Tetraciclinum Tzf

Package Leaflet: Information for the Patient

Tetracyclinum TZF, 250 mg, Film-Coated Tablets

Tetracycline Hydrochloride

Read the package leaflet carefully before taking 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 pharmacist.
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tetracyclinum TZF and what is it used for
• 2. Important information before taking Tetracyclinum TZF
• 3. How to take Tetracyclinum TZF
• 4. Possible side effects
• 5. How to store Tetracyclinum TZF
• 6. Contents of the pack and other information

1. What is Tetracyclinum TZF and what is it used for

Tetracyclinum TZF is an antibiotic belonging to the tetracycline group. It acts on many Gram-negative and Gram-positive bacteria, including bacteria that cause acne (Propionibacterium acnes), and some protozoa.

Indications for Use

Tetracyclinum TZF is used to treat all forms of common acne, especially the papulopustular form.

2. Important Information Before Taking Tetracyclinum TZF

When Not to Take Tetracyclinum TZF:

• if you are allergic to tetracycline or any other antibiotic from the tetracycline group, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver failure;
• in children under 12 years of age.

Warnings and Precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Tetracyclinum TZF:

• you have liver failure and/or are taking medicines that may have a toxic effect on the liver;
• you have kidney failure;
• you have myasthenia gravis; taking tetracycline may worsen the symptoms of the disease;
• you have systemic lupus erythematosus; taking tetracycline may worsen the symptoms of the disease;
• you are pregnant or breastfeeding.

If, during treatment with Tetracyclinum TZF, any of the following situations occur, you should inform your doctor.

• Excessive growth of insensitive microorganisms (e.g. yeast). The medicine should then be discontinued and appropriate treatment started under medical supervision.
• Allergic reactions, including severe ones (e.g. exfoliative dermatitis, angioedema, anaphylactic shock). The medicine should then be discontinued and you should see a doctor as soon as possible. Patients allergic to any tetracycline antibiotic may also be allergic to tetracycline.
• During treatment with tetracycline, you should avoid sunbathing or exposure to artificial UV radiation (e.g. solarium) due to the possibility of sun sensitivity. It is recommended to use UV filters, especially during treatment, and if redness or any other changes appear on the skin, you should stop taking the medicine and contact your doctor.
• Prolonged treatment with tetracycline. Your doctor will recommend liver, kidney, and blood tests.
• Diarrhea occurring during or after the end of tetracycline treatment. This may be a sign of pseudomembranous colitis - a complication associated with antibiotic use. It is then necessary to discontinue the medicine and sometimes use appropriate treatment. You should not take medicines that slow down bowel movements or have a constipating effect.

Children and Adolescents

Tetracyclinum TZF should not be used in children under 12 years of age, as the use of tetracycline during the formation of teeth and bones may cause discoloration and damage to teeth or delay bone development.

Tetracyclinum TZF and Other Medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• medicines that reduce blood clotting;
• methoxyflurane (an anesthetic used for general anesthesia during surgery, in dentistry);
• diuretics (e.g. furosemide);
• methotrexate (used to treat cancer);
• cyclosporin A (used to treat atopic dermatitis or after organ transplantation);
• penicillins or other bactericidal antibiotics;
• oral contraceptives; tetracycline may reduce their effectiveness; during treatment with tetracycline and for 7 days after the end of treatment, it is recommended to use additional effective contraceptive methods.
• theophylline.

Effect on Diagnostic Test Results

Tetracycline may change the results of glucose, urobilinogen, protein, and catecholamine tests in urine. If you are to undergo such tests, you should inform your doctor that you are taking Tetracyclinum TZF.

Tetracyclinum TZF with Food and Drink

Food, especially dairy products, and medicines containing metal ions inhibit the absorption of tetracycline from the gastrointestinal tract, thereby reducing its antibacterial effect. To minimize this effect, the medicine should be taken 1 to 3 hours before or after eating dairy products or metal-containing medicines.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.

Tetracyclinum TZF should not be used during pregnancy. Tetracycline taken during the formation of teeth and bones (last trimester of pregnancy) may cause discoloration and damage to teeth or delay bone development.

Tetracycline passes into breast milk, so Tetracyclinum TZF should not be used during breastfeeding.

Driving and Using Machines

Tetracyclinum TZF has not been shown to affect the ability to drive and use machines. However, if side effects occur that reduce concentration (e.g. headache, vision disturbances; see section 4. Possible side effects), it is not recommended to drive vehicles or operate machines.

Tetracyclinum TZF Contains Sucrose and Lactose Monohydrate

1 tablet contains 152.6 mg of sucrose and 56.2 mg of lactose monohydrate.

