FENIHYDROCORT

FENIHYDROCORT Cream 0.5%

Important notes (mandatory information)

FeniHydrocort Cream 0.5%. Active ingredient: Hydrocortisone. Areas of application: for the relief of moderately pronounced inflammatory skin conditions.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

FeniHydrocort Cream 0.5% for use in children from the age of 6 and adults
The active pharmaceutical ingredient is hydrocortisone.

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, FeniHydrocort Cream 0.5% must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2 weeks, you must consult a doctor.
• If any of the listed side effects affect you significantly or you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet includes

1. WHAT IS FENIHYDROCORT CREAM 0.5% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING FENIHYDROCORT CREAM 0.5%?
3. HOW SHOULD FENIHYDROCORT CREAM 0.5% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FENIHYDROCORT CREAM 0.5% BE STORED?
6. FURTHER INFORMATION

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

FeniHydrocort Cream 0.5% is a synthetically produced glucocorticoid (adrenal cortex hormone) for use on the skin. Area of application: For the relief of moderately pronounced inflammatory skin conditions.

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

FeniHydrocort Cream 0.5% must not be used:

• if you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of FeniHydrocort Cream 0.5%,
• in certain skin conditions (e.g. syphilis, skin tuberculosis),
• in viral infections such as herpes simplex (painful blisters on the lips or genitals), herpes zoster (shingles), chickenpox,
• in vaccination reactions,
• in inflammatory redness of the face (rosacea),
• in fungal infections (mycoses),
• in bacterial skin infections,
• in acne vulgaris and steroid acne,
• on open wounds,
• on mucous membranes,
• in skin inflammations near the mouth (perioral dermatitis),
• in the eye,
• during the first third of pregnancy (see section Pregnancy and breastfeeding).

Special care is required when using FeniHydrocort Cream 0.5%:

• in the case of a skin infection caused by bacteria or fungi. This must be treated separately.
• when used on the face (especially in the area of the eyes, in the case of a predisposition to an increase in intraocular pressure),
• when applied in body folds (intertriginous areas),
• in the vicinity of skin ulcers,
• in the genital and anal area.

Do not apply the cream to an area larger than 1/10 of the body surface (approx. 10 palms), especially under occlusive dressings (tightly closing and covering dressings) or on severely damaged skin, as in these cases systemic corticoid effects and side effects may occur. Before using in these areas, please consult your doctor for advice.

Children and the elderly

Special care is required in children, as they have a larger body surface area in relation to their body weight. Children up to the age of 6 should therefore only be treated with the medicine on doctor's orders. Here, one application per day is usually sufficient. The duration of treatment should be limited to a maximum of 3 weeks. Special care is required in the elderly, as they have thinner, more permeable skin due to a weakened barrier function of the horny layer (ageing skin).

When using FeniHydrocort Cream 0.5%

with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Interactions are not to be expected when used as directed.

Pregnancy and

breastfeeding

Pregnancy

FeniHydrocort Cream 0.5% must not be used during the first third of pregnancy. In later stages of pregnancy, the cream may only be used after careful consideration of the benefits and risks by the treating doctor. In particular, large-area or long-term use and occlusive dressings should be avoided during pregnancy.

Breastfeeding

The active ingredient contained in FeniHydrocort Cream 0.5% passes into breast milk. In the case of large-area or long-term use, breastfeeding should be discontinued. Contact between the infant and the treated skin areas should be avoided. Ask your doctor or pharmacist for advice before taking/using any medicines.

Driving and operating machinery

No effects are known.

Important information about certain other ingredients of FeniHydrocort Cream 0.5%:
Potassium sorbate and cetyl stearyl alcohol can cause localised skin irritation (e.g. contact dermatitis).

3. HOW SHOULD FENIHYDROCORT CREAM 0.5% BE USED?

Always use FeniHydrocort Cream 0.5% exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose for adults and children from the age of 6 is: At the start of treatment, you generally apply the cream 1 - 2 times a day. Once the symptoms improve, one application per day is usually sufficient. Children up to the age of 6 should only be treated with the medicine on doctor's orders. Here, one application per day is usually sufficient. The duration of treatment should be limited to a maximum of 3 weeks.

Method of application

Apply FeniHydrocort Cream 0.5% thinly to the affected skin areas and rub in gently. Please wash your hands after applying the cream.

Duration of application

The duration of treatment depends on the type, severity and course of the disease. In general, a treatment period of 2 weeks should not be exceeded. Longer-term use is only possible after consultation with a doctor. Large-area (more than 1/10 of the body surface) application should be avoided or carried out according to the doctor's instructions. Please talk to your doctor or pharmacist if you have the impression that the effect of FeniHydrocort Cream 0.5% is too strong or too weak.

If you have applied too much FeniHydrocort Cream 0.5%

than you should

If you have applied more than you should, remove the excess cream from the skin with a cloth. No acute poisoning symptoms are to be expected after an overdose. Reduce the dose or - if possible - discontinue the medication after high-dose and long-term (longer than 4 weeks) use. In the case of 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, full moon face). If these side effects occur, consult your doctor.

If you forget to use FeniHydrocort Cream 0.5%

Do not use double the dose to make up for the missed application, but continue using as directed in this package leaflet.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, FeniHydrocort Cream 0.5% 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 from 6 years of age.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

In rare cases, skin irritation or allergic skin reactions are possible. The following side effects (frequency not known) are possible with prolonged use (longer than 4 weeks):

• Thinning of the skin,
• visible dilation of capillaries on the skin (telangiectasias),
• stretch marks on the skin (striae),
• pustule formation caused by the active ingredient (steroid acne),
• skin inflammation near the mouth (perioral dermatitis),
• increased body hair growth (hypertrichosis),
• change in skin pigmentation.

If side effects occur, you should stop treatment immediately.

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 SHOULD FENIHYDROCORT CREAM 0.5% BE STORED?

Keep out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and tube after "use by". Storage conditions: Do not store above 25°C. Note on shelf life after opening: Shelf life after opening: 3 months.

6. FURTHER INFORMATION

What FeniHydrocort Cream 0.5%

contains

1 g of cream for application to the skin contains 5 mg of hydrocortisone as the active pharmaceutical ingredient. The other ingredients are dexpanthenol; glycerol 85%; [(Z)-0ctadec-9-en-1 -yl oleate; emulsifying cetyl stearyl alcohol (type A) (emulsifier); medium-chain triglycerides; octyldodecanol; glycerol monostearate; dimethicone (350 cSt); potassium sorbate (preservative); carbomer (40,000-60,000 cP); sodium edetate; trometamol; purified water.

What FeniHydrocort Cream 0.5%

looks like and contents of the pack

FeniHydrocort Cream 0.5% is a white cream and is available in packs of 15 g cream and 30 g cream.

Pharmaceutical entrepreneur and manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Barthstraße 4
80339 Munich
Telephone: (089) 7877-209
Fax: (089) 7877-304
Email: medical.contactcenter@gsk.com

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Hydrocortisone. Areas of application: for the relief of moderately pronounced inflammatory skin conditions.