Package leaflet: Information for the user

DERVIN 0.3% cream

diflucortolone valerate
Please read all of this leaflet carefully before you start 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DERVIN is and what it is used for

DERVIN is a topical cream containing the active substance diflucortolone valerate,
which belongs to a group of medicines called corticosteroids.
DERVIN is indicated for the treatment of chronic dermatoses (skin inflammations) such as:

psoriasis, a chronic inflammatory skin disease involving the immune system;
neurodermatitis (endogenous eczema, atopic dermatitis), a skin inflammation;
lichen ruber planus and verrucosus, a disease of the skin and mucous membranes characterized by redness and lesions;
chronic discoid lupus erythematosus (chronic discoid erythematosus), a chronic autoimmune disease characterized by skin lesions;
chronic eczema (chronic inflammatory skin reaction).

2. What you need to know before using DERVIN

Do not use DERVIN

If you are allergic to diflucortolon valerate or to any of the other ingredients of this medicine (listed in section 6);
if you have a type of bacterial skin infection called cutaneous tuberculosis;
if you have a type of bacterial skin infection called syphilis;
if you have a viral skin infection such as herpes zoster or varicella;
if you have had skin reactions after vaccination;
if you suffer from rosacea, a skin condition characterized by irritation and redness of the face;
if you have skin ulcers (skin lesions);
if you have burns or frostbite of grade 2 or higher severity.

Warnings and precautions
Talk to your doctor or pharmacist before using DERVIN.
Do not apply DERVIN to the eyes.
If you have skin diseases caused by bacterial or fungal (mycotic) infections, your doctor will prescribe this medicine together with an antibiotic or an antifungal agent, respectively.
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Treatment over large areas and/or for long periods, especially when using occlusive bandaging techniques, may significantly increase the risk of adverse effects due to systemic absorption of the medicine.
Do not use occlusive bandaging if you have pus-forming lesions (exudative) or skin infections.
During treatment, your doctor may want to monitor your health periodically to prevent unwanted effects caused by excessive corticosteroid exposure.
Use the cream for the shortest duration possible and do not apply it to the face.
Glaucoma (an eye disease characterized by increased intraocular pressure) may occur if excessive doses are used, or if the medicine is applied over large areas for prolonged periods, particularly with occlusive bandaging techniques.
The use of DERVIN in children under 4 years of age should be avoided (see section "How to use DERVIN").
The use, especially if prolonged, of topical glucocorticoid medicines may lead to sensitization (allergy). In such cases, discontinue treatment and contact your doctor, who will recommend appropriate therapy.
If you apply DERVIN in the genital or anal area, the effectiveness of latex products such as condoms may be reduced due to certain components present in the medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.
Consult your doctor or pharmacist if you need further information.

Other medicines and DERVIN
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.

Fertility, 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.

Pregnancy
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 this medicine during pregnancy only if clearly needed and under direct medical supervision.
Do not use DERVIN during the first trimester of pregnancy.
If you are pregnant, avoid in particular applying DERVIN over large areas, for prolonged periods, or with occlusive bandaging.

Breastfeeding
It is not known whether the active ingredient passes into breast milk. A risk to the breastfed infant therefore cannot be excluded.
If you are breastfeeding:

do not apply DERVIN on the breasts; 2/5
avoid applying DERVIN under occlusive bandaging or over large areas of the body;
avoid using DERVIN for prolonged periods.

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

DERVIN contains parahydroxybenzoates
May cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.

3. How to use DERVIN

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The cream is particularly suitable for the treatment of exuding lesions and moist skin areas, such as the anal region and axillary cavity, as well as exposed skin areas.
Apply a small amount of cream to the affected area, gently massaging it in.
Initial treatment consists of a thin application 2 or 3 times daily. This may be reduced to once daily once your condition has improved.
Use in children
DERVIN should not be used in children under 4 years of age.
In children over 4 years of age, treatment with this medicine should not exceed 3 weeks, especially if applied under the diaper area.
If you use more DERVIN than you should
If you apply an excessive amount of the product or accidentally ingest the entire contents of a package, significant intoxication is not expected.
In case of accidental ingestion or application, contact your doctor immediately or go to the nearest hospital.
If you stop using DERVIN
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.
The following side effects may occur in isolated cases:

infections caused by pathogenic organisms in case of an impaired immune system;
local allergic reactions;
osteoporosis, growth retardation in children;
redness or pain of the skin, burning, blistering, allergic contact dermatitis/dermatitis (an inflammatory skin disease), skin redness, swelling of the skin and mucous membranes (edema), irritation with pustular eruptions (pustules), skin thinning, dry or wrinkled skin, dilation of superficial blood vessels (telangiectasias), changes in skin pigmentation, itching, infection affecting hair follicles (folliculitis), acne-like skin eruptions, increased fragility of blood vessels, skin disease with redness and lesions (purpura);
irritation or pain at the application site;
hair loss or impaired hair growth, increased hair growth (hypertrichosis);
increased blood glucose levels (hyperglycemia); 3/5
increased glucose levels in urine (glucosuria).

Prolonged use and/or high doses, especially under occlusive dressing, may lead to the development of a condition characterized by obesity and moon-shaped face (Cushingoid syndrome) (with higher incidence when occlusive dressing is used).
Prolonged use and high doses of DERVIN may cause decreased potassium levels in the blood (hypokalemia) and alteration of blood pH (metabolic alkalosis), skin disorders with blister formation (rebound pustular dermatitis), blurred vision, glaucoma, cataract, changes in heart rhythm (arrhythmias), increased blood pressure (hypertension), weakness (asthenia), reduced levels of the hormone cortisol in the blood.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store DERVIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 DERVIN contains

The active substance is diflucortolone valerate. Each 100 g of cream contains 0.3 g of diflucortolone valerate.
The other components are: white petrolatum, stearic acid, mineral oil, sorbitan monopalmitate, polysorbate 80, 70% sorbitol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of DERVIN and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bionativa S.p.A.,
Via Raffaello 15 - Loc. Sambuca V.P.
50028 Florence
Italy
Manufacturer
LACHIFARMA SPA, Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy
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