Doxiciclinum Tzf

Leaflet attached to the packaging: patient information

Doxycyclinum TZF, 20 mg/ml, solution for infusion

Doxycyclinum
One ampoule contains 100 mg of doxycycline (in the form of doxycycline hyclate)
in 5 ml of solution.

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 you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Doxycyclinum TZF contains the active substance doxycycline, an antibiotic belonging to the tetracycline group. Doxycycline inhibits the growth of many microorganisms (bacteria and protozoa).

Indications for use

Doxycyclinum TZF is used in the following infections caused by microorganisms sensitive to doxycycline:

• infections of the upper and lower respiratory tract (e.g., tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, pneumonia);
• urinary tract infections - cystitis;
• sexually transmitted diseases - uncomplicated urethritis, inflammatory conditions in the pelvic area;
• gastrointestinal infections, including salmonellosis, traveler's diarrhea, cholera, amoebiasis;
• skin and soft tissue infections, including severe forms of common acne caused by microorganisms sensitive to the medicine.

2. Important information before using Doxycyclinum TZF

When not to use Doxycyclinum TZF

if the patient is allergic (hypersensitive) to doxycycline, other tetracyclines, or any of the other ingredients of the medicine (listed in section 6);
in pregnant and breastfeeding women.

Warnings and precautions

The patient should inform their doctor if they have:

• kidney function disorders;
• liver function disorders;
• myasthenia (a disease characterized by excessive fatigue and muscle weakness);
• systemic lupus erythematosus (a disease with an allergic background, characterized by joint pain, skin rash, fever);
• porphyria (a rare disease related to blood pigment).

In diseases where syphilis infection is suspected, the doctor will recommend diagnostic tests before starting treatment.
Doxycycline should not be used during the development of teeth (second half of pregnancy, neonatal period, infant period, children under 8 years), as it may cause permanent discoloration of teeth (yellow-gray-brown) or disrupt normal tooth growth.
However, in some cases (e.g., severe or life-threatening conditions), the doctor may recommend the use of doxycycline in children under 8 years of age, if the potential benefits of its use outweigh the risk of these disorders.
Tetracyclines, including doxycycline, may cause hypersensitivity to light. During treatment, the patient should avoid sunbathing or artificial UV radiation (e.g., solarium) due to the possibility of photosensitivity, which may manifest as skin redness, swelling, blisters. If such symptoms occur, the medicine should be discontinued immediately and the doctor informed.
Similarly, as with other antibiotics, the use of doxycycline may lead to the overgrowth of microorganisms insensitive to the antibiotic. If symptoms indicating the development of, for example, thrush (persistent itching, skin redness) occur, the doctor should be informed.
If the patient experiences persistent diarrhea during or after the use of Doxycyclinum TZF, they should inform their doctor. This may be a sign of colitis - a complication associated with the use of antibiotics. It is then necessary to discontinue the use of the medicine and sometimes apply appropriate treatment. Medicines that inhibit intestinal peristalsis or have a constipating effect should not be administered.
There have been reports of bulging fontanelle in infants and mild increased intracranial pressure in children and adults after taking therapeutic doses. These symptoms quickly resolved after the medicine was discontinued.

Doxycyclinum TZF and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.
In particular, the doctor should be informed if the patient is taking:

• warfarin or other oral anticoagulants (medicines that prevent blood clots);
• cyclosporin (a medicine used, among other things, after transplants);
• methotrexate (used in the treatment of arthritis);
• penicillin or other antibiotics from the penicillin group;
• sleeping pills;
• rifampicin (an anti-tuberculosis medicine);
• carbamazepine, phenytoin (medicines used in the treatment of epilepsy).

Oral contraceptives
Doxycyclinum TZF may reduce their effectiveness, so during treatment with doxycycline and for 7 days after the end of treatment, it is recommended to use additional non-hormonal contraceptive methods.

Doxycyclinum TZF with food, drink, or alcohol

Drinking alcohol during the use of Doxycyclinum TZF may reduce the effectiveness of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
If the patient is pregnant or suspects they may be pregnant
The medicine should not be used in pregnant women.
If the patient is breastfeeding
Doxycycline passes into human milk. During treatment with doxycycline, breastfeeding should be discontinued.

Driving and operating machines

Doxycyclinum TZF is unlikely to affect the ability to drive and operate machines. However, it may sometimes cause dizziness, blurred or double vision.
Therefore, before starting to drive or operate machines, the patient should make sure how they react to the medicine.

Doxycyclinum TZF contains sodium metabisulfite (E 223)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Doxycyclinum TZF contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of prepared infusion solution, which means the medicine is considered "sodium-free".
The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see the section "Information intended exclusively for healthcare professionals"). To obtain accurate information about the sodium content in the solution used for dilution, you should consult the leaflet of the solvent used.

3. How to use Doxycyclinum TZF

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 administered by intravenous infusion.
Recommended dose

Adults and children from 12 to 18 years of age

On the first day of treatment, 200 mg of doxycycline (2 ampoules) is administered in a single dose or in 2 divided doses - 100 mg every 12 hours, and then a maintenance dose of 100 mg per day is used.
In severe infections, 200 mg per day is administered throughout the treatment period.
The treatment duration depends on the severity of the infection.

Children from 8 to 12 years of age

Doxycycline may be administered in the treatment of severe infections in children from 8 to 12 years of age only when other medicines are not available and are likely to be ineffective or are contraindicated.
In such cases, the dosing of doxycycline is as follows:
Children with a body weight of 45 kg or less:
Initial dose (first day of treatment): 4.4 mg/kg body weight (in a single or 2 divided doses), and then, from the second day of treatment, 2.2 mg/kg body weight (in a single or 2 divided doses). The treatment duration depends on the severity of the infection.
In the treatment of more severe infections, up to 4.4 mg/kg body weight should be administered throughout the treatment period.
Children with a body weight over 45 kg - the dose should be used as in adults.
On the first day, 200 mg, and then 100 mg per day. The treatment duration depends on the severity of the infection.

Children under 8 years of age

Doxycycline should not be used in children under 8 years of age due to the risk of tooth discoloration (see sections 2 and 4).

Treatment duration

The treatment duration depends on the severity and type of infection.
The doctor will determine the appropriate treatment duration, which should be followed.
Method of preparation and administration of Doxycyclinum TZFis given at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

Use of a higher than recommended dose of Doxycyclinum TZF

Symptoms of overdose are fever, facial redness, dizziness, and sometimes fainting (loss of consciousness).
Since the medicine will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be administered. However, if the patient believes they have been given too much medicine, they should immediately inform their doctor or go to the emergency department of the nearest hospital.
The patient should take the medicine in its original packaging, so that the medical staff can precisely check which medicine was used.

Missing a dose of Doxycyclinum TZF

A double dose should not be used to make up for a missed dose.

Discontinuing the use of Doxycyclinum TZF

It is important to use the medicine in accordance with the recommended treatment cycle. The treatment should not be discontinued just because the patient feels better. If the treatment cycle is discontinued too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after the end of the recommended treatment cycle, they should consult their attending doctor.

4. Possible side effects

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

If any of the following side effects occur, the patient should stop taking the medicine and immediately inform their doctor or go to the emergency department of the nearest hospital.

Severe side effects that occur very rarely (in 1 to 10 people out of 10,000):
Increased intracranial pressure, which manifests as headache, vision disturbances (blind spots, double vision).
Severe side effects that occur with an unknown frequency (the frequency cannot be determined based on available data):
Allergic reactions, such as rash, sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes that may be accompanied by the formation of ulcers in the mouth, eyes, genitals, and skin, large blisters, peeling of large skin areas, weakness, fever, and joint pain, increased heart rate, anaphylactic shock characterized by confusion, pale skin, decreased blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting.
Skin hypersensitivity to UV radiation (sun, solarium).
Severe diarrhea, persistent over 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). These symptoms may occur after the use of antibiotics, even 2 to 3 months after the end of treatment.

