Polcortolon tc

Package leaflet: Information for the patient

POLCORTOLON TC (23.12 mg + 0.58 mg)/g, cutaneous aerosol, suspension
Tetracyclini hydrochloridum + Triamcinoloni acetonidum
Please read all of this leaflet carefully before using this 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, ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents:

1. What Polcortolon TC is and what it is 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 Polcortolon TC is and what it is used for
Polcortolon TC cutaneous aerosol, suspension, contains two active substances – tetracycline and triamcinolone.
Tetracycline – is a broad-spectrum antibiotic with antibacterial activity.
Triamcinolone – is a corticosteroid with moderately potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
Polcortolon TC acts against tetracycline-sensitive bacteria present in skin inflammatory lesions and reduces local inflammatory processes, erythema, and itching.

Indications
Local treatment of inflammatory skin conditions complicated by bacterial infection caused by tetracycline-sensitive bacteria, as seen in the following diseases:

• 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 vulgaris or rosacea,
• skin cancer or pre-cancerous conditions,
• perioral dermatitis,
• in the anal or genital areas.

Warnings and precautions

• This medicine is intended for cutaneous use only.
• Avoid contact with mucous membranes.
• Protect the eyes from contact with the medicine. If contact occurs, rinse thoroughly with water.
• Do not inhale the sprayed substance.
• If skin irritation occurs at the site of application, inform your doctor. The doctor will decide whether the medicine should be discontinued.
• Prolonged use on the skin may cause dilation of blood vessels and skin atrophy. Use with particular caution on facial skin.
• Do not bandage the skin area treated with the medicine, and do not use under occlusive dressings. Application under occlusive dressings increases the penetration of the medicine through the skin into the bloodstream, which may lead to systemic adverse effects of tetracycline or triamcinolone.
• Triamcinolone may be absorbed through the skin into the bloodstream and exert immunosuppressive effects (reducing the body's immunity). Therefore, during treatment, the patient should take care to avoid contracting infectious viral diseases (e.g., chickenpox, measles).
• The medicine should not be used long-term, over large skin areas, or on wounds, due to the risk of systemic adverse effects of tetracycline and triamcinolone. The steroid component of the medicine, triamcinolone, may be absorbed into the bloodstream and produce systemic effects, including suppression of the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, glycosuria, hyperglycemia). If systemic adverse effects of corticosteroids occur, consult a doctor. The doctor will decide whether to discontinue treatment with Polcortolon TC.
• During treatment, avoid exposure to sunlight or artificial ultraviolet radiation (e.g., solarium). Due to the presence of tetracycline in the medicine, skin hypersensitivity reactions (photodermatoses) may occur.
• Prolonged use may lead to overgrowth of fungi or tetracycline-resistant bacterial strains, or sensitization to tetracycline. If infections caused by tetracycline-resistant bacteria or fungi develop, the doctor should initiate appropriate antibacterial or antifungal treatment.
• Extreme caution should be exercised when using this medicine in children over 3 years of age, due to the risk of systemic effects of tetracycline or the steroid component, triamcinolone. In children, due to the higher body surface area to body weight ratio compared to adults, the risk of systemic corticosteroid effects, including disturbances in the function of the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome), is greater than in adults. Moreover, prolonged corticosteroid use may impair growth and development in children.

Polcortolon TC and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to use.
Do not use other topical medicines simultaneously during treatment, as this may affect the concentration of active substances at the application site and may lead to interactions or skin irritation.

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

Driving and operating machinery
There is no data available on the effects of this medicine on the ability to drive or operate machinery.

3. How to use Polcortolon TC

Polcortolon TC should be used as directed by the physician.
If in doubt, consult your doctor again.
Recommended dose
Adults and children over 3 years of age
Affected skin areas should be sprayed with the suspension, holding the container upright, nozzle upwards, from a distance of 15 to 20 cm, for 1 to 3 seconds.
The medicine is usually applied 2 to 4 times daily at regular intervals.
Children
Do not use in children under 3 years of age.
Extremely flammable aerosol. Do not spray near open flame or other sources of ignition.
Warning: Protect eyes from the medicine; do not inhale the sprayed substance.
Before each use, shake the container vigorously several times.
After each application, hands should be thoroughly washed with soap and water.
If during treatment the patient feels that the effect of the medicine is too strong or too weak,
the patient should consult the doctor.
Use of a higher than recommended dose of Polcortolon TC
If the medicine is used over large skin areas, in large amounts, under occlusive dressing, or on damaged skin, it may be absorbed into the bloodstream and cause systemic effects of triamcinolone or tetracycline (see section 2. When to be particularly careful using Polcortolon TC).
If a higher than recommended dose has been used, consult a doctor immediately.
Missed dose of Polcortolon TC
If a dose is missed at the usual scheduled time and there is sufficient time before the next dose, apply the medicine as soon as possible or continue treatment as directed.
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Polcortolon TC may cause adverse effects, although not everyone experiences them.

• Triamcinolone – the steroid component of the medicine – may cause local adverse reactions such as burning, itching, irritation at the site of application, excessive skin dryness, skin atrophy, contact dermatitis, perioral dermatitis, skin maceration, acneiform changes, striae, hypertrichosis, skin depigmentation, secondary skin infections, and folliculitis. With prolonged use and/or application over large areas of skin, triamcinolone may be absorbed into the bloodstream and cause systemic adverse effects typical of corticosteroids. In children, growth and developmental disorders may additionally occur.
• Prolonged use of the medicine on the facial skin may lead to skin atrophy and telangiectasia (dilated blood vessels).
• Tetracycline contained in the medicine may cause local skin irritation, allergic reactions, photosensitivity skin reactions, overgrowth of fungi or resistant bacterial strains.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, consult a doctor or pharmacist.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 adverse effects helps to provide 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 refers to the last day of the specified month.

• Extremely flammable aerosol.
• Pressurised container. May burst if heated.
• Keep away from heat sources, hot surfaces, sparks, open flames and other sources of ignition. No smoking.
• Do not spray on an open flame or other source of ignition.
• Pressurised container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.

Medicines must 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 are tetracycline hydrochloride and triamcinolone acetonide.
1 g of the suspension contains:
23.12 mg tetracycline hydrochloride and 0.58 mg triamcinolone acetonide.
Other components are: sorbitan trioleate (Span 85), lecithin, myristyl isopropylate,
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 cutaneous aerosol, suspension.
The suspension is yellow and homogeneous.
Pack: a container with 17.3 g of suspension in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
For further information, please contact the representative of the Marketing Authorisation Holder.

Polfa Tarchomin S.A.
Warsaw
Telephone number: 22 811-18-14