Gentamicin Mylan Generics
Italy
Package leaflet: Information for the patient
Gentamicin Mylan Generics 0.1% cream
Gentamicin
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 others, even if their symptoms are the same as yours, as it may be harmful.
- 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:
- What Gentamicin Mylan Generics is and what it is used for
- What you need to know before using Gentamicin Mylan Generics
- How to use Gentamicin Mylan Generics
- Possible side effects
- How to store Gentamicin Mylan Generics
- Contents of the pack and other information
1. What Gentamicina Mylan Generics is and what it is used for
Gentamicina Mylan Generics is a topical cream containing the active substance gentamicin. Gentamicina Mylan Generics belongs to a group of medicines called aminoglycoside antibiotics, which are used against bacterial infections.
Gentamicina Mylan Generics is indicated for the treatment of skin inflammations caused by bacteria, such as:
- skin infections with lesions and blisters (ecthyma), boils, skin irritation (eczema) caused by microorganisms, stasis ulcers, and traumatic injuries;
- inflammation of the hair follicles (folliculitis, sycosis);
- secondary bacterial infections of skin lesions (impetigo);
- infected burns and abrasions;
- acne with inflammation and pustules;
- a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
- skin inflammation caused by persistent friction between two body parts (intertrigo);
- bacterial infections of the superficial skin layers and nails (paronychia).
This medicine is not active against fungal infections; however, it is useful in fungal and viral infections when these are secondarily infected with bacteria. Gentamicina Mylan Generics has demonstrated particular efficacy in the treatment of burns.
2. What you need to know before using Gentamicina Mylan Generics
Do not use Gentamicina Mylan Generics
- if you are allergic to gentamicin sulfate, to closely related 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 Mylan Generics.
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.
Systemic absorption (into the bloodstream) of topical gentamicin increases when large areas of the body are treated, particularly if there is skin damage, or if long-term treatment is expected.
With prolonged use of gentamicin, as with other antibiotics, resistant microorganisms, including fungi, may develop. If this occurs, or if irritation, sensitization, or superinfection develops, your doctor will advise you to stop treatment and will prescribe appropriate therapy.
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).
Avoid the concomitant and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic), whether administered systemically or topically.
When using Gentamicina Mylan Generics together with systemic therapy, be aware of the possibility of increased blood levels of the medicine.
Use in children
In newborns and very young infants, use this medicine only when clearly necessary and under direct medical supervision.
Other medicines and Gentamicina Mylan Generics
Inform your doctor or pharmacist if you are 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 might 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 necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Gentamicina Mylan Generics 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 Mylan Generics
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Do not apply Gentamicina Mylan Generics to the eyes.
Apply a small amount of cream to the affected area 3–4 times a day until improvement occurs.
Thereafter, you may reduce application to 1–2 times a day.
After applying the cream, protect the treated area with a sterile gauze dressing.
Use in children
In very young children, use this medicine only when strictly necessary and under direct medical supervision.
If you use more Gentamicina Mylan Generics than you should
Cases of overdose have not been reported.
In case of accidental ingestion/intake of Gentamicina Mylan Generics, contact your doctor or go immediately to the Emergency Department of the nearest hospital.
Excessive or prolonged use of gentamicin for local treatment may lead to increased lesions caused by fungi or bacteria resistant to the drug.
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 everybody will experience them.
Treatment with this medicine may cause temporary skin irritation such as redness or itching. These effects usually do not require discontinuation of therapy.
Allergic contact reactions are also possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Gentamicina Mylan Generics
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 carton after “Exp.”.
The expiry date refers to the last day of that month.
Gentamicina Mylan Generics should be used within 12 weeks after first opening the tube.
After this period, discard the tube, even if there is still some cream left. To help you remember, write the date of first opening of the tube on the carton.
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 Mylan Generics 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, monobasic sodium phosphate, purified water.
Description of the appearance of Gentamicina Mylan Generics and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
Temmler Italia S.r.l., Via delle Industrie 2, 20061 Carugate (MI)