Doxycycline tzf

Package leaflet: Information for the patient

DOXYCYCLINUM TZF, 100 mg, hard capsules
Doxycyclinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

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

Doxycycline is an antibiotic belonging to the tetracycline group. It inhibits the growth of many microorganisms (bacteria and protozoa). It is used in various infections caused by microorganisms sensitive to it.
Doxycycline crosses the placental barrier and is excreted into human milk.
It is eliminated in urine and feces.

Therapeutic indications
Doxycyclinum TZF is indicated for the treatment of the following infections caused by microorganisms sensitive to doxycycline.

Therapeutic uses:

• Infections of the upper and lower respiratory tract – tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, pneumonia.
• Urinary tract infections – pyelonephritis, cystitis, urethritis.
• Sexually transmitted diseases: chlamydial infections, syphilis, chancroid, lymphogranuloma venereum, gonorrhea.
• Certain soft tissue infections.
• Gastrointestinal tract infections.
• Ophthalmic infections – due to infections caused by staphylococci and Neisseria gonorrhoeae, Haemophilus influenzae, chronic conjunctivitis known as trachoma.
• Other infections – psittacosis, brucellosis (in combination with streptomycin), plague, tularemia.
• Lyme disease (Lyme borreliosis).

Prophylactic use:

• Malaria.

2. Important information before using Doxycyclinum TZF

When not to use Doxycyclinum TZF

• In patients allergic to doxycycline or other antibiotics of the tetracycline group, or
  to any of the other components of this medicine (listed in section 6).

• In patients with severe hepatic impairment.

• During tooth development, due to the risk of permanent tooth discoloration.

• In pregnant women.

• In breastfeeding women.

Warnings and precautions
Before starting treatment with Doxycyclinum TZF, discuss this with your doctor.
Patients who have previously experienced hypersensitivity reactions to antibiotics or other allergens should inform their doctor before taking Doxycyclinum TZF.
Doxycycline should not be used during tooth development (second half of pregnancy, neonatal period, infancy, children under 8 years of age), as it may cause permanent tooth discoloration (yellow-gray-brown) or interfere with normal tooth development.
However, in certain cases (e.g. severe or life-threatening conditions), the doctor may decide to prescribe doxycycline to children under 8 years of age if the potential benefits outweigh the risks of these adverse effects.
Tetracyclines, including doxycycline, may cause photosensitivity. During treatment, avoid exposure to sunlight or artificial UV radiation (e.g. sunbeds), due to the risk of light-induced skin disorders (photodermatoses), which may manifest as skin redness, swelling, or blistering. If such symptoms occur, discontinue the medicine immediately and contact your doctor.
During treatment with doxycycline, overgrowth of microorganisms resistant to the antibiotic may occur. If symptoms indicating development of another infection (e.g. fungal infection such as persistent itching, skin redness) appear, contact your doctor.
Doxycycline, like other broad-spectrum antibacterial antibiotics (e.g. macrolides, synthetic penicillins, cephalosporins), may occasionally cause pseudomembranous colitis. Disruption of normal intestinal bacterial flora may allow overgrowth of Clostridium difficile, whose toxins cause clinical symptoms of pseudomembranous colitis. Therefore, patients who develop diarrhoea during or shortly after antibiotic treatment should not self-medicate but should consult a doctor. If pseudomembranous colitis is diagnosed, immediate discontinuation of the antibiotic and initiation of appropriate treatment are required. In mild cases, stopping the antibiotic may be sufficient; in more severe cases, oral metronidazole or vancomycin should be administered. Drugs that inhibit intestinal peristalsis or have constipating effects are contraindicated.
In patients with venereal diseases and suspected concurrent syphilis infection, the doctor should order appropriate tests before starting, during, and after treatment to confirm possible infection and cure.
Patients with liver disease should inform their doctor.
Patients with myasthenia gravis, systemic lupus erythematosus, or porphyria should inform their doctor about these conditions before taking the medicine, as doxycycline may exacerbate symptoms of the disease.
In patients with severe renal impairment, renal excretion of doxycycline may be reduced.
After administration of tetracycline antibiotics, benign intracranial hypertension (pseudotumor cerebri) with bulging fontanelle in infants and mild increased intracranial pressure in children and adults has been reported. These symptoms usually resolve after discontinuation of treatment.
Oesophagitis and oesophageal ulceration have occurred in patients taking tetracycline tablets or capsules (including doxycycline). In most cases, patients had taken the medicine immediately before going to bed or had taken it with insufficient fluid.
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
Use of Doxycyclinum TZF in patients with renal and/or hepatic impairment
Patients with impaired liver function or taking medicines that may damage the liver should inform their doctor before taking Doxycyclinum TZF. The doctor will determine the dosage individually and, if necessary, recommend periodic liver function tests.
In patients with renal impairment, dosage adjustment is not required.
In all cases, the decision on dosage in patients with renal or hepatic impairment is made by the doctor.
Doxycyclinum TZF with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
Medicines that neutralize gastric acid and contain multivalent cations such as aluminium, calcium (including milk, dairy products, and calcium-fortified fruit juices), magnesium, as well as preparations containing iron, zinc, or bismuth ions, reduce the absorption of doxycycline. Such medicines and foods should be taken at least 2 hours apart from doxycycline.
Metoxiflurane (a medicine used for general anaesthesia). If the patient requires general anaesthesia, they should inform the doctor that they are taking Doxycyclinum TZF capsules.
Oral anticoagulants of the coumarin group. When these medicines are used together with doxycycline, the doctor should recommend monitoring of blood coagulation parameters – dose reduction of anticoagulants may be necessary.
Oral antidiabetic sulfonylurea derivatives. When these medicines are used together with doxycycline, the doctor should recommend monitoring of serum glucose levels – dose reduction of antidiabetics may be necessary.
Cyclosporine (an immunosuppressive medicine used, among others, after organ transplantation or in psoriasis). If concomitant use of both medicines is necessary, the doctor will order monitoring of cyclosporine serum levels.
Penicillin and other bactericidal antibiotics.
Hormonal contraceptives – doxycycline reduces their effectiveness. During treatment with doxycycline, use of additional non-hormonal contraceptive methods is recommended.
Medicines such as barbiturates (e.g. phenobarbital), carbamazepine, diphenylhydantoin, phenytoin, primidone, rifampicin, may reduce the effectiveness of doxycycline. In patients taking these medicines, the doctor should consider increasing the daily dose of doxycycline.
Theophylline may increase the frequency of gastrointestinal adverse effects. If a patient must take theophylline and doxycycline, the interval between administration of both medicines should be as long as possible.
Doxycycline may interfere with test results for urinary catecholamines.
Doxycyclinum TZF with food, drink, or alcohol
Alcohol may reduce the effectiveness of doxycycline.
Foods containing calcium, such as milk and dairy products, calcium-fortified fruit juices, should be consumed at least 2 hours before or 2 hours after taking Doxycyclinum TZF capsules.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
This medicine should not be used in pregnant women.
Doxycycline passes into human milk. Breastfeeding should be discontinued during treatment with doxycycline.
Driving and operating machinery
Transient visual disturbances may occur during treatment, which may affect the ability to drive or operate machinery safely.
Doxycyclinum TZF contains lactose
The medicine contains 100 mg of lactose per capsule. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Doxycyclinum TZF contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Doxycyclinum TZF

Do not translate or modify: "Doxycyclinum TZF" → keep as-is.

Doxycyclinum TZF should be used according to the doctor's recommendations, who will determine the dosage depending on the type of infection and the patient's general condition.
If administration of doxycycline in capsule form is not possible, the doctor may recommend this antibiotic in the form of oral suspension tablets or as an intravenous formulation.

Recommended dosage
Adults weighing up to 70 kg and children aged 12 to 18 years
On the first day, 2 capsules (200 mg doxycycline) are administered as a single dose or in 2 divided doses – 1 capsule (100 mg) every 12 hours, followed by a maintenance dose of 1 capsule per day.
In severe infections, 2 capsules (200 mg) per day are administered throughout the treatment period.
The duration of treatment depends on the severity of the infection.

Adults weighing over 70 kg
Usually, 2 capsules (200 mg doxycycline) per day are administered throughout the treatment period.

Recommended dosage in selected diseases

• Uncomplicated gonorrhea: 1 capsule (100 mg doxycycline) twice daily (every 12 hours) for at least 7 days. Treatment outcomes for gonococcal infections should be confirmed by performing a control culture 3 to 4 days after completion of therapy.
• Sexually transmitted diseases caused by Chlamydia trachomatis or Ureaplasma urealyticum: 1 capsule (100 mg doxycycline) twice daily (every 12 hours) for 7 to 10 days.
• Primary and secondary syphilis (in patients allergic to penicillin): 2 to 3 capsules (200 mg to 300 mg doxycycline) per day in divided doses for 2 weeks.
• Lyme disease: 1 capsule (100 mg doxycycline) twice daily (every 12 hours) for 14 to 28 days; in early stages of the disease, for 14 to 21 days.

Dosage for malaria prophylaxis
1 capsule (100 mg doxycycline) per day is recommended. Prophylaxis should begin 1 to 2 days before travel to malaria-endemic areas. Doxycycline should be continued throughout the stay in the endemic area and for 4 weeks after leaving such areas.

Dosage in elderly patients
Dosage adjustment is not necessary. However, elderly patients are more susceptible to gastrointestinal adverse effects; therefore, they should strictly follow the administration instructions described below under "Method of administration".

Children aged 8 to 12 years
Doxycycline may be used in the treatment of severe infections in children aged 8 to 12 years only when alternative drugs are unavailable or are likely to be ineffective or contraindicated.

In such cases, the doxycycline dosage is as follows:
Children weighing 45 kg or less:
Initial dose (first day of treatment): 4.4 mg/kg body weight (as a single dose or in 2 divided doses), followed from the second day of treatment by 2.2 mg/kg body weight (as a single dose or in 2 divided doses). The duration of treatment depends on the severity of the infection.
For treatment of more severe infections, up to 4.4 mg/kg body weight should be administered throughout the treatment period.

Children weighing over 45 kg: dosage should be as in adults – 200 mg on the first day, followed by 100 mg per day. The duration of treatment 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).

Duration of treatment
The duration of treatment is always determined by the physician. The antibiotic should usually be continued for an additional 24 to 48 hours after symptoms have resolved.
In the treatment of infections caused by group A beta-hemolytic streptococci, capsules should be taken for at least 10 days.

Method of administration
Capsules should be swallowed whole with a glass of water.
To prevent possible irritation of the throat or intestines, capsules should be taken while sitting or standing, at least 30 minutes before bedtime (it is important that the patient does not remain in a lying position immediately after taking the capsule).
If persistent gastrointestinal adverse effects occur, the doctor may recommend taking the medication with food.
Concomitant intake of doxycycline with food reduces gastrointestinal adverse effects and does not significantly affect its absorption.

Administration of a higher than recommended dose of Doxycyclinum TZF
Symptoms of doxycycline overdose include fever, facial flushing, dizziness, and occasionally circulatory collapse. If these symptoms occur, the drug should be discontinued immediately and medical advice should be sought. In conscious patients, vomiting may be induced or agents that neutralize gastric acid or calcium and magnesium salts may be administered.
In case of ingestion of a higher than recommended dose of the drug, medical advice should be sought immediately.

Missed dose of Doxycyclinum TZF
If a dose is missed at the usual scheduled time, the drug should be taken as soon as possible, provided there is sufficient time before the next dose, or regular dosing should be continued.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the medicine immediately
and contact your doctor or go to the nearest hospital emergency department without delay.
Severe adverse reactions occurring very rarely (occur in 1 to 10 people per 10,000):
Increased intracranial pressure, which manifests as headache and visual disturbances (e.g. spots in vision, double vision).

Severe adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
Allergic reactions such as skin rashes, sudden shortness of breath and chest tightness, swelling of the eyelids, face or lips, severe skin rashes which may be associated with development of erosions in the mouth, eyes, genital organs and on the skin, formation of large blisters, peeling of large areas of the epidermis, weakness, fever and joint pain, increased heart rate, anaphylactic shock presenting as confusion, pale skin, drop in blood pressure, sweating, reduced urine output, rapid breathing, weakness and fainting.
Skin sensitivity to UV radiation (sunlight, sunbeds).
Severe diarrhoea, persistent over a long period or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe inflammation of the small or large intestine (called pseudomembranous colitis). These symptoms may occur after antibiotic use, even 2 to 3 months after completion of treatment.
If any of the following adverse reactions occur, contact your doctor as soon as possible:

• Pancreatitis (observed rarely);
• Hepatitis, jaundice (observed with unknown frequency);
• Anaemia caused by breakdown of red blood cells, increase or decrease in the number of certain types of white or red blood cells and platelets, which may manifest as fatigue, bleeding, increased tendency to bruising and infections (observed with unknown frequency);
• Jarisch-Herxheimer reaction, causing fever, chills, headache, muscle pain and skin rash, which usually resolves spontaneously. This occurs shortly after starting doxycycline treatment for spirochetal infections, e.g. Lyme disease (observed with unknown frequency);
• Light-induced separation of the nail plate from the nail bed (observed with unknown frequency).

Other adverse reactions that may occur during treatment with this medicine
Adverse reactions occurring rarely (occur in less than 1 person per 10,000):

• Disorders of haem synthesis (porphyria);

Adverse reactions occurring very rarely (occur in 1 to 10 people per 10,000):

• Bulging of the fontanelle in infants and benign intracranial hypertension in children and adults after therapeutic doses have been administered. Symptoms of increased intracranial pressure include, among others, visual disturbances (e.g. spots in vision, double vision). Cases of permanent vision loss have been reported.

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

• Inflammation in the genital and anal areas, inflammation of the oral mucosa and tongue, vaginal inflammation;
• During long-term administration of tetracyclines, brown-black discoloration of the thyroid gland has been observed, without affecting its function;
• Headache, dizziness, sudden flushing of the face;
• Tinnitus;
• Loss of appetite, nausea, vomiting, diarrhoea, abdominal pain, glossitis, difficulty swallowing, oesophagitis and oesophageal ulceration, enteritis, inflammatory changes around the anus. These symptoms are usually mild and resolve after discontinuation of the medicine. Tooth discoloration and/or lack of tooth development (see section 2).
• Transient, slight increase in liver enzyme activity; liver function disorders;
• Joint pain, muscle pain, disturbances in tooth development, enamel discoloration;
• Increased blood urea concentration;
• Malaise.

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 authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Doxycyclinum TZF

Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the packaging.
Store below 25 °C. Protect from light.

6. Contents of the packaging and other information

What Doxycyclinum TZF contains
The active substance is doxycycline in the form of hyclate.
Each hard capsule contains 100 mg of doxycycline.
Excipients: alginic acid, magnesium stearate, sodium lauryl sulfate, maize starch, monohydrate lactose (100 mg); capsule shell components: indigo carmine, titanium dioxide, yellow iron oxide, gelatin.

What Doxycyclinum TZF looks like and contents of the pack
10 dark green capsules in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22-811-18-14
For further information on this medicinal product, please contact the Marketing Authorisation Holder.