Gentamicin and betamethasone Mylan Generics

Package leaflet: Information for the user

Gentamicin and Betamethasone Mylan Generics 0.1% + 0.1% cream

Gentamicin sulfate + betamethasone valerate
Generic medicine
Read this entire 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gentamicin and Betamethasone Mylan Generics is and what it is used for

Gentamicin and Betamethasone Mylan Generics is a cream for application to the skin that contains two active substances: gentamicin and betamethasone. Gentamicin belongs to the group of aminoglycoside antibiotics, used against bacterial infections. Betamethasone belongs to the group of corticosteroids, used to relieve inflammation and allergic reactions.
Gentamicin and Betamethasone Mylan Generics is indicated for the treatment of allergic or inflammatory skin irritations such as:

• various types of eczema, an inflammatory skin reaction with itching;
• anal and genital pruritus, and pruritus occurring in the elderly;
• immune-mediated inflammatory skin reactions such as contact dermatitis and seborrheic dermatitis (affecting areas rich in sebaceous glands such as scalp, face, chest);
• skin irritation caused by constant friction between two body parts (intertrigo);
• irritation caused by exposure to sunlight (sunburn);
• other forms of skin irritation such as exfoliative dermatitis (skin desquamation), radiation dermatitis, stasis dermatitis and stress dermatitis;
• psoriasis, a chronic inflammatory skin disease involving the immune system.

2. What you need to know before using Gentamicin and Betametasone Mylan Generics

Do not use Gentamicin and Betametasone Mylan Generics

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection called cutaneous tuberculosis;
• if you have a viral skin infection such as herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicin and Betametasone Mylan Generics.
This medicine must not be applied to the eyes.
Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as you may experience an allergic reaction (cross-sensitivity).
Stop treatment and inform your doctor if you develop irritation or an allergic reaction (sensitization) following the use of this medicine, especially with prolonged use or if resistant microorganisms develop, including certain types of fungi, which may occur following prolonged use of gentamicin, as with other antibiotics.
Use the medicine with caution and inform your doctor if treatment is to be applied over large areas or for long periods, as corticosteroids (betamethasone) may be absorbed through the skin. This is even more likely if the cream is applied under occlusive (non-breathable) dressings or if the patient is a child.
If you use topical antibiotics for prolonged periods, sometimes the growth of non-susceptible organisms, including fungi, may occur. In such cases, or if irritation, sensitization, or further infections develop, your doctor will discontinue treatment with gentamicin and prescribe a specific therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
In children, this medicine should be used only when strictly necessary and under direct medical supervision, as there may be an increased risk of adverse effects due to higher absorption of corticosteroids (see section "Additional undesirable effects in children").

Other medicines and Gentamicin and Betametasone Mylan Generics
Inform your doctor or pharmacist if you are currently 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 may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only if clearly necessary and under direct medical supervision.
If you are breastfeeding, use this medicine with caution and under direct medical supervision, as your doctor may consider it necessary to discontinue breastfeeding or stop the treatment.

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

Gentamicin and Betametasone 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 e Betametasone Mylan Generics

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
Gentamicina e Betametasone Mylan Generics must not be applied to the eyes.
Apply a small amount of cream to the affected area 2–3 times daily.
For the treatment of psoriatic lesions or infected deep dermatoses, occlusive bandaging may be used
to achieve a better therapeutic response.
Apply the occlusive dressing as follows:

1. apply a thick layer of cream over the entire lesion surface under a light gauze and cover with a transparent,
   waterproof, flexible plastic material extending beyond the edges of the treated area;
2. seal the edges onto healthy skin with adhesive tape or other means;
3. 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 skin irritation occurs,
   remove the plastic covering.
   If you use more Gentamicina e Betametasone Mylan Generics than you should
   Excessive or prolonged use of this medicine may cause corticosteroid-related side effects such as:
   adrenal gland dysfunction, increased steroid levels in the body (hypercorticism), Cushing's syndrome—a condition in which the body produces too much cortisol—bacterial and fungal infections.
   These symptoms may resolve after gradually discontinuing treatment.
   In case of accidental ingestion/ingestion of Gentamicina e Betametasone Mylan Generics, contact your
   doctor or go immediately to the Emergency Department of 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 everybody gets them.

The following side effects have been reported very rarely:

• hypersensitivity
• rash
• skin discolouration.

During the use of corticosteroids on the skin, some of the following side effects may occur:

• burning, skin irritation (rash), dryness of the skin;
• infection of the hair follicles (folliculitis);
• increased hair growth (hypertrichosis);
• irritation with pimples, dermatitis affecting areas around the mouth, allergic contact dermatitis;
• reduced skin pigmentation (hypopigmentation);
• skin inflammation with red rashes around the mouth (perioral dermatitis);
• skin inflammation due to contact with substances causing allergy (allergic contact dermatitis);
• blurred vision.

Treatment with gentamicin may cause transient skin irritation such as rash, redness or itching. These effects do not require discontinuation of treatment.

The use of occlusive dressings may increase the occurrence of side effects such as skin lesions, secondary infection, skin thinning, stretch marks and a skin inflammation known as miliaria.

Additional side effects in children
Children, who are more sensitive than adults to corticosteroid-related side effects, may experience:

• suppression of the hypothalamic-pituitary-adrenal axis and reduced blood cortisol levels;
• increased cortisol production (Cushing's syndrome);
• growth retardation;
• increased pressure in the brain (intracranial hypertension), manifesting as bulging of the fontanelles, headache and swelling of the optic nerve sheath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult 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 Gentamicin and Betametasone Mylan Generics

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.
Validity after first opening of the tube: 12 weeks.
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 Mylan Generics contains

• The active substances are gentamicin sulfate and betamethasone valerate. 100 g of cream contain 0.1 g of gentamicin sulfate and 0.1 g of betamethasone valerate.
• The other components are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, purified water.

Description of the appearance of Gentamicina e Betametasone Mylan Generics and package contents
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124, Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)