Proxacin 250

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 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 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, you should tell 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 pack 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 a group of antibiotics called fluoroquinolones.
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;
• epididymo-orchitis, including cases caused by susceptible Neisseria gonorrhoeae;
• pelvic inflammatory disease, including cases caused by susceptible Neisseria gonorrhoeae.
• 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.
• Prevention 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 medicines containing fluoroquinolones or quinolones, including Proxacin 250 and Proxacin 500, if you have ever had a severe side effect with 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) - its symptoms may worsen;
• you have heart problems. You should be cautious when taking this type of medicine if: you have been diagnosed with a prolonged QT interval (visible on an ECG - a test of the heart's electrical activity); you have been diagnosed with 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 your 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 been diagnosed with an aneurysm of the aorta or a large peripheral artery;
• you have had an aortic dissection (tear in the aortic wall);
• you have been diagnosed with a heart valve problem;
• there have been cases of aortic aneurysm or aortic dissection, or other risk factors or conditions (e.g. Marfan syndrome or the vascular form of Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or confirmed atherosclerosis), in your family or you have other risk factors;

In the treatment of some 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 tell your doctor.Your doctor will decide whether to stop taking these medicines.

• Severe, sudden allergic reaction(anaphylactic reaction or shock, angioedema). This is unlikely, but even after the first dose, a severe allergic reaction can occur, with symptoms such as: chest tightness, dizziness, nausea, fainting, or dizziness when standing up. If this happens, you should stop taking Proxacin 250 and Proxacin 500 and contact your doctor immediately.
• Long-lasting, disabling, and potentially irreversible serious side effectsFluoroquinolone and quinolone antibacterial medicines, including Proxacin 250 and Proxacin 500, have been associated with very rare but serious 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 can include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) and disturbances of taste, smell, and hearing.
  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 people with kidney problems, or during treatment with corticosteroids. Tendonitis and tendon rupture can occur within the first 48 hours of treatment and up to several months after stopping Proxacin 250 or Proxacin 500. If you experience the first symptoms of pain or inflammation of the tendon (e.g. in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Proxacin 250 or Proxacin 500, contact your doctor, and rest the affected area. You should avoid excessive strain, as it 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, side effects from the central nervous system may occur. If seizures occur, you should stop taking Proxacin 250 and Proxacin 500 and contact your doctor immediately.
• After the first intake of Proxacin 250 or Proxacin 500, psychotic reactionsmay occur. If you have depressionor psychosis, the symptoms of these diseases may worsen during treatment with Proxacin 250 and Proxacin 500. Rarely, depression or psychosis may develop into suicidal thoughts, which can lead to suicide attempts or suicide. If this happens, you should stop taking Proxacin 250 and Proxacin 500 and contact your doctor immediately.
• You may rarely experience symptoms of nerve damage (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 stop taking Proxacin 250 or Proxacin 500 and immediately inform your doctor to prevent the development of a 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 can lead to loss of consciousness (hypoglycemic coma) in severe cases. This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels. If you experience a decrease in blood sugar levels below normal (hypoglycemia), you should contact your doctor immediately.
• While taking antibiotics, including Proxacin 250 and Proxacin 500, or even for several weeks after stopping treatment, diarrheamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, you should stop taking the medicine and contact your doctor immediately, as it can be life-threatening. You should not take medicines that slow down or stop bowel movements, and you should contact your doctor immediately.
• If you are going to have a blood or urine test, you should tell your doctor or laboratory staff that you are taking Proxacin 250 and Proxacin 500.
• If you have kidney problems, you should tell your doctor, as your dose may need to be adjusted.
• Visual disturbances or other eye problemsshould be discussed with an ophthalmologist immediately.
• 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 stop taking the medicine and contact your doctor immediately.
• Proxacin 250 and Proxacin 500 may decrease the number of white blood cells, which can lead to decreased resistance 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, laryngitis, oral cavity problems, and urinary tract problems, you should contact your doctor immediately. Your doctor will order a blood test to check if you have a decrease in the number of white blood cells (agranulocytosis). Remember to tell 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 an aneurysm and 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 tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Do not take Proxacin 250 or Proxacin 500 at the same time as tizanidine, as it 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, fluindione) or other oral anticoagulant medicines ("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);
• cyclosporine (a medicine used in skin diseases, rheumatoid arthritis, and after organ transplantation);
• other medicines that may affect your heart rhythm: medicines belonging to the group of antiarrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial medicines (belonging to the group of macrolides), some 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 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 2 hours before their administration or at least 4 hours after their intake.

Taking Proxacin 250 and Proxacin 500 with food and drink

If you do not take Proxacin with meals, you should not eat or drink any dairy products (such as milk or yogurt) or drinks with added calcium (e.g. calcium-fortified 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, you should 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. Some side effects may affect your ability to drive or operate machinery. Before driving a vehicle or operating machinery, you should check how you react to the medicine Proxacin 250 or Proxacin 500. If in 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 exactly how much Proxacin 250 or Proxacin 500 to take, how often to take it, and how long to continue treatment. This will depend on the type of infection and its severity.
If you have kidney problems, you should tell your doctor, as your dose may need to be adjusted.
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-fortified fruit juices (e.g. calcium-fortified orange juice).
• You should remember to drink plenty of fluids during the entire period of taking Proxacin 250 or Proxacin 500.

Taking a higher dose of Proxacin 250 or Proxacin 500 than recommended

If you have taken a higher dose than recommended, you should immediately seek medical attention. If possible, you should 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, you should not take a double dose to make up for the missed dose, but take the next dose as usual.
You should not take a double dose to make up for a missed dose. 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, even if you feel better after a few days of taking the medicine. If you stop taking the medicine too soon, the infection may not be fully treated, and the symptoms may return or worsen. Bacteria may also develop resistance to the antibiotic.
If you have any further questions about taking this medicine, you should ask 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 contact your doctor immediately, as you may need to take another antibiotic.

Rare side effects(may affect up to 1 in 1,000 people):

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

Very rare side effects(may affect up to 1 in 10,000 people):

• 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 can 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, and possibly on other parts of the body (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).

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

• nervous system disorders, such as pain, burning, tingling, numbness, and/or weakness of the limbs (neuropathy);
• allergic reaction, which can cause 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).

The administration of fluoroquinolone and quinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-lasting (lasting for months or years) or irreversible 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 can include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) and disturbances of taste, smell, and hearing.
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 affect up to 1 in 10 people):
• nausea (vomiting), diarrhea;
• joint pain in children.
• Uncommon side effects(may affect up to 1 in 100 people):
• 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 problems, 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 activity of alkaline phosphatase in the blood (a substance found in the blood).

Rare side effects(may affect up to 1 in 1,000 people):

• muscle pain, joint pain, increased muscle tone, or muscle spasms;
• antibiotic-associated colitis (inflammation of the colon) (very rarely 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 (swelling on an allergic basis) (see section 2 "Warnings and precautions");
• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels (hypoglycemia), which can lead to hypoglycemic coma in severe cases. This is important for people with diabetes (see section 2 "Warnings and precautions");
• confusion, disorientation, anxiety reactions, unusual dreams, depression (which can lead to suicidal thoughts or attempts or suicide), hallucinations (see section 2 "Warnings and precautions");
• abnormal sensations (such as tingling, numbness, prickling, or pain), decreased skin sensitivity to touch; tremors, or dizziness;
• visual disturbances (including double vision) (see section 2 "Warnings and precautions");
• tinnitus, hearing loss, hearing disturbances;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure, or fainting;
• shortness of breath, including asthma attacks, or severe exacerbation of asthma;
• liver problems, jaundice (with bile duct obstruction), or liver inflammation;
• photosensitivity (see section 2 "Warnings and precautions");
• kidney failure, blood or crystals in the urine, urinary tract inflammation;
• fluid retention, excessive sweating;
• increased activity of an enzyme called amylase.

Very rare side effects(may affect up to 1 in 10,000 people):

• a specific type of decreased red blood cell count called hemolytic anemia; a dangerous decrease in the number of white blood cells (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 serum sickness (see section 2 "Warnings and precautions");
• mental disorders (psychotic reactions that can lead to suicidal thoughts, suicide attempts, or suicide) - (see section 2 "Warnings and precautions");
• migraine, coordination problems, unsteady gait (gait disturbances), smell disturbances, increased intracranial pressure, and pseudotumor cerebri;
• disturbed color vision;
• 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 (purpura), various rashes, or skin 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 disorders, life-threatening irregular heartbeat, rapid heartbeat, (called "prolonged QT interval", visible on an ECG - a test of the heart's electrical activity);
• coagulation disorders (in patients treated with vitamin K antagonists);
• a syndrome associated with impaired water excretion and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma). See section 2.
• feeling of excessive excitement (mania) or feeling of excessive optimism and overactivity (hypomania);

Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, or rupture of the aortic wall, which can be fatal, as well as cases of heart valve problems. See also section 2.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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
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. 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 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, anhydrous colloidal silica, 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, anhydrous colloidal silica, magnesium stearate, sodium croscarmellose, hypromellose, macrogol 6000, titanium dioxide (E171).

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, oval, 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 about this medicine, you should 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: ---------------------------------------------------------------------------------------------------------------------

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.

As a result, to maintain the effectiveness of this medicine, you should:

• 1 – take antibiotics only when prescribed by a doctor;
• 2 – strictly follow the doctor's instructions;
• 3 – do not take 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 that they can be disposed of properly.