Gentamicin Almus

Package leaflet: information for the patient

GENTAMICIN ALMUS 0.1 g/100 g cream

Generic medicine
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, 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 could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENTAMICINA ALMUS is and what it is used for

GENTAMICINA ALMUS is a topical cream containing the active substance gentamicin,
which belongs to a group of medicines called aminoglycoside antibiotics, used against bacterial infections.
GENTAMICINA ALMUS is indicated for the treatment of bacterial skin inflammations such as:

• skin infections with lesions and blisters (ecthyma), boils, microbially-induced eczema, stasis ulcers and traumatic wounds;
• inflammation of the hair follicles (folliculitis, sycosis);
• secondary bacterial infections of skin lesions (impetigo);
• infected burns and abrasions;
• acne with inflammatory lesions;
• a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
• skin inflammations caused by persistent friction between body parts (intertrigo);
• bacterial infection of the superficial layers of the skin and nails (paronychia).

This medicine is not active against fungal infections; however, it may be useful in fungal and viral infections
when these are simultaneously complicated by resistant bacteria.
Particular efficacy has been demonstrated in the treatment of burns.

2. What you need to know before using GENTAMICINA ALMUS

Do not use GENTAMICINA ALMUS:
if you are allergic to gentamicin sulfate, to similar substances, or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICINA ALMUS.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially with prolonged use.
With prolonged use of gentamicin, as with other antibiotics, resistant microorganisms may develop. In such cases, your doctor will instruct you to stop treatment and will prescribe an appropriate therapy.
Use this medicine with caution and inform your doctor in the following cases:

• if you are allergic to other antibiotics of the aminoglycoside group, as an allergic reaction may occur (cross-sensitivity);
• if you need to treat large areas of the body over a prolonged period, especially when used in infants and children;
• if you are taking medicines containing gentamicin via systemic routes.

Avoid using this medicine after taking or together with other medicines that are toxic to the kidneys (nephrotoxic) and/or to the nervous system (neurotoxic).

Other medicines and GENTAMICINA ALMUS
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.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
In pregnant women and very young infants, this product should be administered only when clearly needed and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

GENTAMICINA ALMUS contains chlorocresol and cetyl alcohol
This medicine 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 ALMUS

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
GENTAMICINA ALMUS must not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until initial results are achieved.
Afterwards, you may reduce the frequency to 1-2 times a day.
Protect the treated area with a sterile gauze dressing after applying the cream.
If you use more GENTAMICINA ALMUS than you should
In case of accidental ingestion/uptake of GENTAMICINA ALMUS, contact your doctor or go immediately
to the Emergency Room of the nearest hospital.
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:

• allergic contact reactions;
• temporary skin irritation such as erythema or pruritus.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICIN ALMUS

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.
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 ALMUS contains

• The active substance is gentamicin. 100 g of cream contain 0.166 g of gentamicin sulfate, equivalent to 0.1 g of gentamicin.
• The other components are: liquid paraffin, white soft paraffin, chlorocresol, cetomacrogol, cetyl alcohol, monosodium phosphate, purified water.

Description of the appearance of GENTAMICINA ALMUS and contents of the pack
Pack containing one tube of 30 g of cream.
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genoa - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1 - 29016 Cortemaggiore (PC) - Italy