Proxacin 500

Leaflet accompanying the packaging: patient information

Proxacin 250, 250 mg, film-coated tablets

Proxacin 500, 500 mg, film-coated tablets

Ciprofloxacin

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Proxacin 250 and Proxacin 500 are and what they are used for
• 2. Important information before taking Proxacin 250 and Proxacin 500
• 3. How to take Proxacin 250 and Proxacin 500
• 4. Possible side effects
• 5. How to store Proxacin 250 and Proxacin 500
• 6. Contents of the packaging and other information

1. What Proxacin 250 and Proxacin 500 are and what they are used for

Proxacin 250 and Proxacin 500 contain the antibiotic ciprofloxacin, which belongs to the fluoroquinolone group.
Ciprofloxacin works by killing the bacteria that cause infections. It only works against certain types of bacteria.

Adults

• Lower respiratory tract infections caused by Gram-negative bacteria:
• exacerbation of chronic obstructive pulmonary disease (COPD) - Proxacin 250 and Proxacin 500 should only be used when other commonly recommended antibacterial agents for the treatment of these infections are considered inappropriate;
• pulmonary infections in patients with cystic fibrosis or bronchiectasis;
• community-acquired pneumonia.
• Chronic suppurative otitis media.
• Severe exacerbation of chronic sinusitis, especially when caused by Gram-negative bacteria.
• Uncomplicated acute urinary tract infections. In uncomplicated urinary tract infections, Proxacin 250 and Proxacin 500 should only be used when other commonly recommended antibacterial agents for the treatment of these infections are considered inappropriate.
• Acute pyelonephritis
• Complicated urinary tract infections
• Bacterial prostatitis
• Genital tract infections:
• gonococcal urethritis or cervicitis caused by susceptible Neisseria gonorrhoeae strains;
• epididymo-orchitis, including cases caused by susceptible Neisseria gonorrhoeae strains;
• pelvic inflammatory disease, including cases caused by susceptible Neisseria gonorrhoeae strains.
• Gastrointestinal infections (e.g. traveler's diarrhea).
• Intra-abdominal infections.
• Skin and soft tissue infections caused by Gram-negative bacteria.
• Malignant otitis externa.
• Bone and joint infections.
• Prophylaxis of invasive infections caused by Neisseria meningitidis.
• Pulmonary tuberculosis (prevention of infections after contact with bacteria and treatment). Ciprofloxacin can be used to treat patients with neutropenia and fever, which is presumed to be caused by a bacterial infection.

Children and adolescents

• Pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
• Complicated urinary tract infections and acute pyelonephritis.
• Pulmonary tuberculosis (prevention of infections after contact with bacteria and treatment).

Ciprofloxacin can also be used to treat severe infections in children and adolescents when it is considered necessary.
Treatment should only be initiated by doctors who have experience in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

2. Important information before taking Proxacin 250 and Proxacin 500

When not to take Proxacin 250 and Proxacin 500:

• if you are allergic to ciprofloxacin, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking tizanidine - see section 2 "Proxacin 250 and Proxacin 500 with other medicines".

Warnings and precautions

Before taking Proxacin 250 and Proxacin 500, you should discuss this with your doctor or pharmacist.
You should not take antibacterial agents containing fluoroquinolones or quinolones, including Proxacin 250 and Proxacin 500, if you have ever had a severe side effect while taking a quinolone or fluoroquinolone. In such cases, you should inform your doctor immediately.
Before taking Proxacin 250 and Proxacin 500, you should tell your doctor if:

• you have ever had kidney problems, as your treatment may need to be adjusted;
• you have epilepsy or other neurological disorders;
• you have ever had tendon problems during treatment with such antibiotics as Proxacin 250 and Proxacin 500;
• you have diabetes - ciprofloxacin may cause a significant decrease in blood sugar levels (hypoglycemia) - see also below and section 4;
• you have myasthenia gravis (a type of muscle weakness) - symptoms may worsen;
• you have heart problems. Caution should be exercised when using this type of medicine if: you have a congenital or familial prolonged QT interval (visible on an ECG - a test of heart electrical activity); you have an electrolyte imbalance in the blood (especially low potassium and magnesium levels); you have a very slow heart rate (called bradycardia); you have poor heart function (heart failure); you have had a heart attack; you are a woman or an elderly person; you are taking other medicines that may affect the ECG (see section 2 "Proxacin 250 and Proxacin 500 with other medicines");
• you or a family member have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should inform your doctor - ciprofloxacin may cause anemia;
• you have an aortic aneurysm or a large peripheral arterial aneurysm;
• you have had an aortic dissection (tear in the aortic wall);
• you have aortic valve regurgitation;
• there have been cases of aortic aneurysm or aortic dissection, or other risk factors or conditions (e.g. Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or atherosclerosis) in your family;

In the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If you do not improve within three days of treatment, you should consult your doctor.

While taking Proxacin 250 and Proxacin 500

If whiletaking Proxacin 250 or Proxacin 500 you experience any of the following symptoms, you should immediately inform your doctor.Your doctor will decide whether to discontinue treatment with these medicines.

• Severe, sudden allergic reaction(anaphylactic reaction or shock, angioedema). This is unlikely, but even after the first dose, a severe allergic reaction may occur, with symptoms such as: chest tightness, dizziness, nausea, fainting or dizziness when standing up. If this happens, you should discontinue Proxacin 250 and Proxacin 500 and contact your doctor immediately.
• Long-lasting, disabling, and potentially irreversible severe side effectsFluoroquinolone and quinolone antibacterial agents, including Proxacin 250 and Proxacin 500, have been associated with very rare but severe side effects. Some of these have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include: tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, numbness, prickling, burning, or pain) (neuropathy), fatigue, memory and concentration problems, and effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) as well as hearing, vision, taste, and smell disorders.
  If you experience any of these side effects after taking Proxacin 250 or Proxacin 500, you should contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Rarely, pain and swelling of the joints and inflammation or rupture of tendonsmay occur. The risk is increased in elderly people (over 60 years), after organ transplantation, in patients with kidney problems, or during treatment with corticosteroids. Tendonitis and tendon rupture may occur within the first 48 hours of treatment, and even up to several months after discontinuation of Proxacin 250 or Proxacin 500. If you experience the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), you should discontinue Proxacin 250 or Proxacin 500, contact your doctor, and rest the affected area. You should avoid excessive strain, as this may increase the risk of tendon rupture.
• If you have epilepsyor other neurological disorders, such as cerebral ischemia (insufficient blood flow to the brain) or stroke, neurological side effects may occur. If you experience seizures, you should immediately discontinue Proxacin 250 and Proxacin 500 and contact your doctor.
• After the first dose of Proxacin 250 or Proxacin 500, psychotic reactionsmay occur. If you have depressionor psychosis, symptoms of these conditions may worsen during treatment with Proxacin 250 and Proxacin 500. Rarely, depression or psychosis may develop into suicidal thoughts, which may lead to suicide attempts or suicide. If this happens, you should discontinue Proxacin 250 and Proxacin 500 and contact your doctor immediately.
• You may rarely experience nerve damage symptoms(neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs and hands and arms. In such cases, you should discontinue Proxacin 250 or Proxacin 500 and immediately inform your doctor to prevent the development of potentially irreversible disease.
• Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels below normal (hypoglycemia), which may lead to loss of consciousness (hypoglycemic coma) in severe cases. This is important for patients with diabetes. Patients with diabetes should carefully monitor their blood sugar levels. If you experience a decrease in blood sugar levels below normal (hypoglycemia), you should immediately contact your doctor.
• While taking antibiotics, including Proxacin 250 and Proxacin 500, or even for several weeks after treatment, diarrheamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, you should immediately discontinue the medicine and contact your doctor, as this can be life-threatening. You should not take medicines that slow down or stop bowel movements, and you should immediately contact your doctor.
• If you are going to have a blood or urine test, you should inform your doctor or laboratory personnel that you are taking Proxacin 250 or Proxacin 500.
• If you have kidney problems, you should inform your doctor, as dose adjustment may be necessary.
• Visual disturbances or other eye problemsshould be immediately consulted with an ophthalmologist.
• Proxacin 250 and Proxacin 500 may cause liver damage. If you notice any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, you should discontinue the medicine and immediately contact your doctor.
• Proxacin 250 and Proxacin 500 may decrease the number of white blood cells, which can lead to a decreased immune response to infections. If you notice symptoms such as fever and severe deterioration of your general condition or fever with local signs of infection, such as sore throat, pharyngitis, or urinary tract problems, you should immediately contact your doctor. Your doctor will order a blood test to check if you have a decreased white blood cell count (agranulocytosis). Remember to inform your doctor that you are taking this medicine.
• While taking Proxacin 250 and Proxacin 500, your skin becomes more sensitive to sunlight and ultraviolet radiation (UV). You should avoid exposure to strong sunlight or artificial UV radiation (e.g. in a solarium)

In case of sudden severe abdominal, back, or chest pain, which may be a sign of aortic aneurysm or aortic dissection, you should immediately go to the emergency department. The risk of these changes may be higher during treatment with systemic corticosteroids.
In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), you should immediately consult your doctor.

Proxacin 250 and Proxacin 500 with other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Proxacin 250 or Proxacin 500 at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to take Proxacin 250 and Proxacin 500").
The following medicines will interact with Proxacin 250 and Proxacin 500 in the body.

• vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindion) or other oral anticoagulants ("blood thinners");
• probenecid (a medicine used in gout);
• methotrexate (a medicine used in certain types of cancer, psoriasis, or rheumatoid arthritis);
• theophylline (a medicine used in respiratory disorders);
• tizanidine (a medicine that reduces excessive muscle tension in multiple sclerosis);
• olanzapine (an antipsychotic medicine);
• clozapine (an antipsychotic medicine);
• ropinirole (a medicine used in Parkinson's disease);
• phenytoin (a medicine used in epilepsy);
• metoclopramide (a medicine used in nausea and vomiting);
• cyclosporin (a medicine used in skin diseases, rheumatoid arthritis, and after organ transplantation);
• other medicines that may affect heart rhythm: antiarrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, and certain antibacterial agents (macrolides), as well as certain antipsychotic medicines.
• zolpidem (a medicine used in insomnia).

Proxacin 250 and Proxacin 500 may increase the levels of the following medicines in the blood:

• pentoxifylline (a medicine used in circulatory disorders);
• caffeine;
• duloxetine (a medicine used in depression, diabetic neuropathy, and urinary incontinence);
• lidocaine (a medicine used in heart diseases and anesthesiology);
• sildenafil (a medicine used e.g. in erectile dysfunction);
• agomelatine (a medicine used in depression).

Some medicines may reduce the effect of Proxacin 250 and Proxacin 500. You should inform your doctor if you are taking or plan to take:

• antacids;
• omeprazole (a medicine used in stomach ulcers);
• mineral supplements;
• sucralfate;
• phosphate-binding polymers (e.g. sevelamer or lanthanum carbonate);
• medicines containing calcium, magnesium, aluminum, or iron, or supplements of these substances. If it is necessary to take these medicines, Proxacin 250 or Proxacin 500 should be taken about two hours before their administration or at least four hours after their intake.

Taking Proxacin 250 and Proxacin 500 with food and drink

If you take Proxacin without meals, do not eat or drink any dairy products (such as milk or yogurt) or drinks with added calcium (e.g. calcium-enriched orange juice) while taking the tablet, as this may affect the absorption of the active substance.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended to avoid taking Proxacin 250 and Proxacin 500 during pregnancy.
You should not take Proxacin 250 or Proxacin 500 while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and using machines

Proxacin 250 and Proxacin 500 may cause drowsiness. Certain side effects may affect the nervous system. Before driving a vehicle or operating machinery, you should check how you react to the medicine.
In case of doubt, consult your doctor.

Proxacin 250 and Proxacin 500 contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Proxacin 250 and Proxacin 500

Your doctor will explain in detail the dose of Proxacin 250 or Proxacin 500 you should take, how often to take the medicine, and how long to continue treatment. This will depend on the type and severity of the infection.
If you have kidney problems, you should inform your doctor, as dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer.
Tablets should always be taken as directed by your doctor. If you are unsure about the number of tablets to take or how to take Proxacin 250 or Proxacin 500, you should contact your doctor or pharmacist.

• Tablets should be swallowed with a large amount of liquid, e.g. a glass of water. The tablets should not be chewed, as they have an unpleasant taste.
• It is best to take the tablets at about the same time each day.
• Tablets can be taken with or without food. Calcium in food does not significantly affect absorption. However, you should not take Proxacin 250 and Proxacin 500 with dairy products, such as milk or yogurt, or with calcium-enriched fruit juices (e.g. calcium-enriched orange juice).
• You should remember to drink plenty of fluids during the entire treatment period with Proxacin 250 or Proxacin 500.

Taking more than the recommended dose of Proxacin 250 or Proxacin 500

If you have taken more than the recommended dose, you should immediately seek medical attention. If possible, take the tablets or packaging with you to show the doctor.

Missing a dose of Proxacin 250 or Proxacin 500

You should take the prescribed dose as soon as possible, and then continue treatment as directed by your doctor. However, if it is almost time for the next dose, do not take a double dose to make up for the missed dose, just take the next dose as usual.
It is important to take all the tablets prescribed by your doctor.

Stopping treatment with Proxacin 250 or Proxacin 500

It is important not to stop treatment too early, even if you feel better after a few days of taking the medicine. If you stop taking the medicine too early, the infection may not be fully treated, and the symptoms may return or worsen. Bacterial resistance to the antibiotic may also develop.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Proxacin 250 and Proxacin 500 can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with this medicine are listed below:

If you notice any of the following symptoms, you should stop taking Proxacin 250 and Proxacin 500 and immediately contact your doctor, as you may need to take a different antibiotic.

Rare side effects

(may occur in less than 1 in 100 patients):

• seizures (see section 2 "Warnings and precautions").

Very rare side effects(may occur in less than 1 in 10,000 patients):

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting or dizziness when standing up (anaphylactic reaction/anaphylactic shock) (see section 2 "Warnings and precautions");
• muscle weakness, tendonitis, which may lead to tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions");
• a life-threatening skin rash with blisters or peeling of the skin, usually on the lips, eyes, mouth, and genitals, with a rash spreading and peeling of the skin (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).

Frequency of side effects not known(frequency cannot be estimated from the available data):

• nerve disorders, such as pain, burning, tingling, numbness, and/or weakness (neuropathy);
• allergic reaction, which causes a rash, fever, inflammation of internal organs, blood disorders, and systemic diseases (drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or acute generalized exanthematous pustulosis, also known as AGEP).

Administration of fluoroquinolone and quinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-lasting (lasting for months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, numbness, prickling, burning, or pain) (neuropathy), fatigue, memory and concentration problems, and effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) as well as hearing, vision, taste, and smell disorders.
Other side effectsthat have been observed during treatment with Proxacin 250 and Proxacin 500 are listed below, according to their frequency.

Common side effects(may occur in less than 1 in 10 patients):

• nausea (vomiting), diarrhea;
• joint pain in children.

Uncommon side effects(may occur in less than 1 in 100 patients):

• joint pain in adults;
• fungal superinfections;
• high levels of eosinophils (a type of white blood cell);
• decreased appetite;
• excessive psychomotor activity or agitation;
• headache, dizziness, sleep disturbances, taste disturbances;
• vomiting, abdominal pain, digestive disorders, such as indigestion (dyspepsia), or gas;
• increased levels of certain substances in the blood, such as transaminases and/or bilirubin;
• rash, itching, or hives;
• kidney problems;
• muscle and bone pain, general feeling of being unwell (malaise), fever;
• increased alkaline phosphatase activity in the blood (a certain substance found in the blood).

Rare side effects(may occur in less than 1 in 1,000 patients):

• muscle pain, tendonitis, increased muscle tension, or muscle cramps;
• antibiotic-associated colitis (inflammation of the colon), which can be life-threatening (see section 2 "Warnings and precautions");
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased platelet count (which plays a role in blood clotting);
• allergic reaction, angioedema (see section 2 "Warnings and precautions");
• high blood sugar levels (hyperglycemia) or low blood sugar levels (hypoglycemia), which may lead to hypoglycemic coma in severe cases. This is important for patients with diabetes (see section 2 "Warnings and precautions");
• confusion, disorientation, anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts or attempts or suicide), hallucinations (see section 2 "Warnings and precautions");
• sensory disturbances (tingling, numbness, or abnormal sensations), decreased skin sensitivity to touch; tremors, or dizziness;
• visual disturbances (including double vision) (see section 2 "Warnings and precautions");
• ringing in the ears, hearing loss, hearing disturbances;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure, or fainting;
• shortness of breath, including asthma attacks;
• liver problems, jaundice (with bile duct obstruction), or hepatitis;
• photosensitivity (see section 2 "Warnings and precautions");
• kidney failure, blood or crystals in the urine, urinary tract infection;
• fluid retention, excessive sweating;
• increased activity of an enzyme called amylase.

Very rare side effects(may occur in less than 1 in 10,000 patients):

• a specific type of decreased red blood cell count called hemolytic anemia; a potentially life-threatening decrease in white blood cell count (agranulocytosis) (see section 2 "Warnings and precautions"), a decrease in the number of red and white blood cells and platelets (pancytopenia), which can be life-threatening, and bone marrow failure, which can also be life-threatening;
• an allergic reaction similar to a disease called serum sickness (see section 2 "Warnings and precautions");
• mental disorders (psychotic reactions that may lead to suicidal thoughts, attempts, or suicide) - (see section 2 "Warnings and precautions");
• migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumor cerebri), and benign intracranial hypertension;
• color vision disturbances;
• vasculitis (inflammation of blood vessels);
• pancreatitis;
• liver cell death (liver necrosis), which can very rarely lead to life-threatening liver failure (see section 2 "Warnings and precautions");
• small dark spots visible under the skin (ecchymoses), various skin rashes or eruptions
• worsening of myasthenia gravis symptoms (see section 2 "Warnings and precautions").

Frequency of side effects not known(frequency cannot be estimated from the available data):

• heart rhythm disturbances, life-threatening irregular heartbeat, rapid heartbeat, (called "QT interval prolongation", visible on an ECG - a test of heart electrical activity);
• coagulation disorders (in patients treated with vitamin K antagonists);
• a syndrome associated with water imbalance and low sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma). See section 2.
• feeling of excessive excitement (mania) or excessive optimism and overactivity (hypomania);

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, or aortic valve regurgitation, which can be life-threatening, as well as cases of aortic aneurysm or aortic dissection. See also section 2.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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 this medicine.

5. How to store Proxacin 250 and Proxacin 500

Store in the original packaging to protect from light.
Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton 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 Proxacin 250 contains

• The active substance is ciprofloxacin hydrochloride. One tablet contains 250 mg of ciprofloxacin (as ciprofloxacin hydrochloride).
• The other ingredients are: maize starch, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, sodium croscarmellose, hypromellose, macrogol 6000, titanium dioxide (E 171).

What Proxacin 500 contains

• The active substance is ciprofloxacin hydrochloride. One tablet contains 500 mg of ciprofloxacin (as ciprofloxacin hydrochloride).
• The other ingredients are: maize starch, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, sodium croscarmellose, hypromellose, macrogol 6000, titanium dioxide (E 171).

What Proxacin 250 and Proxacin 500 look like and contents of the pack

Proxacin 250 tablets are white, round, and biconvex.
Proxacin 500 tablets are white, oblong, and biconvex.
The medicines are packaged in cardboard boxes containing 10 tablets in one blister pack of Al/PVC foil.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(logo of the marketing authorization holder)

Manufacturer

Labormed-Pharma S.A.,
Bd. Theodor Pallady nr. 44B, sector 3,
032266 Bucharest
Romania
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00

Date of approval of the leaflet: ---------------------------------------------------------------------------

Medical advice - medical education

Antibiotics are used to treat bacterial infections. They do not work against viral infections.
Antibiotics should only be used for diseases that your doctor has prescribed them for. Despite the action of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic therapies may become ineffective.
Incorrect use of antibiotics increases resistance. You can even cause bacteria to become resistant and prolong treatment or reduce the effectiveness of the antibiotic if you do not follow your doctor's instructions regarding:
­ the size of the dose,
­ the frequency of administration,
­ the duration of treatment.

Consequently, to maintain the effectiveness of this medicine:

• 1 – use antibiotics only when prescribed by a doctor;
• 2 – strictly follow the doctor's instructions;
• 3 – do not use antibiotics again without a doctor's prescription, even if the current disease is similar to the disease for which the antibiotic was prescribed;
• 4 – never give antibiotics to another person, as they may be inappropriate for their disease;
• 5 – after completing treatment, return unused medicines to the pharmacy, so they can be properly disposed of.