Package leaflet: Information for the user

CORTANEST PLUS 0.025% + 5% Cream

Fluocinolone acetonide and lidocaine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CORTANEST PLUS is and what it is used for

CORTANEST PLUS contains the active substances: fluocinolone, a corticosteroid anti-inflammatory agent, and lidocaine, a local anesthetic.
CORTANEST PLUS is indicated for local treatment:

of inflammatory or allergic skin diseases (atopic, seborrheic, exfoliative, actinic, contact, toxic dermatoses, neurodermatitis, urticaria, burns, dyshidrosis);
of anogenital pain and irritation, or following perianal surgical procedures.

2. What you need to know before using CORTANEST PLUS

Do not use CORTANEST PLUS

if you are allergic to fluocinolone, lidocaine, or any of the other ingredients of this medicine;
if you have a skin infection (cutaneous tuberculosis, luetic skin conditions);
if you have a viral infection (herpes simplex, varicella);
if you have skin lesions caused by a viral infection (vaccinia pustules).

Warnings and precautions
Talk to your doctor or pharmacist before using CORTANEST PLUS.
CORTANEST PLUS contains lidocaine; therefore, use this medicine with caution and under direct medical supervision if you have extensive skin lesions or bleeding hemorrhoids.
Prolonged use of this medicine may cause allergic skin reactions (sensitization phenomena).
When treating widespread skin infections or when using occlusive dressings, increased absorption of the medicine may occur. Therefore, if you have multiple or extensive skin lesions, apply CORTANEST PLUS to small areas at a time.
If you have both skin inflammation and infections, your doctor may prescribe an appropriate treatment.
Do not apply CORTANEST PLUS to the eyes or near the eyes (ophthalmic use), or into the ear in case of eardrum perforation (external ear use with perforated eardrum).

Children
Use this medicine with caution in children, as it may cause hormonal imbalances known as Cushing's syndrome (facial swelling, fat deposition around the shoulders and back of the neck, upper back), growth retardation, and increased pressure in the head (endocranial hypertension, fontanelle tension, headache, bilateral papilledema).

Other medicines and CORTANEST PLUS
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between CORTANEST PLUS and other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use CORTANEST PLUS during pregnancy only if clearly needed and under direct medical supervision.

Driving and using machines
This medicine does not affect your ability to drive or operate machinery.

CORTANEST PLUS contains cetostearyl alcohol, propylene glycol, and parahydroxybenzoates
This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
This medicine contains propylene glycol, which may cause skin irritation.
This medicine contains propyl p-hydroxybenzoate and methyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use CORTANEST PLUS

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before applying this medicine, it may be necessary to clean and disinfect the area to be treated.
Apply a thin layer of CORTANEST PLUS, gently massaging it in, extending also to the surrounding skin areas near the lesion. Repeat the application 2–3 times a day, or as directed by your doctor. If improvement occurs, once daily application may be sufficient.

Use in children
In infants and children under 4 years of age, treatment duration should not exceed 3 weeks, especially when applying this medicine to areas covered by diapers.

If you use more CORTANEST PLUS than you should
Cases of overdose have not been reported.
In case of accidental ingestion or excessive intake of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to use CORTANEST PLUS
Do not use a double dose of this medicine to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Not known (frequency cannot be estimated from the available data)

skin redness;
fluid accumulation in tissues (oedema);
skin changes (desquamation);
itching;
changes in hormone levels (inhibition of the hypothalamic-pituitary-adrenal axis, signs of hypercorticism) in case of occlusive dressing, treatment of extensive areas and/or areas with lesions due to systemic absorption. With prolonged therapy, the following may occur:
dryness of the skin;
inflammation of hair follicles and skin glands (sebaceous glands);
decreased skin pigmentation;
increased hair growth;
skin disorders such as maceration, striae, and changes due to sweat retention (with occlusive dressing);
increased blood pressure (hypertension);
fatigue and weakness (asthenia);
heart rhythm disturbances;
decreased potassium levels in the blood (hypokalaemia).

Plastic films used for occlusive dressing are flammable and may cause allergic reactions (sensitisation phenomena). In such cases, replace them with films made of different materials.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store CORTANEST PLUS

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 medicines 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 CORTANEST PLUS contains

The active substances are: fluocinolone acetonide and lidocaine hydrochloride. Each 30 g tube contains 0.0075 g of fluocinolone acetonide and 1.5 g of lidocaine hydrochloride.
The other components are: cetostearyl alcohol, macrogol 4000, propylene glycol, propyl p-hydroxybenzoate, methyl p-hydroxybenzoate, citric acid, rose fragrance.

Description of the appearance of CORTANEST PLUS and contents of the pack
Pack containing one tube of 30 g of cream.
Marketing Authorization Holder
PIAM farmaceutici S.p.A. - Via Fieschi, 8 - 16121 - GENOA
Manufacturer
Bruschettini srl, Via Isonzo, 6 - 16147 Genoa