If any of the following side effects occur, the patient should contact their doctor as soon as possible:

• hepatitis, jaundice (observed rarely);
• pancreatitis (observed very rarely);
• anemia caused by the breakdown of red blood cells, increased or decreased number of certain types of white or red blood cells and platelets, which may manifest as fatigue, bleeding, increased susceptibility to bruising and infections (observed with an unknown frequency);
• Jarisch-Herxheimer reaction, causing fever, chills, headache, muscle pain, and skin rash, which usually resolves on its own. It occurs soon after the start of treatment with doxycycline for spirochetal infections, e.g., borreliosis (observed with an unknown frequency);
• separation of the nail plate from the nail bed caused by light (observed with an unknown frequency).

Other side effects that may occur during the use of Doxycyclinum TZF

Side effects that occur rarely (in less than 1 person out of 10,000):

• thrombophlebitis.

Side effects that occur very rarely (in 1 to 10 people out of 10,000):

• observed bulging fontanelle in infants and mild increased intracranial pressure in children and adults receiving large doses of tetracyclines. These symptoms quickly resolved after the medicine was discontinued. There have also been reports of complete loss of vision.

Side effects with an unknown frequency (the frequency cannot be determined based on available data):

• inflammatory conditions in the genital and anal areas, oral mucosa and tongue inflammation, vaginal inflammation;
• porphyria (a disorder of heme synthesis)
• during long-term administration of tetracyclines, brown-black discoloration of the thyroid gland has been observed, without affecting its function;
• headache;
• tinnitus;
• abdominal pain, loss of appetite, nausea, vomiting, diarrhea, indigestion, difficulty swallowing, esophageal inflammation and ulceration. These symptoms are usually mild and do not require discontinuation of treatment. The vast majority of these side effects occurred during treatment with doxycycline administered in the form of capsules (see section 2. Important information before using Doxycyclinum TZF). Tooth discoloration and (or) lack of tooth growth.
• transient, slight increase in liver enzyme activity; liver function disorders;
• in patients taking tetracyclines for a long time, joint pain, muscle pain, tooth discoloration, and enamel underdevelopment may occur;
• increased urea levels in the blood;
• malaise, pain, irritation, burning at the injection site.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, it is possible to gather more information on the safety of the medicine.

5. How to store Doxycyclinum TZF

The medicine should be stored out of sight and reach of children.
Store in a temperature of 2°C to 8°C. Protect from light.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 Doxycyclinum TZF contains

The active substance of the medicine is doxycycline (in the form of doxycycline hyclate).
1 ml of solution contains 20 mg of doxycycline
Other ingredients of the medicine are: povidone K17, ethanolamine, magnesium chloride hexahydrate, sodium metabisulfite (E 223), water for injections.

What Doxycyclinum TZF looks like and what the packaging contains

A clear solution with a yellow to amber color.
Packaging: 10 ampoules of 5 ml in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals:

• Method of administrationDoxycycline is administered slowly, exclusively as an intravenous infusion. The infusion should last from 1 to 4 hours (not less than 1 hour and not more than 12 hours). Doxycycline solutions should be protected from light.
• Preparation of the infusion solutionThe basic solution - the contents of the ampoule should be diluted with water for injections to 10 ml.

Infusion solution - 10 ml of the basic solution should be diluted in 100 to 1000 ml of 0.9% sodium chloride solution or 5% glucose solution.
The resulting solution containing 0.1 to 1 mg of doxycycline per 1 ml should be prepared immediately before use.
The solution should be protected from light.
Diluted doxycycline solutions should not be stored.

• IncompatibilitiesThe doxycycline infusion solution has an acidic pH, which is why it exhibits physicochemical incompatibilities with alkaline products and medicines that are unstable at low pH, e.g., aminophylline, hydrocortisone, erythromycin, vitamin B complex, warfarin, and some sulfonamides.