Ciphin 500

Package leaflet: Information for the patient

CIPHIN 500, 500 mg, coated tablets
Ciprofloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Ciphin 500 is and what it is used for
2. Important information before taking Ciphin 500
3. How to take Ciphin 500
4. Possible side effects
5. How to store Ciphin 500
6. Contents of the pack and other information

1. What Ciphin 500 is and what it is used for

Ciphin 500 is an antibiotic belonging to the fluoroquinolone group. The active substance is ciprofloxacin.
Ciprofloxacin works by destroying bacteria causing infections. It acts only on specific strains
of bacteria.
Before starting treatment, your doctor will pay special attention to available information regarding
bacterial resistance to ciprofloxacin.

Adults

• Lower respiratory tract infections caused by Gram-negative bacteria:
  • exacerbations of chronic obstructive pulmonary disease (COPD); Ciphin 500 should be used in exacerbations of COPD only when other antibacterial agents commonly recommended for treating these infections are considered inappropriate.
  • bronchopulmonary infections in cystic fibrosis or bronchiectasis;
  • community-acquired pneumonia. In this indication, Ciphin 500 should be used only when other antibacterial agents commonly recommended for treating these infections are considered inappropriate.
• Chronic suppurative otitis media.
• Acute exacerbation of chronic sinusitis, particularly caused by Gram-negative bacteria.
• Uncomplicated acute cystitis. In uncomplicated acute cystitis, Ciphin 500 should be used only when other antibacterial agents commonly recommended for treating these infections are considered inappropriate.
• Acute pyelonephritis.
• Complicated urinary tract infections.
• Bacterial prostatitis.
• Gonococcal urethritis or cervicitis caused by susceptible strains of Neisseria gonorrhoeae.
• Epididymo-orchitis, including that caused by Neisseria gonorrhoeae.
• Pelvic inflammatory disease, including that caused by Neisseria gonorrhoeae.

If your doctor suspects or diagnoses any of the above-mentioned genital tract infections caused by
Neisseria gonorrhoeae, it is particularly important to obtain local data on resistance prevalence to ciprofloxacin and to confirm susceptibility based on laboratory testing.

• Gastrointestinal infections (e.g. traveller's diarrhoea).
• Intra-abdominal infections.
• Skin and soft tissue infections caused by Gram-negative bacteria.
• Malignant external otitis.
• Bone and joint infections.
• Ciprofloxacin may be used in the treatment of febrile neutropenic patients (with very low white blood cell count) in whom bacterial infection is suspected.
• Prevention of invasive infections caused by Neisseria meningitidis.
• Inhalational anthrax (post-exposure prophylaxis and treatment).

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 if considered necessary.
Treatment should be prescribed only by physicians experienced in the management of cystic fibrosis and/or severe infections in children and adolescents.
The doctor will take into account official guidelines on the appropriate use of antibacterial agents.

2. Important information before using Ciphin 500

When not to use Ciphin 500:

• 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 “Ciphin 500 and other medicines”).

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

• if the patient has ever had kidney problems, as the dose may need to be adjusted;
• if the patient has epilepsy or other neurological disorders;
• if the patient has previously experienced tendon problems while being treated with antibiotics such as Ciphin 500;
• if the patient has myasthenia gravis (a type of muscle weakness);
• if the patient has previously had an irregular heartbeat (arrhythmia);
• if the patient has been diagnosed with heart valve insufficiency;
• if the patient has diabetes (see below and section 4);
• if the patient has been diagnosed with an enlargement of a large blood vessel (aortic aneurysm or large peripheral artery);
• if the patient has previously experienced aortic dissection (tearing of the aortic wall);
• if there is a family history 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, 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 arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

Quinolone antibiotics may cause blood glucose levels to rise above normal
(hyperglycaemia) or fall below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for diabetic patients. Diabetic patients should carefully monitor their blood glucose levels. If hypoglycaemia occurs, the patient should contact the doctor immediately.
Heart-related disorders
Exercise caution when using this type of medicine if:

• the patient has been diagnosed with congenital or familial QT prolongation (visible on ECG – an examination of the heart's electrical activity);
• the patient has electrolyte imbalance in the blood (especially low levels of potassium and magnesium);
• the patient has a very slow heart rate (called bradycardia);
• the patient has 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 “Ciphin 500 and other medicines”).

While taking Ciphin 500
If any of the following symptoms occur during treatment with Ciphin 500, inform the doctor immediately. The doctor will decide whether treatment with Ciphin 500 should be discontinued.

• If sudden severe abdominal, back or chest pain occurs, which may be a sign of an aneurysm or aortic dissection, seek emergency medical attention immediately. The risk of these conditions may be higher in patients treated with systemic corticosteroids.
• If sudden shortness of breath occurs, especially when lying down, or if swelling of the ankles, feet or abdomen is observed, or palpitations (feeling of rapid or irregular heartbeat) develop, contact the doctor without delay.
• Severe, sudden allergic reaction (anaphylactic reaction or shock, “angioedema”). Although rare, a severe allergic reaction may occur even after the first dose, with symptoms such as chest tightness, dizziness, nausea, fainting, or dizziness upon standing. If this occurs, discontinue Ciphin 500 and contact the doctor immediately.
• Rarely, joint pain and swelling, tendon inflammation or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), organ transplant recipients, 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 Ciphin 500. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue Ciphin 500, contact the doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
• 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, discontinue Ciphin 500 and inform the doctor immediately to prevent potentially irreversible nerve damage.

Long-lasting, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones/quinolones, including Ciphin 500, have been associated with very rare but serious adverse reactions. Some of these were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (neuropathy), sensory disturbances, including disturbances of vision, taste, smell and hearing, memory and concentration problems, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), fatigue.
If any of these adverse reactions occur after taking Ciphin 500, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, taking into account antibiotics from other groups.

• If the patient has epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, adverse effects on the central nervous system may occur. If this happens, discontinue Ciphin 500 and contact the doctor immediately.
• Psychiatric reactions may occur after the first dose of Ciphin 500. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Ciphin 500. If this occurs, discontinue Ciphin 500 and contact the doctor immediately.
• Diarrhoea may occur during treatment with antibiotics, including Ciphin 500, or even several weeks after treatment has ended. If diarrhoea is severe or persistent, or if blood or mucus is observed in the stool, discontinue Ciphin 500 immediately, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal motility, and contact the doctor.
• If the patient is providing a blood or urine sample for analysis, inform the doctor or laboratory staff that Ciphin 500 is being taken.
• Ciphin 500 may cause liver damage. If the patient notices symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itchy skin, or stomach irritation, discontinue Ciphin 500 and contact the doctor immediately.
• Ciphin 500 may reduce the number of white blood cells, which may reduce resistance to infections. If the patient notices symptoms such as fever and severe worsening of general condition, or fever with local signs of infection such as sore throat, laryngitis, oral cavity problems, or urinary tract issues, contact the doctor immediately. A blood test will be ordered to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.
• If the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor, as the use of ciprofloxacin may increase the risk of anaemia.
• During treatment with Ciphin 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 solarium).

If the patient experiences visual disturbances or any adverse reactions affecting the eyes, consult an ophthalmologist immediately.
Ciphin 500 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ciphin 500 must not be taken together with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 “When not to use Ciphin 500”).
The following medicines may interact with Ciphin 500 in the body. Taking Ciphin 500 together with these medicines may affect their therapeutic effect and may also increase the likelihood of adverse effects.
Inform the doctor if the patient is taking any of the following medicines:

• warfarin or other oral anticoagulant (blood "thinner");
• probenecid (used in gout);
• methotrexate (used in certain types of cancer, psoriasis, rheumatoid arthritis);
• theophylline (used in respiratory disorders);
• tizanidine (used to reduce excessive muscle tension in multiple sclerosis);
• clozapine (an antipsychotic medicine);
• ropinirole (used in Parkinson's disease);
• phenytoin (used in epilepsy).

If the patient is taking other medicines that may affect heart rhythm, such as antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial drugs (macrolide group), or certain antipsychotics, they must inform the doctor.
Ciphin 500 may increase blood levels of the following medicines:

• pentoxifylline (used in circulatory disorders);
• caffeine; agomelatine (used in depression); zolpidem (used in sleep difficulties).

Some medicines weaken the effect of Ciphin 500. Inform the doctor if the patient is taking or plans to take:

• medicines that neutralise gastric acid;
• mineral supplements;
• sucralfate;
• polymeric phosphate binders (e.g. sevelamer);
• medicines containing calcium, magnesium, aluminium or iron, or supplements containing these elements. If use of these products is necessary, Ciphin 500 should be taken approximately two hours before or at least four hours after taking the above-mentioned medicines.

Ciphin 500 with food and drink
If Ciphin 500 is not taken with meals, do not eat or drink any dairy products (such as milk or yoghurt) or calcium-fortified beverages during tablet intake, as this may affect the absorption of the active substance.
Pregnancy and breastfeeding
If the patient is pregnant, 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 Ciphin 500 during pregnancy. Do not take Ciphin 500 while breastfeeding, as ciprofloxacin passes into breast milk and may be harmful to the child.
Driving and operating machinery
Ciphin 500 may impair concentration. Some neurological adverse reactions may occur. Before driving or operating machinery, the patient should assess how they react to Ciphin 500. If in doubt, consult the doctor.
Ciphin 500 contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Ciphin 500

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Your doctor will explain precisely what dose of Ciphin 500 to take, how often, and for how long. This
will depend on the type and severity of the infection.
Inform your doctor if the patient has kidney problems, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer in severe infections. Tablets should
always be taken exactly as directed by the doctor. If you have any doubts about the number of
tablets or how to take Ciphin 500, contact your doctor or pharmacist.
a) Swallow the tablets with a large amount of liquid. Do not chew the tablets,
as they have an unpleasant taste.
b) It is best to take the tablets at approximately the same time each day.
c) Tablets may be taken with meals or between meals. Calcium contained in food does not
have a significant effect on absorption. However, do not take Ciphin 500 exclusively
with dairy products such as milk or yogurt, or with fortified fruit juices (e.g. calcium-fortified
orange juice).
Remember to drink plenty of fluids while taking Ciphin 500.

Taking more Ciphin 500 than prescribed
If the patient has taken more than the prescribed dose, seek medical help immediately.
If possible, take the tablets or packaging along to show the doctor.

Missing a dose of Ciphin 500
Take the missed dose as soon as possible, then continue treatment as prescribed. However, if it is
almost time for the next dose, do not take the missed dose and continue as usual. Do not take a
double dose to make up for a missed dose. It is important to take all the tablets prescribed by the
doctor.

Stopping Ciphin 500 treatment
It is important not to stop treatment, even if you feel better after a few days of taking the
medicine. If the patient stops taking the medicine too early, the infection may not be fully treated,
and symptoms may return or worsen. Antibiotic resistance may also develop.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The most serious side effects observed during treatment with Ciphin 500
are listed below:
If you notice any of the following symptoms, stop taking Ciphin 500 and contact your doctor immediately,
as alternative treatment may be required.
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 insufficiency. See also section 2.
Rare side effects (may occur in 1 to 10 out of 10,000 people):

• increased blood glucose levels (hyperglycaemia) or decreased blood glucose levels (hypoglycaemia), which in severe cases may lead to diabetic coma. This is important for people with diabetes (see section 2 “Warnings and precautions”),
• seizures (see section 2 “Warnings and precautions”),
• inflammation of the intestine (colon) associated with antibiotic use (very rarely may be fatal) (see section 2 “Warnings and precautions”);

Very rare side effects (may occur in fewer than 1 out of 10,000 people):

• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2 “Warnings and precautions”);
• liver cell death (hepatic necrosis), very rarely leading to life-threatening liver failure;
• small dark spots visible under the skin (petechiae); various skin rashes or eruptions (e.g. potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell’s syndrome]);
• a specific type of reduced number of red blood cells (haemolytic anaemia); dangerous reduction in white blood cells (agranulocytosis), reduced numbers of red and white blood cells and platelets (aplastic anaemia, which may be fatal), and bone marrow suppression, which may also be fatal (see section 2 “Warnings and precautions”);
• mental disturbances (psychotic reactions) (see section 2 “Warnings and precautions”);
• pancreatitis;
• muscle weakness;
• tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”); worsening of myasthenia symptoms (see section 2 “Warnings and precautions”).

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

• a disease syndrome related to impaired water excretion from the body and reduced sodium concentration in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• hypersensitivity reaction known as DRESS syndrome (drug reaction with eosinophilia and systemic symptoms);
• very rapid heartbeat; life-threatening irregular heartbeat; disturbance of heart rhythm (known as “QT prolongation”, visible on ECG – an examination of the heart’s electrical activity; see section 2 “Warnings and precautions”);
• inflammation of the eye’s vascular membrane, which may cause pain, redness, blurred vision, and light sensitivity;
• feeling of intense excitement (mania) or feeling of excessive optimism and hyperactivity (hypomania);
• loss of consciousness due to significant reduction in blood glucose levels (hypoglycaemic coma). See section 2.

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely led 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 side effects observed during therapy with Ciphin 500 are listed below,
according to their likelihood of occurrence.
Common side effects (may occur in 1 to 10 out of 100 people):

• nausea, diarrhoea;
• joint pain in children.

Uncommon side effects (may occur in 1 to 10 out of 1,000 people):

• fungal infections;
• high levels of eosinophils (a type of white blood cells);
• loss of appetite (anorexia);
• excessive activity or restlessness;
• headache, dizziness, sleep problems or taste disturbances;
• vomiting, stomach pain, digestive disturbances such as indigestion (dyspepsia, heartburn) or flatulence;
• increased levels of certain substances in the blood [aminotransferases and (or) bilirubin];
• skin rash, itching or urticaria;
• joint pain in adults;
• impaired kidney function;
• muscle and bone pain, malaise (weakness) or fever;
• increased blood levels of alkaline phosphatase (a specific blood substance).

Rare side effects (may occur in 1 to 10 out of 10,000 people):

• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased number of blood clotting factors (platelets);
• confusion, disorientation, anxiety reactions, unusual dreams, depression or hallucinations;
• pricking sensation, increased sensitivity to sensory stimuli, reduced skin sensitivity, tremor or dizziness;
• vision problems;
• tinnitus, hearing loss, hearing disturbances;
• rapid heartbeat (tachycardia);
• blood vessel dilation, low blood pressure or fainting;
• shallow breathing, including asthma-like symptoms;
• liver function disorders, jaundice (with bile stasis) or hepatitis;
• light sensitivity (see section 2 “Warnings and precautions”);
• muscle pain, joint inflammation, increased muscle tension or cramps;
• kidney failure, blood or crystals in urine (see section 2 “Warnings and precautions”), urinary tract inflammation;
• fluid retention or excessive sweating;
• abnormal levels of blood clotting factor (prothrombin) or increased activity of an enzyme called amylase.

Very rare side effects (may occur in fewer than 1 out of 10,000 people):

• migraine, coordination disorders, unstable gait (gait disturbances), disturbances of smell, pressure on the brain (increased intracranial pressure);
• impaired colour vision;
• inflammation of blood vessel walls (vasculitis);

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

• nervous system problems such as: pain, burning sensation, tingling, numbness and (or) limb weakness;

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ciphin 500

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ciphin 500 contains

• The active substance is ciprofloxacin. One coated tablet contains 500 mg of ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate (583 mg).
• Other ingredients are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate; coating ingredients: hypromellose, macrogol 4000, titanium dioxide.

What Ciphin 500 looks like and contents of the pack
White or yellowish, round, biconvex, coated tablets.
Pack size: 10 coated tablets.
Marketing Authorisation Holder
Zentiva, a.s., Einsteinova 24, 851 01 Bratislava, Slovak Republic
Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00