DERVIN 0.3% Krem

Treść ulotki

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

DERVIN 0,3% cream

diflucortolone valerate

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DERVIN is and what it is used for

DERVIN is a cream for topical application that contains the active ingredient diflucortolone valerate
belonging 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), an inflammation of the skin;
• lichen ruber planus and verrucosus, a disease of the skin and mucous membranes characterized by redness and lesions;
• chronic lupus erythematosus (chronic discoid lupus erythematosus), a chronic autoimmune disease characterized by skin lesions;
• chronic eczema (chronic inflammatory reaction of the skin).

2. What you need to know before using DERVIN

Do not use DERVIN

• If you are allergic to diflucortolone valerate or any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection caused by bacteria called cutaneous tuberculosis;
• if you have a type of skin infection caused by bacteria called syphilis;
• if you have a skin infection caused by viruses such as herpes zoster and varicella;
• if you have had skin reactions after the administration of vaccines;
• if you suffer from rosacea, a skin disease characterized by irritation and redness on the face;
• if you have skin ulcers (skin lesions);
• if you have burns and frostbite of severity equal to or greater than 2nd degree.

Warnings and precautions
Consult your doctor or pharmacist before using DERVIN.
Do not apply DERVIN to the eyes.
If you have skin diseases caused by bacterial or fungal infections (mycoses), your doctor will prescribe
this medicine together with an antibiotic or an antifungal, respectively.
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Treatment on extensive areas and/or for long periods, particularly with occlusive dressing techniques
may significantly increase the risk of undesirable effects due to absorption of the medicine
into the body.
Do not apply occlusive dressings if you have weeping (exudative) lesions or skin infections.
During therapy, your doctor will want to periodically check your state of health to prevent the onset of
undesirable effects caused by an excess of corticosteroids.
Use the cream for the shortest possible time and do not apply it to the face.
Glaucoma (an eye disease in which there is an increase in intraocular pressure) may occur if you use excessive doses of medicine or use it on extensive areas for prolonged periods, with occlusive dressing 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 can give rise to sensitization (allergy) phenomena. In this case, discontinue treatment and contact your doctor who will advise
you on appropriate therapy.
If you apply DERVIN to the genital or anal region, 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 more information.

Other medicines and DERVIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, 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
supervision of your doctor.
Do not use DERVIN during the first trimester of pregnancy.
If you are pregnant, you should particularly avoid applying DERVIN to extensive areas, for a prolonged
period or with an occlusive dressing.
Breastfeeding
It is not known whether the active ingredient passes into breast milk. A risk to the
infant cannot therefore be excluded.
If you are breastfeeding:

• do not apply DERVIN to the breast; 2/5
• avoid applying DERVIN covered with an occlusive dressing or to extensive areas of the body;
• avoid using DERVIN for a prolonged period of time.
• Driving and using machinesDERVIN does not impair the ability to drive vehicles and operate machinery.

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

3. How to use DERVIN

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.
The cream is particularly indicated for the treatment of exuding lesions, of moist skin areas, such as the
anal region and the armpits, and also of exposed skin areas.
Apply a small amount of cream to the affected area, massaging gently.
Initial treatment involves a thin application 2 or 3 times a day, which may be reduced to 1
application a day following an improvement in your condition.

Use in children
The use of DERVIN in children under 4 years of age should be avoided.
In children over 4 years of age, the use of this medicine should not exceed 3 weeks,
especially if applied to areas covered by a diaper.

If you use more DERVIN than you should
If you apply an excessive amount of product or accidentally ingest the entire contents of a
pack, no risk of intoxication is predictable.
In case of ingestion/accidental application of DERVIN, contact your doctor immediately or go to the
nearest hospital.

If you stop using DERVIN
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.
The following side effects may occur, in isolated cases:

• infections caused by pathogenic organisms if your immune system is compromised;
• local allergic reactions;
• osteoporosis, delayed growth in children;
• redness or pain on the skin, burning, blister formation, allergic contact dermatitis/dermatitis (inflammatory skin disease), skin redness, swelling of the skin and mucous membranes (edema), irritation with the formation of boils (pustules), thinning of the skin, dry or rough skin, dilation of superficial blood vessels (telangiectasias), alteration of skin color, itching, infection affecting hair follicles (folliculitis), acne-like skin rash, fragility of blood vessels, skin disease with redness and lesions (purpura);
• irritation or pain at the application site;
• hair loss or problems with hair growth, increased hair growth (hypertrichosis);
• increased amount of glucose in the blood (hyperglycemia); 3/5
• increased amount of glucose in the urine (glycosuria).

Prolonged and/or high-dose use and after occlusive bandaging can determine the appearance of a disease
characterized by obesity and a moon-like face (Cushingoid syndrome) (with a higher incidence in the case
of occlusive bandaging).
Prolonged use and high doses of DERVIN can cause a decrease in potassium levels in the blood
(hypokalemia) and alteration of blood pH (metabolic alkalosis), skin diseases with blister formation
(pustular rebound dermatitis), blurred vision, glaucoma, cataracts, alteration of heart rhythm (arrhythmias), an increase in blood pressure (hypertension), weakness (asthenia), reduction of
cortisol hormone levels in the blood.

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: 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 DERVIN

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 label after “Scad”.
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 DERVIN contains

• The active ingredient is diflucortolone valerate. Each 100 g of cream contains 0.3 g of diflucortolone valerate.
• The other ingredients are: white soft paraffin, stearic acid, liquid paraffin, sorbitan monopalmitate, polysorbate 80, sorbitol 70%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of the appearance of DERVIN and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder
Bionativa S.p.A.,
Via Raffaello 15 - Loc. Sambuca V.P.
50028 Florence
Italy

Manufacturer
LACHIFARMA SPA, Salento Chemical Pharmaceutical Laboratory
S.S. 16 Industrial Area
73010 Zollino (LE)
Italy
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