Patient Information Leaflet

Ciprofloxacin Zentiva 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ciprofloxacin Zentiva is and what it is used for
What you need to know before taking Ciprofloxacin Zentiva
How to take Ciprofloxacin Zentiva
Possible side effects
How to store Ciprofloxacin Zentiva
Contents of the pack and other information

1. What is ciprofloxacin Zentiva and what is it used for?

Ciprofloxacin Zentiva contains the active substance ciprofloxacin, which belongs to a group of medicines called
fluoroquinolone antibiotics that work by killing the bacteria causing infections.
This medicine is effective only against certain strains of bacteria.
Adults
Ciprofloxacin Zentiva is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
urinary tract infections
genital tract infections in men and women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to prevent and treat infections in patients with very low white blood cell counts (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
to prevent and treat infections caused by exposure to inhaled anthrax spores

If you have a severe infection or an infection caused by more than one type of bacteria, your doctor may prescribe another antibiotic treatment in addition to Ciprofloxacin Zentiva.
Children and adolescents
Ciprofloxacin Zentiva is used in children and adolescents under the supervision of a specialist doctor to treat the following bacterial infections:

lung and bronchial infections in children and adolescents with cystic fibrosis
complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
exposure to inhaled anthrax spores

Ciprofloxacin Zentiva may also be used to treat other specific severe infections in children and adolescents when considered necessary by the doctor.

2. What you need to know before taking ciprofloxacin Zentiva

Do not take Ciprofloxacin Zentiva:

if you are allergic to the active substance, to other quinolones, or to any of the excipients of Ciprofloxacin Zentiva (see section 6);
if you are taking tizanidine (see section 2: “Other medicines and Ciprofloxacin Zentiva”).

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin Zentiva, if in the past you have experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycaemia) or a decrease below normal levels, which in severe cases could potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
Talk to your doctor before taking Ciprofloxacin Zentiva

if you have kidney problems, as your treatment may need to be adjusted.
if you suffer from epilepsy or other neurological disorders.
if you have had tendon problems during previous treatment with antibiotics similar to Ciprofloxacin Zentiva.
if you have diabetes, because you may be at risk of hypoglycaemia when using ciprofloxacin.
if you have a muscle disease characterised by muscle weakness (myasthenia gravis), as symptoms may worsen.
if you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
if you have been diagnosed with failure of one of the heart valves (aortic or mitral regurgitation).
if you have a family history of aortic aneurysm, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
if you have a heart condition. Special caution is required when using ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on ECG (see section 2 “Other medicines and Ciprofloxacin Zentiva”).
if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of reduced red blood cells (haemolytic anaemia).

For the treatment of certain infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement after 3 days of treatment, consult your doctor.
While taking Ciprofloxacin Zentiva
Inform your doctor immediately if, during treatment with Ciprofloxacin Zentiva, you experience any of the following conditions. Your doctor will decide whether treatment with Ciprofloxacin Zentiva should be discontinued.

If you experience a severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, or angioedema). There is a remote possibility of a severe allergic reaction even after the first dose, with symptoms such as chest tightness and difficulty breathing, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop taking Ciprofloxacin Zentiva and inform your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Zentiva, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, pins and needles, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin Zentiva, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Pain and swelling in joints and tendon inflammation or rupture may rarely occur. The risk is higher if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Ciprofloxacin Zentiva. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin Zentiva, contact your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
If you experience sudden and severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (a sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. If you develop seizures, stop taking Ciprofloxacin Zentiva and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness may occur, particularly in the feet and legs or hands and arms. In such a case, stop taking Ciprofloxacin Zentiva and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin Zentiva. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Zentiva, and in rare cases suicidal or self-harming thoughts may occur. If this happens, contact your doctor immediately, as treatment with the medicine must be stopped.
If you develop diarrhoea during treatment with antibiotics, including Ciprofloxacin Zentiva, and this worsens or becomes persistent (even several weeks later), or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Zentiva must be stopped immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or you experience any eye problems, consult an ophthalmologist immediately.
If your skin becomes more sensitive to sunlight or ultraviolet (UV) light while taking ciprofloxacin. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Zentiva if you are undergoing blood or urine tests.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
Ciprofloxacin Zentiva may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking the medicine and contact your doctor immediately.
If you are undergoing tuberculosis testing, as results may be inaccurate.
Ciprofloxacin Zentiva may cause a reduction in white blood cell count, leading to reduced resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with signs of a localised infection such as sore throat, throat or mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Ciprofloxacin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking other medicines that may alter heart rhythm, such as medicines belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants (medicines for depression), certain antibiotics (belonging to the macrolide class), or certain antipsychotics (medicines for mental illnesses).
Do not take this medicine with tizanidine, as it may cause low blood pressure and drowsiness (sedation).
The following medicines interact with Ciprofloxacin Zentiva in the body. Taking Ciprofloxacin Zentiva together with these medicines may affect their therapeutic effect and increase the likelihood of side effects.
Inform your doctor if you are taking the following medicines:

vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
metoclopramide (for nausea and vomiting)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
phenytoin (for epilepsy)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes)
ropinirole (for Parkinson’s disease)
olanzapine (antipsychotic)
clozapine (antipsychotic)
zolpidem (for sleep disorders)

Ciprofloxacin Zentiva may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g. for erectile dysfunction)
agomelatine (for depression)

The following medicines reduce the effect of ciprofloxacin. Inform your doctor if you are taking or plan to take:

antacids
omeprazole
mineral salt supplements
sucralfate
polymeric phosphate binders (e.g. sevelamer)
medicines or supplements containing calcium, magnesium, aluminium, or iron.

If you need to take Ciprofloxacin Zentiva together with these medicines, take it approximately 1–2 hours before or at least 4 hours after taking these products.
Ciprofloxacin Zentiva with food and drinks
Unless otherwise directed, do not consume dairy products (such as milk or yoghurt) or calcium-fortified drinks when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin Zentiva during pregnancy.
Do not use Ciprofloxacin Zentiva while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
This medicine may affect your ability to concentrate. As neurological adverse events may occur, assess your response to Ciprofloxacin Zentiva before driving a vehicle or operating machinery. If in doubt, consult your doctor.

3. How to take ciprofloxacin Zentiva

Your doctor will explain exactly what dose of Ciprofloxacin Zentiva you should take, how often, and for how long. This will depend on the type and severity of your infection.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
The usual duration of treatment is 5 to 21 days, but it may last longer for severe infections. Always take the tablets exactly as your doctor has instructed. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin Zentiva.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets, as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take this medicine with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids throughout the entire treatment period with Ciprofloxacin Zentiva.
If you take more Ciprofloxacin Zentiva than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, take the tablets or the pack with you to show the doctor.
If you forget to take Ciprofloxacin Zentiva
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.
If you stop taking Ciprofloxacin Zentiva
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, the infection may not be completely cured, and symptoms may return or worsen. You may also develop resistance to the antibiotic.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ciprofloxacina Zentiva can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:

Common (may affect up to 1 in 10 people):

nausea, diarrhoea;
joint pain in children.

Uncommon (may affect up to 1 in 100 people):

fungal superinfections;
increase in certain white blood cells (eosinophilia) in the blood;
loss of appetite (anorexia);
hyperactivity or agitation;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn), intestinal gas;
increased bilirubin and/or transaminases in the blood;
itching, urticaria, skin rash;
joint pain in adults;
reduced kidney function;
muscle and bone pain, loss of muscle strength (asthenia), fever;
increased alkaline phosphatase in the blood (a certain substance in the blood).

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

inflammation of the intestine (colitis) associated with antibiotic use (in rare cases may be life-threatening) (see section “Warnings and precautions”);
increase or decrease in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia, thrombocytopenia, thrombocytosis);
hyperglycaemia and hypoglycaemia (see section “Warnings and precautions”);
allergic reaction, swelling (oedema);
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema);
confusion, disorientation, anxiety, unusual dreams, hallucinations;
depression which may potentially lead to suicidal thoughts or suicide attempts (see section “Warnings and precautions”);
altered sensation in limbs (paraesthesia, dysaesthesia, hypoesthesia);
tremor, vertigo and convulsions (including status epilepticus, see section “Warnings and precautions”);
visual disturbances (e.g. double vision);
ringing in the ears (tinnitus), decreased/hearing loss;
rapid heartbeat (tachycardia);
dilation of blood vessels (vasodilation), low blood pressure (hypotension);
fainting;
breathing difficulties (dyspnoea), including asthma-like symptoms;
liver disorders, yellowing of the skin and whites of the eyes (cholestatic jaundice), inflammation of the liver (hepatitis);
sensitivity to light (photosensitivity) (see section “Warnings and precautions”);
muscle pain, joint inflammation, increased muscle tone, cramps;
kidney failure, blood or crystals in urine, inflammation of the urinary tract;
excessive sweating;
swelling due to fluid accumulation (oedema);
increased levels of the enzyme amylase.

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

decrease in red blood cells (haemolytic anaemia), decrease in a type of white blood cells (agranulocytosis) (see section “Warnings and precautions”);
decrease in all blood cells (pancytopenia) and bone marrow suppression, which may be life-threatening;
severe allergic reactions, some of which may be life-threatening (anaphylactic reaction, serum sickness-like reaction, anaphylactic shock) (see section “Warnings and precautions”);
mental disorders (psychotic reactions) which may potentially lead to suicidal thoughts or suicide attempts (see section “Warnings and precautions”);
headache (migraine), disturbances in sense of smell (olfactory disturbances);
coordination problems, unsteady gait (gait disturbances), increased pressure inside the brain (intracranial hypertension including pseudotumour cerebri);
distortion in colour perception;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
liver tissue death (hepatic necrosis), which very rarely may lead to life-threatening liver failure (see section “Warnings and precautions”);
pinpoint bleeding under the skin (petechiae), various types of skin eruptions or rashes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, potentially life-threatening);
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section “Warnings and precautions”);
worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”).

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of extremities;
changes in heart rhythm (arrhythmias, QT interval prolongation, torsades de pointes);
skin irritation with redness, crusting, swelling under the skin and blisters (acute generalized exanthematous pustulosis);
altered blood clotting times (in patients treated with vitamin K antagonists);
syndrome associated with impaired water excretion and low sodium levels (SIADH);
loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.
feeling extremely excited (mania) or sensation of great optimism and hyperactivity (hypomania);
drug reaction with eosinophilia and systemic symptoms (DRESS), characterised by skin rash, increased eosinophils (a type of white blood cells), fever and symptoms that may involve multiple organs.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store ciprofloxacin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina Zentiva contains
Ciprofloxacina Zentiva 250 mg film-coated tablets

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 291.5 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of ciprofloxacin.
The other components are:
Core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate;
Tablet coating (Opadry OYS 28905): hypromellose, polyethylene glycol 4000, titanium dioxide (E171).

Ciprofloxacina Zentiva 500 mg film-coated tablets

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of ciprofloxacin.
The other components are:
Core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate;
Tablet coating (Opadry OYS 28905): hypromellose, polyethylene glycol 4000, titanium dioxide (E171).

Ciprofloxacina Zentiva 750 mg film-coated tablets

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of ciprofloxacin.
The other components are:
Core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate;
Tablet coating (Opadry OYS 28905): hypromellose, polyethylene glycol 4000, titanium dioxide (E171).

Description of the appearance of Ciprofloxacina Zentiva and pack contents
CIPROFLOXACINA ZENTIVA 250 mg: pack containing 10 white, biconvex, film-coated tablets, with a score line on one side and marked with "4" on the other.
CIPROFLOXACINA ZENTIVA 500 mg: pack containing 6 white, oblong, film-coated tablets, with a score line on one side and marked with "5" on the other.
CIPROFLOXACINA ZENTIVA 750 mg: pack containing 12 white, oblong, film-coated tablets, marked with "6" on one side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa n.7, 20121 Milano, Italy
Manufacturer
PHARMATHEN S.A. Dervenakion 6, 15351 Pallini Attikis – Greece

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, it is because you specifically need them for your current illness.
Despite antibiotic treatment, certain bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of bacterial resistance and delay recovery or reduce the effectiveness of antibiotics if you do not adhere to:

dosage,
frequency of administration,
duration of treatment. Therefore, to preserve the effectiveness of this medicine:
1 - Use antibiotics only when prescribed.
2 - Strictly follow your doctor's instructions.
3 - Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
4 - Never give your antibiotics to someone else; they may not be suitable for their illness.
5 - At the end of treatment, return all unused medicines to a pharmacy, to ensure they are properly disposed of.