EBENOL hydrocortisone Spray

• 5 mg hydrocortisone

• Citric acid monohydrate
• Ethanol 96% (V / V)
• Glycerol 85%
• Hypromellose
• Disodium edetat-2-water
• Sodium hydroxide for pH adjustment
• Propylene glycol
• Purified water

EBENOL hydrocortisone Spray Indication / application

• What is the medicine?
  • The medicine contains a hormone from the adrenal cortex called a glucocorticoid. The spray is intended for use on the skin.
• What is it used for?
  • The spray is used to relieve uninfected mild inflammatory, allergic or itchy skin conditions that respond to symptomatic treatment with low-potency glucocorticosteroids.
  • For short-term (maximum 2 weeks) external use in adults and children from the age of 6.
  • The spray is ideal for use on normal or oily skin.
  • If you don't feel better or even worse after 2 weeks, contact your doctor.

EBENOL hydrocortisone Spray dosage

• Always use this medicine exactly as described or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• How and how often should you use the medicine?
  • Unless otherwise prescribed by your doctor, the recommended dose for adults and children over the age of 6 is:
    • Use 2 to 3 times a day at the start of treatment
    • Use once a day or once a day only every 2 to 3 days when the symptoms improve
  • Please talk to your doctor if you have the impression that the effect of the spray is too strong or too weak.

• How long can you use the spray?
  • The duration of treatment depends on the type, severity and course of the disease. In general, a treatment duration of 2 weeks should not be exceeded.
  • Do not use the spray for more than 2 weeks without medical advice.
  • Long-term and / or large-area application may only be carried out as directed by your doctor.
  • Do not apply the spray to an area larger than 10% of the body surface for more than 1 week.
  • The spray contains alcohol and can therefore dry out the skin. Please consult a doctor if you notice significant signs of dehydration (e.g. flaking, tension, itching) and / or if the symptoms persist for more than 2 weeks or worsen.

• What to do if you have used too much?
  • Reduce the dose or - if possible - stop the spray if you have used it in high doses and have used it for a long time.

• If you forget to use an application
  • If you have forgotten an application, do not make up for it, but continue with the next application.

• If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

EBENOL hydrocortisone Spray way

• The solution is intended for use on the skin. It is sprayed onto the skin.

Side effects

• Like all medicines, this medicine can have side effects, although not everybody gets them.
• Rare (1 to 10 users in 10,000): allergic skin reactions.
• Long-term use can lead to local symptoms of drying out of the skin, such as flaking, tension, itching.
• With long-term use, the following side effects are known:
  • Skin atrophy, widening of the capillaries visible on the skin (telangiectasias), stretch marks on the skin (striae), steroid acne, skin inflammation near the mouth (perioral dermatitis), abnormally increased body hair (hypertrichosis)
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

EBENOL hydrocortisone Spray Interactions

• Use with other medicines
  • Medicines can affect each other so that their effects are stronger or weaker than usual. Therefore, please tell your doctor or pharmacist if you are taking, have recently used or intend to use any other medicines.
  • Intended external use
    • When used externally as intended, interactions with other medicinal products are not to be expected.
  • Accidental internal use
    • If you accidentally swallow the spray, or spray it in your mouth or on open wounds, it may interact with any of the following medicines:
      • Medicines to treat heart failure (cardiac glycosides)
      • Diuretic drugs (saluretics)
      • Medicines to prevent blood clotting (coumarin derivatives)
      • Medicines used to treat tuberculosis (rifampicin)
      • Medicines used to treat epilepsy (phenytoin, barbiturates)
      • Painkillers (non-steroidal anti-inflammatory drugs) / anti-inflammatory drugs)
    • In this case, please speak to your doctor immediately.

Contraindications

• You must not use the preparation
  • if you are allergic to hydrocortisone or any of the other ingredients of this medicine,
  • with specific skin symptoms (syphilis, tuberculosis),
  • with viral infections (e.g. chickenpox, herpes simplex, herpes zoster),
  • in case of vaccination reactions,
  • in case of fungal attack (mycoses),
  • for bacterial skin infections, acne vulgaris, steroid acne,
  • for skin inflammation near the mouth (perioral dermatitis),
  • with inflammatory reddening of the face (rosacea),
  • on open wounds,
  • in children under 6 years of age.

EBENOL hydrocortisone Spray pregnancy and breast feeding period

• Ask your doctor or pharmacist for advice before taking or using any medicine.
• pregnancy
  • During pregnancy, the use of the drug should be avoided as much as possible and, if absolutely necessary, as short and as small as possible.
  • As long-term treatment with glucocorticoids during pregnancy cannot rule out growth disturbances and damage to the unborn child, please inform your doctor if you want to become pregnant, are already pregnant or suspect that you may be pregnant.
• Breastfeeding
  • Glucocorticoids, including hydrocortisone, are excreted in breast milk. An impairment of the baby has not yet become known.
  • Nevertheless, you should only use the preparation during breastfeeding after consulting your doctor. If your attending doctor deems it necessary to use the drug while breastfeeding, you must not use the spray in the breast area in order to avoid unwanted absorption by the baby. If your doctor thinks higher doses are necessary for reasons of illness, you should stop breastfeeding.

EBENOL hydrocortisone Spray Patient information

• Warnings and Precautions
  • Particular caution is required when using it
    • on the face (especially around the eyes)
    • on sore skin areas, especially in skin folds (intertriginous areas)
    • around skin ulcers
    • in the genital and anal area
  • Avoid extensive and / or prolonged use of the drug.
  • The spray is not suitable for people with dry skin or skin diseases associated with such.
  • What should you watch out for with children?
    • The spray must not be used in children under 6 years of age.
    • In children from the age of 6, external therapy with the spray should be carried out with caution and normally not for longer than 2 weeks.
    • Particular caution is required with children because children have a larger body surface area in relation to body weight.
  • What should be considered in the elderly?
    • Particular caution is required in older people because the barrier performance of the outer skin layer (horny layer) is weaker in old age.

• Driving and using machines
  • There are no known effects.