Hexaniacin 60 capsules

What Doxycycline TZF is and what it is used for

Doxycycline TZF contains doxycycline as an active substance - an antibiotic belonging to the class of tetracycline antibiotics. Doxycycline inhibits the growth of many microorganisms (bacteria and protozoa).

Therapeutic indications

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

infections of the upper and lower respiratory tract (eg tonsillitis, pharyngitis, otitis, sinusitis, bronchitis, pneumonia);

urinary tract infections - cystitis;

sexually transmitted diseases - uncomplicated urethritis, inflammatory conditions in the small pelvis;

gastrointestinal infections, including salmonella, traveler's diarrhea, cholera, purpura (amoebiasis);

skin and soft tissue infections, including severe forms of acne vulgaris, caused by microorganisms sensitive to doxycycline.

2. What you need to know before you use Doxycycline TZF

Do not use Doxycycline TZF

if you are allergic (hypersensitive) to doxycycline, other tetracyclines or to any of the other ingredients of this medicine (listed in section 6);

if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor if you have:

impaired kidney function;

impaired liver function;

myasthenia gravis (a disease characterized by excessive fatigue and weakening of the skeletal muscles);

systemic lupus erythematosus (an allergic disease characterized by arthralgia, skin rash, fever);

porphyria (a rare disease related to blood pigment).

In diseases where syphilis co-infection is suspected, your doctor will recommend that you undergo appropriate tests before starting treatment.

Doxycycline should not be used during tooth development (second half of pregnancy, in infants and children under 8 years of age), as it may cause permanent staining of the teeth (yellow-gray-brown) or disrupt normal growth on the teeth. However, in some cases (for example, severe or life-threatening conditions), a doctor may recommend doxycycline to children under 8 years of age if the potential benefits outweigh the risk of these disorders.

Tetracyclines, including doxycycline, can cause photosensitivity. During treatment, you should avoid exposure to sunlight or artificial UV light (eg tanning beds) as you may develop a light allergy, which manifests as skin redness, swelling and blisters. If such symptoms occur, immediately stop taking the drug and inform your doctor.

As with other antibiotics, overgrowth of non-susceptible microorganisms may occur during the use of doxycycline. If you have symptoms suggesting e.g. mycosis (persistent itching, reddening of the skin), inform your doctor.

If persistent diarrhea occurs during or after treatment with Doxycycline TZF, tell your doctor. This may be a symptom of enterocolitis, which is a complication of antibiotic use. If this happens, you should stop taking the medicine and sometimes you will need to get appropriate treatment. Drugs that slow down peristalsis or other drugs with a constipating effect should not be administered.

Bombarded fontanelles in infants and benign intracranial hypertension (increased intracranial pressure) have been reported in children and adults after receiving therapeutic doses. These symptoms quickly resolve when treatment is discontinued.

Other drugs and Doxycycline TZF

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular, you should tell your doctor if you use:

warfarin or other oral anticoagulants (medicines to prevent blood clots);

cyclosporine (a medicine used, among others, after a transplant);

methotrexate (used to treat joint inflammation);

penicillin or other penicillin antibiotics;

hypnotics;

rifampicin (a medicine used to treat tuberculosis); carbamazepine, diphenylhydantoin (medicines used to treat epilepsy).

Oral contraceptives

Doxycycline TZF may reduce their effectiveness, therefore it is recommended to use additional non-hormonal methods of contraception while taking this medicine and for 7 days after the end of treatment.

Doxycycline TZF with food, drink, and alcohol

The use of alcohol during treatment with Doxycycline TZF may reduce the effect of the drug.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

If you are pregnant and think you may be pregnant

This medicine should not be used during pregnancy.

If you are breastfeeding

Doxycycline is excreted in breast milk. Breast-feeding should be discontinued for the duration of doxycycline treatment.

Driving and using machines

Doxycycline TZF is unlikely to affect your ability to drive or use machines. However, it can sometimes cause dizziness, blurred or double vision. Therefore, you should be sure how you react to the medicine, whether you drive or operate machinery.

Doxycycline TZF contains sodium metabisulphite (E 223)

Therefore, in rare cases it can cause severe hypersensitivity reactions and bronchospasm.

3. How to use Doxycycline TZF

Always use this medicine exactly as your doctor has told you. If you are not sure about something, ask your doctor.

This medicine is given by intravenous infusion.

Recommended dose

Adults and children aged 12 to 18 years

On the first day of treatment, 200 mg doxycycline (2 ampoules) is administered as a single dose or divided into 2 doses -100 mg every 12 hours, followed by a maintenance dose of 100 mg/day. For severe infections, 200 mg daily should be administered throughout the treatment period. The duration of treatment depends on the severity of the infection.

Children between the ages of 8 and 12

For the treatment of severe infections in children aged 8 to 12 years, doxycycline can only be used in situations where other medicines are not available and the medicines available are unlikely to be effective or are contraindicated. In such cases, the doses of doxycycline are as follows:

In children weighing 45 kg or less

Initial dose (first day of treatment): 4.4 mg/kg (as a single dose or divided into two doses), followed by a dose of 2.2 mg/kg (as a single dose or divided into two doses) from the second day of treatment . The duration of treatment depends on the severity of the infection.

To control more severe infections, doses up to 4.4 mg/kg should be administered throughout the treatment period.

Children weighing more than 45 kg - adult doses should be used.

200 mg on the first day and then 100 mg daily. The duration of treatment depends on the severity of the infection.

Children up to 8 years old

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

Duration of treatment

The duration of treatment depends on the severity and type of infection. The doctor will determine the correct duration of treatment and you should follow his/her instructions.

Instructions for the preparation and administration of Doxycycline TZF are given at the end of this leaflet, in the section "Information intended for medical professionals only".

If you have taken more than the required dose of Doxycycline TZF

Overdose symptoms include fever, facial flushing, dizziness, sometimes collapse (loss of consciousness).

This medicine is given by a doctor or nurse, so an overdose is unlikely. However, if you think that the dose given is too high, tell the doctor immediately or go to the nearest emergency department.

Take the medicine in the original packaging with you so that the medical staff can check exactly which medicine has been used.

If you forget to use Doxycycline TZF

Do not take a double dose to make up for a missed dose.

If you have stopped using Doxycycline TZF

It is important to take the medication in accordance with the recommended treatment cycle. Do not stop treatment even if you feel better. If the treatment cycle is interrupted prematurely, the infection may recur.

If you feel worse during treatment or if you do not feel better after taking the recommended course of treatment, talk to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the side effects listed below, stop taking this medicine and tell your doctor immediately or go to the nearest emergency department. Severe, very rare side effects (affects 1 to 10 patients in 10,000): Increased intracranial pressure manifested by headache, visual disturbances (scotomas (partial change or loss of visual acuity), double vision).

Serious side effects have been reported with an unknown frequency (from the available data it cannot be

be assessed):

Allergic reactions such as rash, sudden shortness of breath and tightness in the chest, swelling of the eyelids, face or lips, severe skin rashes that may be associated with erosions in the mouth, eyes, genitals and skin, large burst blisters, large areas of peeling on the epidermis, weakness, fever and joint pains; rapid heart rate, anaphylactic shock manifested by confusion, pallor of the skin, a sharp decrease in

blood pressure, sweating, passing a small amount of urine, rapid breathing, tiredness and fatigue and fainting.

Skin sensitivity to UV rays (

Severe diarrhea that lasts a long time or diarrhea with blood, abdominal pain or fever. This may be a sign of serious inflammation of the small or large intestine (called pseudomembranous enterocolitis). These symptoms can occur with antibiotics, even 2 to 3 months after the end of treatment.

Contact your doctor immediately if you experience any of the following side effects:

hepatitis, jaundice (rarely observed);

inflammation of the pancreas (observed very rarely);

anemia caused by the destruction of red blood cells, an increase or decrease in the number of certain types of white or red blood cells and platelets, which may present with fatigue, bleeding, increased susceptibility to infections and an increased risk of bruising (observed with unknown frequency);

Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle aches and skin rash, and which is usually self-limiting. It may appear soon after you start taking doxycycline to treat an infection caused by spirochetes, e.g. Lyme disease (observed with an unknown frequency);

separation of the nails from the nail bed under the influence of light (observed with an unknown frequency).

Other side effects that may occur during treatment with Doxycycline TZF

Rare side effects (affects less than 1 in 10,000 people):

thrombophlebitis.

Very rare side effects (affects 1 to 10 people in 10,000):

fontanelle bombardment in infants and benign intracranial hypertension (increased intracranial pressure manifested by headache) have been observed in children and adults receiving high-dose tetracyclines. These symptoms disappear quickly after stopping the treatment. Complete loss of vision has also been reported.

Adverse reactions with an unknown frequency (frequency cannot be estimated from the available data):

inflammation around the anus and genitals, inflammation of the mouth (mucositis) and tongue (glossitis), inflammation of the vagina (vaginitis);

disorders of hemoglobin synthesis (porphyria);

when administered for a long time, tetracyclines cause a brownish-black discoloration of the thyroid gland, without any effects on thyroid function;

headache;

noise in the ears;

abdominal pain, anorexia, nausea, vomiting, diarrhoea, dyspepsia (indigestion), difficulty swallowing, inflammation and ulceration of the esophagus (oesophagitis). These reactions are usually mild and there is no need to stop treatment. The majority of these side effects occurred during treatment with doxycycline capsules (see section 2. What you need to know before you use Doxycycline TZF).

Tooth discoloration and/or lack of tooth growth.

temporary mild elevation of liver enzymes; impaired liver function

joint pain (arthralgia), muscle pain (myalgia);

tooth staining, enamel hypoplasia may occur in patients taking long-term tetracyclines

increased levels of urea in the blood;

general malaise, pain, irritation, burning at the site of application

5. How to store Doxycycline TZF

Keep out of the reach of children.

Store in the original package in order to protect from light.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date corresponds to the last day of the month stated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What DOXYCYCLINE TZF contains

The active substance is doxycycline (as doxycycline hyclate).

Each 1 ml solution contains 20 mg doxycycline (as doxycycline hyclate).

The other ingredients (excipients) are: povidone K17, ethanolamine, magnesium chloride hexahydrate, sodium metabisulfite (E 223), water for injections.

What Doxycycline TZF looks like and contents of the pack

Clear, yellow to brownish solution for infusion.

Packaging: 10 ampoules of 5 ml, placed in a cardboard box.