Doxycycline genoptim

Patient Information Leaflet

Doxycycline Genoptim
100 mg, hard capsules
Doxycyclinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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.
• It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Doxycycline Genoptim is and what it is used for

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

Therapeutic Indications

Doxycycline Genoptim is indicated for the treatment of the following infections caused by microorganisms sensitive to doxycycline.

Therapeutic use:

• 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 trachomatis, syphilis, chancroid, granuloma inguinale, gonorrhoea.
• Certain soft tissue infections.
• Gastrointestinal tract infections.
• Ophthalmic infections – infections caused by staphylococci and Neisseria gonorrhoeae, Haemophilus influenzae, and chronic conjunctivitis known as trachoma. These infections may be treated with doxycycline alone or in combination with locally acting medicines.
• Lyme disease (Lyme borreliosis).
• Other infections – psittacosis, brucellosis (in combination with streptomycin), plague, tularemia.

Prophylactic use:

• Malaria.

2. Important information before using Doxycycline Genoptim

When not to use Doxycycline Genoptim:

• in patients allergic to doxycycline or other tetracycline antibiotics, or to any of the other components of this medicine (listed in section 6).
• in pregnant women or women planning to become pregnant.
• in breastfeeding women.

Do not use Doxycycline Genoptim during tooth development (pregnancy, neonatal period, or in children under 8 years of age), as treatment may cause permanent tooth discoloration (yellow-gray-brown) or impair normal tooth development.
There may be circumstances (e.g. severe or life-threatening conditions) in which a doctor may prescribe Doxycycline Genoptim to a child under 8 years of age, considering that the expected benefits outweigh the risks of treatment.

Warnings and precautions
Before starting treatment with Doxycycline Genoptim, discuss this with your doctor.

• Patients who have previously experienced hypersensitivity reactions to antibiotics or other allergens should inform their doctor before taking Doxycycline Genoptim.
• Doxycycline used during tooth development (third trimester of pregnancy, perinatal period, early childhood) may cause tooth discoloration and damage.
• Tetracyclines, including doxycycline, may cause photosensitivity. During treatment, avoid sun exposure 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 antibiotic-resistant microorganisms may occur. If symptoms indicating development of another infection appear (e.g. persistent itching, skin redness), 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 Clostridioides difficile, whose toxins cause clinical symptoms of pseudomembranous colitis. Therefore, patients who develop diarrhoea during or shortly after antibiotic treatment should not self-treat but should consult a doctor. If pseudomembranous colitis is diagnosed, immediate discontinuation of the medicine and appropriate treatment are required. In mild cases, discontinuation of the antibiotic is usually sufficient; in severe cases, oral metronidazole or vancomycin should be administered. Medicines 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, during, and after treatment to confirm possible infection and cure.
• In some patients infected with spirochetes, a Jarisch-Herxheimer reaction (see section 4) may occur shortly after starting doxycycline treatment. This is usually a self-limiting consequence of antibiotic treatment for spirochetal infections.
• Patients with liver impairment 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, doxycycline excretion via the kidneys may be reduced.
• After using tetracycline antibiotics, bulging fontanelles in infants and benign intracranial hypertension in children and adults have occasionally been reported. These symptoms resolve after discontinuation of treatment.
• Oesophagitis and oesophageal ulceration have been reported in some patients taking tetracycline tablets or capsules (including doxycycline). In most cases, patients had taken the medicine immediately before going to bed or had insufficient fluid when swallowing the dose.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

Use of Doxycycline Genoptim in patients with renal and/or hepatic impairment
Patients with impaired liver function or those taking medicines that may damage the liver should inform their doctor before taking Doxycycline Genoptim. The doctor will determine an individual dosage and, if necessary, recommend periodic liver function tests. Dosage adjustment is not required in patients with renal impairment.
In all cases, the decision on dosage in patients with renal or hepatic impairment is made by the doctor.

Doxycycline Genoptim and 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.
• Metoxyflurane (a medicine used for general anaesthesia). If a patient requires general anaesthesia, they should inform the doctor that they are taking Doxycycline Genoptim capsules.
• Oral anticoagulants of the coumarin group. When these medicines are used concomitantly 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 concomitantly with doxycycline, the doctor should recommend monitoring 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 should order monitoring of cyclosporine serum levels.
• Penicillin and other bactericidal antibiotics.
• Hormonal contraceptives – doxycycline reduces their effectiveness. During treatment with doxycycline, it is recommended to use additional non-hormonal contraceptive methods.
• Medicines such as barbiturates (e.g. phenobarbital), carbamazepine, diphenylhydantoin, phenytoin, primidone, and 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 taking both medicines should be as long as possible.
• Doxycycline may interfere with tests detecting catecholamines in urine.

Doxycycline Genoptim with food, drink, or alcohol
Alcohol may reduce the effectiveness of doxycycline.
Foods containing calcium, such as milk and dairy products, or calcium-fortified fruit juices, should be consumed at least 2 hours before or 2 hours after taking Doxycycline Genoptim capsules.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Doxycycline Genoptim during pregnancy. Tetracycline antibiotics cross the placenta and deposit in fetal tissues. Use of tetracycline antibiotics during tooth development (third trimester of pregnancy, perinatal period, early childhood) may cause permanent tooth discoloration and enamel damage.

Breastfeeding
Doxycycline passes into human milk. Breastfeeding should be discontinued during treatment with doxycycline due to the risk of causing permanent photosensitivity reactions or candidiasis in infants, as well as adverse effects on bone and tooth development.

Driving and operating machinery
Transient visual disturbances may occur during treatment, which could affect the ability to drive or operate machinery safely.

Doxycycline Genoptim contains sunset yellow and sodium
This medicine contains 0.195 mg sunset yellow (E 110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule; therefore, the medicine is considered "sodium-free".

3. How to use Doxycycline Genoptim

Do not crush or chew the capsules. Swallow them whole with a full glass of water.

Take Doxycycline Genoptim exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose depending on the type of infection and your overall condition.
It is not possible to achieve a dose lower than 100 mg with Doxycycline Genoptim. Your doctor will decide which other available medicinal product containing doxycycline should be used instead.

Recommended dosage
Adults and adolescents (aged over 12 to below 18 years)
The usual dose of doxycycline for treating acute infections in adults and adolescents aged 12 to below 18 years is 200 mg on the first day (as a single dose or divided into two doses), followed by 100 mg daily. For the treatment of more severe infections, a dose of 200 mg daily should be maintained throughout the treatment period.

Children aged 8 to below 12 years:
The use of doxycycline for treating acute infections in children aged 8 to below 12 years should be carefully considered only when alternative treatments are unavailable, likely to be ineffective, or contraindicated. In such cases, the following doses are recommended:
In children weighing 45 kg or less:
Initial dose: 4.4 mg/kg body weight (as a single dose or divided into two doses), followed by 2.2 mg/kg body weight (as a single dose or divided into two doses).
For the treatment of more severe infections, a dose of up to 4.4 mg/kg body weight should be administered throughout the treatment period.

In children weighing more than 45 kg:
The adult dose should be used.

Children from birth to below 8 years
Do not use doxycycline in children under 8 years of age due to the risk of tooth discoloration (see sections 2 and 4).

Recommended dosing in certain disease conditions

• 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 a follow-up culture performed 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) daily in divided doses for at least 2 weeks.
• Lyme borreliosis: 1 capsule (100 mg doxycycline) twice daily (every 12 hours) for 14 to 28 days, or 14 to 21 days in early-stage disease.

Dosing for malaria prophylaxis
Take 1 capsule (100 mg doxycycline) daily. Begin prophylaxis 1 to 2 days before travel to malaria-endemic areas. Continue doxycycline throughout the stay in the endemic area and for 4 weeks after leaving the malaria-risk area.

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

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

Method of administration
Swallow the capsules whole with a glass of water.
To prevent possible irritation of the throat or intestines, the 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 medicine with food.
Taking doxycycline with food reduces gastrointestinal side effects and does not significantly affect its absorption.

Use of a higher than recommended dose of Doxycycline Genoptim
Symptoms of doxycycline overdose include fever, facial flushing, dizziness, and occasionally circulatory collapse. If any of these symptoms occur, discontinue the drug immediately and contact your doctor. In conscious patients, vomiting may be induced, or antacids, or calcium and magnesium salts may be administered. If a higher than recommended dose has been taken, seek medical advice immediately.

Missed dose of Doxycycline Genoptim
If a dose is missed at the usual scheduled time, take it as soon as possible, provided there is sufficient time before the next dose, or continue with the regular dosing schedule.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Doxycycline Genoptim can cause adverse reactions, although not everyone will experience them. The adverse reactions listed below have been observed in patients receiving tetracyclines, including doxycycline.
If any of the following serious adverse reactions occur, stop taking the medicine immediately and contact your doctor or go to the emergency room of the nearest hospital.
Serious adverse reactions:

• Anaphylactic reactions: sudden wheezing, angioedema – swelling of the eyelids, lips or face, difficulty breathing, chest tightness, rapid heartbeat, fever, skin rash or urticaria (severe allergic reaction), anaphylactic shock with significant drop in blood pressure (common).
• Stomach disturbances, loss of appetite, severe, persistent or bloody diarrhoea (rare). These may occur up to two or three months after taking the last dose of the medicine and may be associated with abdominal pain or fever. They may occur following antibiotic treatment and may indicate a serious bowel inflammation (pseudomembranous colitis).
• Fever, swollen lymph nodes or skin rash (rare). These may be symptoms of a condition known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), which can be severe and life-threatening.
• Severe skin reactions leading to general malaise (rare).

If any of the following adverse reactions occur, contact your doctor immediately:

• Jarisch-Herxheimer reaction (rare), causing fever, chills, headache, muscle pain and skin rash, which is usually self-limiting. This occurs shortly after starting doxycycline treatment for spirochetal infections, such as Lyme disease (see section 2 "Warnings and precautions").
• Skin rash (common) or skin peeling (rare).
• Increased sensitivity of the skin to sunlight than usual (common). Skin rash, itching, redness or severe sunburn may occur (common). In such a case, stop using the medicine and contact your doctor immediately.
• Headache (common), which, if very severe, may be associated with visual disturbances such as blurred vision or loss of vision.
• Inflammation and/or ulcers of the oesophagus (rare).
• Blood disorders (rare). These result from changes in the number of various types of blood cells. Symptoms may include fatigue, easy bruising or susceptibility to infections.
• Low blood pressure (common).
• Increased heart rate (common).
• Joint or muscle pain (rare).
• Abdominal pain or diarrhoea (rare).

Other adverse reactions:
Common adverse reactions (may occur in up to 1 in 10 patients):

• nausea or vomiting
• exacerbation of a condition called systemic lupus erythematosus (SLE). This is an allergic condition causing joint pain, skin rash and fever
• pericarditis (inflammation affecting the heart)
• headache

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• heartburn, indigestion
• vaginal inflammation

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• pancreatitis, causing severe abdominal and back pain
• yellowing of the skin and eyes (jaundice), pancreatitis
• difficulty swallowing, pain in the tongue or mouth
• skin redness (erythema)
• ringing or buzzing in the ear
• pain and itching of the anus and/or genital organs
• intestinal inflammation
• bulging fontanelle (soft spot on the head) in infants
• increased intracranial pressure (severe headache with visual changes)
• liver inflammation and damage
• abnormal liver function tests
• discoloration of thyroid tissue with long-term use
• anxiety
• nail separation from the nail bed following sun exposure
• elevated blood urea levels
• dark spots on the skin

Frequency unknown (frequency cannot be estimated from available data):

• tooth discoloration.

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Doxycycline Genoptim

Keep this medicine out of sight and reach of children.
Store below 25℃.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Doxycycline Genoptim contains
The active substance is doxycycline in the form of hyclate. Each hard capsule contains 100 mg of
doxycycline.
Excipients: hypromellose (12.25 - 21 mPa.s), hypromellose (4.0 – 6.0 mPa.s), sodium lauryl sulfate,
magnesium stearate, microcrystalline cellulose. Capsule composition (cap and body): gelatin, purified water, titanium dioxide (E 171), brilliant blue (E 133), quinoline yellow (E 104), sunset yellow (E 110).
What Doxycycline Genoptim looks like and contents of the pack
Hard, gelatin capsule consisting of green cap and body, size “2”.
PVC/Aluminium blister pack in a cardboard box. The pack contains 10 hard capsules.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel. 607 696 231
email: [email protected]
Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
For further information about this medicinal product, please contact the Marketing Authorisation Holder.