Gentamicin Doc Generici
Italy
Table of Contents
Patient Information Leaflet
GENTAMICINA DOC Generici 0.1% cream
Generic medicine
Please read all of 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 they have the same symptoms as yours, because it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What GENTAMICINA DOC Generici is and what it is used for
- What you need to know before using GENTAMICINA DOC Generici
- How to use GENTAMICINA DOC Generici
- Possible side effects
- How to store GENTAMICINA DOC Generici
- Contents of the pack and other information
1. What GENTAMICINA DOC Generici is and what it is used for
GENTAMICINA DOC Generici is a topical cream containing the active substance
gentamicin, which belongs to a group of medicines called aminoglycoside antibiotics, used
against bacterial infections.
GENTAMICINA DOC Generici is indicated for the treatment of skin inflammations caused by
bacteria, such as:
- skin infections with lesions and blisters (ecthyma), boils, microbial-induced eczema, stasis ulcers and traumatic wounds;
- inflammation of hair follicles (folliculitis, sycosis);
- secondary bacterial infections of skin lesions (impetigo);
- infected burns and abrasions;
- inflammatory acne (acne);
- a chronic inflammatory skin disease involving the immune system and characterized by pus-filled pustules (pustular psoriasis);
- skin inflammations caused by persistent friction between body parts (intertrigo);
- bacterial inflammation affecting the tissues surrounding the nail (paronychia).
This medicine is not active against fungal infections; however, it is useful in infections caused
by resistant bacteria, particularly in the treatment of burns.
2. What you need to know before using GENTAMICINA DOC Generici
Do not use GENTAMICINA DOC Generici
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 DOC Generici.
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 after prolonged use, or if resistant microorganisms develop, which may occur following prolonged use of gentamicin, as with other antibiotics.
Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as an allergic reaction may occur (cross-sensitivity).
Children
In early infancy, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and GENTAMICINA DOC Generici
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, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
In pregnant women and in early infancy, this product should be administered only when clearly necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
GENTAMICINA DOC Generici contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
3. How to use GENTAMICINA DOC Generici
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
GENTAMICINA DOC Generici must not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until initial improvement is observed. Thereafter, you may reduce application to 1-2 times a day.
After applying the cream, protect the treated area with a sterile gauze dressing.
If you use more GENTAMICINA DOC Generici than you should
In case of accidental ingestion/ingestion of GENTAMICINA DOC Generici, contact your doctor or go immediately to the Emergency Department 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 will experience them.
Treatment with this medicine may cause transient skin irritation such as erythema or itching, which usually does not require discontinuation of therapy.
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 through 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 GENTAMICINA DOC Generici
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 DOC Generici contains
- The active substance is gentamicin. 100 g of cream contain 0.1 g of gentamicin (equivalent to 0.166 g of gentamicin sulfate).
- The other components are: liquid paraffin, white vaseline, chlorocresol, cetomacrogol, cetostearyl alcohol, monobasic sodium phosphate, purified water.
Description of the appearance of GENTAMICINA DOC Generici and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121, Milan (MI).
Manufacturer
Temmler Italia S.r.l. - Via delle Industrie 2 - 20061 Carugate (MI)
IDI FARMACEUTICI S.r.l. – Via dei Castelli Romani n. 83/85, 00040 Pomezia (RM).