Citrizan Antibiotic

Package leaflet: Information for the user

CITRIZAN ANTIBIOTIC 800,000 IU/100 g + 0.1% GEL

equine catalase, gentamicin sulfate
Please read all of this leaflet carefully before you start 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CITRIZAN ANTIBIOTIC is and what it is used for

2. What you need to know before using CITRIZAN ANTIBIOTIC

3. How to use CITRIZAN ANTIBIOTIC

4. Possible side effects

5. How to store CITRIZAN ANTIBIOTIC

6. Contents of the pack and other information

7. What CITRIZAN ANTIBIOTIC is and what it is used for
   CITRIZAN ANTIBIOTIC contains the active substances equine catalase (an enzyme) and gentamicin sulfate (an antibiotic), and is a healing medicine belonging to the group of skin wound treatment preparations. CITRIZAN ANTIBIOTIC is indicated for the healing of mild burns (first- and second-degree) and of infected superficial abrasions and wounds.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using CITRIZAN ANTIBIOTIC

Do not use CITRIZAN ANTIBIOTIC

• if you are allergic to equine catalase, gentamicin sulfate, to other substances closely related chemically, 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 CITRIZAN ANTIBIOTIC.
CITRIZAN ANTIBIOTIC does not cause dependence.
The use of topical products, especially if prolonged, may lead to sensitization reactions.
When applied over large body surface areas, absorption of gentamicin may occur in sufficient amounts
to cause toxic effects on hearing and balance.

Other medicines and CITRIZAN ANTIBIOTIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are currently known with the use of CITRIZAN ANTIBIOTIC.
Avoid simultaneous use with other topical medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
This medicine may be used, when strictly necessary, during pregnancy and breastfeeding,
but only under direct medical supervision.

Driving and using machines
No negative effects on the ability to drive or operate machinery have been reported.

3. How to use CITRIZAN ANTIBIOTIC

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
CITRIZAN ANTIBIOTIC is for topical use only (cutaneous use) on areas of skin affected by minor wounds or burns. The recommended dose is to apply the medicine to completely cover the affected area, two or more times a day, as directed by the doctor.
Clean the area to be treated before applying CITRIZAN ANTIBIOTIC.
If you use more CITRIZAN ANTIBIOTIC than you should
Symptoms of overdose have not been reported.
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.
Skin irritation reactions such as erythema and dermatitis have been reported. Systemic allergic reactions, which may affect the whole body, are possible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly through 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 CITRIZAN ANTIBIOTIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Store below 25°C.
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 CITRIZAN ANTIBIOTIC contains

• The active substances are: equine catalase and gentamicin sulfate. 100 g of gel contain 800,000 IU of equine catalase and gentamicin sulfate equivalent to 0.100 g of base.
• The other components are: pentylene glycol, hydroxypropyl guar, purified water.

Description of the appearance of CITRIZAN ANTIBIOTIC and contents of the package
Gel. Tube of 50 g.
Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI srl - Via dei Castelli Romani 83/85 - POMEZIA (RM)