),
• in chronic skin inflammation and inflammatory redness of the face (Rosacea),
• on open wounds.

Warnings and Precautions:
Special caution is required in the application:

• on the face (especially in the area of the eyes, since there is the risk of increasing the intraocular pressure),
• in body folds (intertrigious areas),
• in the environment of skin ulcer (ulcer),
• in the genital and anal range.

Apply the cream to no larger area than 1/5 (20%) of the body surface.

What should be considered in children?
Special caution is required in children, as their body surface is larger in relation to your body weight than in adults. Children up to the age of 6 years (Under 6 years) may only according to the medical prescription with Ebenol HCA 0.25% creme are treated.

What do you need in pregnancy and lactation?
There are no sufficient data for the use of Ebenol HCA 0.25% cream in pregnant women. Glucocorticoids showed fruit harmful effects in animal experiments. Even with human fetuses, an increased risk of oral cleavage formations is discussed in the application of glucocorticoids during pregnancy. Animal studies have also shown that the administration of glucocorticoiden in therapeutic doses during pregnancy delays the growth of the unborn child and contribute to the triggering of cardiovascular diseases and / or metabolic diseases in adulthood and a permanent change in behavior. If you are pregnant, you are allowed to Ebenol HCA 0.25% creams therefore only apply if their attending physician holds this mandatory. Please contact your doctor immediately. The in Ebenol HCA 0.25% cream contained drug occurs in the breast milk. For a large-scale or long-term use, it should be removed. A contact of the infant with the treated skin parts is to be avoided. Ask your doctor or pharmacist for advice before taking / application of all medicines.

What should be considered in older people?
Special caution is required in older people because the barrier performance of the horny layer is weakened at the age-skin.

Driving and ability to operate machines:
There are no effects.

Interactions:
Medicines can affect each other, so that their effect is stronger or weaker than usual . Please inform your doctor or pharmacist if you apply other medicines, recently applied other medicines or intend to apply other medicines.

What should be considered if you apply other medicines at the same time?
No interactions after external use with hydrocortisone are known. Ebenol HCA 0.25% cream should not be applied simultaneously with other medicines to be applied to the skin, unless the doctor has prescribed this.

3. How is Ebene HCA to apply 0.25% cream?

Always use this medicine as described in this leaflet or exactly after the arrangement made with your doctor or pharmacist. Please ask your doctor or pharmacist if you are not sure.

How and how often should you Ebenol Apply HCA 0.25% cream?
Unless otherwise prescribed by the doctor, the usual dose is: At the beginning of treatment, use the cream 2 to 3 times a day. After recording has occurred only 1 times a day and then apply only every second or third day. Apply the cream thin to the diseased skin portions. Do not cover the treated skin sections with pests, mull or similar, because this can cause the risk of overdose. Please talk to your doctor or pharmacist if you have the impression that the effect of Ebenol HCA 0.25% cream too strong or too weak. Children up to the age of 6 may only be treated with this medicine according to the medical prescription.

How long are you allowed to Ebenol Apply HCA 0.25% cream?
Use Ebenol HCA 0.25% cream without medical advice no longer than 8 weeks, in children from 6 years no longer than 3 to 4 Weeks on . Talk to your doctor if no improvement occurred after 4 weeks or if the clinical picture is worsening.

If you have applied a bigger amount than you should, take the excess cream with a cloth back from the skin. For long-term large-scale application, especially under final associations or heavily preheated skin, it can lead to a recording of the active ingredient into the body and thus to side effects. Locate your doctor. If you use the application of Ebenol HCA have forgotten 0.25% cream once, then do not wear the double dose afterwards, but stay with the receiverohlenen crowd and carry the cream thinly.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Possible side effects:
Rarely (1 to 10 treated by 10,000), allergic skin reactions occur. With longer-lasting application, the following side effects may occur: Change of skin pigmentation, thinner of the skin (skin corridors), extension and propagation of small superficial skin vessels (Teleanangiektasien), Stripes on the skin (Striae), acne skin symptoms (steroidakne), skin inflammation in the oral region (Perioral dermatitis), increased body hair (Hypertrichosis).

Which countermeasures are to take with side effects?
If you are affected by one of the named side effects, use Ebenol HCA 0.25% cream not further and look for your doctor as soon as possible.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Ebene HCA 0.25% cream?

Storage conditions: Keep medicines inaccessible to children. Do not store more than 25 ° C. Shelf life: You may not use the medicine after the expiration date. This date is specified on the tube and folding carton. The expiration date refers to the last day of the month. Durability after a break: The cream is stable after a break 6 weeks. Do not dispose of the medicine in the household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Ebenol HCA 0.25% cream contains:
The active ingredient is hydrocortisone acetate. 100 g cream contain 0.25 G Hydrocortisone acetate (Ph.eur.). The other ingredients are: Carbomer copolymer (type b), decyloleate, thick paraffin, purified water, isopropyl myristate (ph.eur.), Isopropyl palmitate, macrogol 400, sodium diet (ph.eur.), Sodium hydroxide, 2-propanol (Ph.eur.).

Like Ebenol HCA 0.25% cream looks and content of the pack:
Ebenol HCA 0.25% cream is white. It is filled in aluminum tubes, which are inserted in folding boxes. It is available in packs with 25 g, 30 g and 50 g. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
Strathmann GmbH & Co. KG
Mailbox 610425
22424 Hamburg
Tel.: 040/55 90 5-0
Fax: 040/55 90 5-100
E-Mail: [email protected]

Manufacturer:
Biokirch GmbH
At the damps 11
21220 Seevetal

This information information was last revised in April 2014.

Source: Information of the leaflet
Status: 12/2016