Trofodermin

Package leaflet: Information for the user

Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension

Clostebol acetate + Neomycin sulfate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What Trofodermin is and what it is used for

Consult your doctor if you do not feel better or if you feel worse after a few days.
Trofodermin contains clostebol acetate and neomycin sulfate.

• Clostebol acetate belongs to a group of medicines called steroids. It helps heal skin lesions. Neomycin sulfate is an antibiotic. It fights bacterial skin infections.

This medicine is used to help heal skin wounds such as:

• skin abrasions and erosions;
• skin injuries and wounds, such as venous ulcers due to poor blood circulation, pressure sores (caused by immobility in bed), or traumatic ulcers;
• nipple fissures (small cuts) that may occur during breastfeeding;
• anal fissures (small cuts around the anus);
• burn wounds;
• infected wounds;
• wounds with delayed scar formation;
• skin irritation, redness, and sensitization occurring after radiotherapy (radiodermatitis);
• dryness, cracking with ulceration of the skin, or desquamation.

2. What you need to know before using Trofodermin

Do not use Trofodermin

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not use Trofodermin continuously, over large areas of skin, or for long periods of time,
as the sulfate neomycin contained in the medicine may cause kidney or hearing problems.
Shake the container before use. Do not spray the suspension onto a flame or hot surface. Do not invert the container during dispensing. Do not inhale and do not spray the suspension into the eyes.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children
Do not use Trofodermin for prolonged periods, especially in young children.
Other medicines and Trofodermin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Using Trofodermin together with other medicines containing antibiotics may increase the risk of allergy or may worsen adverse effects.
Trofodermin with food, drinks and alcohol
No interactions are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use Trofodermin during pregnancy and breastfeeding only if necessary.
Driving and using machines
No interference occurs.

3. How to use Trofodermin

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 applications per day. Spray the cutaneous suspension onto the wound and, if necessary, cover it with a sterile gauze (see section 2 "Warnings and precautions").
Use only topically on the skin.
If you use more Trofodermin than you should
If applied for long periods and over large areas of wounded skin, undesirable effects due to passage of the drug into the bloodstream may occur, such as increased hair growth on the skin.
In this case, discontinue treatment and consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use, especially if prolonged, of topical (local) products may lead to allergic reactions.
Furthermore, prolonged application over large areas of damaged skin may cause increased hair growth on the skin due to absorption of large amounts of clostebol acetate into your body.
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, talk to your doctor or pharmacist.
You can also report side effects directly via the 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 Trofodermin

The container is a pressurized container. Do not pierce or burn the container, even after use.
Protect the pressurized container from sunlight and heat.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 Trofodermin contains
In a pressurised container:

• The active substances are clostebol acetate 0.150 g, neomycin sulfate 0.150 g.
• The other components are: magnesium stearate; liquid paraffin; isobutane at 3.2 bar.

Description of the appearance of Trofodermin and contents of the pack
Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension comes in a pressurised container containing 30 ml of suspension.
Marketing Authorisation Holder
Laboratorio Farmaceutico SIT S.r.l. – Via Cavour, 70 – 27035 Mede (PV).
Manufacturer
Aerosol Service Italiana S.r.l. – Via Del Maglio, 6 – 23868 Valmadrera (LC).
Package leaflet: information for the user

Trofodermin 500 mg/100 g + 500 mg/100 g cream

Clostebol acetate + Neomycin sulfate
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

1. What Trofodermin is and what it is used for
2. What you need to know before using Trofodermin
3. How to use Trofodermin
4. Possible side effects
5. How to store Trofodermin
6. Package contents and other information

1. What Trofodermin is and what it is used for

Consult your doctor if you do not feel better or if you feel worse after a few days.
Trofodermin contains clostebol acetate and neomycin sulfate.

• Clostebol acetate belongs to a group of medicines called steroids. It helps heal skin lesions.
• Neomycin sulfate is an antibiotic. It fights skin infections caused by bacteria.

This medicine is used to help heal skin wounds such as:

• skin abrasions and erosions;
• skin lesions and wounds, such as venous ulcers due to poor blood circulation, pressure sores (caused by prolonged bed rest), or traumatic ulcers;
• nipple fissures (small cuts) that may occur during breastfeeding;
• anal fissures (small cuts around the anus);
• burn wounds;
• infected wounds;
• wounds with delayed healing or impaired scar formation;
• skin irritation, redness, and sensitivity occurring after radiotherapy (radiodermatitis);
• dryness, cracked skin with ulceration or peeling.

2. What you need to know before using Trofodermin

Do not use Trofodermin

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not use Trofodermin continuously, over large areas of skin, or for prolonged periods of time,
because the neomycin sulfate contained in the medicine may cause kidney or hearing problems.
For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children
Do not use Trofodermin for prolonged periods, especially in young children.
Other medicines and Trofodermin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Using Trofodermin together with other medicines containing antibiotics may increase the risk of allergy or may worsen adverse effects.
Trofodermin with food, drinks and alcohol
No interactions 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.
During pregnancy and breastfeeding, this medicine should only be used if necessary.
Driving and using machines
No interference.
Trofodermin cream contains:

• lanolin: may cause local skin reactions (e.g. contact dermatitis).
• Nipasept (methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate and propyl p-hydroxybenzoate): may cause allergic reactions (including delayed reactions).

3. How to use Trofodermin

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1–2 applications per day. Apply a thin layer of cream to the wound and, if necessary, cover it with a sterile gauze (see section 2, "Warnings and precautions").
Use only topically on the skin.

If you use more Trofodermin than you should
If applied for prolonged periods or over large areas of damaged skin, undesirable effects due to absorption of the drug into the bloodstream may occur, such as increased hair growth on the skin.
In this case, discontinue treatment and consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use, especially if prolonged, of topical (local) products may lead to allergic reactions.
Furthermore, prolonged application over large areas of injured skin may cause increased hair growth on the skin due to the absorption of large amounts of clostebol acetate into your body.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the 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 Trofodermin

Once opened, the cream should be used within 30 days.
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 Trofodermin contains
In 100 g of cream:

• The active substances are clostebol acetate 500 mg, neomycin sulfate 500 mg.
• The other components are: polyethylene glycol stearate; stearic acid; liquid paraffin; lanolin; dimethicone; nipasept (methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate and propyl p-hydroxybenzoate); floranol; purified water.

Description of the appearance of Trofodermin and contents of the pack
Trofodermin 500 mg/100 g + 500 mg/100 g cream is available in tubes of 10 g, 30 g and 50 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. – Via Cavour, 70 – 27035 Mede (PV).

Manufacturer
Tubilux Pharma S.p.A. – Via Costarica, 20/22 – 00040 Pomezia (RM).