Desamix neomycin

Package leaflet: Information for the patient

desamix neomicina 0.5% + 0.5% cream

desametasone + neomycin sulfate
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, consult 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 could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What DESAMIX NEOMICINA is and what it is used for
  2. What you need to know before using DESAMIX NEOMICINA
  3. How to use DESAMIX NEOMICINA
  4. Possible side effects
  5. How to store DESAMIX NEOMICINA
  6. Contents of the pack and other information

1. What DESAMIX NEOMICINA is and what it is used for

DESAMIX NEOMICINA is a topical cream containing two active substances:
dexamethasone and neomycin sulfate.
Dexamethasone is a corticosteroid with anti-inflammatory and antiallergic properties.
Neomycin is an aminoglycoside antibiotic used against infections caused by certain bacteria.
DESAMIX NEOMICINA is indicated for the treatment of:

• infantile eczema (inflammatory skin reaction with itching), eczema due to microbial infection, allergic eczema, and ear eczema.
• seborrheic dermatitis (skin eruption affecting areas rich in sebaceous glands such as the scalp, face, chest, and ear canal) and contact dermatitis (both are allergic inflammatory skin reactions).
• itching of the anus and external female genitalia.
• small cracks or cuts on the nipple (fissures).
• psoriasis (chronic inflammatory skin disease).
• scleroderma (chronic connective tissue disease involving the immune system).

2. What you need to know before using DESAMIX NEOMICINA

Do not use DESAMIX NEOMICINA

• if you are allergic to dexamethasone, neomycin sulfate, or any of the other ingredients of this medicine (listed in section 6).
• if you have skin conditions such as: acne (boils), rosacea (flushing or redness of the skin and face), perioral dermatitis (red skin eruptions around the mouth), syphilis (lues), cutaneous tuberculosis.
• if you have a viral skin infection such as herpes simplex or varicella (chickenpox).
• if you develop a skin reaction following vaccination.

Warnings and precautions
Talk to your doctor or pharmacist before using DESAMIX NEOMICINA.
Applying the cream over large areas of skin or for prolonged periods may allow corticosteroids (dexamethasone) to pass into the bloodstream. This is even more likely if the cream is applied under an occlusive dressing (non-breathable) or under diapers in infants.
Contact your doctor if you notice swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome.
Adrenal gland suppression may occur after stopping prolonged or intensive treatment with DESAMIX NEOMICINA.
Do not stop treatment on your own—consult your doctor first.
These risks are particularly important in children and in patients taking a medicine called ritonavir.
Contact your doctor if you experience blurred vision or other visual disturbances.
Use of topical skin products, especially for long periods, may lead to sensitization (allergy to one or more components). If this occurs, stop treatment and contact your doctor, who will recommend appropriate therapy.
Prolonged use of neomycin, as with other antibiotics, may lead to the development of resistant microorganisms, including fungi. In such cases, discontinue treatment and contact your doctor.
Pay special attention if you are allergic to an aminoglycoside antibiotic, as you may also be allergic to neomycin contained in this medicine.
Avoid application in the external ear canal if the eardrum is perforated, as there is a risk of hearing loss.
Avoid prolonged use of this product in treating skin infections resulting from extensive burns or trophic ulcers (lesions due to circulatory disorders), or in other conditions where absorption of neomycin may occur, as it may pose risks to hearing and kidney function.
As with other aminoglycoside antibiotics, avoid concomitant and/or subsequent administration of other medicines that may be harmful to the kidneys.
If a concurrent skin infection is present, appropriate covering therapy should be initiated.

Children
In very early infancy, use this medicine only when strictly necessary and under direct medical supervision. In newborns, diapers may produce the same effects as occlusive dressings (see above “Warnings and precautions”).

Other medicines and DESAMIX NEOMICINA
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when clearly needed and under direct medical supervision.

Driving and using machines
DESAMIX NEOMICINA does not impair the ability to drive or operate machinery.

DESAMIX NEOMICINA contains propyl parahydroxybenzoate and stearyl alcohol
Propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
Stearyl alcohol may cause localized skin reactions (e.g., contact dermatitis).

3. How to use DESAMIX NEOMICINA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not apply DESAMIX NEOMICINA to the eyes.
Apply a small amount of cream to the affected area and gently spread it.
Repeat the treatment 2–3 times a day.
If you use more DESAMIX NEOMICINA than you should
Prolonged application over large skin areas or lesions may result in absorption through the skin into the bloodstream of desametasone and/or neomycin.
In such cases, effects similar to those of orally taken corticosteroids may occur, including impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones) and high levels of steroids in the body (hypercorticism).
This may lead to a condition known as Cushing's syndrome (a disorder in which the body produces too much cortisol, a type of steroid) and, very rarely, intracranial hypertension (increased pressure in the brain).
These symptoms resolve after stopping treatment, which should be done gradually.
In case of accidental ingestion/ingestion of DESAMIX NEOMICINA, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
When corticosteroids are used on the skin, especially intensively and for long periods of time, some of the following side effects may occur:

• burning sensation, itching, irritation
• dryness of the skin
• thinning of the skin (cutaneous atrophy)
• excessive hair growth (hypertrichosis)
• appearance of blackheads and boils (acneiform eruption)
• loss of skin colour (hypopigmentation)
• thinning of the skin (atrophy) and stretch marks (striae) in skin folds treated for a prolonged period with occlusive dressing
• toxicity to hearing and kidneys following absorption of locally applied neomycin
• hormonal problems (frequency not known): increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”)
• blurred vision (frequency not known).

Following the instructions provided in this leaflet reduces the risk of side effects.

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.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 DESAMIX NEOMICINA

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.
The expiry date applies to the product stored in its original intact packaging and properly stored.
Store this medicine below 30°C.
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 DESAMIX NEOMICINA contains

• The active substances are dexamethasone and neomycin sulfate. 100 g of cream contain 0.5 g of dexamethasone and 0.5 g of neomycin sulfate.
• The other components are: polysorbate 60, stearic acid, stearyl alcohol, liquid paraffin, sorbitol 70% non-crystallizable, propyl parahydroxybenzoate, purified water.

Description of the appearance of DESAMIX NEOMICINA and contents of the pack
DESAMIX NEOMICINA is a cream contained in a 15-gram tube.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)