Ciprofloxacin Sun 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ciprofloxacin SUN 500 mg film-coated tablets EFG

Ciprofloxacin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Ciprofloxacin SUN tablets
6. Contents of the pack and other information

1. What Ciprofloxacin SUN Tablets Are and What They Are Used For

Ciprofloxacin Tablets contain an active substance called ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by destroying bacteria that cause infections. It only acts against specific strains of bacteria.

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

It is important that you follow the instructions regarding dosage, dosing intervals, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.

Adults

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

• respiratory tract infections
• long-lasting or recurrent ear or 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
• prevention of infections caused by the bacterium Neisseria meningitidis
• Inhalation anthrax

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

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment alongside 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 considered necessary.

2. What you need to know before starting to take Ciprofloxacin SUN

Do not take Ciprofloxacin SUN:

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

Warnings and precautions

Before taking this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, you must 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 "lump" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• if you have previously experienced an aortic dissection (tearing of the aortic wall).
• if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, known hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• if you have ever had kidney problems, as your treatment may need adjustment.
• if you suffer from epilepsy or other neurological conditions.
• if you have a history of tendon problems during previous treatment with antibiotics such as 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 symptoms may worsen.
• if you have heart problems. Caution is advised when administering ciprofloxacin if you were born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), have electrolyte imbalances (especially low levels of potassium and magnesium in the blood), have a very slow heart rate (known as bradycardia), have a fragile heart (heart failure), have a history of heart attacks (myocardial infarction), are female, are elderly, or are taking other medicines that cause abnormal ECG changes (see section 2).
• if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia when taking ciprofloxacin.

For the treatment of certain 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 stop treatment with Ciprofloxacin.

• Severe and sudden allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose, you may experience a severe allergic reaction, with symptoms such as chest tightness, dizziness, nausea, or fainting, or feeling dizzy upon standing. If this happens, do not take any more Ciprofloxacin and contact your doctor immediately.
• Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping ciprofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
• If you suffer from epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to the central nervous system. If this occurs, stop taking Ciprofloxacin and contact your doctor immediately.
• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.
  • You may experience psychiatric reactions the first time you take Ciprofloxacin. If you have depression or psychosis, your symptoms may worsen with treatment with Ciprofloxacin tablets. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. If this occurs, stop taking Ciprofloxacin and contact your doctor immediately.
  • Rarely, 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 prevent the development of a potentially irreversible condition.
  • Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious adverse effects, some of which 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, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking ciprofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the use of an antibiotic from another class.

• Hypoglycemia has been reported more frequently in diabetic patients, particularly in elderly patients. If this occurs, contact your doctor immediately.
• Diarrhea may develop while you are 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 stools, stop taking Ciprofloxacin immediately, as this could be life-threatening. Do not take medications that stop or delay bowel movements and consult your doctor.
• Consult an ophthalmologist immediately if you experience any vision disturbances or eye problems (see section 4: Possible adverse effects).
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when 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 adjustment.
• Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking Ciprofloxacin immediately and consult your doctor immediately.
• Ciprofloxacin may cause a decrease in white blood cell count and possibly reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible low white blood cell count (agranulocytosis). It is important to inform your doctor about your medication.

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

Taking Ciprofloxacin tablets with other medicines

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

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

The following medicines are known to interact with Ciprofloxacin in your body. Taking Ciprofloxacin at the same time as these medicines may affect their therapeutic effect and may increase the risk of adverse 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 medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide group), and some antipsychotics.

Ciprofloxacin may increase blood levels of the following medicines:

• 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 medicines decrease the effect of Ciprofloxacin. Inform your doctor if you are taking or intend to take:

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

If these preparations are essential, take Ciprofloxacin approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacin SUN with food and drinks

Although you may take Ciprofloxacin with meals, do not consume any dairy products (such as milk or yogurt) or drinks fortified with calcium when taking the tablets, as they may interfere with the absorption of the active ingredient.

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 medicine.

It is preferable to avoid the use of Ciprofloxacin during pregnancy.

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

Driving and using machines

Ciprofloxacin may reduce your level of alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, consult your doctor.

3. How to take Ciprofloxacin SUN tablets

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 and severity of your infection.

Inform your doctor if you have kidney problems, as your dose may need to be adjusted.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

1. Swallow the tablets with plenty of liquid. Do not chew the tablets as they have an unpleasant taste.
2. Try to take the tablets at the same time each day.
3. You may take the tablets with or between meals. Calcium consumed as part of a meal will not significantly affect the absorption of the medicine. However, do not take Ciprofloxacin tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (for example, calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

If you take more Ciprofloxacin SUN than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ciprofloxacin SUN

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

Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin SUN

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, your infection may not be completely cured and symptoms may return or worsen. You may also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Stop taking ciprofloxacin and go to your doctor or nearest hospital immediately if you experience any of the following adverse 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) associated with antibiotic use (may be fatal in very rare cases) (see section 2: Warnings and precautions)
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• decrease in blood sugar (hypoglycaemia) (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, potentially life-threatening – serum sickness) (see section 2: Warnings and precautions)
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis)
• inflammation of the blood vessel walls (vasculitis)
• inflammation of the pancreas including symptoms such as severe upper abdominal pain, 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 longest tendon at the back of the ankle (Achilles tendon) – see section 2.

Frequency not known: frequency cannot be estimated from available data

• abnormally fast heart rate, irregular heart rhythm that may be life-threatening, disturbance in heart rhythm (known as "QT interval prolongation", seen on ECG, electrical activity of the heart)
• unusual sensation of pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) – see section 2

Other adverse effects

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 (due to fungi)
• elevated levels of eosinophils, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep disturbances or taste disturbances
• 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 malaise (asthenia) or fever
• increased alkaline phosphatase in blood (a blood substance measured)

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

• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in levels of blood clotting factor (platelets)
• increased blood sugar (hyperglycaemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, suicide attempts or completed suicides) or hallucinations
• tingling and numbness sensations, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (see section 2) or dizziness
• vision problems, including double vision
• tinnitus (ringing in the ears), hearing loss, hearing impairment
• increased heart rate (tachycardia)
• dilation of blood vessels (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthmatic symptoms
• sensitivity to light (see section 2)
• kidney failure, blood or crystals in urine (see section 2), inflammation of the urinary tract
• fluid retention or excessive sweating
• increased concentrations of amylase enzyme

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

• a specific type of decreased blood cell count (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), a decrease in red and white blood cells and platelets (pancytopenia), potentially life-threatening, and bone marrow suppression, also potentially life-threatening (see section 2: Warnings and precautions)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or completed suicides) (see section 2)
• migraine, coordination disorder, unsteadiness when walking (gait disorders), disorders of the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure and pseudotumour cerebri)
• visual distortions of colours
• death of liver cells (hepatic necrosis), which very rarely leads to liver failure with risk of death

Frequency not known: frequency cannot be estimated from available data

• pustular rash
• effect on blood clotting (in patients treated with vitamin K antagonists)
• feeling highly excited (mania) or sensation of extreme optimism and hyperactivity (hypomania)
• hypersensitivity reaction known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
• Syndrome associated with inadequate water excretion and low sodium concentrations (SIADH).
• Loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even 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, pins and needles, burning, numbness or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), reduced hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse effects:

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

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

5. Storage of Ciprofloxacin SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister or carton, following "EXP": The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin SUN

The active substance is ciprofloxacin.

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

Appearance of Ciprofloxacin SUN and contents of the pack

Ciprofloxacin SUN 500 mg is presented as white, round, film-coated tablets, embossed with '500' on one side and plain on the other.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The 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 most recent revision of this leaflet: February 2025

Medical advice/education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

If your doctor has prescribed antibiotics, it is because they are specifically needed for your current illness.

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

Improper use of antibiotics increases resistance. You may even help bacteria become more resistant, thereby delaying your recovery or reducing the effectiveness of antibiotics if you do not comply with:

• the prescribed dose
• the antibiotic regimen
• the duration of treatment

Therefore, to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Follow the prescription exactly.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4. Never give your antibiotics to someone else; they may not be suitable for that person's condition.
5. After completing a course of treatment, return any unused medicines to the pharmacy, to ensure they are properly disposed of.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es