Document: Hyderm cream ENG PL change

• Hyderm 1 % cream PL
• Hyderm 1 %, cream, Rx PL
• Hyderm cream ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Hyderm, 1%, cream

Hydrocortisone

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Hyderm carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• You must contact a doctor if your symptoms worsen or do not improve after one week.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

Hyderm cream is a white, mild hydrocortisone cream (weak steroid) with an anti-inflammatory and itch relievingeffect. It may be used to treat mild eczema such as contact eczema, insect-bite reactions and sun rashes. The cream may also be used to treat weeping areas of skin. In addition, it may be used to relieve itching around the back passage (anus) if prescribed by adoctor.

Do not use Hyderm

- if you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hyderm.

Take special care with Hyderm

Hyderm should not be applied in open wounds or around the eyes. Perioral dermatitis, rosacea and acne should not be treated with corticosteroids. If you have a skin infection,do not use Hyderm unless the infection is treated at the same time. Consult your doctor, who may decide on a more suitable treatment.

Pregnancy and breast-feeding

No known risks when used during pregnancy.

Hydrocortisone is excreted in breast milk. However, at therapeutic doses it is unlikely to affect a nursing child. Ask your doctor or pharmacist for advice if you use Hyderm more than occasionally during breast-feeding.

Driving and using machines

Hyderm does not affect your ability to drive or use machines.

Important information about some of the ingredients of Hyderm

The cream should be thinly applied in the morning and evening or according to your doctor's instructions. After a few days, the number of applications may be decreased and alternated with a moisturisingcream without hydrocortisone.

The cream should not be used for longer than 4-6 weeks, unless your doctor instructs otherwise.

Children under 2 years should only be treated with Hyderm, if prescribed by a doctor.

4. POSSIBLE SIDE EFFECTS

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

Uncommon side effects (occur in less than 1 of 100 users): contact eczema (hydrocortisone) with increased itching, redness and irritation.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HYDERM

Keep out of the reach and sight of children.

Store below 25C.

Do not use Hyderm after the expiry date which is stated on the carton after Exp.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Hyderm contains

• The active substance is hydrocortisone 10 mg/g.

• The other ingredients are white soft paraffin, hydrogenated canola oil, isopropyl isostearate, myristyl myristate, glycerol monostearate, cetostearyl alcohol, macrogol stearate 100, anhydrous citric acid, sodium citrate, butylene glycol and purified water.

What Hyderm looks like and contents of the pack

The medicine: White cream

Contents of packs:30 g in a plastic tube with a screw top, 100 g in a plastic tube with a snap-on lid.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

ACO HUD NORDIC AB, Box 622, 194 26 Upplands Väsby, Sweden

Manufacturer:

Bioglan AB, Malmö, Sweden

This leaflet was last approved

20 July 2011