DOXYCYCLINUM 100 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. DOXYCYCLINUM TZF, 100 mg, Hard Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Doxycyclinum TZF and what is it used for
   1. Indications for Use
4. Important Information Before Taking Doxycyclinum TZF
   1. When Not to Take Doxycyclinum TZF
   2. Warnings and Precautions
   3. Use in Patients with Renal and/or Hepatic Impairment
   4. Doxycyclinum TZF and Other Medicines
   5. Doxycyclinum TZF with Food, Drinks, or Alcohol
   6. Pregnancy and Breastfeeding
   7. Driving and Using Machines
   8. Doxycyclinum TZF Contains Lactose
   9. Doxycyclinum TZF Contains Sodium
5. How to Take Doxycyclinum TZF
   1. Recommended Dosage
   2. Adults with a Body Weight up to 70 kg and Children Aged 12 to 18 Years
   3. Adults with a Body Weight over 70 kg
   4. Recommended Dosage for Certain Disease Units
   5. Dosage for Malaria Prophylaxis
   6. Dosage in the Elderly
   7. Children Aged 8 to 12 Years
   8. Children Under 8 Years
   9. Treatment Duration
   10. Method of Administration
   11. Use of a Higher Than Recommended Dose of Doxycyclinum TZF
   12. Missing a Dose of Doxycyclinum TZF
6. Possible Side Effects
   1. If You Experience Any of the Following Side Effects, Stop Taking the Medicine and Immediately Consult Your Doctor or Go to the Emergency Department of the Nearest Hospital.
   2. If You Experience Any of the Following Side Effects, Consult Your Doctor as Soon as Possible.
   3. Other Side Effects That May Occur During Treatment with the Medicine
   4. Reporting Side Effects
7. How to Store Doxycyclinum TZF
8. Contents of the Pack and Other Information
   1. What Doxycyclinum TZF Contains
   2. What Doxycyclinum TZF Looks Like and What the Pack Contains
   3. Marketing Authorization Holder and Manufacturer
   4. Date of the Last Update of the Leaflet:

Package Leaflet: Information for the Patient

DOXYCYCLINUM TZF, 100 mg, Hard Capsules

Doxycyclinum

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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Doxycyclinum TZF and what is it 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 is Doxycyclinum TZF and what is it 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 passes through the placental barrier and into human milk.
It is excreted in the urine and feces.

Indications for Use

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

• Infections of the upper and lower respiratory tract - tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, pneumonia.
• Urinary tract infections - pyelonephritis, cystitis, urethritis.
• Sexually transmitted diseases: infections caused by Chlamydia, syphilis, soft chancre, lymphogranuloma venereum, gonorrhea.
• Some soft tissue infections.
• Gastrointestinal tract infections.
• Ophthalmic infections - resulting from infections caused by staphylococci and gonococcal diplococci, Haemophilus influenzae, chronic conjunctivitis called trachoma.
• Other infections - psittacosis, brucellosis (in combination with streptomycin), plague, tularemia.
• Lyme disease.

Prophylactically

• Malaria.

2. Important Information Before Taking Doxycyclinum TZF

When Not to Take Doxycyclinum TZF

• In patients allergic to doxycycline or other tetracycline antibiotics or

any of the other ingredients of this medicine (listed in section 6).

• In patients with severe liver failure.
• During tooth development, due to the possibility of permanent tooth discoloration.
• In pregnant women.
• In breastfeeding women.

Warnings and Precautions

Before starting Doxycyclinum TZF, discuss it with your doctor.
Patients who have had hypersensitivity reactions to antibiotics or other allergens in the past should inform their doctor before taking Doxycyclinum TZF.
Doxycycline should not be used during tooth development (second half of pregnancy, neonatal period, infant period, children under 8 years), as it may cause permanent tooth discoloration (yellow-gray-brown) or disrupt normal tooth growth.
However, in some cases (e.g., severe or life-threatening conditions), the doctor may recommend giving doxycycline to children under 8 years of age, if the potential benefits of its use outweigh the risk of these disorders.
Tetracyclines, including doxycycline, can cause hypersensitivity to light. During treatment, you should avoid sunbathing or artificial UV radiation (e.g., solarium) due to the possibility of light-induced skin diseases (photodermatosis), manifesting as, for example, skin redness, swelling, blisters. If such symptoms occur, the medicine should be discontinued and a doctor consulted.
During doxycycline treatment, an overgrowth of non-antibiotic-sensitive microorganisms may occur. If symptoms indicating the development of another infection occur, e.g., thrush (persistent itching, skin redness), you should contact your doctor.
Doxycycline, like other broad-spectrum antibacterial antibiotics (e.g., macrolides, semi-synthetic penicillins, cephalosporins), may occasionally cause pseudomembranous colitis. The disruption of normal bacterial flora in the intestines allows the multiplication of Clostridium difficile, whose toxins cause clinical symptoms of pseudomembranous colitis.
Therefore, patients who develop diarrhea during antibiotic treatment or soon after its discontinuation should not self-medicate, but consult a doctor. In case of pseudomembranous colitis, it is necessary to discontinue the medicine and apply appropriate treatment. In milder cases, it is usually sufficient to discontinue the medicine, while in more severe cases, metronidazole or vancomycin is administered orally. It is contraindicated to administer drugs that inhibit intestinal peristalsis or have a constipating effect.
Patients with venereal diseases and suspected concurrent syphilis before, during, and after treatment should have their doctor order appropriate tests to confirm possible infection and cure.
Patients with liver dysfunction should inform their doctor.
Patients with myasthenia, systemic lupus erythematosus, or porphyria should inform their doctor about these conditions before taking the medicine, as doxycycline may exacerbate the symptoms of the disease.
In patients with severe renal impairment, the excretion of doxycycline by the kidneys may decrease.
After the use of tetracycline antibiotics, a bulging fontanelle may occasionally occur in infants, as well as mild intracranial hypertension in children and adults. These symptoms disappear after discontinuation of treatment.
In patients taking tetracycline tablets or capsules (including doxycycline), esophageal inflammation and ulceration have occasionally occurred. In most cases, patients took the medicine without lying down or with a small amount of liquid.
You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.
It is recommended to consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Use in Patients with Renal and/or Hepatic Impairment

Patients with liver dysfunction or taking medications that may damage the liver should inform their doctor before taking Doxycyclinum TZF. In these patients, the doctor will determine the dosage individually and, if necessary, recommend periodic liver function tests.
In patients with renal impairment, a dose adjustment is not necessary.
In each case, the doctor decides on the dosage of the medicine in patients with renal or hepatic impairment.

Doxycyclinum TZF and Other Medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Antacids containing multivalent ions of aluminum, calcium (including milk, dairy products, and 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 an interval of at least 2 hours from the intake of doxycycline.
Methoxyflurane (a medicine used for general anesthesia). If you need to undergo general anesthesia, you should inform your doctor that you are taking Doxycyclinum TZF capsules.
Anticoagulant medicines derived from coumarin. When taking these medicines with doxycycline, your doctor should recommend monitoring the parameters of blood coagulation function - it may be necessary to reduce the doses of these medicines.
Oral anti-diabetic medicines derived from sulfonylurea. When taking these medicines with doxycycline, your doctor should recommend monitoring the glucose concentration in the serum - it may be necessary to reduce the doses of these medicines.
Cyclosporine (a medicine that weakens the immune system, used, among others, after organ transplantation or in psoriasis). If it is necessary to use both medicines simultaneously, your doctor will recommend monitoring the cyclosporine concentration in the serum.
Penicillin and other bactericidal antibiotics.
Hormonal contraceptives - doxycycline reduces their effectiveness. During doxycycline treatment, it is recommended to use additional non-hormonal contraceptive methods.
Such medicines as barbiturates (e.g., phenobarbital), carbamazepine, phenytoin, primidone, rifampicin, may weaken the effect of doxycycline. In patients taking these medicines, the doctor should consider possible increased daily doses of doxycycline.
Theophylline may increase the frequency of gastrointestinal side effects. If you need to take theophylline and doxycycline, the time between taking both medicines should be as long as possible.
Doxycycline may interfere with the results of urine tests for catecholamines.

Doxycyclinum TZF with Food, Drinks, or Alcohol

Alcohol may weaken the effect of doxycycline.
Foods containing calcium, such as milk and its products, fruit juices enriched with calcium, should be consumed at least 2 hours before taking Doxycyclinum TZF capsules or 2 hours after their administration.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
The medicine should not be used in pregnant women.
Doxycycline passes into human milk. During doxycycline treatment, breastfeeding should be discontinued.

Driving and Using Machines

During treatment, transient vision disturbances may occur, which may affect safety during driving.

Doxycyclinum TZF Contains Lactose

The medicine contains 100 mg of lactose per capsule. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Doxycyclinum TZF Contains Sodium

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

3. How to Take Doxycyclinum TZF

Doxycyclinum TZF should be taken as directed by your doctor, who will determine the dose based on the type of infection and the patient's overall condition.
If taking doxycycline in capsule form is not possible, the doctor may recommend this antibiotic in the form of tablets for preparing an oral suspension or for intravenous administration.

Recommended Dosage

Adults with a Body Weight up to 70 kg and Children Aged 12 to 18 Years

On the first day, 2 capsules (200 mg of doxycycline) are administered in a single dose or in 2 divided doses - 1 capsule (100 mg) every 12 hours, and then a maintenance dose - 1 capsule per day.
In severe infections, 2 capsules (200 mg) are administered per day throughout the treatment period.
The treatment duration depends on the severity of the infection.

Adults with a Body Weight over 70 kg

Usually, 2 capsules (200 mg of doxycycline) are administered per day throughout the treatment period.

Recommended Dosage for Certain Disease Units

• Uncomplicated gonorrhea: 1 capsule (100 mg of doxycycline) 2 times a day (every 12 hours) for at least 7 days. The results of gonorrhea treatment should be confirmed by a control culture 3 to 4 days after the end of treatment.
• Sexually transmitted diseases caused by Chlamydia trachomatis or Ureaplasma urealyticum: 1 capsule (100 mg of doxycycline) 2 times a day (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 of doxycycline) per day in divided doses for 2 weeks.
• Lyme disease: 1 capsule (100 mg of doxycycline) 2 times a day (every 12 hours) for 14 to 28 days, in the early stage of the disease for 14 to 21 days.

Dosage for Malaria Prophylaxis

1 capsule (100 mg of doxycycline) is administered per day. Prophylaxis should be started 1 to 2 days before the planned trip to malaria-endemic areas. Doxycycline should be administered throughout the stay in the endangered area and for another 4 weeks after the end of the stay in malaria-endemic areas.

Dosage in the Elderly

A dose adjustment is not necessary. However, it should be remembered that these patients are more susceptible to gastrointestinal side effects, so they should strictly follow the recommendations described below in the "Method of Administration" section.

Children Aged 8 to 12 Years

Doxycycline may be administered in the treatment of severe infections in children aged 8 to 12 years only in situations where other medicines are not available, and the available medicines are likely to be ineffective or are contraindicated.
In such cases, the doxycycline dosage 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, a dose of 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

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 is always determined by the doctor. The antibiotic should usually be administered for another 24 to 48 hours after the symptoms have subsided.
In the treatment of infections caused by beta-hemolytic streptococci group A, capsules should be taken for at least 10 days.

Method of Administration

Capsules should be swallowed whole, washed down with a glass of water.
To avoid possible irritation of the throat or intestines, capsules should be taken sitting or standing, at least 30 minutes before bedtime (it is essential that the patient does not remain in a lying position immediately after taking the capsule).
Patients who experience persistent gastrointestinal side effects may have their doctor recommend taking the medicine during meals.
Concomitant administration of doxycycline with meals reduces the occurrence of gastrointestinal side effects and does not significantly affect its absorption.

Use of a Higher Than Recommended Dose of Doxycyclinum TZF

Symptoms of doxycycline overdose are: fever, facial redness, dizziness, and occasionally fainting. If the above symptoms occur, the medicine should be discontinued immediately, and a doctor consulted. In conscious patients, vomiting can be induced or antacids or calcium and magnesium salts can be administered.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.

Missing a Dose of Doxycyclinum TZF

In case of missing a dose of the medicine at a fixed, specified time, the medicine should be taken as soon as possible, if the time to administer the next dose is long enough, or continue regular administration of the medicine.
Do not take a double dose to make up for a missed dose.

4. Possible Side Effects

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

If You Experience Any of the Following Side Effects, Stop Taking the Medicine and Immediately Consult Your 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):
Increase in intracranial pressure, which manifests as headache, vision disturbances (blind spots, double vision).
Severe side effects that occur with an unknown frequency (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 rash, which can be accompanied by the formation of ulcers in the mouth, eyes, genitals, and skin, bursting giant blisters, exfoliation of large skin flakes, weakness, fever, and joint pain, increased heart rate, anaphylactic shock manifesting as confusion, paleness, blood pressure drop, sweating, production of a small amount of urine, rapid breathing, weakness, and fainting.
Skin hypersensitivity to UV radiation (sun, solarium).
Severe diarrhea, lasting for a longer period or containing blood, accompanied by abdominal pain or fever. It may be a symptom of severe small or large intestine inflammation (called pseudomembranous colitis). These symptoms may occur after taking antibiotics, even 2 to 3 months after the end of treatment.

If You Experience Any of the Following Side Effects, Consult Your Doctor as Soon as Possible.

• Pancreatitis (observed rarely);
• Hepatitis, jaundice (observed with an unknown frequency);
• 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 can manifest as fatigue, bleeding, increased susceptibility to bruising and infections (observed with an unknown frequency);
• Jarisch-Herxheimer reaction, causing fever, chills, headaches, muscle pain, and skin rash, which usually resolves on its own. It occurs soon after starting doxycycline treatment for spirochetal infections, e.g., Lyme disease (observed with an unknown frequency);
• Detachment of the nail plate from the bed caused by light (observed with an unknown frequency).

Other Side Effects That May Occur During Treatment with the Medicine

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

• Disorders of hem synthesis (porphyria);

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

• Observed bulging fontanelle in infants and mild intracranial hypertension in children and adults after administration of therapeutic doses. Symptoms of intracranial hypertension include, among others, vision disturbances (e.g., blind spots, double vision). Cases of permanent vision loss have been reported.

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

• Inflammatory conditions of the genital and anal areas, inflammation of the oral mucosa and tongue, vaginal inflammation;
• During long-term administration of tetracycline, brown-black discoloration of the thyroid has been observed, without affecting its function;
• Headache, dizziness, sudden facial redness;
• Tinnitus;
• Lack of appetite, nausea, vomiting, diarrhea, abdominal pain, tongue inflammation, difficulty swallowing, esophageal inflammation and ulceration, intestinal inflammation, inflammatory changes in the anal area. These symptoms are usually mild and disappear after discontinuation of the medicine. Tooth discoloration and/or lack of tooth growth (see section 2).
• Transient, slight increase in liver enzyme activity; liver dysfunction;
• Joint pain, muscle pain, disorders of tooth development, tooth discoloration;
• Increased urea concentration in the blood;
• Malaise.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please tell your 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, you can help provide more information on the safety of the medicine.

5. How to Store Doxycyclinum TZF

The medicine should be stored in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging.
Store at a temperature below 25°C. Protect from light.

6. Contents of the Pack and Other Information

What Doxycyclinum TZF Contains

The active substance of the medicine is doxycycline in the form of hyclate.
One hard capsule contains 100 mg of doxycycline.
Excipients: alginic acid, magnesium stearate, sodium lauryl sulfate, cornstarch, lactose monohydrate (100 mg); capsule ingredients: indigo dye, titanium dioxide, yellow iron oxide, gelatin

What Doxycyclinum TZF Looks Like and What the Pack Contains

10 dark green capsules in a cardboard box.

Marketing Authorization Holder and Manufacturer

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

Date of the Last Update of the Leaflet: