Doxiciclinum Polfarmex

Leaflet attached to the packaging: information for the user

DOXYCYCLINUM POLFARMEX, 100 mg, hard capsules

Doxycycline

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 further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The active substance of Doxycyclinum Polfarmex is doxycycline, an antibiotic belonging to the group of tetracyclines. It inhibits the growth of many microorganisms (bacteria and protozoa).

Indications

• - Respiratory tract infections: pneumonia and other lower respiratory tract infections caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniaeand other microorganisms. Pneumonia caused by Mycoplasma pneumoniae.Chronic bronchitis, sinusitis.
• - Urinary tract infections: caused by susceptible strains of Klebsiellaspp., Enterobacterspp., Escherichia coli, Enterococcus faecalisand other microorganisms.
• - Sexually transmitted diseases:including uncomplicated urethral infection, cervical or rectal infections caused by Chlamydia trachomatis,non-gonococcal urethritis caused by Ureaplasma urealyticum, soft chancre (Haemophilus ducreyi),granuloma inguinale (Calymmatobacterium granulomatis).Doxycycline can be used as an alternative antibiotic in the treatment of syphilis and gonorrhea when penicillin cannot be used.
• - Gastrointestinal tract infections:traveler's diarrhea (caused by enteropathogenic strains of Escherichia coli),including acute intestinal amoebiasis (as adjunctive therapy to amoebicides), cholera (Vibrio cholerae).
• - Eye infections: caused by susceptible strains of gonococci, staphylococci, Haemophilus influenzae;trachoma, inclusion conjunctivitis caused by Chlamydia trachomatis.
• - Rickettsioses:Q fever, Rocky Mountain spotted fever, typhus, endocarditis caused by Coxiellaspp., tick-borne diseases.
• - Soft tissue infections: caused by susceptible strains of Clostridiumspp., Propionibacterium acnes.
• -Lyme disease.
• - Other infections:psittacosis (Chlamydia psittaci),brucellosis (Brucellaspp., treated in combination with streptomycin), plague (Yersinia pestis),tularemia (Francisella tularensis),

infections of etiology Pseudomonas pseudomallei,malaria.

• - Leptospirosis, gas gangrene, tetanus:doxycycline is used as an alternative drug.
• - Prevention:of malaria, traveler's diarrhea, leptospirosis.

2. Important information before taking Doxycyclinum Polfarmex

When not to take Doxycyclinum Polfarmex:

• if the patient is hypersensitive (allergic) to doxycycline or other tetracycline antibiotics or any of the other ingredients of this medicine (listed in section 6);
• in infants and children under 12 years of age;
• in pregnant and breastfeeding women.

Doxycycline should not be used during tooth development (pregnancy, infants, and children up to 12 years of age), as it may cause permanent discoloration (yellow-gray-brown) of teeth, disrupt normal tooth development, and affect the skeletal system.

Warnings and precautions

Before starting treatment with this medicine, the patient should inform the doctor if they have:

• liver and/or kidney function disorders;
• porphyria (a rare disease related to disorders of porphyrin metabolism - one of the elements of red blood cells);
• myasthenia gravis (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).

During treatment with Doxycyclinum Polfarmex, the patient should tell the doctor if:

• severe, prolonged diarrhea occurs; antidiarrheal medications or other medications that slow down intestinal motility should not be used;
• symptoms of a new bacterial infection or fungal infection occur (e.g., persistent itching, skin redness), especially during prolonged antibiotic treatment.

In diseases where syphilis is suspected, the doctor will recommend diagnostic tests before starting treatment.
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 risk of photosensitivity, which may manifest as skin redness, swelling, blisters. If such symptoms occur, the medicine should be discontinued immediately and the doctor consulted.
To avoid esophageal inflammation and ulceration, the medicine should be taken at least 30 minutes before bedtime and washed down with a glass of water. See "Method of administration" in section 3.

Doxycyclinum Polfarmex and other medicines

The patient should tell the doctor about all medicines taken recently, including those available without a prescription.
In particular, the doctor should be informed if the patient is taking:
Antacids (containing multivalent ions of aluminum, calcium, magnesium, as well as products containing iron, zinc, or bismuth ions) may reduce the absorption of doxycycline. Therefore, these food or medicinal products should be taken at least 2 to 3 hours after taking doxycycline.
Sedatives (barbiturates); rifampicin (an antitubercular medicine); carbamazepine, phenytoin, primidone, phenobarbital (antiepileptic medicines) or cyclosporine (a medicine used after organ transplantation) may reduce the effectiveness of Doxycyclinum Polfarmex.
Antibiotics from the penicillin group and other antibiotics may reduce the effectiveness of Doxycyclinum Polfarmex.
Cephalosporins may enhance the toxic effects of Doxycyclinum Polfarmex.
Methoxyflurane (a medicine used in general anesthesia) may increase the toxicity of Doxycyclinum Polfarmex and cause severe kidney damage.
Anticoagulants (e.g., warfarin) may enhance the effect of Doxycyclinum Polfarmex.
Oral antidiabetic medicines (sulfonylurea derivatives) may enhance the effect of Doxycyclinum Polfarmex.
Oral contraceptives may reduce the effectiveness of Doxycyclinum Polfarmex, so during treatment with doxycycline, it is recommended to use additional non-hormonal contraceptive methods.
Theophylline (used, e.g., in asthma) may increase the frequency of gastrointestinal side effects when taken with Doxycyclinum Polfarmex.
Doxycyclinum Polfarmex may affect urine catecholamine test results. If the patient is to undergo any tests, they should inform the doctor about taking Doxycyclinum Polfarmex.

Doxycyclinum Polfarmex and alcohol

Consuming alcohol during treatment with Doxycyclinum Polfarmex may reduce the effectiveness of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine should not be used in pregnant or breastfeeding women.

Driving and using machines

In individual cases, transient vision disturbances have been observed, which may affect safety while driving.

Doxycyclinum Polfarmex contains lactose and sodium

The medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means it is considered "sodium-free".

3. How to take Doxycyclinum Polfarmex

This medicine should always be taken exactly as prescribed by the doctor. If you have any doubts, you should ask your doctor or pharmacist.
The medicine is taken orally.
The doctor will determine the appropriate dosage of the medicine, depending on the disease and the patient's condition, as well as current official guidelines for the use of antibacterial medicines. Before starting treatment with doxycycline, a test will be performed to isolate the microorganism causing the infection and its antibiotic susceptibility. Treatment may be initiated before the results of the antibiotic susceptibility test are available.
After receiving the results, it may be necessary to change the medicine.

Recommended dosage for adults and children over 12 years of age

On the first day, 200 mg of doxycycline 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 administered.
In severe infections, 200 mg per day is administered throughout the treatment period.

Recommended dosage for certain infections

Tropical malaria resistant to chloroquine

200 mg per day for at least 7 days. Doxycycline should be administered in combination with quinine.

Lyme disease

100 mg twice a day (every 12 hours) for 14-28 days, in the early stage of the disease for 14-21 days.

Sexually transmitted diseases

Gonococcal uncomplicated infections (except for rectal infections in men); uncomplicated urethral, cervical, or rectal infections caused by Chlamydia trachomatis;non-gonococcal urethritis caused by Ureaplasma urealyticum:100 mg twice a day (every 12 hours) for 7 days.
Acute epididymitis and prostatitis caused by Chlamydia trachomatisor Neisseria gonorrhoeae:100 mg twice a day (every 12 hours) for 10 days.
Primary and secondary syphilis: in patients allergic to penicillin (except for pregnant women), 200 mg twice a day for 2 weeks, as an alternative treatment to penicillin.

Dosage for prevention of infections

Malaria

In adults and children over 12 years of age, 100 mg per day is administered. Prophylaxis should be started 1-2 days before the planned trip to malaria-endemic areas. Doxycycline should be administered throughout the stay in the malaria-endemic area and for 4 weeks after leaving the area. You should consult current guidelines for malaria prevention in the specific geographic region.

Traveler's diarrhea

In adults, 200 mg is administered on the first day of travel (in a single dose or 100 mg twice a day, every 12 hours), and then 100 mg per day during the stay, for no longer than 21 days.

Leptospirosis

200 mg is administered once a week during the stay in the area where leptospirosis occurs (for no longer than 21 days) and once, 200 mg after the trip.

Dosage for children under 12 years of age

The medicine should not be used in children under 12 years of age (see also section 2).

Dosage for elderly patients

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.

Dosage for patients with renal and/or hepatic impairment

In patients with renal impairment, dose adjustment is not necessary.
In patients with hepatic impairment, caution should be exercised. In these patients, especially during prolonged treatment, high doses, or concomitant use of other hepatotoxic medicines, regular monitoring of liver function is recommended.

Duration of treatment

The duration of treatment is always determined by the doctor. The antibiotic is usually administered for 24-48 hours after the symptoms have resolved.
In infections caused by β-hemolytic streptococci group A, treatment usually lasts for at least 10 days.

Method of administration

The capsules should be swallowed whole, washed down with a glass of water.
To prevent possible irritation of the throat or intestines, the capsules should be taken in a sitting or standing position, at least 30 minutes before bedtime (it is essential that the patient does not lie down immediately after taking the capsule).
Patients who experience persistent gastrointestinal side effects may be advised by their doctor to take the medicine with food.
Taking doxycycline with food reduces the occurrence of gastrointestinal side effects and does not significantly affect its absorption.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Use of a higher than recommended dose of Doxycyclinum Polfarmex

Symptoms of doxycycline overdose are: fever, facial redness, dizziness, sometimes fainting. If these symptoms occur, the medicine should be discontinued immediately and the doctor consulted.
In conscious patients, vomiting can be induced or antacids or calcium and magnesium salts can be administered.
In the event of an overdose, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Doxycyclinum Polfarmex

If a dose is missed, it should be taken as soon as remembered, unless it is close to the time of the next dose.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Doxycyclinum Polfarmex

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Immediately contact your doctor if you experience any of the following serious side effects:

• anaphylactic shock - confusion, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting, pericarditis, occurring rarely,
• angioedema - localized swelling, usually in the face or throat, making breathing difficult, rash, itching, drug reaction with eosinophilia (increased number of a certain type of white blood cell) and systemic symptoms, occurring rarely,
• hypersensitivity reactions, hypotension, dyspnea, tachycardia, pericarditis - sharp chest pain, dry cough, and shortness of breath, frequency of occurrence unknown,
• severe skin reactions - rash with blisters all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters that rupture, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, weakness, fever, and joint pain, sometimes with involvement of internal organs (most commonly: liver, kidneys, lungs), frequency of occurrence unknown,
• numerous, watery stools, sometimes with mucus, pus, or blood, fever, crampy abdominal pain, usually below the navel (pseudomembranous colitis due to excessive growth of Clostridium difficile), esophageal ulceration, esophagitis, occurring not very often,
• rarely occurring hypersensitivity to light,
• Jarisch-Herxheimer reaction, causing fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. It occurs shortly after starting treatment with doxycycline for spirochetal infections, e.g., Lyme disease, frequency of occurrence unknown,
• liver damage, sometimes with pancreatitis during prolonged use, occurring rarely.

Other side effects that may occur during treatment with the medicine:

Frequency of occurrence - below
Side effects that occur frequently (in 1 to 10 out of 100 patients taking the medicine):

• loss of appetite, nausea, vomiting, diarrhea, tongue inflammation, difficulty swallowing, small intestine and colon inflammation, inflammatory changes in the anal area;
• rash.

Side effects that occur not very often (in 1 to 10 out of 1,000 patients taking the medicine):

• hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia;
• exfoliative dermatitis.

Side effects that occur rarely (in 1 to 10 out of 10,000 patients taking the medicine):

• bulging fontanelle in infants due to mild increased intracranial pressure; mild increased intracranial pressure also in older children and adults (symptoms of increased intracranial pressure include visual disturbances - blindness, double vision). These may be accompanied by headaches, dizziness;
• visual disturbances such as blindness, double vision;
• hives, tooth development disorders, irreversible tooth discoloration;
• increased blood urea levels;
• photoonycholysis (separation of the nail plate from the nail bed caused by light).

Side effects that occur very rarely (less than 1 in 10,000 patients taking the medicine):

• brown-black discoloration of the thyroid gland after prolonged use (without thyroid function disorders);
• tinnitus.

Side effects whose frequency is unknown (frequency cannot be determined based on available data):

• infections and infestations - during prolonged or repeated antibiotic treatment, local skin or mucous membrane infections with bacteria or fungi insensitive to the medicine may occur, manifesting as anal itching, oral and tongue inflammation, external genital and vaginal inflammation. Also, staphylococcal enteritis and colitis have been observed;
• porphyria;
• symptoms of serous disease, anaphylactoid purpura;
• sudden facial redness;
• abdominal pain,
• symptoms of hepatotoxicity with transient, slight increase in liver aminotransferase activity,
• itching,
• muscle pain, joint pain;
• malaise

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Doxycyclinum Polfarmex

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Doxycyclinum Polfarmex contains

The active substance of the medicine is doxycycline (Doxycyclinum).
1 hard capsule contains 100 mg of doxycycline in the form of doxycycline hyclate.
The other ingredients are: lactose monohydrate, cornstarch, magnesium stearate, sodium lauryl sulfate.
The composition of the capsule shell and body: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

What Doxycyclinum Polfarmex looks like and what the pack contains

A hard capsule, size N 1, consisting of a body and a cap, green in color, without indentations and damage.
The pack contains 10 hard capsules in a blister pack, in a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland (Poland)
phone: 24 357 44 44
fax: 24 357 45 45
email: [email protected]

Date of last revision of the leaflet: