Tetracycline tzf

Package leaflet: Information for the patient

Tetracyclinum TZF, 250 mg, coated tablets
Tetracycline hydrochloride
Please read carefully the entire leaflet before taking 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 questions, please consult your doctor or pharmacist.
• 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Tetracyclinum TZF is an antibiotic belonging to the tetracycline group. It acts against many Gram-negative and Gram-positive bacteria, including bacteria causing acne (Propionibacterium acnes), as well as some protozoa.
Indications
Tetracyclinum TZF is used in the treatment of all forms of acne vulgaris, particularly nodular-pustular acne.

2. Important information before using Tetracyclinum TZF

When not to use Tetracyclinum TZF:

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

Warnings and precautions
If any of the following situations apply to the patient, discuss them with the doctor before starting
treatment with Tetracyclinum TZF:

• the patient has liver failure and/or is taking medicines that may have a toxic effect on the liver;
• the patient has kidney failure;
• the patient suffers from myasthenia gravis; use of tetracycline may worsen the symptoms of the disease;
• the patient has systemic lupus erythematosus; use of tetracycline may worsen the symptoms of the disease;
• the patient is pregnant or breastfeeding.

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

• Overgrowth of resistant microorganisms (e.g. Candida). In such a case, discontinue the medicine and start appropriate treatment under medical supervision.
• Allergic reactions, including severe ones (e.g. exfoliative dermatitis, angioedema, anaphylactic shock). The medicine should then be discontinued and the patient should consult a doctor immediately. Patients allergic to any tetracycline antibiotic may also be allergic to tetracycline.
• During treatment with tetracycline, avoid exposure to sunlight or artificial UV radiation (e.g. sunbeds) due to the risk of photosensitivity. Use of UV-filter creams is recommended, especially during treatment. If redness or any other skin changes appear, discontinue the medicine and contact the doctor.
• Long-term treatment with tetracycline. The doctor may recommend monitoring of liver and kidney function and blood counts.
• Diarrhea occurring during or after completion of tetracycline treatment. This may be a symptom of pseudomembranous colitis—a complication associated with antibiotic use. In such cases, treatment with the medicine should be stopped, and sometimes specific treatment may be required. Do not administer drugs that inhibit peristalsis or have constipating effects.

Children and adolescents
Do not use this medicine in children under 12 years of age, as use of tetracycline during tooth and bone development may cause tooth discoloration and damage or delay in skeletal development.
Tetracyclinum TZF and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• anticoagulant drugs;
• methoxyflurane (an anaesthetic agent used for general anaesthesia during surgery or dental procedures);
• diuretics (e.g. furosemide);
• methotrexate (used in the treatment of neoplastic diseases);
• cyclosporine A (used in atopic dermatitis or after organ transplantation);
• penicillins or other bactericidal antibiotics;
• oral contraceptives; tetracycline may reduce their effectiveness; during tetracycline treatment and for 7 days after completion of treatment, additional effective contraceptive methods are recommended;
• theophylline.

Effect on diagnostic test results
Tetracycline may alter test results for glucose, urobilinogen, protein, and catecholamines in urine. If the patient is to undergo such tests, the doctor should be informed about the use of Tetracyclinum TZF.
Tetracyclinum TZF with food and drink
Food, especially dairy products, and medicinal products containing metal ions, reduce the absorption of tetracycline from the gastrointestinal tract and thus weaken its antibacterial effect. To minimize this interaction, the medicine should be taken 1 to 3 hours before or after consuming dairy products or medicinal products containing metal ions.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Tetracyclinum TZF should not be used during pregnancy. Tetracycline taken during tooth and bone development (third trimester of pregnancy) may cause tooth discoloration and damage or delay in skeletal development.
Tetracycline passes into human milk; therefore, Tetracyclinum TZF should not be used in breastfeeding women.
Driving and operating machinery
No evidence has been found that Tetracyclinum TZF impairs the ability to drive motor vehicles or operate machinery. However, if adverse effects affecting concentration occur (e.g. headache, visual disturbances; see section 4. Possible side effects), driving motor vehicles or operating machinery is not recommended.
Tetracyclinum TZF contains sucrose and monohydrate lactose
One tablet contains 152.6 mg of sucrose and 56.2 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Tetracyclinum TZF contains carmine red (E 124)
The medicine may cause allergic reactions.
Tetracyclinum TZF contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to use Tetracyclinum TZF
This medicine should always be used as directed by the doctor. If in doubt, consult the doctor.
The usual dose is 750 mg to 1.5 g per day, divided into doses administered every 6 hours.
Method of administration
The medicine should be taken between meals (at least 1 hour before or 2 hours after meals) with a large amount of fluid—at least 250 ml (a glass)—except milk and milk products.
Taking more than the recommended dose of Tetracyclinum TZF
In case of tetracycline overdose and appearance of any symptoms, discontinue the medicine immediately and contact a doctor. In conscious patients, vomiting may be induced.
If a higher than recommended dose is taken, seek medical advice immediately.
Missed dose of Tetracyclinum TZF
If a dose is missed at the usual scheduled time, take the medicine as soon as possible, provided there is sufficient time before the next dose, or continue with the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Tetracyclinum TZF
It is important that the medicine is used according to the recommended treatment course. Do not stop treatment just because the patient feels better. If the treatment course is stopped too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment course, consult the doctor.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following serious adverse effects occur, discontinue use of the medicine immediately and promptly contact your doctor or go to the nearest hospital emergency department.
Allergic reactions such as sudden shortness of breath and chest tightness, swelling of the eyelids, face or lips, severe skin rashes which may be associated with blister formation affecting the eyes, mouth, throat and genital organs, loss of consciousness (fainting), rapid heartbeat, inflammation of the pericardium.
These may be symptoms of serious allergic reactions such as: anaphylactic shock, angioedema, serum sickness-like syndrome, anaphylactoid purpura, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
Increased intracranial pressure, manifesting as headache and visual disturbances.
Severe, persistent diarrhoea lasting for a prolonged period or containing blood, accompanied by abdominal pain or fever. This may be a sign of a serious inflammation of the small or large intestine (called pseudomembranous colitis), which may occur following antibiotic treatment.
Other adverse reactions
Infections and parasitic infestations: during prolonged or repeated antibiotic treatment, local infections of the skin or mucous membranes caused by microorganisms resistant to the antibiotic may occur, presenting as: anal itching, inflammation of the oral mucosa and tongue, external genital organs and vagina.
Blood and lymphatic system disorders: anaemia due to haemolysis, decreased platelet count, reduced numbers of certain types of white blood cells, disturbances in haem synthesis, increased number of acidophilic blood cells, occur rarely.
Endocrine disorders: brownish-black discolouration of the thyroid gland has been observed following long-term tetracycline administration, without affecting its function.
Nervous system disorders: headache, dizziness, sudden flushing of the face, very rarely bulging fontanelle in infants and benign intracranial hypertension in children and adults have been observed.
Ear and labyrinth disorders: tinnitus.
Gastrointestinal disorders: loss of appetite, nausea, vomiting, diarrhoea, abdominal pain, inflammation of the tongue, difficulty in swallowing, oesophageal ulceration, intestinal inflammation, inflammatory changes around the anus. These effects are usually mild and resolve after discontinuation of the medicine.
Hepatobiliary disorders: transient, slight increase in liver enzyme activity; liver function disorders, hepatitis, jaundice, pancreatitis have been observed very rarely.
Skin and subcutaneous tissue disorders: in some patients with systemic lupus erythematosus, exacerbation of disease symptoms has been observed.
Musculoskeletal and connective tissue disorders: joint pain, muscle pain. Disorders of tooth development, discolouration of the enamel. In patients with myasthenia gravis, symptoms of the disease may worsen.
Renal and urinary disorders: increased blood urea concentration.
General disorders and administration site conditions: malaise.
Diagnostic investigations: increased serum blood urea nitrogen concentration.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. Storage of Tetracyclinum TZF
Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tetracyclinum TZF contains
The active substance is tetracycline hydrochloride.
One coated tablet contains 250 mg of tetracycline hydrochloride.
Other ingredients are:
tablet core: potato starch, sodium carboxymethyl starch (type A), gelatin, talc, magnesium stearate, monohydrate lactose;
coating: polyvinyl alcohol, talc, sucrose, titanium dioxide, cochineal red A dye E 124, Opaglos 6000: shellac (E 904), carnauba wax, yellow (E 903); beeswax, white (E 901).
What Tetracyclinum TZF looks like and contents of the pack
The coated tablets are pink, round, biconvex, smooth, glossy, without spots, chips or cracks. The tablet's break surface is yellow.
Pack: 16 tablets in a cardboard box.
Marketing authorisation holder and manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Phone number: 22 811-18-14
For further information on this medicinal product, please contact the marketing authorisation holder's representative.