Package leaflet: Information for the patient

CHLOROCYCLINUM 3%, 30 mg/g, ointment
(Chlortetracyclini hydrochloridum)
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet:

What is Chlorocyclinum 3% and what it is used for
Important information before using Chlorocyclinum 3%
How to use Chlorocyclinum 3%
Possible side effects
How to store Chlorocyclinum 3%
Contents of the package and other information

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

Chlorocyclinum 3% is an ointment containing the active substance chlortetracycline hydrochloride.
Chlortetracycline has a broad spectrum of activity. Chlortetracycline acts against:

Gram-positive bacteria: staphylococci, streptococci, Listeria spp., Erysipelothrix spp., Bacillus anthracis, Clostridium spp., Nocardia spp.;
Gram-negative bacteria: Escherichia coli, Klebsiella spp., Enterobacter spp., Shigella spp., Neisseria gonorrhoeae, Brucella spp., Pasteurella spp., Vibrio cholerae, Haemophilus spp., Bordetella pertussis, Actinobacillus mallei, Bacteroides spp., Fusobacterium spp., Bartonella spp.;
others: Spirochaeta spp., Mycobacterium spp., Rickettsia spp., Chlamydia spp., Mycoplasma spp., Actinomyces spp.

It has no effect against Pseudomonas aeruginosa, Proteus spp., Serratia marcescens, Providencia spp.
It also does not act against fungi, protozoa, or viruses.
Resistant strains occur in all bacterial species, but to varying degrees. Resistant strains are most frequently observed among staphylococci, enterococci, and enterobacteria.

Indications
Chlorocyclinum 3% ointment is indicated:

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, scabies);
for treatment of inflammatory forms of acne, primarily acne papulo-pustulosa. The ointment may be used in monotherapy or in combination with topical preparations containing retinoids or benzoyl peroxide;
for treatment of phlegmonous acne (acne phlegmonosa) as an adjunctive therapy with orally administered retinoids.

2. Important information before using Chlorocyclinum 3%

When not to use Chlorocyclinum 3%:

if the patient is allergic to chlorotetracycline, 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
Exposure to sunlight should be avoided when using Chlorocyclinum 3% ointment.
Caution: the medicine produces yellow fluorescence under ultraviolet light (e.g. disco light).

Chlorocyclinum 3% and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use, especially: penicillins, cephalosporins, rifampicin (a medicine used in tuberculosis), aminoglycoside antibiotics, β-lactam antibiotics, erythromycin, triacetyloleandomycin, chloramphenicols, sulfonamides, phenothiazine derivatives (antipsychotic medicines), phenytoin, carbamazepine, barbiturates (medicines used, among others, in epilepsy).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
This medicine should not be used in pregnant women.
The safety of use in breastfeeding women has not been established. Therefore, in mothers who are breastfeeding, it is necessary to consider either discontinuing breastfeeding or stopping the use of this medicine.

Driving and operating machinery
Chlorocyclinum 3% has no influence on the ability to drive or operate machinery.

3. How to use Chlorocyclinum 3%

This medicine should always be used according to the doctor's instructions. In case of doubt, consult your
doctor or pharmacist.
This medicine is intended for topical application to the skin.
Apply a thin layer of the medicine to the affected areas 3 to 5 times daily, or apply the ointment under an occlusive dressing.
After applying the ointment, wash your hands.
Use in children
Do not use in children under 12 years of age.
Missed dose of Chlorocyclinum 3%
Do not use a double dose to make up for a missed dose.
If you miss a dose, apply the medicine as soon as possible. Then continue treatment as previously prescribed by your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Stopping treatment with Chlorocyclinum 3%
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
Skin hypersensitivity reactions (rash, urticaria, photosensitivity, oedema) may occur, as well as overgrowth of yeasts or resistant bacterial strains, and rarely exfoliative dermatitis.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 of adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Chlorocyclinum 3%

Store the tube tightly closed.
Store below 25°C.
Keep the medicine out of the sight and reach of children.
Pay particular attention 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Chlorocyclinum 3% contains

The active substance is chlorotetracycline in the form of chlorotetracycline hydrochloride. 1 g of ointment contains 30 mg of chlorotetracycline hydrochloride.
The other ingredient is: white vaseline.

What Chlorocyclinum 3% looks like and contents of the pack
Chlorocyclinum 3% is a uniform, greasy yellow ointment.
The available pack is an aluminium tube containing 10 g of ointment, placed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Spółdzielnia Pracy
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]