BIDIEN 0.025% Cream

Зміст інструкції

1. BIDIEN 0.025 % Cream, 0.025% Ointment, 0.025% Cutaneous Solution
   1. What is BIDIEN and what is it for
   2. What you need to know before using BIDIEN
   3. How to use BIDIEN
   4. Possible side effects
   5. How to store BIDIEN
   6. Contents of the pack and other information

BIDIEN 0.025 % Cream, 0.025% Ointment, 0.025% Cutaneous Solution

Budesonide

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

1. What is BIDIEN and what is it for

BIDIEN contains the active ingredient budesonide which belongs to the group of corticosteroids
for topical treatment and has an anti-inflammatory, anti-pruritic and
vasoconstrictor action.
BIDIEN is used for the treatment of skin conditions sensitive to corticosteroids (seborrheic
dermatitis, atopic dermatitis, contact dermatitis, allergic or irritative, lichen, psoriasis,
neurodermatitis and others) and for the symptomatic treatment of pruritus.

2. What you need to know before using BIDIEN

Do not use BIDIEN

• if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
• In case of tuberculous and viral infections of the treated skin (herpes, varicella, etc.).
• In case of rosacea, skin ulcers.

Occlusive dressings are contraindicated in exuding lesions and skin infections.

Warnings and precautions
Consult your doctor or pharmacist before using Bidien.
The product is not for ophthalmic use.
Epicutaneous (i.e. on the skin) application of corticosteroids in the treatment of extensive dermatoses
and/or for long periods of time, may determine secondary phenomena from systemic absorption into the
blood (Cushing's syndrome, inhibition of the hypothalamic-pituitary axis). This is more
frequent in children (due to a high ratio between skin surface area and body weight) and in case of
occlusive bandaging. In pediatric use, skin folds and diapers
can act as an occlusive bandage. Therefore, in the treatment of chronic conditions that
require long-term therapies, if a favorable therapeutic effect has been achieved, the frequency
of applications and dosage should be reduced to the minimum necessary to control symptoms and
avoid relapses (i.e. recurrence of the disease) stopping the use of the medicine as soon as
possible. During therapy, it is necessary to monitor the patient's condition in order to isolate
early signs and symptoms of excess corticosteroids (asthenia, i.e. fatigue, hypertension i.e.
high blood pressure, electrolyte disturbances, i.e. alteration of the amount of sodium, potassium,
chlorine in the blood, etc.). In all other cases, it is advisable to limit the use of topical steroids to short
periods of time.
Topical corticosteroids can be applied to infected skin only if preceded or accompanied by
adequate antibacterial and antifungal therapy; in case of failure, treatment should be discontinued. Prolonged or repeated use of the product can give rise to phenomena of
sensitization.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and BIDIEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. Since the function of the adrenal glands can be inhibited, an ACTH stimulation test to diagnose possible pituitary insufficiency may provide
false results (low values).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Bidien Cream contains:

• Propylene glycol:may cause skin irritation.
• Methylparahydroxybenzoateandpropylparahydroxybenzoate:may cause allergic reactions (even delayed).
• Cetyl alcohol:may cause localized skin reactions (e.g. contact dermatitis).
• Lanolin alcohols:may cause localized skin reactions (e.g. contact dermatitis).

BidienOintment contains:

• Lanolin alcohols:may cause localized skin reactions (e.g. contact dermatitis).
• Propylparahydroxybenzoate: may cause allergic reactions (even delayed)

Bidien Cutaneous solution contains:

• Ethanol:this medicine contains 31.6g of alcohol (ethanol) in each bottle. It may cause a burning sensation on damaged skin.
• Propylene glycol:may cause skin irritation.

3. How to use BIDIEN

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Apply a small amount of product with gentle massage twice a day. As
maintenance treatment, a daily application is usually sufficient.
The cream is easily spreadable and is absorbed with gentle massage; it is non-greasy and is used
especially in dressings without bandages in irritative and exudative dermatoses.
The ointment, thanks to its fatty component, is recommended for squamous, crusty, lichenified (consistent with skin thickening) dermatological forms and is particularly
suitable for occlusive dressings that can be kept in place for 12 - 24
hours.
The cutaneous solution, due to its particular composition, is indicated for dermatoses of the scalp
and hairy areas: apply by massaging the area to be treated.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Locally, redness, edema (swelling), desquamation (loss of the superficial part of the skin), and itching may occur as signs of hypersensitivity to the product; other side effects include hypertrichosis (increased hair growth), acneiform eruptions (skin blisters with pus), skin atrophy (reduction of skin thickness), telangiectasia (dilation of superficial skin vessels), vascular fragility (weakness of skin vessels), purpura (bluish skin spots due to rupture of superficial blood vessels), and, after prolonged treatments (especially on the face), rebound pustular dermatitis (skin inflammation with pus blisters) which, being sensitive to steroids, become evident only upon discontinuation of these. Prolonged and/or high-dose use may induce an excess syndrome (overdose) with
arterial hypertension (increased blood pressure), asthenia (fatigue), adynamia
(decreased muscle strength), cardiac rhythm disturbances (arrhythmia, altered heart rate),
hypokalemia (decreased potassium in the blood) and metabolic alkalosis (reduction of blood acidity).
In occlusive treatments, it should be noted that the films used for bandaging may themselves cause
sensitization phenomena.
Blurred vision may occur with uncommon frequency.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
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. Reporting side effects can help provide more information on the
safety of this medicine.

5. How to store BIDIEN

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. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 BIDIEN contains
BidienCream

• The active ingredient is budesonide. 100 g of cream contains 0.025 g of budesonide.
• The other ingredients are: white soft paraffin, isopropyl myristate, cetyl alcohol, cetostearyl alcohol ethoxylates, lanolin alcohols, glyceryl monostearate, propylene glycol, propylparahydroxybenzoate, methylparahydroxybenzoate, citric acid monohydrate, disodium phosphate anhydrous, disodium edetate, purified water.

BidienOintment

• The active ingredient is budesonide. 100 g of ointment contains 0.025 g of budesonide.
• The other ingredients are: paraffin oil, white paraffin, mineral oil and lanolin alcohols, distilled water, propylparahydroxybenzoate, white soft paraffin.

Bidien Cutaneous solution

• The active ingredient is budesonide. 100 g of solution contains 0.025 g of budesonide.
• The other ingredients are: ethyl alcohol, ethoxylated methylglucose, citric acid, propylene glycol.

Description of the appearance of BIDIEN and contents of the pack
Bidien Cream: tube containing 30 g
Bidien Ointment: tube containing 30 g
Bidien Cutaneous solution: bottle containing 30 ml.

Marketing Authorisation Holder and Manufacturer
IDI FARMACEUTICI SRL - Via dei Castelli Romani 83/85 - Pomezia (RM)

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