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Tetracyclinum TZF Contains E 124 (Cochineal Red)

The medicine may cause allergic reactions.

Tetracyclinum TZF Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is considered "sodium-free".

3. How to Take Tetracyclinum TZF

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor.

The usual dose is 750 mg to 1.5 g per day, divided into doses taken every 6 hours.

Method of Administration

The medicine should be taken between meals (at least 1 hour before eating or 2 hours after a meal) with a large amount of liquid, at least 250 ml (a glass), except for milk and its products.

Overdose of Tetracyclinum TZF

In case of overdose of tetracycline and the occurrence of any symptoms, you should immediately stop taking the medicine and contact your doctor. In conscious patients, vomiting can be induced.

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.

Missed Dose of Tetracyclinum TZF

In case of missing a dose of the medicine at a fixed, specified time, you should take it as soon as possible, unless the time to take the next dose is too short, or continue taking the medicine regularly.

You should not take a double dose to make up for a missed dose.

Discontinuation of Tetracyclinum TZF

It is important to take the medicine according to the recommended treatment cycle. You should not stop treatment just because you feel better. If the treatment cycle is interrupted too early, the infection may return.

If you feel worse during treatment or do not feel well after the end of the recommended treatment cycle, you should consult your doctor.

If you have any further questions about taking the medicine, ask your doctor.

4. Possible Side Effects

Like all medicines, Tetracyclinum TZF can cause side effects, although not everybody gets them.

Severe Side Effects

If you experience any of the following severe side effects, you should stop taking the medicine and immediately inform your doctor or go to the nearest emergency department in a hospital.

Allergic reactions, such as sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes that may be accompanied by blistering of the eyes, mouth, throat, and genitals, loss of consciousness (fainting), rapid heartbeat, pericarditis.

These may be symptoms of severe allergic reactions, such as anaphylactic shock, angioedema, serum sickness-like reaction, anaphylactoid purpura, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis.

Increased intracranial pressure, which manifests as headache, vision disturbances.

Severe diarrhea, lasting for a longer period or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe inflammation of the small or large intestine (pseudomembranous colitis), which may occur after antibiotic use.

Other Side Effects

Infections and Infestations: during prolonged or repeated antibiotic treatment, local infection of the skin or mucous membranes with insensitive bacteria or fungi may occur, manifested by: anal itching, oral mucositis and tongue, external genitalia, and vaginal inflammation.

Blood and Lymphatic System Disorders: hemolytic anemia, decreased platelet count, decreased white blood cell count, disorders of hem synthesis, increased eosinophil count in blood, occur rarely.

Endocrine Disorders: in the case of prolonged administration of tetracycline, brown-black discoloration of the thyroid has been observed, without affecting its function.

Nervous System Disorders: headache, dizziness, facial flushing, very rarely bulging fontanelle in infants and mild intracranial hypertension in children and adults.

Ear and Labyrinth Disorders: tinnitus.

Gastrointestinal Disorders: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, glossitis, difficulty swallowing, esophageal ulceration, enteritis, inflammatory changes in the anal area. These effects are usually mild and disappear after discontinuation of the medicine.

Hepatobiliary Disorders: transient, slight increase in liver enzyme activity; liver dysfunction, hepatitis, jaundice, pancreatitis, occur very rarely.

Skin and Subcutaneous Tissue Disorders: in some patients with systemic lupus erythematosus, worsening of the disease symptoms has been observed.

Musculoskeletal and Connective Tissue Disorders: joint pain, muscle pain. Tooth development disorders, tooth discoloration. In patients with myasthenia gravis, the symptoms of the disease may worsen.

Renal and Urinary Disorders: increased urea levels in the blood.

General Disorders and Administration Site Conditions: malaise.

Investigations: increased azotemia in blood serum.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tetracyclinum TZF

The medicine should be stored out of the sight and reach of children.

Store in a temperature below 25°C. Protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

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 Tetracyclinum TZF Contains

The active substance of the medicine is tetracycline hydrochloride.

One film-coated tablet contains 250 mg of tetracycline hydrochloride.

The other ingredients are:

tablet core:potato starch, sodium carboxymethyl starch (type A), gelatin, talc, magnesium stearate, lactose monohydrate;

coating:polyvinyl alcohol, talc, sucrose, titanium dioxide, cochineal red E 124, Opaglos 6000: shellac (E 904), carnauba wax, yellow wax (E 903); beeswax, white (E 901).

What Tetracyclinum TZF Looks Like and Contents of the Pack

The tablets are pink, round, biconvex, smooth, shiny, without spots, cracks, or chips. The tablet break is yellow.

Packaging: 16 tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna, ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14.

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder.

Date of Approval of the Leaflet: