Visiocetina

Package leaflet: Information for the patient

Visiocetina 10 mg/g eye ointment

chloramphenicol
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, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Visiocetina is and what it is used for

Visiocetina contains the active substance chloramphenicol, which belongs to a group of medicines called antibiotics (used to treat bacterial infections).
Visiocetina is used to treat external eye infections such as conjunctivitis, keratitis, keratoconjunctivitis, trachoma, and dacryocystitis.
It is also used to prevent microbial infections associated with mechanical and thermal injuries, and for pre- and post-surgical treatment.
If, after completing the prescribed course of treatment, you do not notice improvement or if your condition worsens during treatment, consult your doctor.

2. What you should know before using Visiocetina

Do not use Visiocetina

• if you are allergic to chloramphenicol or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have previously had bone marrow depression (reduced or absent production of blood cells by the bone marrow) or blood dyscrasias (alteration in blood composition).

Warnings and precautions
Talk to your doctor or pharmacist before using Visiocetina.
Exercise particular caution during treatment with Visiocetina:

• Topical application of chloramphenicol may cause toxic effects on the blood (see “How to use Visiocetina”, “Do not use Visiocetina if” and “Possible side effects”).
• If you have liver and/or kidney problems or immaturity, this medicine should be used with caution, as serious adverse effects may occur (see “How to use Visiocetina” and “Possible side effects”).
• If allergic reactions occur, which may manifest as skin rash, fever, and angioedema (swelling of the face, eyes, lips, throat, which may cause breathing and swallowing difficulties), stop treatment and consult your doctor for appropriate therapy.
• Prolonged use of topical antibiotics may lead to the growth of microorganisms not sensitive to them.
• Do not wear contact lenses during treatment.

Children
In children under 2 years of age, Visiocetina should be administered only when strictly necessary.
In children under 2 years of age, immaturity of the liver and kidneys may lead to drug accumulation causing the so-called “gray baby syndrome”; typical symptoms include hypothermia (body temperature drops below 35°C), cyanosis (bluish or grayish skin or mucous membranes due to lack of oxygen in the blood), flaccidity, vomiting, sucking difficulties, breathing problems, and cardiovascular collapse (severe reduction in blood flow to organs and tissues due to decreased heart activity).
Brain damage and death may also occur; therefore, careful monitoring of blood levels of the drug is recommended if used.
Chloramphenicol intake by the mother during pregnancy and breastfeeding may also cause gray baby syndrome (see “Pregnancy, breastfeeding and fertility”).

Other medicines and Visiocetina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are using:

• Medicines that cause bone marrow suppression (a condition in which the bone marrow produces insufficient red blood cells, white blood cells, and platelets);
• Other ophthalmic medicines containing different antibiotics (used to treat bacterial infections);
• Antibiotics such as rifampicin;
• Oral medicines that delay blood coagulation, such as dicoumarol;
• Phenytoin and phenobarbital used to treat epilepsy (a disease causing loss of consciousness and violent involuntary muscle contractions);
• Oral medicines for diabetes treatment, a disease causing increased blood glucose (blood sugar levels), such as chlorpropamide and tolbutamide.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy and breastfeeding
Chloramphenicol crosses the placenta and is excreted in breast milk. In newborns, it may cause a condition called gray baby syndrome (vomiting, pallor, bluish skin and mucous membranes, abdominal distension, and circulatory problems).
This medicine should not be used during pregnancy unless your doctor considers it necessary.

Driving and using machines
Visiocetina may cause temporary blurred vision or other visual disturbances; therefore, it may impair your ability to drive vehicles or operate machinery.

Visiocetina 10 mg/g ophthalmic ointment contains anhydrous lanolin
Lanolin may cause local skin reactions (e.g. contact dermatitis).

3. How to use Visiocetina

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Apply the ointment 3 - 4 times daily. If you have liver or kidney problems, your doctor will prescribe
a reduced number of applications.
Visiocetina will be prescribed for children under 2 years of age only if strictly necessary
(see "Warnings and precautions" and "Possible side effects").
Duration of treatment
Short-term use of Visiocetina is recommended. Prolonged use is not recommended (see
"Warnings and precautions" and "Possible side effects").
If symptoms persist, consult your doctor.
Method of administration
Apply Visiocetina to the eyes.
Instructions for use

1. Wash/disinfect hands thoroughly.
2. Open the tube.
3. Squeeze the tube until the product comes out, taking care not to touch the eye, eyelid, or any other surface with the tip of the tube to avoid contamination.
4. Close the tube immediately after application.
   If you use more Visiocetina than you should
   No cases of overdose have been reported with the use of Visiocetina.
   If you forget to use Visiocetina
   Do not use a double dose to make up for the missed dose.
   If you stop using Visiocetina
   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 gets them.
The following side effects may occur during the use of Visiocetina:
Not known ( frequency cannot be estimated from the available data ):

• Hypersensitivity (allergic reactions),
• angioedema (swelling of the face, eyes, lips, throat which may cause difficulty in breathing and swallowing),
• urticaria (skin rash),
• blood dyscrasia (alteration in blood composition),
• myelosuppression (reduced or absent production of blood cells by the bone marrow),
• eye burning sensation,
• conjunctival edema (swelling of the membrane covering the white part of the eye),
• eyelid edema (swelling of the eyelids),
• fever,
• vesicular skin eruption (formation of small fluid-filled lesions on the skin),
• maculopapular skin rash (skin patches and raised lesions).

Burning and transient irritation at the site of application have also been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Visiocetina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, undamaged packaging,
properly stored.
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. Pack contents and other information

What Visiocetina contains

• The active substance is chloramphenicol; 1 g of ointment contains 10 mg of chloramphenicol.
• The other components are: liquid paraffin, anhydrous lanolin, white soft paraffin.

Description of the appearance of Visiocetina and pack sizes
Pack containing one 5 g aluminium tube.
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy
Manufacturer
S.I.F.I. S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT), Italy