Package leaflet: Information for the user

Dermocortal 5 mg/g cream

Hydrocortisone
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a few days.

Contents of this leaflet:

What Dermocortal is and what it is used for
What you need to know before using Dermocortal
How to use Dermocortal
Possible side effects
How to store Dermocortal
Contents of the pack and other information

1. What Dermocortal is and what it is used for

Consult your doctor if you do not feel better or if you feel worse after a few days.
Dermocortal contains the active substance hydrocortisone, which belongs to a group of medicines called corticosteroids. Hydrocortisone helps reduce local inflammation, swelling, and itching.
This medicine is used in the treatment of:

insect bites;
localized itching or burns;
skin inflammations (eczema);
skin redness (erythema).

2. What you should know before using Dermocortal

Do not use Dermocortal

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have an infection caused by viruses, bacteria, or fungi.

Warnings and precautions
Talk to your doctor or pharmacist before using Dermocortal.
Do not use this medicine:

in the eyes or around the eye area.
for the treatment of vaginal itching in the presence of vaginal discharge.
for prolonged periods or on large areas of skin. If after a short period of treatment you do not notice significant improvement, consult your doctor. Use, especially if prolonged, of topical (local) skin products may lead to sensitization reactions (excessive immune response to foreign substances contacted). In this case, stop the treatment and consult your doctor to begin appropriate therapy (see section 3 “If you use more Dermocortal than you should”).

Contact your doctor if you experience blurred vision or other visual disturbances.
Children
In children under 2 years of age, this product should be used only when strictly necessary and under direct medical supervision. Consult your doctor before using Dermocortal in children under 2 years of age.
This medicine is for external use only.
Other medicines and Dermocortal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, use this medicine only if considered necessary by your doctor and under their supervision.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Dermocortal contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: these may cause allergic reactions (including delayed reactions).
Dermocortal contains benzyl alcohol: may cause mild local irritation.
Dermocortal contains perfume essence, which in turn contains amyl cinnamic aldehyde, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, ethyl cinnamic aldehyde, hydroxycitronellal, hydroxymethyl pentyl cyclohexene carboxaldehyde, isoeugenol, limonene, linalool.
Amyl cinnamic aldehyde, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, ethyl cinnamic aldehyde, hydroxycitronellal, hydroxymethyl pentyl cyclohexene carboxaldehyde, isoeugenol, limonene, and linalool may cause allergic reactions.

3. How to use Dermocortal

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 applications per day. Apply a thin layer of cream to the affected area, gently massaging it in.
The maximum recommended duration of treatment is 3 days for redness (erythema) and 7 days for other indications (insect bites, itching, localized burns, skin inflammations).
Caution: Use this medicine only for short periods of treatment as specified above and do not exceed the indicated doses without medical advice.
Consult your doctor if the condition recurs or if you notice any recent changes in its characteristics.
If you use more Dermocortal than you should
With prolonged use and application over large areas of skin, irritation or sensitization may occur.
In this case, discontinue treatment and consult your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Blurred vision, frequency not known.
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dermocortal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dermocortal contains

The active substance is hydrocortisone. 1 g of cream contains 5 mg of hydrocortisone.
The other components are: glyceryl palmitostearate and polyethylene glycol associated with cetostearyl alcohol polyoxyethylene ether, polyglycolized isostearic glycerides, glycerol monostearate, phenoxyethanol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, isostearic isostearate, liquid paraffin, perfumed essence, purified water.

Description of the appearance of Dermocortal and contents of the pack
Dermocortal is a cream presented in a 20 g aluminium tube.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT s.r.l. – Via Cavour, 70 – 27035 Mede (PV)