Package leaflet: Information for the patient

TETRACYCLINUM, 30 mg/g, ointment
(Tetracyclini hydrochloridum)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further 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 someone else, even if their symptoms are the same.
If any side effects occur in the patient, including side effects not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Tetracyclinum is and what it is used for
Tetracyclinum is an ointment containing the active substance tetracycline hydrochloride.

Indications
Tetracyclinum is used:

for local treatment of purulent skin infections caused by bacteria sensitive to tetracyclines;
for treatment of inflammatory forms of acne, characterized by skin papules, pustules, nodules, cysts, and purulent abscesses. Mainly in papulopustular acne (acne papulo-pustulosa). The ointment may be used in monotherapy as well as in combination therapy with topical preparations containing retinoids or benzoyl peroxide;
for treatment of phlegmonous acne (acne phlegmonosa) as an adjunctive agent with orally administered retinoids.

2. Important information before using Tetracyclinum

When not to use Tetracyclinum:

if the patient is allergic to tetracycline, to any other tetracycline-class substances, or to any of the other ingredients of this medicine (listed in section 6);
in children under 12 years of age;
during pregnancy and breastfeeding.

Warnings and precautions
Exposure to sunlight (solarium or natural sun) is contraindicated during treatment with Tetracyclinum ointment.
Note: The medicine produces yellow fluorescence under ultraviolet light (e.g. disco light).

Tetracyclinum and other medicines
Please inform your doctor or pharmacist about any medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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 her doctor or pharmacist before using this medicine.
This medicine must not be used in pregnant women or in breastfeeding mothers.

Driving and operating machinery
Tetracyclinum has no influence on the ability to drive or operate machinery.

3. How to use Tetracyclinum

This medicine should always be used exactly as prescribed by your doctor. 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 2 to 3 times daily, or apply the ointment under an occlusive dressing, usually for a period of 4 to 6 weeks.

If necessary, your doctor may recommend continuing treatment up to 12 weeks.

If there is no improvement after 2 weeks of treatment, or if symptoms worsen, contact your doctor.

After applying the ointment, wash your hands.

Use in children
Do not use in children under 12 years of age.

Missed dose of Tetracyclinum
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 directed by your doctor.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

Discontinuation of Tetracyclinum
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
Skin hypersensitivity reactions may occur (rash, urticaria, photosensitivity, swelling), fungal infections or overgrowth of resistant bacterial strains, and rarely exfoliative dermatitis.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions allows further information on the safety of the medicine to be collected.

5. How to store Tetracyclinum

Keep in the tightly closed container.
Store below 25°C.
Keep the medicine out of sight and reach of children.
Pay special attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube or 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 your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tetracyclinum contains

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

What Tetracyclinum looks like and contents of the pack
Tetracyclinum is a homogeneous, greasy yellow mass.
The medicinal product is available in an aluminum tube containing 10 g of ointment, packed in a cardboard box.
For further detailed 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]