HYDROCUTAN

HYDROCUTAN Cream 0.5%

Important notes (mandatory information)

Hydrocutan Cream 0.5%. Active ingredient: Hydrocortisone. Areas of application: For the relief of moderately pronounced inflammatory skin conditions. Warning: Contains cetyl stearyl alcohol and potassium sorbate. Do not apply to open wounds or mucous membranes! Do not get in eyes!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrocutan Cream 0.5%, for application to the skin
Active ingredient: Hydrocortisone

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

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact 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 even worse after 2 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS HYDROCUTAN CREAM 0.5% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HYDROCUTAN CREAM 0.5%?
3. HOW TO USE HYDROCUTAN CREAM 0.5%?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HYDROCUTAN CREAM 0.5%?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS HYDROCUTAN CREAM 0.5% AND WHAT IS IT USED FOR?

The active ingredient hydrocortisone is a synthetically produced glucocorticoid (adrenal cortex hormone) for application to the skin. Hydrocutan Cream 0.5% is used to relieve moderately pronounced inflammatory skin conditions.

2. WHAT SHOULD YOU CONSIDER BEFORE USING HYDROCUTAN CREAM 0.5%?

Hydrocutan Cream 0.5% must not be used:

• if you are hypersensitive (allergic) to hydrocortisone or any of the other ingredients of this medicine listed in section 6
• in 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 inflammations around the mouth (perioral dermatitis) and inflammatory redness of the face (rosacea)
• on the eye and on mucous membranes
• in diseases associated with a disorder of the pituitary hypothalamic regulation (e.g. Cushing's syndrome)

Warnings and precautions

Please talk to your doctor or pharmacist before using Hydrocutan Cream 0.5%.

Special care is required when using Hydrocutan Cream 0.5%

is required

When used on the face (especially around the eyes. If predisposed: risk of increased intraocular pressure) and when applied in body folds (intertriginous areas), around skin ulcers (ulcers), as well as on the genital and anal area.

Special care is required in the elderly (aged skin) due to the weakened barrier function of the horny layer, or in children due to a larger body surface area in relation to body weight. Do not apply to open wounds. Do not apply the cream to an area larger than 1/10 of the body surface. If you experience blurred vision or other visual disturbances, contact your doctor.

Children

Hydrocutan Cream 0.5% must not be used in children under 6 years of age without a doctor's prescription.

Elderly people

See above.

Use of Hydrocutan Cream 0.5%

together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions are not to be expected with intended external application.

Pregnancy and breast-feeding Pregnancy

There are no sufficient data for the use of Hydrocutan Cream 0.5% in pregnant women. Glucocorticoids have shown embryotoxic effects in animal studies. An increased risk of oral clefts has also been discussed in human fetuses when glucocorticoids are used during the first trimester of pregnancy. Animal studies have also shown that the administration of glucocorticoids in therapeutic doses during pregnancy delays the growth of the unborn child and can contribute to the development of cardiovascular diseases and/or metabolic diseases in adulthood and to a permanent change in behavior. If you are pregnant, you should therefore only use Hydrocutan Cream 0.5% if your doctor considers it absolutely necessary. Please contact your doctor immediately.

Breast-feeding

The active ingredient contained in Hydrocutan Cream 0.5% passes into breast milk. In case of extensive or long-term use, you should stop breastfeeding. Contact of the infant with the treated skin areas should be avoided. Nursing mothers should not apply hydrocortisone to the breast area.

Driving and operating machinery

There are no known effects of Hydrocutan Cream 0.5% on the ability to drive and operate machinery.

Hydrocutan Cream 0.5%

contains cetyl stearyl alcohol and potassium sorbate

Cetyl stearyl alcohol and potassium sorbate can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE HYDROCUTAN CREAM 0.5%?

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 for adults and children from the age of 6 years is:
At the beginning of treatment: generally 1 - 2 times daily.

With improvement of the clinical picture: usually a single application per day is sufficient.

Type of application

Cream for application to the skin.

Duration of application

Hydrocutan Cream 0.5% may be used for a maximum of 2 weeks. Children up to the age of 6 years may only be treated with the medicine after a doctor's prescription. Here, one application per day is usually sufficient. The duration of use is determined by the attending physician. Please talk to your doctor or pharmacist if you have the impression that the effect of Hydrocutan Cream 0.5% is too strong or too weak.

If you have used more Hydrocutan Cream 0.5% than you should:
Reduce the dose or - if possible - discontinue the medication after high-dose and long-term (longer than four weeks) use.

In case of long-term (longer than four 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 disease (truncal obesity, full moon face). In this case, consult your doctor.

If you forget to use Hydrocutan Cream 0.5%

Do not use a double dose to make up for the missed application.

If you stop using Hydrocutan Cream 0.5%

You could jeopardize the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with Hydrocutan Cream 0.5%.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

The following side effects are possible with long-term use (longer than four weeks) or under occlusion:
Thinning of the skin, changes in skin pigmentation, visible capillary dilatations on the skin (telangiectasias), stretch marks on the skin (striae), steroid acne, skin inflammations around the mouth (perioral dermatitis) and pathological increased body hair (hypertrichosis), promotion of secondary infections, delayed wound healing.

Rare (1 to 10 in 10,000 treated patients):
Allergic skin reactions.

Not known (frequency cannot be estimated from the available data):
Blurred vision General effects due to absorption of the active ingredient into the body, such as inhibition of adrenal cortex function, symptoms of Cushing's syndrome and increased intraocular pressure, are conceivable.

With long-term, high-dose use of hydrocortisone on the skin, especially under cover (e.g. in the diaper area), so much active ingredient can be absorbed into the body that the body's own ACTH secretion is inhibited. This can lead to a drop in the cortisol level in the blood. The possibility of general side effects must be considered especially in children.

Special notes

If side effects occur, you should stop treatment immediately and consult a doctor.

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 about the safety of this medicine.

5. HOW TO STORE HYDROCUTAN CREAM 0.5%?

Keep this medicine out of the reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton and container after "use by". The expiry date refers to the last day of the month indicated.

Note on shelf life after opening

After first opening the tube, Hydrocutan Cream 0.5% is stable for 3 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Hydrocutan Cream 0.5%

contains

The active ingredient is hydrocortisone. 1 g cream contains 5 mg hydrocortisone.

The other ingredients are

Glycerol 85%, [(Z)-Octadec-9-en-1-yl]oleate, emulsifying cetyl stearyl alcohol (Type A) (Ph.Eur.), medium-chain triglycerides, octyldodecanol (Ph.Eur.), glycerol monostearate, dimethicone (35 cSt), potassium sorbate (Ph.Eur.), carbomer (40,000-60,000 cP), sodium edetate (Ph.Eur.), trometamol, purified water.

How Hydrocutan Cream 0.5%

looks like and contents of the pack

Hydrocutan Cream 0.5% is a white cream and is available in packs of 20 g cream.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/641860
Fax: 089/64186130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This leaflet was last revised in March 2018.

Source: Information from the package leaflet
Status: 11/2024
Active ingredient: Hydrocortisone. Areas of application: For the relief of moderately pronounced inflammatory skin conditions. Warning: Contains cetyl stearyl alcohol and potassium sorbate. Do not apply to open wounds or mucous membranes! Do not get in eyes!