CIPROPOL 500 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Cipropol, 500 mg, film-coated tablets
   1. Table of contents of the leaflet
3. What is Cipropol and what is it used for
4. Important information before taking Cipropol
   1. When not to take Cipropol:
   2. Warnings and precautions
   3. Before starting treatment with Cipropol, you should discuss the following with your doctor:
   4. During ciprofloxacin treatment
   5. Long-lasting, debilitating and potentially irreversible severe side effects.
   6. Cipropol and other medicines
   7. If you are taking any of the following medicines, you should tell your doctor:
   8. Cipropol with food and drink
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Cipropol contains sodium
5. How to take Cipropol
   1. Overdose of Cipropol
   2. Missing a dose of Cipropol
   3. Stopping treatment with Cipropol
6. Possible side effects
   1. The most serious side effects observed during treatment with this medicine are
   2. Reporting side effects
7. How to store Cipropol
8. Contents of the packaging and other information
   1. What Cipropol contains
   2. What Cipropol looks like and contents of the pack
   3. Marketing authorisation holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. Medical advice – medical education
   7. Consequently, to maintain the effectiveness of this medicine:

Leaflet accompanying the packaging: patient information

Cipropol, 500 mg, film-coated tablets

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

• 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 for you only. 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 is Cipropol and what is it used for
• 2. Important information before taking Cipropol
• 3. How to take Cipropol
• 4. Possible side effects
• 5. How to store Cipropol
• 6. Contents of the packaging and other information

1. What is Cipropol and what is it used for

Cipropol contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone group. Ciprofloxacin kills bacteria that cause infections. It only works on certain strains of bacteria.
Adults
Cipropol is used in adults to treat the following bacterial infections:

• certain respiratory tract infections;
• certain long-term or recurring ear or sinus infections;
• urinary tract infections;
• genital infections in women and men;
• gastrointestinal tract infections and intra-abdominal infections;
• skin and soft tissue infections;
• bone and joint infections;
• prevention of infections caused by the bacterium Neisseria meningitidis;
• exposure to anthrax spores.

Ciprofloxacin can be used to treat patients with neutropenia and fever, which is likely to be caused by a bacterial infection.
If the infection is severe or caused by more than one type of bacteria, the doctor may recommend an additional antibiotic to be taken together with Cipropol.
Children and adolescents
Cipropol is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

• lung and bronchial infections in children and adolescents with cystic fibrosis;
• complicated urinary tract infections, including kidney infections (pyelonephritis);
• exposure to anthrax spores.

Cipropol can also be used to treat severe infections in children and adolescents, if the doctor considers it necessary.

2. Important information before taking Cipropol

When not to take Cipropol:

• 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. Cipropol and other medicines).

Warnings and precautions

Before taking this medicine
You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Cipropol, if you have ever had a severe side effect while taking a quinolone or fluoroquinolone antibiotic. In such cases, you should inform your doctor as soon as possible.

Before starting treatment with Cipropol, you should discuss the following with your doctor:

• if you have ever had kidney problems, as your doctor may need to adjust your dose;
• if you have epilepsy or other neurological disorders;
• if you have ever had tendon problems during treatment with antibiotics such as Cipropol;
• if you have diabetes, as ciprofloxacin treatment may increase the risk of hypoglycaemia;
• if you have myasthenia gravis (a type of muscle weakness) - your symptoms may worsen;
• if you have been diagnosed with a dilated blood vessel (aortic aneurysm or large peripheral arterial aneurysm);
• if you have had a dissection of the aorta (a tear in the aortic wall);
• if you have been diagnosed with a heart valve problem;
• if you have a family history of aortic aneurysm or aortic dissection or other risk factors or conditions (e.g. Marfan syndrome, 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 [infection of the heart]);
• if you have heart problems. You should be cautious when taking ciprofloxacin-containing medicines, if: you have been diagnosed with a congenital or familial 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 in the blood); 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 elderly.

if you are taking other medicines that may affect the ECG (see section 2. Cipropol and other medicines).

• if you or a family member have been diagnosed with a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should inform your doctor - ciprofloxacin may cause anaemia.

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

During ciprofloxacin treatment

If any of the following symptoms occur during treatment with Cipropol, you should immediately inform your doctor. Your doctor will decide whether to stop taking Cipropol.

• Severe, sudden allergic reaction(anaphylactic reaction or shock, angioedema). Although rare, a severe allergic reaction can occur even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting or dizziness when standing up. If this happens, you should stop taking Cipropol and contact your doctor immediately.

Long-lasting, debilitating and potentially irreversible severe side effects.

Fluoroquinolone and quinolone antibacterial medicines, including Cipropol, have been associated with very rare but severe side effects. Some of these have been long-lasting (lasting for months or years), debilitating or potentially irreversible. These include: tendon pain, muscle and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations such as tingling, numbness, prickling, burning, tingling or pain (paresthesia), sensory disturbances, including vision, taste and smell and hearing disturbances, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Cipropol, 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, tendon pain and swelling, as well as tendon inflammation or rupturemay occur. The risk is increased in the elderly (over 60 years), after organ transplantation, in patients with kidney problems or those taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and up to several months after stopping Cipropol. If you experience the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), you should stop taking Cipropol, contact your doctor and rest the affected area. You should avoid excessive strain, as this may increase the risk of tendon rupture.
• In case of sudden, severe abdominal, back or chest pain, which may be a sign of an aortic aneurysm or aortic dissection, you should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or palpitations (a feeling of rapid or irregular heartbeat), you should immediately consult your doctor.
• If you have epilepsyor other neurological disorders, such as cerebral ischaemia or stroke, side effects from the central nervous system may occur. If this happens, you should stop taking ciprofloxacin and contact your doctor immediately.

układu nerwowego. Jeśli tak się stanie, należy przerwać stosowanie cyprofloksacyny i
natychmiast skontaktować się z lekarzem.

• U pacjenta mogą rzadko wystąpić objawy uszkodzenia nerwów (neuropatii), takie jak ból, pieczenie, mrowienie, drętwienie i (lub) osłabienie, zwłaszcza stóp i nóg oraz dłoni i rąk. W takim przypadku należy przerwać przyjmowanie leku Cipropol i natychmiast poinformować lekarza, aby zapobiec rozwojowi potencjalnie nieodwracalnej choroby.
• Po pierwszym przyjęciu leku Cipropol mogą wystąpić zaburzenia psychiczne. Jeśli u pacjenta występuje depresjalub psychoza,objawy tych chorób mogą się nasilać podczas stosowania leku Cipropol. Rzadko depresja lub psychoza mogą rozwinąć się do stadium myśli samobójczych, mogących prowadzić do prób samobójczych lub samobójstwa. Jeśli tak się stanie, należy przerwać stosowanie leku Cipropol i natychmiast skontaktować się z lekarzem.
• Antybiotyki chinolonowe mogą powodować zwiększeniestężenia cukru we krwi powyżej normy (hiperglikemię) lub zmniejszenie stężenia cukru we krwiponiżej normy mogące w ciężkich przypadkach prowadzić do utraty przytomności (śpiączki hipoglikemicznej) (patrz punkt 4). Jest to ważne dla pacjentów chorych na cukrzycę. U chorych na cukrzycę zaleca się uważne monitorowanie stężenia cukru we krwi.
• Podczas przyjmowania antybiotyków, w tym leku Cipropol, lub nawet przez kilka tygodni po zakończeniu leczenia może pojawić się biegunka.Jeżeli będzie ona ciężka lub uporczywa, albo pacjent zauważy krew lub śluz w stolcu, należy natychmiast przerwać stosowanie leku Cipropol, ponieważ może to zagrażać życiu. Nie należy przyjmować leków, które hamują lub spowalniają ruchy jelit i należy skontaktować się z lekarzem.
• Jeśli u pacjenta wystąpi pogorszenie widzenia lub jakiekolwiek inne zaburzenia wzroku, należy niezwłocznie skontaktować się z lekarzem okulistą.
• Podczas przyjmowania leku Cipropol skóra staje się bardziej wrażliwa na światło słoneczne i promieniowanie ultrafioletowe (UV).Należy unikać narażenia na silne światło słoneczne lub sztuczne promienie UV (np. w solarium).
• Jeżeli pacjent oddaje próbkę krwi lub moczu do analizy, powinien poinformować lekarza lub personel laboratorium o tym, że stosuje lek Cipropol.
• Jeśli pacjent ma chore nerki, powinien powiedzieć o tym lekarzowi, ponieważ może być konieczna modyfikacja dawki leku.
• Lek Cipropol może spowodować uszkodzenie wątroby.Jeśli pacjent zauważy następujące objawy: utrata apetytu, żółtaczka (zażółcenie skóry), ciemny mocz, swędzenie skóry lub drażliwość żołądka, należy przerwać stosowanie leku Cipropol i natychmiast skontaktować się z lekarzem.
• Lek Cipropol może zmniejszać liczbę białych krwinek, co może powodować zmniejszenie odporności na zakażenia. Jeżeli pacjent zauważy, że podczas zakażenia występują takie objawy, jak: gorączka i silne pogorszenie stanu ogólnego lub gorączka z miejscowymi objawami zakażenia, takimi jak: ból gardła, krtani, jamy ustnej i problemy z układem moczowym, należy natychmiast skontaktować się z lekarzem. Lekarz zaleci badanie krwi, żeby sprawdzić, czy nie doszło do zmniejszenia liczby białych krwinek (agranulocytoza). Należy pamiętać, aby poinformować lekarza o przyjmowaniu tego leku.

Cipropol and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Cipropol must not be taken 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 Cipropol").
The following medicines may interact with Cipropol in the body. Taking Cipropol with these medicines may affect their therapeutic effect. This may also increase the risk of side effects.

If you are taking any of the following medicines, you should tell your doctor:

• vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindion) or other oral anticoagulant medicines ("blood thinners");
• probenecid (in gout);
• methotrexate (in certain types of cancer, psoriasis, rheumatoid arthritis);
• theophylline (in respiratory disorders);
• tizanidine (to reduce excessive muscle tension in multiple sclerosis);
• olanzapine (an antipsychotic medicine);
• clozapine (an antipsychotic medicine);
• ropinirole (in Parkinson's disease);
• phenytoin (in epilepsy);
• metoclopramide (for nausea and vomiting);
• cyclosporin (in skin disorders, rheumatoid arthritis and organ transplantation);
• other medicines that may affect heart rhythm: anti-arrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial medicines (belonging to the macrolide group), certain antipsychotic medicines;
• zolpidem (in sleep disorders).

Cipropol may increasethe levels of the following medicines in the blood:

• pentoxifylline (in circulatory disorders);
• caffeine;
• duloxetine (in depression, diabetic neuropathy and urinary incontinence);
• lidocaine (in heart disorders and anaesthetic applications);
• sildenafil (e.g. in erectile dysfunction);
• agomelatine (in depression).

Some medicines may reducethe effect of Cipropol. You should inform your doctor if you are taking or plan to take:

• antacids;
• omeprazole;
• mineral supplements;
• sucralfate;
• phosphate-binding polymers (e.g. sevelamer or lanthanum carbonate);
• medicines containing calcium, magnesium, aluminium or iron, or supplements containing these minerals.

If it is necessary to take these products, Cipropol should be taken about 2 hours before or at least 4 hours after taking them.

Cipropol with food and drink

Taking calcium, including dairy products and calcium-enriched juices (such as orange juice with added calcium), at the same time as Cipropol may affect the action of Cipropol:

• When taken as part of a meal, they will not have a significant effect on the action of this medicine.
• However, if Cipropol is taken at the same time as dairy products and calcium-enriched juices taken on their own (not as part of a meal), this may reduce the effect of Cipropol. Therefore, Cipropol should be taken 1-2 hours before or at least 4 hours after taking dairy products or calcium-enriched juices on their own (not as part of a meal) (see also section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cipropol should be avoided during pregnancy.
You should not take Cipropol while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and using machines

Cipropol may cause drowsiness. Some neurological side effects may occur. Before driving or operating machinery, you should check how you react to Cipropol.
In case of doubt, consult your doctor.

Cipropol contains sodium

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

3. How to take Cipropol

Your doctor will explain in detail what dose of Cipropol you should take, how often and for how long. 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. You should always take the tablets as directed by your doctor. If you are unsure about the number of tablets to take or how to take Cipropol, you should consult your doctor or pharmacist.
a.
Swallow the tablets with a large amount of liquid.
b.
Do not chew or crush the tablets. If you are unable to swallow the tablet, you should inform your doctor so that they can prescribe a more suitable form of the medicine for you.
c.
It is best to take the tablets at about the same time each day.
d.
The tablets can be taken with or without food. Cipropol can be taken during meals containing dairy products (such as milk or yoghurt) or calcium-enriched juices (such as orange juice with added calcium). However, you should not take Cipropol at the same time as dairy products or calcium-enriched juices taken on their own (not as part of a meal). Exceptions are situations where the tablets are taken 1-2 hours before or at least 4 hours after consuming these products.
You should remember to drink plenty of fluids while taking this medicine.

Overdose of Cipropol

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

Missing a dose of Cipropol

If you miss a dose of Cipropol, and:

• 6 hours or more have passed since the next planned dose, you should take the missed dose immediately. Then take the next dose at the usual time.
• less than 6 hours have passed since the next planned dose, do not take the missed dose. Take the next dose at the usual time.

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 Cipropol

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

4. Possible side effects

Like all medicines, Cipropol can cause side effects, although not everybody gets them.

The most serious side effects observed during treatment with this medicine are

listedbelow:
In case of the following symptoms, you should stop taking Cipropol and contact your doctor immediately, as you may need to take another antibiotic.
Rarely(may occur in less than 1 in 1,000 patients):

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

Very rarely(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);
• weakness, tendon inflammation, 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, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and genital areas, with subsequent spread of blisters or skin peeling (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).

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

• nerve disorders, such as pain, burning, tingling, numbness and (or) weakness of the limbs (neuropathy) (see section 2. "Warnings and precautions");
• an allergic reaction that causes a rash, fever, inflammation of internal organs, blood disorders and systemic diseases (drug reaction with eosinophilia and systemic symptoms, DRESS); acute generalized exanthematous pustulosis (AGEP).

Other side effectsthat have been reported during treatment with Cipropol are listed below, according to their frequency of occurrence.
Common(may occur in less than 1 in 10 patients):

• nausea (nausea), diarrhoea;
• joint pain and arthritis in children.

Uncommon(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 activity or agitation;
• headache, dizziness, sleep disturbances or taste disturbances;
• vomiting, stomach pain, digestive disorders, such as indigestion (dyspepsia) or flatulence;
• increased levels of certain substances in the blood [transaminases and (or) bilirubin];
• skin rash, itching or hives;
• kidney function impairment;
• muscle and bone pain, general malaise (weakness) or fever;
• increased activity of alkaline phosphatase in the blood (a specific substance in the blood).

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

• muscle pain, tendon inflammation, increased muscle tension or cramps;
• antibiotic-associated colitis (very rarely can be life-threatening) (see section 2. Warnings and precautions);
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased platelet count;
• allergic reaction, swelling (oedema) or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. "Warnings and precautions");
• high blood sugar levels (hyperglycaemia);
• low blood sugar levels (hypoglycaemia), which in severe cases can lead to loss of consciousness (hypoglycaemic coma). This is important for patients with diabetes (see section 2. "Warnings and precautions");
• confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. "Warnings and precautions") or hallucinations (delusions);
• tingling sensation, increased sensitivity to stimuli, decreased skin sensitivity, tremors or dizziness;
• vision disturbances, including double vision (see section 2. "Warnings and precautions");
• tinnitus, hearing loss, hearing disturbances;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure or fainting;
• shallow breathing, including asthma symptoms;
• liver function disorders, jaundice (with bile stagnation) or hepatitis;
• sensitivity to light (see section 2. Warnings and precautions);
• kidney function impairment, blood or crystals in the urine, urinary tract inflammation;
• fluid retention or excessive sweating;
• increased activity of the enzyme amylase.

Very rarely(may occur in less than 1 in 10,000 patients):

• a specific type of reduced red blood cell count (haemolytic anaemia), a dangerous reduction in the number of white blood cells (agranulocytosis) (see section 2. "Warnings and precautions"); reduction 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 potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions);
• migraine, coordination disorders, unstable gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumour cerebri);
• colour vision disturbances;
• vasculitis (inflammation of blood vessel walls);
• pancreatitis;
• liver cell death (liver necrosis), very rarely leading to life-threatening liver failure (see section 2. Warnings and precautions);
• small dark spots visible under the skin (purpura); various skin rashes or eruptions;
• worsening of myasthenia gravis symptoms (see section 2. Warnings and precautions).

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

• a syndrome associated with impaired water excretion and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• a feeling of great excitement (mania) or an unusually good mood associated with overactivity (hypomania);
• heart disorders, such as very rapid heartbeat, life-threatening irregular heartbeat, heart rhythm disorders (called "prolonged QT interval", visible on an ECG - a test of the heart's electrical activity);
• effect on blood clotting (in patients treated with vitamin K antagonists);
• loss of consciousness due to significantly low blood sugar levels (hypoglycaemic coma). See section 2. Warnings and precautions;

Administration of fluoroquinolone and quinolone antibacterial medicines, in some cases regardless of existing risk factors, has very rarely led to long-lasting (lasting for months or years) or permanent drug side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations such as tingling, numbness, prickling, burning, tingling or pain (neuropathy), fatigue, memory impairment, concentration disorders, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts) and disturbances of hearing, vision, taste and smell.
In patients taking fluoroquinolones, cases of aortic dilatation and aortic aneurysm or aortic dissection have been reported, which can be fatal, as well as cases of aortic valve regurgitation. 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 or pharmacist.
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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cipropol

The medicine should be kept out of the sight and reach of children.
You should not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging.
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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Cipropol contains

The active substance of Cipropol is ciprofloxacin. One film-coated tablet contains 500 mg of ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate, in a quantity of 583 mg.
The other ingredients are:
microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, sodium glycolate starch, maize starch; OPADRAY OY-S-28842 (white) coating: hypromellose (E 464), macrogol, titanium dioxide.

What Cipropol looks like and contents of the pack

Oval, film-coated tablets, biconvex, white, with a score line on one side. The tablet can be divided into equal doses.
The carton contains 10 tablets and a patient information leaflet.

Marketing authorisation holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter România S.A.
Cuza Vodă street 99-105
Târgu-Mureş
Romania – 540306
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
For more detailed information on this medicine, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 22 755 96 48
[email protected]

Date of last revision of the leaflet:

Medical advice – medical education

Antibiotics are used to treat bacterial infections. They do not work in viral infections.
Antibiotics should only be used for the diseases for which the doctor has prescribed them. Improper use of antibiotics increases resistance. You can even cause bacteria to become resistant, making antibiotic treatment ineffective, if you do not follow the doctor's instructions regarding:

• dose size
• frequency of administration
• duration of treatment

Consequently, to maintain the effectiveness of this medicine:

• 1 – You should only take an antibiotic if it has been prescribed by a doctor.
• 2 – You should strictly follow the doctor's instructions.
• 3 – You should not take an antibiotic again without a doctor's prescription, even if your current illness is similar to the one for which the antibiotic was prescribed.
• 4 – You should never give an antibiotic to another person, as it may be inappropriate for their illness.
• 5 – After completing treatment, you should return any unused medicine to the pharmacy, so that it can be disposed of properly.

(logo of the marketing authorisation holder)
(pharmaceutical company)