Tetraciclinum

Leaflet included in the packaging: patient information

TETRACYCLINUM, 30 mg/g, ointment

(Tetracycline hydrochloride)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific purpose. Do not pass it on to others. The medicine may harm another person, even if the symptoms of the disease are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tetracyclinum and what is it used for

Tetracyclinum is an ointment that contains the active substance tetracycline hydrochloride.

Indications

Tetracyclinum is used:

• for local treatment of purulent skin infections caused by bacteria sensitive to tetracyclines;
• for the treatment of inflammatory forms of acne, whose symptoms include the appearance of papules, pustules, nodules, cysts, and abscesses on the skin. Mainly in papulo-pustular acne (acne papulo-pustulosa). The ointment can be used as monotherapy and in combination with topical retinoid or benzoyl peroxide preparations;
• for the treatment of phlegmonous acne (acne phlegmonosa) as an auxiliary agent with retinoids administered orally.

2. Important information before using Tetracyclinum

When not to use Tetracyclinum:

• if the patient is allergic to tetracycline or any other tetracycline group substances or 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

When using Tetracyclinum ointment, sunbathing is contraindicated.
Note: The medicine gives a yellow glow in ultraviolet light (e.g., disco light).

Tetracyclinum and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine should not be used in pregnant women and breastfeeding mothers.

Driving and operating machinery

Tetracyclinum does not affect the ability to drive and operate machinery.

3. How to use Tetracyclinum

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.
Pathologically changed areas should be covered with a thin layer of the medicine 2 to 3 times a day or applied to a closed dressing, usually for 4 to 6 weeks.
If necessary, the doctor may recommend continuing treatment for up to 12 weeks.
If after 2 weeks of treatment there is no improvement or the symptoms worsen, the patient should contact their doctor.
After using the ointment, the patient should wash their hands.

Use in children

Do not use in children under 12 years of age.

Missing a dose of Tetracyclinum

Do not use a double dose to make up for a missed dose.
In case of a missed dose, the patient should use the medicine as soon as possible. Then, they should continue treatment using the medicine according to the previously recommended dosage by the doctor.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

Stopping the use of Tetracyclinum

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
They may include skin hypersensitivity reactions (redness, hives, hypersensitivity to light, swelling), fungal or bacterial superinfections, and rare exfoliative dermatitis.

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the patient should inform their doctor or pharmacist. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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 undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Tetracyclinum

Store in a closed packaging.
Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Particular attention should be paid to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube or carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tetracyclinum contains

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

What Tetracyclinum looks like and what the packaging contains

Tetracyclinum is a uniform, greasy mass of yellow color.
The available packaging of the medicine is an aluminum tube containing 10 g of ointment, placed in a cardboard box.
To obtain more detailed information, the patient should contact the marketing authorization holder.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]

Date of the last update of the leaflet: