Doxicicline Genoptim

Leaflet attached to the packaging: patient information

Doxycycline Genoptim

100 mg, hard capsules

Doxycycline

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Doxycycline Genoptim and what is it 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 packaging and other information

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

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

Indications for use

Doxycycline Genoptim is used in the following infections caused by microorganisms susceptible 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 trachomatis, 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. These infections can be treated with doxycycline alone or in combination with topical medications.
• Lyme disease.
• Other infections - psittacosis, brucellosis (in combination with streptomycin), plague, tularemia.

Prophylactically:

• Malaria.

2. Important information before taking Doxycycline Genoptim

When not to take Doxycycline Genoptim:

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

Doxycycline Genoptim should not be taken during tooth development (pregnancy, infancy, or in children under 8 years of age), as it may cause permanent discoloration of teeth (yellow-gray-brown) or disrupt normal tooth development. There may be circumstances (e.g., life-threatening or severe conditions) in which the doctor prescribes Doxycycline Genoptim to a child under 8 years of age, considering that the expected benefits outweigh the risk of taking the medicine.

Warnings and precautions

Before starting Doxycycline Genoptim, discuss it with your doctor.

• Patient with a history of hypersensitivity reactions to antibiotics or other allergens should inform their doctor before taking Doxycycline Genoptim.
• Doxycycline taken during tooth development (last trimester of pregnancy, perinatal period, early childhood) may cause tooth discoloration and damage.
• Tetracyclines, including doxycycline, may cause photosensitivity. During treatment, avoid sunbathing or artificial UV radiation (e.g., solarium) due to the possibility of light-induced skin diseases (photodermatosis), manifested by, 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 appear, e.g., thrush (persistent itching, skin redness), consult a doctor.
• Patient with liver failure should inform their doctor.
• Patient with myasthenia, systemic lupus erythematosus, or porphyria should inform their doctor before taking the medicine, as doxycycline may exacerbate the symptoms of the disease.
• In patients with severe renal impairment, doxycycline excretion by the kidneys may be reduced.
• After taking tetracycline antibiotics, a bulging fontanelle may occasionally occur in infants, and mild intracranial hypertension may occur in children and adults. These symptoms disappear after discontinuation of treatment.
• When 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.

Consult a doctor, even if the above warnings refer to past situations.

Using the medicine in patients with kidney and/or liver function disorders

Patient with liver function disorders or taking medicines that may damage the liver should inform their doctor before taking Doxycycline Genoptim. The doctor will determine the individual dosage and, if necessary, recommend periodic liver function tests. In patients with renal impairment, dosage adjustment is not necessary. In each case, the doctor decides on the dosage of the medicine for a patient with renal or liver impairment.

Doxycycline Genoptim and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any 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 doxycycline absorption. Such medicines and foods should be taken at least 2 hours apart from doxycycline.
• Methoxyflurane (a medicine used for general anesthesia). If the patient needs to be given general anesthesia, they should inform their doctor that they are taking Doxycycline Genoptim capsules.
• Anticoagulant medicines derived from coumarin. When taking these medicines with doxycycline, the doctor should recommend monitoring coagulation parameters - it may be necessary to reduce the doses of these medicines.
• Oral anti-diabetic medicines derived from sulfonylurea. When taking these medicines with doxycycline, the doctor should recommend monitoring blood glucose levels - it may be necessary to reduce the doses of these medicines.
• Cyclosporine (an immunosuppressive medicine used, among others, after organ transplantation or in psoriasis). If it is necessary to take both medicines simultaneously, the doctor will recommend monitoring cyclosporine levels in the blood.
• 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, difenylhydantoin, 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 the patient must 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.

Doxycycline Genoptim with food, drink, or alcohol

Alcohol may reduce the effect of doxycycline.

Food containing calcium, such as milk and dairy products, and fruit juices fortified with calcium, should be consumed at least 2 hours before or 2 hours after taking Doxycycline Genoptim capsules.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Doxycycline Genoptim should not be taken during pregnancy. Tetracycline antibiotics pass through the placental barrier and accumulate in fetal tissues. Taking tetracycline antibiotics during tooth development (last trimester of pregnancy, perinatal period, early childhood) may cause permanent tooth discoloration and damage to the enamel.

Breastfeeding

Doxycycline passes into human milk. During doxycycline treatment, breastfeeding should be discontinued due to the possibility of causing permanent hypersensitivity to light in infants or fungal infections and side effects related to bone and tooth development.

Driving and using machines

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

Doxycycline Genoptim contains orange yellow and sodium

The medicine contains 0.195 mg of orange yellow (E 110), which may cause allergic reactions.

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

3. How to take Doxycycline Genoptim

Doxycycline Genoptim should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

The doctor will determine the dose based on the type of infection and the patient's overall condition.

When taking Doxycycline Genoptim, a dose less than 100 mg cannot be obtained. The doctor will decide which other available medicinal product containing doxycycline should be used.

Recommended dosage

Adults and adolescents (over 12 years to under 18 years)

The usual dose of doxycycline in the treatment of acute infections in adults and adolescents over 12 years of age is 200 mg on the first day (single dose or divided doses), then 100 mg/day. In the treatment of more severe infections, a dose of 200 mg/day should be administered throughout the treatment period.

Children over 8 years to under 12 years:

The use of doxycycline in the treatment of acute infections in children over 8 years to under 12 years should be carefully considered when other medicines are not available, likely to be ineffective, or contraindicated. In such cases, the following doses are used:

For children with a body weight of 45 kg or less:

The initial dose is: 4.4 mg/kg body weight (single dose or divided into 2 doses), then 2.2 mg/kg body weight (single dose or divided into 2 doses).

In the treatment of more severe infections, a dose of up to 4.4 mg/kg body weight should be administered throughout the treatment period.

For children with a body weight over 45 kg:

The dose should be the same as for adults.

Children under 8 years:

Doxycycline should not be taken in children under 8 years due to the risk of tooth discoloration (see sections 2 and 4).

Recommended dosage for certain diseases

• Uncomplicated gonorrhea: 1 capsule (100 mg 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 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 doxycycline) per day in divided doses for at least 2 weeks.
• Lyme disease: 1 capsule (100 mg 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 doxycycline) per day is taken. Prophylaxis should be started 1 to 2 days before the planned trip to malaria-endemic areas. Doxycycline should be taken throughout the stay in the endemic area and for 4 weeks after leaving the malaria-endemic areas.

Dosage in the elderly

Dosage 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.

Treatment duration

The treatment duration is always determined by the doctor. The antibiotic should usually be taken 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 with a glass of water.

To prevent 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 lie down immediately after taking the capsule).

Patient with 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.

Taking a higher dose of Doxycycline Genoptim than recommended

Symptoms of doxycycline overdose are: fever, flushing, dizziness, and occasionally fainting. If the above symptoms occur, the medicine should be discontinued and a doctor consulted immediately. 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, consult a doctor immediately.

Missing a dose of Doxycycline Genoptim

In case of missing a dose at a fixed, specified time, the medicine should be taken as soon as possible, if the time to 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, Doxycycline Genoptim can cause side effects, although not everybody gets them. The following side effects have been observed in patients taking tetracyclines, including doxycycline.

If you experience any of the following serious side effects, stop taking the medicine and consult a doctor or go to the nearest hospital immediately:

go to the emergency department of the nearest hospital.

Severe side effects:

• Anaphylactic reactions: sudden wheezing, angioedema - swelling of the eyelids, lips, or face, difficulty breathing, chest tightness, rapid heartbeat, fever, skin rash or hives (severe allergic reaction), anaphylactic shock with significant blood pressure drop. (frequent)
• Gastrointestinal disorders, loss of appetite, severe, persistent, or bloody diarrhea (rare). These may occur up to two or three months after the last dose of the medicine and may be associated with abdominal pain or fever. They may occur after antibiotic treatment and be a sign of a serious intestinal infection (pseudomembranous colitis).
• Fever, lymph node swelling, or skin rash (rare). These may be symptoms of a condition known as DRESS (drug reaction with eosinophilia and systemic symptoms) and may be severe and life-threatening.
• Severe skin reactions leading to poor health (rare).

If you experience any of the following side effects, consult a doctor immediately:

consult a doctor immediately:

• Jarisch-Herxheimer reaction (rare), causing fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. It occurs shortly after starting doxycycline treatment for spirochetal infections, e.g., Lyme disease (see section 2 "Warnings and precautions").
• Skin rash (frequent) or peeling skin (rare).
• Increased sensitivity of the skin to sunlight than usual (frequent). Skin rash, itching, redness, or severe sunburn may occur (frequent). In such a case, the medicine should be discontinued and a doctor consulted immediately.
• Headache (frequent), which, if very severe, may be associated with vision disturbances, such as blurred vision or loss of vision.
• Esophageal inflammation and (or) ulcers (rare).
• Blood disorders (rare). This is due to changes in the number of different types of cells in the blood. Symptoms may include fatigue, easy bruising, or infections.
• Low blood pressure (frequent).
• Increased heart rate (frequent).
• Joint or muscle pain (rare).
• Abdominal pain or diarrhea (rare).

Other side effects:

Frequent side effects (may occur in up to 1 in 10 patients):

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

Uncommon side effects (may occur in up to 1 in 100 patients):

• heartburn, indigestion
• vaginitis

Rare side effects (may occur in up to 1 in 1000 patients):

• pancreatitis, which causes severe abdominal and back pain
• yellow skin and eyes (jaundice), pancreatitis
• difficulty swallowing, tongue or mouth pain
• skin redness (erythema)
• ringing or buzzing in the ears
• anal or genital pain and (or) itching
• enteritis
• bulging fontanelle in infants
• increased intracranial pressure (severe headache with vision changes)
• hepatitis and liver damage
• abnormal liver function test results
• thyroid tissue discoloration with long-term administration
• anxiety
• separation of the nail from the nail bed after sun exposure
• increased urea levels in the blood
• darker skin spots

Frequency not known (frequency cannot be estimated from available data):

• tooth discoloration.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. 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 this medicine.

5. How to store Doxycycline Genoptim

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Doxycycline Genoptim contains

The active substance of the medicine is doxycycline in the form of hyclate. One 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 shell (cap and body):

gelatin, purified water, titanium dioxide (E 171), brilliant blue (E 133), quinoline yellow (E 104), orange yellow (E 110).

What Doxycycline Genoptim looks like and contents of the pack

Hard gelatin capsule, green, size "2".

PVC/Aluminum blister pack, in a cardboard box. The pack contains 10 hard capsules.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

tel. 607 696 231

email: [email protected]

Importer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

To obtain more detailed information about this medicine, please contact the marketing authorization holder.

Date of last revision of the leaflet: