Package leaflet: Information for the patient

CHLORCHINALDIN, 30 mg/g, ointment
Chlorquinaldolum
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 questions, 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Chlorchinaldin and what is it used for
Important information before using Chlorchinaldin
How to use Chlorchinaldin
Possible side effects
How to store Chlorchinaldin
Contents of the pack and other information

1. What is Chlorchinaldin and what is it used for

Chlorchinaldin is an ointment containing the active substance chlorquinaldol, a derivative of quinoline.
Chlorquinaldol exerts a bactericidal effect against Gram-positive and Gram-negative bacteria, including bacteria of the genera Salmonella, Shigella, Proteus vulgaris, Escherichia coli, as well as Corynebacterium diphtheriae, Streptococcus pyogenes, and Staphylococcus aureus. In addition, chlorquinaldol inhibits the growth of fungi (Candida albicans) and has protozoicidal activity.
Indications
Chlorchinaldin ointment is indicated for the local treatment of bacterial suppurative inflammatory skin conditions and nasal mucosal inflammation caused by microorganisms sensitive to chlorquinaldol.

2. Important information before using Chlorchinaldin

When not to use Chlorchinaldin:

if the patient is allergic to chlorquinaldol, its derivatives (e.g. clioquinol), or to any of the other ingredients of this medicine (listed in section 6);
during the first trimester of pregnancy;
in children under 12 years of age;
in varicose ulcers of the leg;
for prophylactic use;
for prolonged use.

Warnings and precautions
Do not use Chlorchinaldin together with medicines that may cause interactions described below under "Chlorchinaldin with other medicines".
If allergic symptoms occur, discontinue use of the medicine immediately.
Protect the eyes and mucous membranes, except for the nasal mucosa, from contact with the medicine.
If symptoms of illness do not improve after several days of treatment, consult a doctor; the doctor will recommend alternative treatment.
When used as directed, systemic adverse effects of chlorquinaldol such as gastrointestinal disturbances, optic nerve damage, or polyneuritis are unlikely to occur.
If neurological symptoms or visual disturbances occur, discontinue use of the medicine and consult a doctor immediately.

Chlorchinaldin with other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.
When used together with quaternary ammonium bases, sensitization may occur. Do not use Chlorchinaldin simultaneously with other locally applied medicines containing iodine or metals with a similar mechanism of action, as they may reduce treatment efficacy.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use during the first trimester of pregnancy.
Due to lack of data on use during later stages of pregnancy, the medicine should only be used after the first trimester if, in the opinion of the doctor, the benefits outweigh the potential risks to the fetus.
Do not use during breastfeeding, as the safety of use has not been established.

Driving and operating machinery
Chlorchinaldin has no effect or has a negligible effect on the ability to drive and operate machinery.

Chlorchinaldin contains lanolin and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Chlorchinaldin contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (including delayed-type reactions).

3. How to use Chlorchinaldin

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The medicine is intended for topical use only.
Affected areas are usually covered 2 or 3 times daily with a thin layer of ointment; if necessary, and
if directed by the physician, an occlusive dressing may be applied.
Hands should be washed after applying the medicine.
Use in children
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Chlorchinaldin
If more than the recommended dose is used, contact your doctor.
Symptoms of overdose are unknown when the medicine is used according to the indications and
recommended method of administration.
In case of ingestion, contact your doctor immediately.
If the medicine is swallowed or used in excessive amounts, on damaged skin, or for prolonged
periods, systemic adverse effects of chloroquinaldol may occur, such as gastrointestinal disturbances,
optic nerve damage, and polyneuritis.
Missed dose of Chlorchinaldin
Do not use a double dose to make up for a missed dose.
If a dose is missed, apply the medicine as soon as possible. Then continue treatment according to
the dosing regimen previously recommended by your doctor.
Discontinuation of Chlorchinaldin
If you have any further questions regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Possible reactions include transient skin irritation, drying, redness, itching or burning sensation, contact dermatitis, and allergic reactions.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Chlorchinaldin

Store below 25°C.
Keep the tube tightly closed.
Store the medicine in a place inaccessible and out of sight of children.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube and the cardboard box.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What the medicine Chlorchinaldin contains

The active substance is chlorochinaldol.

30 mg of chlorochinaldol is contained in 1 g of ointment.

Other ingredients are: white vaseline, lanolin, cetyl alcohol, white wax, methyl parahydroxybenzoate (E 218).

What Chlorchinaldin looks like and contents of the pack
Chlorchinaldin is a homogeneous ointment of greenish-cream color with a greyish tint.
The medicine pack consists of a tube containing 20 g of ointment. The tube together with the patient leaflet is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Workers' Co-operative
Przemysłowa Street 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]