CHLORCHINALDIN 30 mg/10 mg Ointment

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. CHLORCHINALDIN H, (30 mg + 10 mg)/g, Ointment
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Chlorchinaldin H and what is it used for
   1. Indications
4. Important information before using Chlorchinaldin H
   1. When not to use Chlorchinaldin H:
   2. Warnings and precautions
   3. Children and adolescents
   4. Chlorchinaldin H and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to use Chlorchinaldin H
   1. Use in children and adolescents
   2. Using a higher dose of Chlorchinaldin H than recommended
   3. Missing a dose of Chlorchinaldin H
   4. Stopping treatment with Chlorchinaldin H
6. Possible side effects
   1. Reporting side effects
7. How to store Chlorchinaldin H
8. Contents of the pack and other information
   1. What Chlorchinaldin H contains
   2. What Chlorchinaldin H looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last revision of the leaflet:

Package Leaflet: Information for the Patient

CHLORCHINALDIN H, (30 mg + 10 mg)/g, Ointment

Chlorquinaldolum + Hydrocortisoni acetas

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Chlorchinaldin H and what is it used for

Chlorchinaldin H is an ointment that contains the active substances: chlorquinaldol, a derivative of 8-hydroxyquinoline, and hydrocortisone acetate, which is a glucocorticosteroid.
Chlorquinaldol has a bactericidal effect on Gram-positive and Gram-negative bacteria, including bacteria of the genus Salmonella, Shigella, Proteus vulgaris, Escherichia coli,as well as Corynebacterium
diphtheriae, Streptococcus pyogenesand Staphylococcus aureus.
Additionally, chlorquinaldol has a fungistatic effect (inhibits fungal growth) on Candida albicansand a protozoicidal effect.
Hydrocortisone acetate is a topical glucocorticosteroid with mild action, which has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications

Chlorchinaldin H is used for the local treatment of purulent, superficial skin diseases with an inflammatory reaction, as well as purulent complications of bacterial allergic skin diseases, including fungal infections, in leg ulcers - in infections with microorganisms sensitive to chlorquinaldol.

2. Important information before using Chlorchinaldin H

When not to use Chlorchinaldin H:

• if the patient is allergic to hydrocortisone acetate, chlorquinaldol, or its derivatives (e.g., clioquinol) or any of the other ingredients of this medicine (listed in section 6);
• in the first trimester of pregnancy,
• in children under 12 years of age,
• in liver or kidney failure,
• in non-bacterial diarrhea,
• in viral skin infections,
• on tubercular or syphilitic skin lesions,
• on deep and extensive purulent wounds,
• in perioral dermatitis,
• in granulomatous vasculitis,
• in patients with Buerger's disease due to trophic disorders and delayed wound healing,
• prophylactically,
• for a long time.

Warnings and precautions

Before starting treatment with Chlorchinaldin H, discuss it with your doctor or pharmacist.
Corticosteroids are absorbed through the skin, so during treatment with the medicine, systemic side effects related to the content of hydrocortisone acetate may occur, characteristic of corticosteroids.
Therefore, you should avoid using the medicine:

• on a large skin surface, wounds, damaged skin, in large doses,
• in areas of skin with a thin stratum corneum (e.g., in the genital area, skin folds, armpits, in children) when the stratum corneum is missing, and in acute inflammatory skin conditions,
• under occlusive dressings (cerate, diaper).

Occlusive dressings increase the absorption of corticosteroids into the body and may cause bacterial and fungal superinfections.
During long-term treatment, atrophy of the stratum corneum, post-steroid acne, and skin striae may occur.
If the medicine is used as recommended, it is unlikely to cause systemic side effects of chlorquinaldol, such as gastrointestinal disorders, optic nerve damage, and polyneuritis.
In case of neurological symptoms or vision disturbances, stop using the medicine and consult a doctor.
Do not use the medicine simultaneously with medicines that may cause interactions described below in Chlorchinaldin H and other medicines.
If symptoms of hypersensitivity occur, stop using the medicine and consult a doctor.

Children and adolescents

Do not use in children under 12 years of age.

Chlorchinaldin H and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
The medicine used with quaternary ammonium compounds may cause hypersensitivity. Do not use the medicine simultaneously with other topical medicines containing iodine or metals with a similar mechanism of action, as they reduce the effectiveness of treatment.
Vaccinations should not be performed during treatment with Chlorchinaldin H.

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 in the first trimester of pregnancy. In the remaining period of pregnancy, do not use the medicine on large areas of affected skin and do not use it for a long time.
In each case, the decision to use the medicine in pregnant women should be made by a doctor, after considering whether the benefits of using the medicine outweigh the potential risk to the fetus.
Do not use the medicine during breastfeeding, as its safety has not been established.

Driving and using machines

Chlorchinaldin H has no influence or negligible influence on the ability to drive and use machines.
Chlorchinaldin H contains:lanolin and cetyl alcohol. Due to the presence of lanolin and cetyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Chlorchinaldin H

This medicine should always be used as directed by your doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for topical use on the skin.
Affected areas of the skin should be covered with a thin layer of the medicine once or twice a day and covered with a sterile gauze.
On the skin of the face, use the medicine with caution and for a short time.
After using the medicine, wash your hands.

Use in children and adolescents

Do not use in children under 12 years of age.

Using a higher dose of Chlorchinaldin H than recommended

In case of using a higher dose of the medicine than recommended, consult a doctor.
In case of using the medicine in excessive amounts, on damaged skin, or for a long time, due to absorption into the blood, systemic side effects of chlorquinaldol (such as gastrointestinal disorders, optic nerve damage, and polyneuritis) and hydrocortisone acetate (including inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome) may occur.
In case of ingestion of the medicine, consult a doctor immediately.

Missing a dose of Chlorchinaldin H

Do not use a double dose to make up for a missed dose.
In case of doubts about using the medicine, consult a doctor or pharmacist.
In case of missing a dose, use the medicine as soon as possible. Then continue treatment using the medicine according to the previously recommended dosage.

Stopping treatment with Chlorchinaldin H

In case of further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Chlorchinaldin H can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).
Transient skin irritation, dryness, redness, itching or burning sensation, contact dermatitis, allergic reactions may occur.
Due to the presence of hydrocortisone acetate in the medicine, skin atrophy, telangiectasias, skin pigmentation disorders, acne-like changes, bacterial, viral, and fungal superinfections may occur

• mainly after using occlusive dressings. The medicine used on the skin of the face can quickly cause perioral dermatitis, atrophic dermatitis, and persistent vasodilation. As a result of hydrocortisone acetate absorption into the blood, systemic side effects characteristic of corticosteroids may also occur, including inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome. These occur mainly in case of long-term use of the medicine, using it on a large skin surface, under occlusive dressings, or in children.

Allergic reactions may occur due to hypersensitivity to excipients.

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, 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 the medicine.

5. How to store Chlorchinaldin H

Store in a temperature below 25°C.
Store the tube tightly closed.
Protect from light.
Keep the medicine out of the 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 and carton.
The expiration date refers to 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. Contents of the pack and other information

What Chlorchinaldin H contains

• The active substances of the medicine are chlorquinaldol and hydrocortisone acetate. 1 g of ointment contains 30 mg of chlorquinaldol and 10 mg of hydrocortisone acetate.
• The other ingredients are: white petrolatum, lanolin, cetyl alcohol, white wax.

What Chlorchinaldin H looks like and what the pack contains

Chlorchinaldin H is a greenish-cream ointment with a lanolin odor.
The pack contains an aluminum tube with 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: [email protected]

Date of the last revision of the leaflet: