Hlorociclinum 3%

Leaflet included in the packaging: patient information

CHLOROCYCLINUM 3%, 30 mg/g, ointment

(Chlortetracycline hydrochloride)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Chlorocyclinum 3% and what is it used for

Chlorocyclinum 3% is an ointment that contains the active substance chlortetracycline hydrochloride.
The range of action of chlortetracycline is very broad. Chlortetracycline acts on:

• Gram-positive bacteria: staphylococci, streptococci, Listeriaspp., Erysipelothrixspp., Bacillusanthracis, Clostridiumspp., Nocardiaspp.;
• Gram-negative bacteria: Escherichia coli, Klebsiellaspp., Enterobacterspp., Shigellaspp., Neisseria gonorrhoeae, Brucellaspp., Pasteurellaspp., Vibrio cholerae, Haemophilusspp., Bordetella pertussis, Actinobacillus mallei, Bacteroidesspp., Fusobacteriumspp., Bartonellaspp.;
• others: Spirochaetaspp., Mycobacteriumspp., Rickettsiaspp., Chlamydiaspp., Mycoplasmaspp., Actinomycesspp.

It does not act on Pseudomonas aeruginosa, Proteusspp., Serratia marcescens, Providenciaspp.
It also does not have an effect on fungi, protozoa, and viruses.
Strains resistant to tetracyclines occur in all species of bacteria, but to a varying degree. The most common resistant strains are found among staphylococci, enterococci, and enterobacteria.

Indications

Chlorocyclinum 3% is used:

• for local treatment of purulent skin infections caused by bacteria sensitive to tetracyclines, as well as purulent complications of burns, frostbite, and (in combination with corticosteroids) purulent complications of allergic skin diseases (e.g., eczema, neurodermatitis);
• for the treatment of inflammatory forms of acne. Mainly in acne papulo-pustulosa. The ointment can be used as monotherapy and in combination therapy with topical retinoid or benzoyl peroxide preparations;
• for the treatment of phlegmonous acne (acne phlegmonosa) as an auxiliary agent with retinoids administered orally.

2. Important information before using Chlorocyclinum 3%

When not to use Chlorocyclinum 3%:

• if the patient is allergic to chlortetracycline, as well as to its derivatives or any of the other components of this medicine (listed in section 6);
• in children under 12 years of age.

Warnings and precautions

When using Chlorocyclinum 3% ointment, sunbathing is contraindicated.
Note: The medicine gives a yellow glow in ultraviolet light (e.g., disco light).

Chlorocyclinum 3% and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take, especially: penicillins, cephalosporins, rifampicin (a medicine used for tuberculosis), aminoglycoside antibiotics, beta-lactam antibiotics, erythromycin, triacetyloleandomycin, chloramphenicols, sulfonamides, phenothiazine derivatives (antipsychotic medicines), phenytoin, carbamazepine, barbiturates (medicines used for epilepsy).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
The medicine should not be used in pregnant women.
The safety of using the medicine in breastfeeding women has not been established. Therefore, breastfeeding mothers should consider stopping breastfeeding or discontinuing the medicine.

Driving and operating machinery

Chlorocyclinum 3% does not affect the ability to drive and operate machinery.

3. How to use Chlorocyclinum 3%

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The medicine is intended for topical use on the skin.
Pathologically changed areas should be covered with a thin layer of the medicine 3 to 5 times a day or applied to a closed dressing.
After using the ointment, you should wash your hands.

Use in children

Do not use in children under 12 years of age.

Missing a dose of Chlorocyclinum 3%

You should not take a double dose to make up for a missed dose.
If a dose is missed, you should take the medicine as soon as possible. Then, you should continue treatment using the medicine according to the previously recommended dosage by the doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

Stopping the use of Chlorocyclinum 3%

In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They may include skin hypersensitivity reactions (redness, hives, hypersensitivity to light, swelling), fungal or bacterial superinfections, and rare exfoliative dermatitis.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Chlorocyclinum 3%

Store the tube tightly closed.
Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Particular attention should be paid to 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Chlorocyclinum 3% contains

• The active substance of the medicine is chlortetracycline in the form of chlortetracycline hydrochloride. 1 g of ointment contains 30 mg of chlortetracycline hydrochloride.
• The other ingredient is white petrolatum.

What Chlorocyclinum 3% looks like and what the packaging contains

Chlorocyclinum 3% is a uniform, greasy ointment of yellow color.
The packaging of the medicine is an aluminum tube containing 10 g of ointment, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder.

Marketing authorization holder and manufacturer

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

Date of the last update of the leaflet: