Detreomicina 2%

Package Leaflet: Information for the Patient

DETREOMYCIN 2% 20 mg/g, ointment
Chloramphenicol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Detreomycin 2% and what is it used for
• 2. Important information before using Detreomycin 2%
• 3. How to use Detreomycin 2%
• 4. Possible side effects
• 5. How to store Detreomycin 2%
• 6. Contents of the pack and other information

1. What is Detreomycin 2% and what is it used for

Detreomycin 2% is an ointment that contains the active substance chloramphenicol.
Chloramphenicol is a broad-spectrum bacteriostatic antibiotic effective against Gram-negative and Gram-positive bacteria, spirochetes, and rickettsiae. Chloramphenicol is effective against Haemophilus influenzae, Salmonellaspp., Neisseriaspp., Klebsiellaspp., Streptococcus pneumoniae, and anaerobic bacteria (moderately effective against Bacteroides fragilisand highly effective against Propionibacterium acnes).
It is also effective against Staphylococcusspp., Streptococcus pyogenes, Escherichia coli, Proteusmirabilis, Shigellaspp., Serratia marcescens, Mycoplasmaspp., Rickettsiaspp., and Chlamydiaspp.
Pseudomonas aeruginosa, acid-fast bacilli, and some Bacillusspecies are resistant to chloramphenicol.

Indications

Detreomycin 2% is used for local treatment of purulent skin diseases infected with microorganisms resistant to other antibiotics.

2. Important information before using Detreomycin 2%

When not to use Detreomycin 2%

• during pregnancy and breastfeeding;
• in newborns, children, and adolescents up to 18 years of age;
• in patients with liver disease or severe kidney function disorders;
• in patients with bone marrow diseases, blood disorders, or if you have had abnormal blood counts in the past;
• as a preventive measure;

Warnings and precautions

Before using Detreomycin 2%, discuss it with your doctor or pharmacist.
Do not use for longer than necessary, i.e., until the symptoms of the disease disappear.
Using the medicine for more than 14 days or on a large skin surface increases the risk of serious side effects of chloramphenicol.
Repeated treatment with chloramphenicol should be avoided.
Do not use the medicine at the same time as medicines that may cause bone marrow suppression.
Do not use with medicines that may cause interactions, see: Detreomycin 2% and other medicines.

Detreomycin 2% and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Chloramphenicol should not be given at the same time as penicillins and cephalosporins due to antagonistic effects. Chloramphenicol should not be given with macrolide antibiotics, as they have the same mechanism of action (inhibition of protein synthesis, binding to the same site in the ribosome). Chloramphenicol is an inhibitor of many microsomal enzymes, which increases the effect and prolongs the action of many medicines metabolized in the liver, such as tolbutamide, chlorpropamide, phenytoin, cyclophosphamide, and warfarin, which may cause severe toxic effects of these medicines. Chloramphenicol disrupts vitamin K synthesis, so in patients taking anticoagulant medicines at the same time, close monitoring of prothrombin time is necessary. Chloramphenicol enhances the hypoglycemic effect of sulfonylurea derivatives, increases the concentration and prolongs the half-life of dihydroxycoumarin derivatives in the blood, and significantly enhances the toxic effect on the hematopoietic system of many medicines, such as phenylbutazone, indomethacin, and cotrimoxazole.
The medicine should not be used at the same time as erythromycin applied locally, due to the competitive mechanism of action of these medicines.
Interactions with other locally applied medicines are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Do not use during pregnancy and breastfeeding.

Driving and using machines

Detreomycin 2% has no effect on the ability to drive and use machines.

Detreomycin 2% contains arachis oil (from peanuts).

Do not use if you are hypersensitive to peanuts or soy.

Detreomycin 2% contains lanolin.

Due to the presence of lanolin, the medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Detreomycin 2%

Use this medicine always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The medicine is intended for use on the skin.
The dose depends on the extent and location of the diseased area. A thin layer of ointment is usually applied to the cleaned, diseased skin once to three times a day, every 6 to 8 hours.
Do not use the medicine for more than 14 days.
After using the medicine, wash your hands.

Use in children and adolescents

Do not use in newborns, children, and adolescents up to 18 years of age.

Using more than the recommended dose of Detreomycin 2%

If you use more than the recommended dose, contact your doctor.

Missing a dose of Detreomycin 2%

Do not take a double dose to make up for a missed dose.
If you miss a dose, use the medicine as soon as possible. Then continue treatment with the medicine as directed by your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Irritations in the form of redness, stinging, itching, angioedema, skin inflammation, and skin allergic reactions may occur, which are a reason to discontinue the medicine (hives, rash). Fungal superinfection may occur.
In rare cases, bone marrow damage with aplastic anemia and abnormal blood counts have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Detreomycin 2%

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Check the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Detreomycin 2% contains

• The active substance is chloramphenicol - 1 g of ointment contains 20 mg of chloramphenicol.
• The other ingredients are: white petrolatum, lanolin, arachis oil.

What Detreomycin 2% looks like and contents of the pack

Detreomycin 2% is a light yellow ointment with a uniform consistency.
The pack contains an aluminum tube with 5 g of ointment. The tube, together with the patient leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: [email protected]

Date of last revision of the leaflet: