Proxacin 500: detailed information

Package leaflet: Information for the patient

Proxacin 250, 250 mg, film-coated tablets
Proxacin 500, 500 mg, film-coated tablets
Ciprofloxacinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Proxacin 250 and Proxacin 500 are and what they are used for
Important information before taking Proxacin 250 and Proxacin 500
How to take Proxacin 250 and Proxacin 500
Possible side effects
How to store Proxacin 250 and Proxacin 500
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 are antibiotics belonging to the fluoroquinolone group – ciprofloxacin.
Ciprofloxacin works by killing bacteria that cause infections. It acts only against certain bacterial strains.
Adults

Lower respiratory tract infections caused by Gram-negative bacteria:
- Exacerbation of chronic obstructive pulmonary disease – Proxacin 250 and Proxacin 500 should be used only when other antibacterial agents commonly recommended for treatment of these infections are considered inappropriate;
- Bronchopulmonary infections in cystic fibrosis or bronchiectasis;
- Community-acquired pneumonia.
Chronic suppurative otitis media.
Severe exacerbation of chronic sinusitis, particularly caused by Gram-negative bacteria.
Uncomplicated acute cystitis. In uncomplicated cystitis, Proxacin 250 and Proxacin 500 should be used only when other antibacterial agents commonly recommended for treatment of these infections are considered inappropriate.
Acute pyelonephritis.
Complicated urinary tract infections.
Bacterial prostatitis.
Genitourinary tract infections:
- Gonococcal urethritis or cervicitis caused by susceptible strains of Neisseria gonorrhoeae;
- Epididymo-orchitis, including that caused by susceptible strains of Neisseria gonorrhoeae;
- Pelvic inflammatory disease, including that caused by susceptible strains of Neisseria gonorrhoeae.
Gastrointestinal tract infections (e.g. traveler's diarrhea).
Intra-abdominal infections.
Skin and soft tissue infections caused by Gram-negative bacteria.
Malignant external otitis.
Bone and joint infections.
Prevention of invasive infections caused by Neisseria meningitidis.
Inhalational anthrax (post-exposure prophylaxis and treatment). Ciprofloxacin may be used to treat febrile neutropenic patients with suspected bacterial infection.

Children and adolescents

Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Complicated urinary tract infections and acute pyelonephritis.
Inhalational anthrax (post-exposure prophylaxis and treatment).

Ciprofloxacin may also be used to treat severe infections in children and adolescents when considered necessary.
Treatment should be initiated only by physicians experienced in managing cystic fibrosis and/or severe infections in children and adolescents.

2. Important information before using Proxacin 250 and Proxacin 500 medicines

When not to use Proxacin 250 and Proxacin 500 medicines:

if the patient is allergic to ciprofloxacin, to other drugs in the quinolone group, or to any of the other ingredients of this medicine (listed in section 6.);
if the patient is taking tizanidine at the same time – see section 2. “Proxacin 250 and Proxacin 500 medicines and other medicines”.

Warnings and precautions
Before starting treatment with Proxacin 250 and Proxacin 500, discuss this with your doctor or
pharmacist.
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Proxacin 250 and Proxacin 500 medicines, if the patient has previously experienced any
severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case,
contact your doctor as soon as possible.
Before taking Proxacin 250 and Proxacin 500 medicines, tell your doctor if:

the patient has ever had kidney problems, as treatment may need to be adjusted;
the patient suffers from epilepsy or other neurological disorders;
the patient has previously experienced tendon problems while being treated with antibiotics such as Proxacin 250 and Proxacin 500;
the patient has diabetes – after using ciprofloxacin, blood sugar levels may drop significantly (hypoglycaemia may occur) – see also below and section 4;
the patient has myasthenia (a type of muscle weakness) – symptoms may worsen;
the patient has heart disorders. Caution is advised when using this type of medicine if: the patient has congenital or familial QT interval prolongation (visible on ECG – an examination of the heart's electrical activity); the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels); the patient has a very slow heart rate (bradycardia); the patient has impaired heart function (heart failure); the patient has had a heart attack; the patient is female or elderly; the patient is taking other medicines that may cause changes in the ECG (see section 2. “Proxacin 250 and Proxacin 500 medicines and other medicines”);
the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor about this – after using ciprofloxacin, anaemia may occur;
the patient has been diagnosed with a dilated large blood vessel (aortic aneurysm or large peripheral artery);
the patient has previously experienced aortic dissection (tearing of the aortic wall);
the patient has been diagnosed with heart valve insufficiency;
in the patient’s family there have been cases of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

In the treatment of certain urinary-genital tract infections, the doctor may additionally prescribe another antibiotic along with
ciprofloxacin. If the patient does not experience improvement in health after
three days of treatment, consult a doctor.
While using Proxacin 250 and Proxacin 500 medicines
If during treatment with Proxacin 250 or Proxacin 500 any of the following
symptoms occur, tell your doctor immediately. The doctor will decide whether treatment should be discontinued.

Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). This is unlikely, but even after taking the first dose, a severe allergic reaction may occur, with the following symptoms: chest tightness, dizziness, nausea, fainting or dizziness upon standing. If this happens, stop using Proxacin 250 and Proxacin 500 medicines and contact your doctor immediately.
Long-lasting, disabling and potentially irreversible severe adverse effects Antibacterial medicines containing fluoroquinolones/quinolones, including Proxacin 250 and Proxacin 500, have been associated with very rare but serious adverse effects. Some of these were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell. If any of these adverse effects occur after taking Proxacin 250 or Proxacin 500, contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.
Rarely, joint pain and swelling, inflammation or rupture of tendons may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment, or even several months after stopping treatment with Proxacin 250 or Proxacin 500. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Proxacin 250 or Proxacin 500, contact your doctor and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
If the patient has epilepsy or other neurological disorders, such as: cerebral ischaemia (insufficient blood flow to the brain) or stroke, adverse effects on the central nervous system may occur. If seizures occur, stop using Proxacin 250 and Proxacin 500 immediately and contact your doctor.
After the first dose of Proxacin 250 or Proxacin 500, psychiatric reactions may occur. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Proxacin 250 and Proxacin 500. Rarely, depression or psychosis may progress to suicidal thoughts, potentially leading to suicide attempts or suicide. If this occurs, stop using Proxacin 250 and Proxacin 500 and contact your doctor immediately.
The patient 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 a case, stop taking Proxacin 250 or Proxacin 500 and inform your doctor immediately to prevent the development of potentially irreversible disease.
Quinolone antibiotics may cause increased blood sugar levels above normal (hyperglycaemia) or decreased blood sugar levels below normal (hypoglycaemia), which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for diabetic patients. Diabetic patients are advised to carefully monitor their blood sugar levels. If the patient experiences low blood sugar levels (hypoglycaemia), contact your doctor immediately.
While taking antibiotics, including Proxacin 250 and Proxacin 500, or even several weeks after stopping treatment, diarrhoea may occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, stop taking the medicine immediately and contact your doctor, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal movements and contact your doctor immediately.
If the patient is providing a blood or urine sample for testing, they should inform the doctor or laboratory staff about taking Proxacin 250 and Proxacin 500.
If the patient has kidney problems, inform the doctor, as dose adjustment may be necessary.
Vision disturbances or other eye-related complaints should be promptly consulted with an ophthalmologist.
Proxacin 250 and Proxacin 500 may cause liver damage. If the patient notices any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, skin itching or stomach irritation, stop taking the medicine and contact your doctor immediately.
Proxacin 250 and Proxacin 500 may reduce the number of white blood cells, which may lead to reduced immunity against infections. If the patient notices symptoms such as fever and severe worsening of general condition or fever with local infection symptoms such as: sore throat, laryngitis, mouth sores and urinary tract problems, contact your doctor immediately. The doctor will order a blood test to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.
While taking Proxacin 250 and Proxacin 500, the skin becomes more sensitive to sunlight and ultraviolet (UV) radiation. Avoid exposure to strong sunlight or artificial UV radiation (e.g. in a tanning bed).

In case of sudden severe abdominal, back or chest pain, which
may be a symptom of aneurysm or aortic dissection, go immediately to the emergency department. The risk of these conditions may be higher when undergoing systemic corticosteroid treatment.
In case of sudden shortness of breath, especially when lying down, or
observing swelling of the ankles, feet or abdomen, or experiencing palpitations (feeling of rapid or irregular heartbeat), seek medical attention immediately.
Proxacin 250 and Proxacin 500 medicines and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Do not take Proxacin 250 or Proxacin 500 together with tizanidine, as this may
cause adverse effects such as low blood pressure and drowsiness (see section 2 “When not to use Proxacin 250 and Proxacin 500 medicines”)
The following medicines may interact with Proxacin 250
and Proxacin 500 in the human body.
Taking Proxacin 250 or Proxacin 500 together with these medicines may affect their
therapeutic effect. It may also increase the likelihood of adverse effects.
If the patient is taking any of the following medicines, inform your doctor:

vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulant (blood-thinning) medicines;
probenecid (a medicine used in gout);
methotrexate (a medicine used in certain types of cancer, psoriasis, and rheumatoid arthritis);
theophylline (a medicine used in respiratory disorders);
tizanidine (a medicine reducing 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 for nausea and vomiting);
cyclosporine (a medicine used in skin diseases, rheumatoid arthritis and after organ transplantation);
other medicines that may affect heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial medicines (belonging to the macrolide group), some antipsychotic medicines.
zolpidem (a medicine used for insomnia).

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

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 disorders and anaesthesiology);
sildenafil (a medicine used e.g. in erectile dysfunction);
agomelatine (a medicine used in depression).

Some medicines reduce the effectiveness of Proxacin 250 and Proxacin 500. Inform your doctor
if the patient is taking or plans to take:

medicines that neutralise gastric acid;
omeprazole (a medicine used in peptic ulcer disease);
mineral supplements;
sucralfate;
polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate);
medicines containing calcium, magnesium, aluminium or iron, or supplements containing these elements. If taking these medicines is necessary, Proxacin 250 or Proxacin 500 should be taken approximately two hours before or at least four hours after taking them.

Taking Proxacin 250 and Proxacin 500 with food and drink
If Proxacin is not taken with food, do not eat or drink any dairy products (such as milk or yoghurt) or calcium-fortified beverages (e.g. calcium-enriched orange juice) at the same time as the tablet, as this may impair absorption of the active substance.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
It is best to avoid using Proxacin 250 and Proxacin 500 during pregnancy.
Do not take Proxacin 250 or Proxacin 500 while breastfeeding, as ciprofloxacin passes into breast milk and may be harmful to the child.
Driving and operating machinery
Proxacin 250 and Proxacin 500 may impair concentration. Some adverse effects affecting the nervous system may occur. Before the patient starts driving or operating machinery, they should assess how they react to Proxacin 250 or Proxacin 500. 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, meaning the medicine is considered "sodium-free".

3. How to use Proxacin 250 and Proxacin 500

Your doctor will explain exactly what dose of Proxacin 250 or Proxacin 500 to 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 must inform your doctor, as your dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer for severe infections.
Always take the tablets exactly as prescribed by your doctor. If you are unsure about the number of tablets or how to take Proxacin 250 or Proxacin 500, contact your doctor or pharmacist.

Swallow the tablets whole with plenty of fluid, for example a glass of water. Do not chew the tablets, as they have an unpleasant taste.
It is best to take the tablets at approximately the same time each day.
The tablets may be taken with or without food. Calcium present in food does not significantly affect absorption. However, do not take Proxacin 250 and Proxacin 500 with dairy products such as milk or yoghurt, or with fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids throughout the entire period of treatment with Proxacin 250 or Proxacin 500.

Taking more Proxacin 250 or Proxacin 500 than prescribed
If you have taken more than the prescribed dose, seek medical help immediately. If possible, take the tablets or the packaging with you to show the doctor.
Missing a dose of Proxacin 250 or Proxacin 500
Take the missed dose as soon as possible, then continue treatment as prescribed by your doctor. However, if it is almost time for your next dose, do not take the missed dose. Instead, take the next dose at the usual time.
Do 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 early, 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 cured, symptoms may return or worsen, and bacteria may develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions observed during treatment with this medicine are listed
below:
If you notice any of the symptoms listed below, stop taking
Proxacin 250 and Proxacin 500 immediately and contact your doctor straight away, as
another antibiotic may need to be prescribed.
Rare adverse reactions (may occur in no more than 1 in
1,000 patients):

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

Very rare adverse reactions (may occur in fewer than 1 in
10,000 patients):

severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction/shock) (see section 2. "Warnings and precautions");
muscle weakness, tendon inflammation 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");
life-threatening skin rash, usually presenting as blisters or ulcers of the mouth, throat, nose, eyes, and genital mucous membranes, followed by spreading blisters or skin peeling (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).

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

nervous system disorders such as pain, burning, tingling, numbness, and (or) limb weakness (neuropathy);
drug hypersensitivity reaction causing rash, fever, internal organ inflammation, haematological disorders and systemic illness
(drug reaction with eosinophilia and systemic symptoms, known as DRESS, acute generalized exanthematous pustulosis known as AGEP).

Administration of quinolone and fluoroquinolone antibiotics has very rarely led, even in cases without pre-existing risk factors, to long-term (lasting for months or years) or permanent adverse reactions such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.
Other adverse reactions observed during treatment with Proxacin 250
and Proxacin 500 are listed below, according to their likelihood of occurrence.
Common adverse reactions (may occur in no more than 1 in 10 patients):

nausea (feeling sick), diarrhoea;
joint pain and inflammation in children.

Uncommon adverse reactions (may occur in no more 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 restlessness;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive disturbances such as indigestion (dyspepsia, heartburn), flatulence;
increased levels of certain substances in the blood, such as aminotransferases and (or) bilirubin;
rash, itching or hives;
kidney function disorder;
muscle and bone pain, malaise (weakness), fever;
increased blood alkaline phosphatase activity (a specific substance in the blood).

Rare adverse reactions (may occur in no more than 1 in
1,000 patients):

muscle pain, joint inflammation, increased muscle tension or cramps;
antibiotic-associated bowel inflammation (colitis) (very rarely may be fatal) – see section 2. "Warnings and precautions";
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased platelet count (involved in blood clotting);
allergic reaction, oedema (swelling) of allergic origin, or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. "Warnings and precautions");
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels (hypoglycaemia), which in severe cases may lead to diabetic coma. This is important for people with diabetes (see section 2. "Warnings and precautions");
confusion, disorientation, anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts, suicidal ideation or attempts, or suicide), hallucinations (see section 2. "Warnings and precautions");
sensory disturbances (pricking, tingling sensations or unusual sensitivity to sensory stimuli), reduced skin sensitivity to touch; tremor, or dizziness;
visual disturbances (including double vision) (see section 2. "Warnings and precautions");
tinnitus, hearing loss, hearing disturbances;
rapid heartbeat (tachycardia);
blood vessel dilation, low blood pressure or fainting;
shortness of breath, including asthmatic condition, i.e. symptoms of severe asthma exacerbation;
liver function disorders, cholestatic jaundice or hepatitis;
photosensitivity (see section 2. "Warnings and precautions");
kidney failure, blood or crystals in urine, urinary tract inflammation;
fluid retention, excessive sweating;
increased activity of an enzyme called amylase.

Very rare adverse reactions (may occur in fewer than 1 in 10,000
patients):

a specific type of reduced red blood cell count called haemolytic anaemia; dangerous reduction in white blood cells (agranulocytosis) (see section 2. "Warnings and precautions"), reduction in red and white blood cells and platelets (pancytopenia), which may be fatal, and bone marrow suppression, which may also be fatal;
serum sickness-like allergic reaction (see section 2. "Warnings and precautions");
mental disturbances (psychotic reactions which 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 (pseudotumour cerebri);
colour vision disturbances;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
liver cell necrosis (liver necrosis), very rarely leading to life-threatening liver failure (see section 2. "Warnings and precautions");
small dark spots visible under the skin (petechiae), various skin eruptions or rashes;
worsening of myasthenia symptoms (see section 2. "Warnings and precautions").

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

heart rhythm disturbances, life-threatening irregular heartbeat, rapid heartbeat (known as "QT interval prolongation", visible on ECG – a test measuring the heart's electrical activity);
blood coagulation disorders (in patients treated with vitamin K antagonists);
a disease syndrome associated with impaired water excretion and reduced sodium concentration in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
loss of consciousness due to significant reduction in blood sugar levels (hypoglycaemic coma). See section 2.
feeling of excessive excitement (mania) or feeling of excessive optimism and hyperactivity (hypomania);

In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial wall rupture (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.
Reporting of adverse reactions
If any 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 Adverse Drug Reactions at the 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Proxacin 250 and Proxacin 500

Keep in the original packaging to protect from light.
Keep 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 stated 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: pregelatinized starch, microcrystalline cellulose, colloidal anhydrous 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: pregelatinized starch, microcrystalline cellulose, colloidal anhydrous 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, oblong, and biconvex.
The medicines are packaged in cardboard boxes containing 10 tablets in a single Al/PVC foil blister.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(logo of the marketing authorisation holder)

Manufacturer
Labormed-Pharma S.A.,
Bd. Theodor Pallady no. 44B, sector 3,
032266 Bucharest
Romania

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Advice – Medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Antibiotics should only be used for conditions in which a doctor has prescribed them. Despite their action, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. It may even cause bacteria to become resistant, prolonging treatment or reducing the antibiotic's effectiveness, if the patient does not follow the doctor's instructions regarding:
- dosage,
- frequency of administration,
- duration of treatment.

Therefore, to maintain the effectiveness of this medicine, you should:
1 – use antibiotics only when prescribed by a doctor;
2 – strictly follow the doctor's instructions;
3 – not reuse antibiotics without a doctor's prescription, even if the current illness appears similar to the one previously treated with antibiotics;
4 – never give antibiotics to another person, as it may be inappropriate for their condition;
5 – after completing treatment, return any unused medicine to a pharmacy for proper disposal.