DERMOCORTAL 5 mg /G Cream

Зміст інструкції

1. Dermocortal 5 mg/g cream
   1. What is Dermocortal and what is it used for
   2. What you need to know before using Dermocortal
   3. How to use Dermocortal
   4. Possible side effects
   5. How to store Dermocortal
   6. Contents of the pack and other information

Dermocortal 5 mg/g cream

Hydrocortisone

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days.

Contents of this leaflet:

• 1. What Dermocortal is and what it is used for
• 2. What you need to know before using Dermocortal
• 3. How to use Dermocortal
• 4. Possible side effects
• 5. How to store Dermocortal
• 6. Contents of the pack and other information

1. What is Dermocortal and what is it used for

Consult your doctor if you do not feel better or if you feel worse after a few days.
Dermocortal contains the active ingredient hydrocortisone which belongs to a group of medicines
called corticosteroids. Hydrocortisone helps to 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 need to know before using Dermocortal

Do not use Dermocortal

• if you are allergic to the active ingredient or 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
Consult your doctor or pharmacist before using Dermocortal.
Do not use this medicine:

• on the eyes, or in the area around the eyes.
• for the treatment of vaginal itching in the presence of vaginal discharge.
• for prolonged treatments and on large areas of skin; after a short period of treatment, if you do not see appreciable results, consult your doctor. The use, especially if prolonged, of products for topical (local) use can give rise to sensitization phenomena (excessive reaction of the body to foreign substances with which it has come into contact). In this case stop thetreatmentand consult your doctor to start 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, the product should be administered only if absolutely necessary and
under the direct supervision of a doctor. Consult your doctor before using Dermocortal in children under
2 years of age.
This medicine is for external use only.

Other medicines and Dermocortal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy, use this medicine only if your doctor has deemed it necessary and under his/her
supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.

Dermocortal contains methyl parahydroxybenzoate and propyl parahydroxybenzoate:these may cause
allergic reactions (even delayed).

Dermocortal contains Benzyl alcohol: it may cause mild local irritation.

Dermocortal containsfragrance, which in turn contains amyl cinnamal, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate,
cinnamal, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hexyl cinnamal aldehyde,
hydroxycitronellal, hydroxy methyl pentyl cyclohexene carboxaldehyde, isoeugenol,
limonene, linalool.
Amyl cinnamal, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl
cinnamate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, citronellol, coumarin, eugenol,
farnesol, geraniol, hexyl cinnamal aldehyde, hydroxycitronellal, hydroxy methyl pentyl cyclohexene
carboxaldehyde, isoeugenol, limonene, linalool may cause allergic reactions.

3. How to use Dermocortal

Use this medicine following exactly as stated in this leaflet, or as instructed 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,
massaging lightly.
The maximum recommended treatment duration is 3 days in case of redness (erythema), 7 days
for other indications (insect bites, itching, localised burns, skin inflammations).
Caution: use this medicine only for short periods of treatment as specified above and do not
exceed the indicated doses without the advice of your doctor.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change
in its characteristics.

If you use more Dermocortal than you should
In case of applications for long periods and on large areas of skin, irritation or
sensitization may occur.
In this case, stoptreatment and consult your doctor or pharmacist.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Blurred vision with frequency not known.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dermocortal contains

• The active ingredient is hydrocortisone. 1 g of cream contains 5 mg of hydrocortisone.
• The other ingredients are: glycerol palmitostearate and polyethylene glycol associated with cetylstearyl alcohol polyoxyethylene, polyglycolysed isostearic glycerides, glycerol monostearate, phenoxyethanol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, isostearyl isostearate, liquid paraffin, perfumed essence, purified water.

Description of the appearance of Dermocortal and contents of the pack
Dermocortal is presented as a cream contained in an aluminium tube of 20 g.

Marketing Authorisation Holder and Manufacturer
Laboratorio Farmaceutico SIT s.r.l. – Via Cavour, 70 – 27035 Mede (PV)