Package leaflet: Information for the user

Streptosil with Neomycin 99.5% + 0.5% cutaneous powder, 2% + 0.5% ointment

sulfathiourea + 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 advice or information, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

What Streptosil with Neomycin is and what it is used for
What you need to know before using Streptosil with Neomycin
How to use Streptosil with Neomycin
Possible side effects
How to store Streptosil with Neomycin
Contents of the pack and other information

1. What Streptosil with Neomycin is and what it is used for

Streptosil with Neomycin is a topical medicine containing neomycin sulfate and sulfathiazole.
Neomycin sulfate is an antibiotic. Sulfathiazole is an antibacterial agent. They are used to treat bacterial skin infections.
This medicine is indicated in adults and children for the treatment of superficial skin infections:

folliculitis (infection of the hair follicle, the structure surrounding the hair root);
furunculosis (inflammation of the skin characterized by the presence of boils);
wounds from minor burns;
infected wounds.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Streptosil with Neomycin

Do not use Streptosil with Neomycin

if you are allergic to sulfathiazole or neomycin sulfate or to any of the other ingredients of this medicine (listed in section 6);
for ear infections.

Warnings and precautions
Talk to your doctor or pharmacist before using Streptosil with Neomycin.
This medicine is not for ophthalmic use; it is intended for external use only and must not be ingested.
Do not use Streptosil with Neomycin for prolonged periods or in large amounts over extensive areas of skin, as neomycin sulfate contained in this medicine, if absorbed, may cause kidney or ear problems.
Do not use this medicine if you have:

secondary skin infections (infections developing on pre-existing skin lesions);
extensive burns;
trophic ulcers (skin lesions due to impaired blood circulation);
conditions where absorption of neomycin is possible.

Prolonged use of this product may cause allergy.
If you use this medicine for a prolonged period and inappropriately, excessive growth of antibiotic-resistant bacteria or fungi may occur, worsening the condition.
If this happens, treatment must be discontinued and you should consult your doctor.

Infants and children
Use Streptosil with Neomycin in early infancy only when necessary and under direct medical supervision. Do not use this medicine on large areas of damaged skin in infants with diaper dermatitis, as the diaper may act as an occlusive dressing and promote absorption of neomycin.

Other medicines and Streptosil with Neomycin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use other aminoglycosides, drugs similar to neomycin, while using this medicine, as concomitant use may increase the risk of toxic effects on the ear and kidneys.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use Streptosil with neomycin during pregnancy and breastfeeding only when necessary and under direct medical supervision.

Driving and using machines
Streptosil with Neomycin has no effect on the ability to drive or operate machinery.

3. How to use Streptosil with Neomycin

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Cutaneous powder
The recommended dose is 2 applications per day. Do not exceed the recommended doses.
Lift the cap, rhythmically and firmly press both sides of the bottle while holding it horizontally or
slightly tilted; lightly spray the powder onto the affected area of skin and cover with a sterile gauze. Spray lightly, using the minimum amount of powder necessary to avoid crust formation and allow rapid dissolution and diffusion of the components.
Ointment
The recommended dose is 2–3 applications per day. Do not exceed the recommended doses.
Apply a small amount of ointment to the affected area.
If you use more Streptosil with Neomycin than you should
No symptoms related to overdose of Streptosil with Neomycin have been reported.
If you think you have used too much of this product, stop treatment and contact your doctor or pharmacist.
If you forget to use Streptosil with Neomycin
Do not use a double dose to make up for the missed dose.
If you stop using Streptosil with Neomycin
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 everyone gets them.
The frequency of these side effects is not known.

Infections and infestations
Bacterial and fungal superinfections.

Immune system disorders
Hypersensitivity reactions.

Skin and subcutaneous tissue disorders
Itching.

General disorders and administration site conditions
Swelling, redness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 Streptosil with Neomycin

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.
Cutaneous powder
This medicine does not require any special storage conditions.
Ointment
Do not store above 30°C.
Do not dispose of medicines 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 Streptosil with Neomycin contains
Cutaneous powder

Active substances: sulfathiazole and neomycin sulfate;
Other components: none.

Ointment

Active substances: sulfathiazole and neomycin sulfate;
Other components: mineral oil, white vaseline, solid paraffin.

Description of the appearance of Streptosil with Neomycin and contents of the package
Streptosil with Neomycin 99.5% + 0.5% cutaneous powder
presented in a 10 g plastic bottle with cap having a central hole.
Streptosil with Neomycin 2% + 0.5% ointment
presented in a 20 g aluminium tube.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald – Germany

Manufacturer
Cutaneous powder
Haupt Pharma Latina S.r.l. – Borgo S. Michele (LT)
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen – Germany

Ointment
Haupt Pharma Latina S.r.l. – Borgo S. Michele (LT)
Temmler Italia S.r.l. – 20061 Carugate (MI)
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen – Germany