CORTIDRO 0.5% Cream

Зміст інструкції

1. Cortidro 0,5% cream
   1. What Cortidro is and what it is used for
   2. What you need to know before you use Cortidro
   3. How to use Cortidro
   4. Possible side effects
   5. How to store Cortidro
   6. Contents of the pack and other information

Cortidro 0,5% cream

Hydrocortisone acetate
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 short period of treatment.

Contents of this leaflet:

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

1. What Cortidro is and what it is used for

Cortidro contains the active ingredient hydrocortisone, which belongs to a group of medicines called
corticosteroids, used to reduce inflammation.
Cortidro is a cream used in adults and children over two years of age, in case of insect bites,
itching, erythema or non-extensive burns, skin inflammations (eczema).

2. What you need to know before you use Cortidro

Do not use Cortidro if:

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

Warnings and precautions
Consult your doctor or pharmacist before using this medicine.
Cortidro is not indicated for the treatment of itching of the outermost part of the female genital organs
(vulva), in case this is associated with vaginal discharge.
Cortidro is not for ophthalmic use, therefore do not use it in the area around the eyes.
The use of this medicine, especially if prolonged and on large areas, may lead to irritation and
allergic reactions (sensitization phenomena). If this should happen, stop the treatment and
consult your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In children under two years of age, Cortidro should only be used in case of actual need and under the
direct control of the doctor.

Other medicines and Cortidro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
You should pay particular attention when using Cortidro together with the following medicines:

• medicines based on amphotericin B used in the treatment of fungal infections (mycoses): concomitant administration with Cortidro may cause a further lowering of potassium levels in the blood (hypokalaemia).

The concomitant use of Cortidro with the following is not recommended:

• anticoagulant medicines (i.e. capable of slowing down or interrupting the blood coagulation process): the action of Cortidro may counteract the effects of these medicines, especially in the case of coumarinic anticoagulants;
• barbiturates (medicines for treating conditions including insomnia and epilepsy): they may reduce the effect of corticosteroids.

Pregnancy, breastfeeding and fertility
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.
If you are pregnant, use this medicine only if absolutely necessary and under the direct control of
your doctor.

Driving and using machines
Cortidro does not impair the ability to drive vehicles or operate machinery.

Cortidro contains:

• methyl P-hydroxybenzoate- propylP-hydroxybenzoatewhich may cause allergic reactions (including delayed reactions);
• cetostearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis).

3. How to use Cortidro

Use this medicine following the instructions of your doctor or pharmacist exactly as given. If you have any doubts
consult your doctor or pharmacist.

Adults and children over two years of age
Take a small amount of cream and apply it to the affected area, massaging lightly to
facilitate absorption, two or three times a day.
Use Cortidro only for short periods of treatment.
If you do not notice any improvement, consult your doctor. Do not exceed the recommended dose.

If you use more Cortidro than you should
In case of ingestion/accidental intake of an excessive dose of Cortidro, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Cortidro
If you forgot to apply the cream, do so as soon as you remember.
Do not apply a double dose to make up for the forgotten dose; therefore continue application according to the
usual schedule.
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.
Side effects with an uncommon frequency (may affect up to 1 in 100 people): Blurred vision
It is very unlikely that systemic side effects occur due to the local application of corticosteroids at the indicated doses. If you experience any side effect, discontinue therapy and consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 Cortidro

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
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 waste water 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 Cortidro contains

• the active ingredient is hydrocortisone acetate. 100 g of cream contains 0.5 g of hydrocortisone acetate.
• the other ingredients are: cetostearyl alcohol, sodium lauryl sulfate, petrolatum oil, liquid paraffin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.

Description of the appearance of Cortidro and contents of the pack
Cortidro is presented in the form of a cream, contained in an aluminum tube of 20 g.

Marketing authorization holder and manufacturer

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturers
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy
DOPPEL FARMACEUTICI Srl,
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)