Polcortolon Tc

Package Leaflet: Information for the Patient

POLCORTOLON TC (23.12 mg + 0.58 mg)/g, skin spray, suspension
Tetracycline hydrochloride+ Triamcinolone acetonide

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.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Polcortolon TC and what is it used for

Polcortolon TC skin spray, suspension, contains two active substances - tetracycline and triamcinolone.
Tetracycline - is an antibiotic with a broad spectrum of antibacterial activity.
Triamcinolone - is a corticosteroid with moderate anti-inflammatory, antipruritic and vasoconstrictive activity.
Polcortolon TC acts on tetracycline-sensitive bacteria in skin inflammation foci and limits local inflammatory processes, reduces redness and itching.
Indications for use
Local treatment of inflammatory skin conditions complicated by bacterial infections caused by tetracycline-sensitive bacteria, in the course of such diseases as:

• allergic skin diseases with secondary bacterial infection,
• first-degree burns and frostbite,
• leg ulcers.

2. Important information before using Polcortolon TC

When not to use Polcortolon TC

• if the patient is allergic to tetracycline, triamcinolone or any of the excipients of the medicine,
• if the patient has:
• viral, fungal or tuberculous skin infections,
• acne or rosacea,
• skin cancer or pre-cancerous condition,
• perioral dermatitis,
• in the anal and genital areas.

Warnings and precautions

• The medicine is intended for use on the skin only.
• Avoid contact with mucous membranes.
• Protect the eyes from contact with the medicine. In case of contact with the eyes, rinse them thoroughly with water.
• Do not inhale the sprayed substance.
• If skin irritation occurs at the site of application, inform the doctor. The doctor will decide whether to discontinue the medicine.
• Prolonged use of the medicine on the skin may cause dilation of blood vessels and skin atrophy. Be especially careful when using on the face.
• Do not bandage the skin surface to which the medicine has been applied and do not use the medicine under occlusive dressings. Using an occlusive dressing increases the absorption of the medicine through the skin into the blood, which may cause systemic side effects of tetracycline or triamcinolone.
• Triamcinolone may be absorbed through the skin into the blood and have immunosuppressive effects (reduce the body's immunity). Therefore, during treatment, the patient should be careful not to contract an infectious viral disease (e.g. chickenpox, measles).
• The medicine should not be used for a long time or on large areas of skin, as well as on wounds, as there is a risk of systemic side effects of tetracycline and triamcinolone. Triamcinolone, the steroid component of the medicine, may be absorbed into the blood and have systemic effects, including suppression of the hypothalamic-pituitary-adrenal axis (e.g. Cushing's syndrome, glucosuria, high blood sugar). If symptoms of systemic corticosteroid side effects occur, consult a doctor. The doctor will decide whether to discontinue treatment with Polcortolon TC.
• Avoid sunbathing or exposure to artificial ultraviolet radiation (e.g. solarium) during treatment. Due to the presence of tetracycline in the medicine, skin symptoms of hypersensitivity (photodermatoses) may occur.
• Prolonged use of the medicine may lead to the proliferation of fungi or bacterial strains resistant to tetracycline, as well as hypersensitivity to tetracycline. In case of infections caused by bacteria insensitive to tetracycline or fungi, the doctor should use appropriate antibacterial or antifungal treatment.
• Particular caution should be exercised when using the medicine in children over 3 years of age, as there is a risk of systemic effects of tetracycline or the steroid component of the medicine - triamcinolone. In children, due to the larger ratio of body surface area to body mass than in adults, the risk of systemic effects of corticosteroids, including disorders of the hypothalamic-pituitary-adrenal axis (e.g. Cushing's syndrome), is higher than in adults. Additionally, prolonged use of corticosteroids may disrupt growth and development in children.

Polcortolon TC and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
During treatment, do not use other medicines locally at the same time, as this may affect the concentrations of the active substances at the site of application and cause interactions or skin irritation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before using this medicine.
Do not use in pregnant or breastfeeding women.

Driving and using machines

No data are available on the effect of the medicine on the ability to drive and use machines.

3. How to use Polcortolon TC

Use Polcortolon TC as directed by your doctor.
In case of doubts, consult your doctor again.
Recommended dose
Adults and children over 3 years
Spray the affected areas of the skin with a stream of suspension, holding the container vertically, with the spray head upwards, at a distance of 15 cm to 20 cm, for 1 to 3 seconds.
Usually, the medicine is used 2 to 4 times a day, at equal intervals.
Children
Do not use in children under 3 years of age.
Highly flammable aerosol. Do not spray near open flames or other ignition sources.
Warning:Protect the eyes from the medicine, do not inhale the sprayed substance.
Shake the container vigorously several times before each use.
After each application of the medicine, wash your hands thoroughly with soap and water.
If you feel that the effect of the medicine is too strong or too weak
consult your doctor.

Using a higher dose of Polcortolon TC than recommended

If the medicine is used on large areas of skin, in high doses, under occlusive dressings or on damaged skin, it may be absorbed into the blood and cause systemic effects of triamcinolone or tetracycline (see section 2. When to be careful when using Polcortolon TC).
In case of using a higher dose of the medicine than recommended, consult your doctor immediately.

Missing a dose of Polcortolon TC

If you miss a dose of the medicine at the scheduled time, and the time to the next dose is long enough, use the medicine as soon as possible or continue using the medicine as directed.
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Polcortolon TC can cause side effects, although not everybody gets them.

• Triamcinolone - the steroid component of the medicine, may cause local side effects, such as: burning, itching, irritation at the site of application, excessive drying, atrophic changes in the skin, contact dermatitis, perioral dermatitis, skin maceration, acne-like changes, stretch marks, folliculitis, rash, excessive hair growth, skin discoloration, secondary skin infections and folliculitis. During prolonged use of the medicine and/or use on large areas of skin, triamcinolone may be absorbed into the blood and cause systemic side effects characteristic of corticosteroids. In children, additional side effects may include growth and development disorders.
• The medicine used for a long time on the face may cause skin atrophy and dilation of blood vessels.
• Tetracycline in the medicine may cause local skin irritation, allergic reactions, skin hypersensitivity reactions to light, fungal or bacterial growth. If any of the side effects get worse or if you experience any side effects not listed in this leafletconsult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Polcortolon TC

Store below 25°C.
Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date is the last day of the given month.

• Highly flammable aerosol.
• Pressurized container. Heating may cause explosion.
• Keep away from heat sources, hot surfaces, ignition sources, open flames and other ignition sources. Smoking is prohibited.
• Do not spray near open flames or other ignition sources.
• Pressurized container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polcortolon TC contains

The active substances of the medicine are tetracycline hydrochloride and triamcinolone acetonide.
1 g of suspension contains:
23.12 mg of tetracycline hydrochloride and 0.58 mg of triamcinolone acetonide
The other ingredients of the medicine are: sorbitan trioleate (Span 85), lecithin, isopropyl myristate, Drivosol 35 (a mixture of isobutane 72%, n-butane 4%, propane 24%).

What Polcortolon TC looks like and contents of the pack

The medicine is a skin spray, suspension.
The suspension is yellow, uniform.
Packaging -a container containing 17.3 g of suspension in a cardboard box.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
For more detailed information, please contact the representative of the Marketing Authorization Holder.
Polfa Tarchomin S.A.
Warsaw
Phone number: 22 811-18-14
Date of last revision of the leaflet: