Ciphin 500

Package Leaflet: Information for the Patient

CIPHIN 500, 500 mg, Film-Coated Tablets

Ciprofloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

Ciphin 500 is an antibiotic belonging to the fluoroquinolone group. The active substance is ciprofloxacin.
Ciprofloxacin works by killing the bacteria that cause infections. It only works against specific strains of bacteria.
Before starting treatment, your doctor will pay particular attention to available information on bacterial resistance to ciprofloxacin.
Adults

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

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

• Gastrointestinal infections (e.g., traveler's diarrhea).
• Intra-abdominal infections.
• Skin and soft tissue infections caused by Gram-negative bacteria.
• Malignant otitis externa.
• Bone and joint infections.
• Ciprofloxacin can be used in the treatment of patients with neutropenia (very low white blood cell count) and fever, which is presumed to be caused by a bacterial infection.
• Prevention of invasive infections caused by Neisseria meningitidis.
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment).

Children and Adolescents

• Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
• Complicated urinary tract infections and acute pyelonephritis.
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment).

Ciprofloxacin can also be used to treat severe infections in children and adolescents when it is considered necessary.
Treatment should only be initiated by doctors who have experience in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
The doctor will take into account official guidelines on the appropriate use of antibacterial agents.

2. Important Information Before Taking Ciphin 500

When Not to Take Ciphin 500:

• if you are allergic to ciprofloxacin, other quinolones, or any of the other ingredients of this medication (listed in section 6);
• if you are taking tizanidine (see section 2 "Ciphin 500 and other medications").

Warnings and Precautions

Before Taking Ciphin 500

You should not take fluoroquinolone or quinolone antibacterial agents, including Ciphin 500, if you have ever experienced a severe side effect while taking a quinolone or fluoroquinolone. In such cases, you should inform your doctor as soon as possible.
Before starting treatment with Ciphin 500, you should discuss the following with your doctor:

• if you have ever had kidney problems, as your dose may need to be adjusted,
• if you have a history of epilepsy or other neurological disorders,
• if you have ever had tendon problems during treatment with antibiotics such as Ciphin 500,
• if you have myasthenia gravis (a type of muscle weakness),
• if you have ever had an abnormal heart rhythm (arrhythmia),
• if you have a heart valve problem,
• if you have diabetes (see below and section 4),
• if you have an aortic aneurysm or a large vessel dilatation,
• if you have ever had an aortic dissection (a tear in the aorta wall),
• 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, or Sjögren's syndrome),

Fluoroquinolone antibacterial agents, including Ciprofloxacin, have been associated with an increased risk of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar), which can lead to coma, particularly in patients with diabetes. It is essential for patients with diabetes to monitor their blood sugar levels closely. If you experience hypoglycemia, you should immediately contact your doctor.

Cardiac Disorders

Caution should be exercised when using this type of medication if:

• you have a congenital or family history of prolonged QT interval (visible on an ECG),
• you have an electrolyte imbalance (especially low potassium and magnesium levels),
• you have a very slow heart rate (bradycardia),
• you have poor heart function (heart failure),
• you have had a heart attack,
• you are a woman or elderly,
• you are taking other medications that may affect your ECG (see section "Ciphin 500 and other medications").

During Treatment with Ciphin 500

If you experience any of the following symptoms while taking Ciphin 500, you should immediately inform your doctor. Your doctor will decide whether to stop treatment with Ciphin 500.

• 500.
• In case of sudden, severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or 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 (feeling of rapid or irregular heartbeat), you should immediately contact your doctor.
• Severe, sudden allergic reactions(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 Ciphin 500 and immediately contact your doctor.
• Rarely, pain and swelling of the joints and inflammation or rupture of tendonsmay occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and up to several months after stopping Ciphin 500. If you experience the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Ciphin 500, contact your doctor, and rest the affected area. You should avoid excessive strain, as it may increase the risk of tendon rupture.
• You may rarely experience symptoms of nerve damage(neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs and hands and arms. In such cases, you should stop taking Ciphin 500 and immediately inform your doctor to prevent the development of potentially irreversible disease.

Long-term, disabling, and potentially irreversible severe side effectshave been reported in patients taking fluoroquinolone and quinolone antibacterial agents, including Ciphin 500. Some of these side effects have been long-lasting (lasting for months or years), disabling, or potentially irreversible. They include tendonitis, tendon rupture, muscle and joint pain, walking difficulties, abnormal sensations (such as tingling, burning, numbness, or pain), neuropathy, vision disturbances, taste and smell disturbances, hearing disturbances, memory and concentration problems, and psychiatric effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), as well as fatigue.

• If you have epilepsyor other neurological disorders, such as cerebral ischemia or stroke, central nervous system side effects may occur. If this happens, you should stop taking Ciphin 500 and immediately contact your doctor.
• After the first dose of Ciphin 500, psychiatric reactionsmay occur. If you have depressionor psychosis, your symptoms may worsen during treatment with Ciphin 500. If this happens, you should stop taking Ciphin 500 and immediately contact your doctor.
• During treatment with antibiotics, including Ciphin 500, or even for several weeks after stopping treatment, diarrheamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, you should immediately stop taking Ciphin 500, as it can be life-threatening. You should not take medications that slow down or stop bowel movements and should contact your doctor.
• If you are going to have a blood or urine test, you should inform your doctor or laboratory staff that you are taking Ciphin 500.
• Ciphin 500 may cause liver damage. If you notice the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, you should stop taking Ciphin 500 and immediately contact your doctor.
• Ciphin 500 may decrease the number of white blood cells, which can lead to a decreased resistance to infections. If you notice symptoms such as fever and severe deterioration of your general condition or fever with local signs of infection, such as sore throat, pharyngitis, or urinary problems, you should immediately contact your doctor. A blood test will be ordered to check if you have a decreased white blood cell count (agranulocytosis). You should remember to inform your doctor that you are taking this medication.
• If you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should inform your doctor, as ciprofloxacin may cause a risk of anemia.
• During treatment with Ciphin 500, your skin may become more sensitive to sunlight and ultraviolet radiation. You should avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).

If you experience vision disturbances or any eye-related side effects, you should immediately consult an ophthalmologist.

Ciphin 500 and Other Medications

You should tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Ciphin 500 should not be taken with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to take Ciphin 500").
The following medications may interact with Ciphin 500 in the body. Taking Ciphin 500 with these medications may affect their therapeutic effect. It may also increase the risk of side effects.

You should inform your doctor if you are taking any of the following medications:

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

If you are taking other medications that may affect your heart rhythm, such as antiarrhythmic agents (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial agents (belonging to the macrolide group), or certain antipsychotic agents, you should inform your doctor.
Ciphin 500 may increasethe levels of the following medications in the blood:

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

Some medications may reducethe effect of Ciphin 500. You should inform your doctor if you are taking or plan to take:

• antacids;
• mineral supplements;
• sucralfate;
• phosphate-binding polymers (e.g., sevelamer);
• medications containing calcium, magnesium, aluminum, or iron, or supplements of these substances. If the use of these products is necessary, Ciphin 500 should be taken approximately 2 hours before or at least 4 hours after taking these medications.

Ciphin 500 with Food and Drink

If Ciphin 500 is not taken with meals, you should not eat or drink any dairy products (such as milk or yogurt) or drinks with added calcium during treatment, as it may affect the absorption of the active substance.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medication.
Ciphin 500 should be avoided during pregnancy. You should not take Ciphin 500 while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and Using Machines

Ciphin 500 may cause drowsiness. Some neurological side effects may occur. Before driving or operating machinery, you should check how you react to Ciphin 500. If in doubt, consult your doctor.

Ciphin 500 Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is considered "sodium-free".

3. How to Take Ciphin 500

This medication should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Your doctor will explain in detail what dose of Ciphin 500 to take, how often, and for how long. This will depend on the type and severity of the infection.
You should inform your doctor if you have kidney problems, 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 Ciphin 500, you should 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)
The tablets can be taken with or without food. Calcium in food does not significantly affect absorption. However, do nottake Ciphin 500 with dairy products, such as milk or yogurt, or with calcium-fortified fruit juices (e.g., orange juice fortified with calcium).
You should remember to drink plenty of fluids during treatment with Ciphin 500.

Overdose of Ciphin 500

If you have taken more than the prescribed dose of Ciphin 500, you should immediately seek medical attention.
If possible, take the tablets or packaging with you to show the doctor.

Missed Dose of Ciphin 500

You should take the missed dose as soon as possible, and then continue treatment as directed by your doctor. 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 the missed dose. It is essential to take all the tablets prescribed by your doctor.

Stopping Treatment with Ciphin 500

It is essential not to stop treatmentprematurely, even if you feel better after a few days of taking the medication. If you stop taking Ciphin 500 too soon, the infection may not be fully treated, and the symptoms may return or worsen. Resistance to the antibiotic may also develop.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Ciphin 500 can cause side effects, although not everybody gets them.
The most serious side effectsreported during treatment with Ciphin 500 are listed below:

If You Experience Any of the Following Symptoms, Stop Taking Ciphin 500 and Immediately Contact Your Doctor, as You May Need to Take a Different Medication.

In patients taking fluoroquinolones, cases of aortic aneurysm and dissection (a tear in the aorta wall) have been reported, which can be fatal, as well as cases of heart valve regurgitation. See also section 2.
Rare side effects(may affect up to 1 in 10,000 people):

• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels (hypoglycemia), which can lead to diabetic coma in severe cases. This is important for patients with diabetes (see section 2 "Warnings and precautions"),
• seizures (see section 2 "Warnings and precautions"),
• antibiotic-associated colitis (very rarely can be fatal) (see section 2 "Warnings and precautions");

Very rare side effects(may affect less than 1 in 10,000 people):

• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness-like reaction);
• liver cell death (liver necrosis), very rarely leading to life-threatening liver failure;
• small, dark spots on the skin (purpura); various skin rashes or eruptions (e.g., potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell's syndrome]);
• a specific type of reduced red blood cell count (hemolytic anemia); a dangerous decrease in the number of white blood cells (agranulocytosis), a decrease in the number of red and white blood cells and platelets (aplastic anemia, which can be fatal), and bone marrow failure, which can also be fatal (see section 2 "Warnings and precautions");
• mental disorders (psychotic reactions) (see section 2 "Warnings and precautions");
• pancreatitis;
• muscle weakness;
• tendinitis, tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions"); worsening of myasthenia gravis symptoms (see section 2 "Warnings and precautions").

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

• a condition related to the regulation of water in the body and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• a hypersensitivity reaction known as DRESS (drug reaction with eosinophilia and systemic symptoms).
• very rapid heartbeat; life-threatening irregular heartbeat; cardiac arrhythmia (known as "QT prolongation", visible on an ECG - a test of heart activity) (see section 2 "Warnings and precautions");
• inflammation of the membrane covering the eye, which can cause pain, redness, blurred vision, and sensitivity to light;
• feeling of intense excitement (mania) or feeling of great optimism and overactivity (hypomania);
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma). See section 2.

The administration of fluoroquinolone and quinolone antibacterial agents, in some cases regardless of pre-existing risk factors, has very rarely led to long-term (lasting for months or years) or permanent side effects, such as tendinitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, burning, numbness, or pain), neuropathy, fatigue, memory and concentration problems, and psychiatric effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), as well as hearing, vision, taste, and smell disturbances.

Other Side Effects that Have Been Reported During Treatment with Ciphin 500 are Listed Below, According to Their Frequency.

Common side effects(may affect up to 1 in 100 people):

• nausea (vomiting), diarrhea;
• joint pain in children.

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

• fungal superinfections;
• high levels of eosinophils (a type of white blood cell);
• loss of appetite (anorexia);
• excessive activity or restlessness;
• headache, dizziness, sleep disturbances, or taste disturbances;
• vomiting, stomach pain, digestive problems, such as indigestion (dyspepsia) or gas;
• increased levels of certain substances in the blood [transaminases and/or bilirubin];
• rash, itching, or hives;
• joint pain in adults;
• poor kidney function;
• muscle and bone pain, general feeling of being unwell (malaise) or fever;
• increased activity of an enzyme called alkaline phosphatase in the blood.

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

• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased platelet count, or decreased blood clotting factors;
• confusion, disorientation, anxiety reactions, unusual dreams, depression, or hallucinations;
• tingling, increased sensitivity to stimuli, decreased skin sensitivity, tremors, or dizziness;
• vision problems;
• ringing in the ears, hearing loss, or hearing disturbances;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure, or fainting;
• shallow breathing, including asthma symptoms;
• liver function disorders, jaundice (with bile duct obstruction), or hepatitis;
• sensitivity to light (see section 2 "Warnings and precautions");
• muscle pain, joint inflammation, increased muscle tone, or muscle spasms;
• kidney failure, blood, or crystals in the urine (see section 2 "Warnings and precautions"), urinary tract infections;
• fluid retention or excessive sweating;
• abnormal blood clotting factor levels or increased activity of an enzyme called amylase.

Very rare side effects(may affect less than 1 in 10,000 people):

• migraine, coordination problems, unstable gait (gait disturbances), smell disturbances, or increased intracranial pressure (pseudotumor cerebri);
• color vision disturbances;
• inflammation of blood vessel walls (vasculitis);

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

• nervous system problems, such as pain, burning, tingling, numbness, and/or weakness of the limbs;

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Ciphin 500

Keep this medication out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Ciphin 500 Contains

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

What Ciphin 500 Looks Like and Contents of the Pack

White or yellowish, round, biconvex, film-coated tablets.
Pack size: 10 film-coated tablets.

Marketing Authorization Holder

Zentiva, a.s., Einsteinova 24, 851 01 Bratislava, Slovakia

Manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
To obtain more detailed information on this medication, you should contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
Phone: +48 22 375 92 00

Date of Last Revision of the Leaflet: