CIPROFLOXACIN SUN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ciprofloxacin SUN 500 mg film-coated tablets EFG

Ciprofloxacin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Ciprofloxacin SUN tablets are and what they are used for
2. What you need to know before taking Ciprofloxacin SUN tablets
3. How to take Ciprofloxacin SUN tablets
4. Possible side effects
5. Storage of Ciprofloxacin SUN tablets
6. Contents of the pack and further information

1. What Ciprofloxacin SUN tablets are and what they are used for

Ciprofloxacin tablets contain the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It only works with specific strains of bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Adults

Ciprofloxacin tablets are used in adults to treat the following bacterial infections:

• respiratory tract infections
• long-term or recurrent ear or sinus infections
• urinary tract infections
• male and female genital tract infections
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• prevention of infections caused by the bacteria Neisseria meningitidis
• Inhalation anthrax

Ciprofloxacin may be used in the treatment of patients with a low count of a type of white blood cell (neutropenia) who have fever suspected to be due to a bacterial infection.

In case you suffer from a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment, in addition to Ciprofloxacin tablets.

Children and Adolescents

Ciprofloxacin tablets are used in children and adolescents, under specialized medical supervision, 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)
• Inhalation anthrax

Ciprofloxacin may also be used to treat severe infections in children and adolescents when deemed necessary.

2. What you need to know before taking Ciprofloxacin SUN

Do not take Ciprofloxacin SUN:

• if you are allergic to ciprofloxacin, other quinolones, or any of the other components of this medication (listed in section 6).
• if you are taking tizanidine (see section 2: Taking Ciprofloxacin tablets with other medications)

Warnings and Precautions

Before taking this medication

You should not take fluoroquinolone antibacterial medicines, including Ciprofloxacin, if you have previously experienced a severe side effect with a fluoroquinolone or quinolone. If this is the case, inform your doctor as soon as possible

Consult your doctor or pharmacist before starting to take Ciprofloxacin tablets:

• if you have been diagnosed with an enlargement or a "bulge" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• if you have had a previous episode of aortic dissection (tear in the aortic wall).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis).
• if you have had kidney problems, as your treatment may need to be adjusted.
• if you suffer from epilepsy or other neurological conditions.
• if you have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin tablets.
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin.
• if you have myasthenia gravis (a type of muscle weakness), as your symptoms may worsen.
• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you have been born with or have a family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have an electrolyte imbalance (especially low potassium and magnesium levels in the blood), have a very slow heart rate (known as bradycardia), have a delicate heart (falloccardiac), have a history of heart attacks (myocardial infarction), are a woman, an elderly patient, or are taking other medications that result in abnormal ECG changes (see section 2).
• if you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia when taking ciprofloxacin.

For the treatment of some genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While taking Ciprofloxacin SUN

Inform your doctor immediately if any of the following situations occur while taking Ciprofloxacin SUN. Your doctor will decide whether it is necessary to interrupt treatment with Ciprofloxacin.

• Severe and sudden allergic reaction(anaphylactic reaction or shock, angioedema). There is a reduced possibility that, even with the first dose, you may experience a severe allergic reaction, with the following symptoms: chest tightness, feeling of dizziness, nausea, or fainting, or experiencing dizziness when standing up. If this happens, do not take any more Ciprofloxacin and contact your doctor immediately.
• In rare cases, joint pain and swelling and tendon inflammation or rupturemay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with ciprofloxacin. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as it may increase the risk of tendon rupture.
• If you suffer from epilepsyor other neurological conditions, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this occurs, stop taking Ciprofloxacin and contact your doctor immediately.
• If you experience a sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start to experience sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• • You may experience psychiatric reactionswhen taking Ciprofloxacin for the first time. If you suffer from depressionor psychosis, your symptoms may worsen with treatment with Ciprofloxacin tablets. In rare cases, depression or psychosis may progress to suicidal thoughts, attempted suicide, or completed suicide. If this occurs, stop taking Ciprofloxacin and contact your doctor immediately.
  • In rare cases, you may experience symptoms of nerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking ciprofloxacin tablets and inform your doctor immediately to avoid the development of a potentially irreversible condition.
  • Severe, disabling, and potentially irreversible side effects. Fluoroquinolone or quinolone antibacterial medicines, including ciprofloxacin, have been associated with very rare but serious side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. These include tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, numbness, or burning, sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking ciprofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, considering the use of an antibiotic from another class.

• Hypoglycemiahas been reported more frequently in diabetic patients, predominantly in elderly patients. If this occurs, contact your doctor immediately.
• Diarrheamay develop while taking antibiotics, including Ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stool, stop taking Ciprofloxacin immediately, as it may be life-threatening. Do not take medications that stop or slow down bowel movements, and consult your doctor.
• Consult an ophthalmologist immediately if you experience any vision changesor have any eye problems (see section 4: Possible side effects)
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightwhen taking Ciprofloxacin. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
• While taking Ciprofloxacin, inform your doctor or laboratory staff if you need to undergo a blood or urine test.
• If you have kidney problems, inform your doctor, as your dose may need to be adjusted.
• Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin (jaundice), dark urine, itching, or stomach pain, stop taking Ciprofloxacin immediately and consult your doctor.
• Ciprofloxacin may cause a decrease in white blood cell count and may decrease your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

Quinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels, which in severe cases can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.

Taking Ciprofloxacin tablets with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Do not take Ciprofloxacin at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin tablets").

It is known that the following medications interact with Ciprofloxacin in your body. If you take Ciprofloxacin at the same time as these medications, it may affect the therapeutic effect of these medications. It may also increase the likelihood of experiencing side effects.

Inform your doctor if you are taking:

• vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporine (for skin diseases, rheumatoid arthritis, and organ transplants)
• other medications that may affect your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

Ciprofloxacin may increaseblood levels of the following medications:

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

Some medications decreasethe effect of Ciprofloxacin. Inform your doctor if you are taking or plan to take:

• antacids
• omeprazole
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)
• medications or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, take Ciprofloxacin approximately twohours before or fourhours after taking these preparations.

Taking Ciprofloxacin SUN with food and drinks

Although you can take Ciprofloxacin with meals, do not eat or drink any dairy products (such as milk or yogurt) or beverages with added calcium when taking the tablets, as they 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 become pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to avoid using Ciprofloxacin during pregnancy.

Do not take Ciprofloxacin during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and Using Machines

Ciprofloxacin may decrease your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or using a machine. If in doubt, consult your doctor.

3. How to Take Ciprofloxacin SUN Tablets

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will explain exactly how much Ciprofloxacin you should take, how often, and for how long. This will depend on the type of infection you have and its severity.

Inform your doctor if you have kidney problems, as it may be necessary to adjust your dose.

Treatment usually lasts from 5 to 21 days, but it can last longer for severe infections.

1. Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is not pleasant.
2. Try to take the tablets at the same time every day.
3. You can take the tablets with or between meals. The calcium you take as part of a meal will not seriously affect the absorption of the medication. However, do nottake Ciprofloxacin tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

Remember to drink a large amount of liquids while taking this medication.

If you take more Ciprofloxacin SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ciprofloxacin SUN

Take the normal dose as soon as possible and then continue treatment as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for missed doses.

Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacin SUN

It is essential that you complete the full treatment, even if you start to feel better after a few days. If you stop taking this medication too soon, your infection may not be completely cured, and symptoms may worsen. You may develop resistance to the antibiotic.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Severe side effects

Stop your treatment with ciprofloxacin and go to your doctor or the nearest hospital immediately if you experience any of the following side effects – you may need urgent medical attention:

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

• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema)
• inflammation of the intestine (colitis) related to antibiotic use (can be fatal in very rare cases) (see section 2: Warnings and Precautions)
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• low blood sugar (hypoglycemia) (see section 2: Warnings and Precautions)

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

• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with risk of death - serum sickness) (see section 2: Warnings and Precautions)
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with risk of death or toxic epidermal necrolysis)
• inflammation of the blood vessel walls (vasculitis)
• inflammation of the pancreas, including symptoms such as severe pain in the upper abdomen, often with nausea and vomiting (pancreatitis)
• muscle pain and/or weakness, joint inflammation and joint pain, increased muscle tone and cramps, tendon inflammation or tendon rupture, particularly affecting the Achilles tendon - see section 2

Frequency not known:frequency cannot be estimated from available data

• abnormally fast heart rate, irregular heart rate that can put the patient's life at risk, alteration of heart rhythm (called "prolongation of the QT interval", seen on ECG, heart electrical activity)
• unusual pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) - see section 2

Other side effects

Frequent:may affect up to 1 in 10 people

• nausea, diarrhea
• joint pain in children

Uncommon:may affect up to 1 in 100 people

• fungal superinfections
• high levels of eosinophils, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep problems, or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• joint pain in adults
• poor kidney function
• muscle and bone pain, feeling of discomfort (asthenia), or fever
• increased alkaline phosphatase in the blood (a blood substance)

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

• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood coagulation factor quantities (thrombocytosis)
• high blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, attempted suicide, or completed suicide), or hallucinations
• tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2), or dizziness
• vision problems, including double vision
• tinnitus (ringing in the ears), hearing loss, impaired hearing
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure, or fainting
• breathing difficulties, including asthma-like symptoms
• sensitivity to light (see section 2)
• kidney failure, blood or crystals in the urine (see section 2), inflammation of the urinary tract
• fluid retention or excessive sweating
• increased amylase enzyme levels

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

• a special type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the number of white and red blood cells and platelets (pancytopenia), with risk of death, and bone marrow depression, also with risk of death (see section 2: Warnings and Precautions)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, attempted suicide, or completed suicide) (see section 2)
• migraine, coordination disorder, instability while walking (gait disorders), disorders of the sense of smell (olfactory disorders); brain pressure (intracranial pressure and pseudotumor cerebri)
• visual color distortions
• death of liver cells (necrosis), which very rarely leads to liver failure with risk of death

Frequency not known:frequency cannot be estimated from available data

• pustular rash
• influence on blood coagulation (in patients treated with vitamin K antagonists)
• feeling very excited (mania) or feeling of great optimism and hyperactivity (hypomania)
• hypersensitivity reaction called DRESS (skin reaction with eosinophilia and systemic symptoms)
• Syndrome associated with inadequate water secretion and low sodium levels (SIADH, by its English acronym)
• Loss of consciousness due to severely low blood sugar levels (hypoglycemic coma). See section 2

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ciprofloxacin SUN

Keep this medication out of sight and reach of children

Do not use this medication after the expiration date shown on the blister or packaging, after "EXP": The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ciprofloxacin SUN

The active ingredient is ciprofloxacin.

The other components are: microcrystalline cellulose, cornstarch, magnesium stearate, talc, anhydrous colloidal silica, sodium starch glycolate (Type A), hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance of Ciprofloxacin SUN and Package Contents

Ciprofloxacin SUN 500 mg is presented in the form of coated tablets, white, round, marked in relief with '500' on one face and smooth on the other.

Each tablet contains 500 mg of ciprofloxacin as the active ingredient (ciprofloxacin hydrochloride).

The tablets are available in packages with 1, 8, 10, 14, 16, 20, 28, 32, or 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA, S.A.

124 Fabricii Street

Cluj-Napoca – Romania

Local Representative:

Sun Pharma Laboratorios, S.L

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

Date of the last revision of this leaflet: February 2025

Medical Advice/Education

Antibiotics are used to treat bacterial infections. They do not work for viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You can even help bacteria become more resistant and thus delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose
• the antibiotic plan
• the treatment duration

Consequently, to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.
2. Follow the prescription strictly.
3. Never reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; it may not be suitable for their illness.
5. After completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es