Detreomicina 1%

Warnings and precautions

Do not use for longer than necessary, i.e., until the disease symptoms disappear.
Using the medicine for more than 14 days or on a large skin surface increases the risk of severe side effects of chloramphenicol.
Repeated treatment with chloramphenicol should be avoided.
Do not use the medicine simultaneously with drugs that may cause bone marrow suppression.
Do not use with drugs that may cause interactions, see: Detreomycina 1% and other medicines.

Detreomycina 1% and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Chloramphenicol should not be administered simultaneously with penicillins and cephalosporins due to antagonistic effects. Chloramphenicol should not be administered 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 enhances the effect and prolongs the action of many drugs metabolized in the liver, such as tolbutamide, chlorpropamide, phenytoin, cyclophosphamide, and warfarin, which may cause severe toxic effects of these drugs. Chloramphenicol disrupts vitamin K synthesis, so in patients taking anticoagulant drugs, 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 drugs, such as phenylbutazone, indomethacin, and cotrimoxazole.
The medicine should not be used simultaneously with erythromycin applied locally, due to the competitive mechanism of action of these drugs.
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, consult your doctor or pharmacist before using this medicine.
Do not use during pregnancy and breastfeeding.

Driving and using machines

Detreomycina 1% does not affect the ability to drive or operate machines.
Detreomycina 1% contains arachis oil (from peanuts).If you are allergic to peanuts or soy, do not use this medicine.
Due to the presence of lanolin, the medicine may cause local skin reactions (e.g., contact dermatitis).

How to use Detreomycina 1%

Always use this medicine as directed by your doctor. If you have any doubts, consult 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 and children under 11 years of age.
Local use of chloramphenicol during puberty should be limited to the necessary minimum.

Using more than the recommended dose of Detreomycina 1%

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

Missing a dose of Detreomycina 1%

Do not use 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, using the medicine as directed by your doctor.
If you have any further doubts about using 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.
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 any side effects 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 181 C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

How to store Detreomycina 1%

Store at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Pay attention to the expiration date of the medicine.
Do not use this medicine after the expiration date stated on the tube. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Detreomycina 1% contains

• The active substance of the medicine is chloramphenicol - 1 g of ointment contains 10 mg of chloramphenicol. The other ingredients are: white petrolatum, lanolin, arachis oil.

What Detreomycina 1% looks like and what the package contains

Detreomycina 1% is a light yellow ointment with a uniform consistency.
The medicine package is an aluminum tube containing 5 g of ointment. The tube, along 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: chema@chema.rzeszow.pl

Date of the last update of the leaflet: