Cortidro
Italy
Table of Contents
Package leaflet: Information for the patient
Cortidro 0.5% cream
Hydrocortisone acetate
Please read 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 instructed.
- 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, please contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What Cortidro is and what it is used for
- What you need to know before using Cortidro
- How to use Cortidro
- Possible side effects
- How to store Cortidro
- Contents of the pack and other information
1. What Cortidro is and what it is used for
Cortidro contains the active substance 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 for insect bites, itching, erythema, minor burns, and skin inflammations (eczema).
2. What you need to know before using Cortidro
Do not use Cortidro if:
- you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- you currently have an infection caused by viruses, bacteria, or fungi.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
Cortidro is not indicated for the treatment of itching of the external female genital organs (vulva) when 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 or over large skin areas, may cause irritation and allergic reactions (sensitization phenomena). If this occurs, stop 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 be used only when strictly necessary and under direct medical supervision.
Other medicines and Cortidro
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Pay particular attention when using Cortidro together with the following medicines:
- amphotericin B-containing medicines used to treat fungal infections (mycoses): concomitant administration with Cortidro may cause further lowering of potassium levels in the blood (hypokalaemia).
Concomitant use of Cortidro is not recommended with:
- anticoagulant medicines (i.e. those that slow down or interrupt the blood clotting process): the action of Cortidro may counteract the effects of these medicines, especially with coumarin anticoagulants;
- barbiturates (medicines used to treat conditions such as insomnia and epilepsy): they may reduce the effect of corticosteroids.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision.
Driving and using machines
Cortidro does not affect the ability to drive or operate machinery.
Cortidro contains:
- methyl p-hydroxybenzoate – propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions);
- cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
3. How to use Cortidro
Use this medicine exactly as instructed by your doctor or pharmacist. 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, gently massaging to aid absorption, two or three times daily.
Use Cortidro only for short-term 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 accidental ingestion/overdose of Cortidro, contact your doctor immediately or go to the nearest hospital.
If you forget to use Cortidro
If you have forgotten to apply the cream, do so as soon as you remember.
Do not apply a double dose to make up for the missed dose; continue using the medicine as directed.
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 everyone experiences them.
Uncommon side effects (may affect up to 1 in 100 people): Blurred vision
Systemic side effects due to local application of corticosteroids at the recommended doses are highly unlikely. If you experience any side effect, stop treatment and consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following address: 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 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 Cortidro contains
- The active substance is hydrocortisone acetate. 100 g of cream contain 0.5 g of hydrocortisone acetate.
- The other components are: cetyl stearyl alcohol, sodium lauryl sulfate, mineral oil, soft paraffin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.
Description of the appearance of Cortidro and contents of the pack
Cortidro is a cream supplied in an aluminium tube of 20 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France
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)