Gentamicin and betamethasone Idi
Italy
Table of Contents
Package leaflet: Information for the user
GENTAMICIN AND BETAMETHASONE IDI
1 mg/g + 1 mg/g Cream
Equivalent medicine
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 they have the same symptoms as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What GENTAMICIN AND BETAMETHASONE IDI is and what it is used for
- What you need to know before using GENTAMICIN AND BETAMETHASONE IDI
- How to use GENTAMICIN AND BETAMETHASONE IDI
- Possible side effects
- How to store GENTAMICIN AND BETAMETHASONE IDI
- Contents of the pack and other information
1. What GENTAMICINA E BETAMETASONE IDI is and what it is used for
GENTAMICINA E BETAMETASONE IDI contains the active substances gentamicin and betamethasone and belongs to the group of corticosteroid medicines combined with antibiotics.
GENTAMICINA E BETAMETASONE IDI is indicated for:
Topical (local) treatment of allergic or inflammatory skin conditions that are secondarily infected or at risk of infection, such as:
- Treatment of eczema, a type of skin inflammation (atopic, infantile, nummular characterized by circular-shaped skin lesions)
- Treatment of anogenital and senile pruritus (itching)
- Treatment of contact dermatitis, seborrheic dermatitis (a skin inflammation characterized by excessive sebum production), neurodermatitis (atopic dermatitis), intertrigo (inflammation due to skin friction), solar erythema, exfoliative dermatitis (skin inflammation with skin peeling), radiation dermatitis, stasis dermatitis (skin inflammation due to blood pooling in dilated leg veins), and psoriasis (chronic skin inflammation).
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before using GENTAMICIN AND BETAMETASONE IDI
Do not use GENTAMICIN AND BETAMETASONE IDI
- if you are allergic to gentamicin, betamethasone or any of the other ingredients of this medicine (listed in section 6).
- in case of cutaneous tuberculosis
- in case of herpes simplex
- in case of viral skin diseases.
Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICIN AND BETAMETASONE IDI.
If irritation or sensitization related to the use of this medicine occurs, treatment must be
discontinued and appropriate therapy initiated. Any of the adverse effects described for systemic corticosteroids, including adrenal suppression (reduced adrenal gland function; the adrenal glands are located above the kidneys), may also occur with topical (local) corticosteroids, especially in pediatric patients.
Systemic absorption (generalized absorption through lymphatic and venous vessels of the skin) of topical corticosteroids increases when large skin areas are treated or when occlusive dressings are used. In such cases, or when prolonged treatment is expected, appropriate precautions are required, particularly in pediatric patients.
Topical use of antibiotics may sometimes allow overgrowth of non-susceptible organisms, including fungi. In such cases, or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and specific therapy initiated.
This product must not be used in the "eye area".
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
In children, this medicine should be used only when clearly needed and under direct medical supervision, as it may increase the risk of adverse effects due to higher corticosteroid absorption (see section "Additional adverse effects in children").
Other medicines and GENTAMICIN AND BETAMETASONE IDI
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
The safety of topical corticosteroids in pregnant women has not been established; therefore, if you are pregnant, use this medicine only when clearly necessary and under direct medical supervision.
If you are pregnant, do not use this medicine at high doses or for prolonged periods.
If you are breastfeeding, your doctor will decide whether it is better to discontinue breastfeeding or interrupt treatment, depending on your condition.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
GENTAMICIN AND BETAMETASONE IDI contains chlorocresol, which may cause allergic reactions, and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
3. How to use GENTAMICINA E BETAMETASONE IDI
Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Apply a small amount of cream to the affected area 2–3 times daily.
For the treatment of more resistant psoriatic lesions or infected deep dermatoses, occlusive
dressing may be used to achieve a better therapeutic response, as described below.
Occlusive dressing technique
- Apply a thick layer of cream over the entire lesion surface, cover with a light gauze, and then cover with a transparent, waterproof, flexible plastic material extending beyond the edges of the treated area;
- Seal the edges to the surrounding healthy skin with adhesive tape or other suitable means;
- Leave the dressing in place for 1–3 days and repeat the procedure 3–4 times as needed. This method often results in significant improvement within a few days. However, if you notice skin irritation, remove the dressing.
If you use more GENTAMICINA E BETAMETASONE IDI than you should
Excessive or prolonged use of this medicine may cause corticosteroid-related adverse effects such as: adrenal gland dysfunction, increased steroid levels in the body (hypercorticism), including Cushing's syndrome—a condition in which the body produces too much cortisol—bacterial and fungal infections.
These symptoms may resolve after discontinuation of treatment, which should be tapered gradually.
In case of accidental ingestion/ingestion of GENTAMICINA E BETAMETASONE IDI, contact your doctor or go immediately to the Emergency Department of the nearest hospital. In this way, a doctor will assess whether therapy is needed to treat your symptoms.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When using corticosteroids on the skin such as Gentamicin and betametasone IDI, some of the
following side effects may occur: burning sensation, itching, irritation, dry skin, folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acneiform eruptions (acne-like rashes), hypopigmentation (reduction in skin colour), perioral dermatitis (inflammation of the skin around the mouth), allergic contact dermatitis.
Blurred vision may occur, frequency unknown.
The use of occlusive dressings may increase the risk of side effects such as skin lesions (skin maceration), secondary infection, skin thinning (cutaneous atrophy), stretch marks (striae), and a skin inflammation known as miliaria.
Treatment with gentamicin (contained in Gentamicin and betametasone IDI) may cause temporary irritation (erythema and itching), which usually does not require discontinuation of treatment.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store GENTAMICINA E BETAMETASONE IDI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This date applies to the product in its original, undamaged packaging, correctly stored.
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 GENTAMICINA E BETAMETASONE IDI contains
The active substances are: gentamicin and betamethasone.
1 g contains 1 mg of gentamicin (equivalent to 1.66 mg of gentamicin sulfate) and 1 mg of
betamethasone (equivalent to 1.22 mg of betamethasone valerate).
- Other components: cetyl stearyl alcohol, cetomacrogol, white vaseline, liquid paraffin, monobasic sodium phosphate, chlorocresol, phosphoric acid, purified water.
Description of the appearance of GENTAMICINA E BETAMETASONE IDI and contents of the pack
Cream. 30 g tube.
Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI S.r.l. – Via Castelli Romani n. 83/85 – 00071 Pomezia (RM)
The package leaflet can be read or listened to by scanning the QR Code or visiting the website http://www.leafletidi.it/gentamicinaebetametasone.
