Package Insert: Information for the Patient

Ciprofloxacin SUN 500 mg Film-Coated Tablets

Ciprofloxacin Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isCiprofloxacin SUN Tabletsand for what it is used

2. What you need to know before starting to takeCiprofloxacin SUN Tablets

3. How to takeCiprofloxacin SUN Tablets

4. Possible adverse effects

5. Storage ofCiprofloxacin SUN Tablets

6. Contents of the package and additional information

Ciprofloxacino tablets contain an active ingredient called ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family. Ciprofloxacin works by destroying bacteria that cause infections. It only acts on specific strains of bacteria.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

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

Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or trash.

Adults

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

− respiratory tract infections

− prolonged or recurrent ear or sinus infections

− urinary tract infections

− male and female genital tract infections

− gastrointestinal and intrabdominal infections

− skin and soft tissue infections

− bone and joint infections

− prevention of infections caused by the bacteriaNeisseria meningitidis

− Inhalation anthrax

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

In cases of severe infection or infection caused by multiple types of bacteria, additional antibiotic treatment may be administered 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:

− pulmonary and bronchial infections in children and adolescents with cystic fibrosis

− complicated urinary tract infections, including kidney infections (pyelonephritis)

− Inhalation anthrax

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

Do not take Ciprofloxacino SUN:

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

Warnings and precautions

Before taking this medication

You should not take antibacterial medications that contain fluoroquinolones or quinolones, including ciprofloxacin, if you have experienced a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

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

• if you have been diagnosed with an enlarged or "bulge" of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm).
• if you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• 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 conditions (e.g., Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• ifyou have ever had kidney problems, as your treatment may need to be adjusted.
• ifyou suffer from epilepsy or other neurological conditions
• ifyou have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacino tablets
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• ifyou suffer from myasthenia gravis (a type of muscle weakness), as your symptoms may be exacerbated
• if you have heart problems. You should exercise caution when taking ciprofloxacin if you have been born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium and magnesium), have a slow heart rate (bradycardia), have a fragile heart (fallocardiac), have a history of heart attacks (myocardial infarction), you are a woman, an elderly patient, or taking other medications that result in 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 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 Ciprofloxacino SUN

Inform your doctor immediately if any of the following situations occur while taking Ciprofloxacino SUN. Your doctor will decide if you need to stop taking Ciprofloxacino.

• Severe and sudden allergic reaction(anaphylactic reaction, 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, dizziness, nausea, or fainting, or experiencing dizziness when standing up.If this happens, do not take any more Ciprofloxacino and contact your doctor immediately.
• In rare cases, you may experiencepain and swelling in the joints and inflammation or rupture of tendons.The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Joint inflammation and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping ciprofloxacin treatment. At the first sign of joint pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• if you sufferepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking Ciprofloxacino 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. You may be at increased risk if you are receiving systemic corticosteroids.
• if you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or palpitations (rapid or irregular heartbeat), you should inform your doctor immediately.
• • You may experiencepsychiatric reactionsfor the first time when taking Ciprofloxacino. If you suffer fromdepressionorpsychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, or completed suicide. If this occurs, stop taking Ciprofloxacino and contact your doctor immediately.
  • In rare cases, you may experience symptoms ofnerve 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, prolonged, and potentially irreversible adverse effects.Fluoroquinolone or quinolone antibacterial medications, including ciprofloxacin, have been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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 or stop treatment, considering the use of another class of antibiotic.

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

Taking Ciprofloxacino tablets with other medications

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

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

We know that the following medications interact with Ciprofloxacino in your body. If you take Ciprofloxacino at the same time as these medications, this may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking:

•anticoagulant medications (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, or rheumatoid arthritis)

•theophylline (for respiratory problems)

•tizanidine (for muscle spasticity in multiple sclerosis)

• orlansoprazole (an antipsychotic)

•clozapine (an antipsychotic)

•ropinirole (for Parkinson's disease)

•phenytoin (for epilepsy)

•metoclopramide (for nausea and vomiting)

•ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplants)

•other medications that may alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics.

Ciprofloxacino mayincreasethe levels of the following medications in your blood:

•pentoxifylline (for circulatory disorders)

•caffeine

• agomelatina

• zolpidem•duloxetine (for depression, diabetic polyneuropathy, or incontinence)

•lidocaine (for heart disease or anesthetic use)

•sildenafil (e.g., for erectile dysfunction)

Some medicationsdecreasethe effect of Ciprofloxacino. Inform your doctor if you are taking or wish 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 Ciprofloxacino approximatelytwohours before orfourhours after taking these preparations.

Taking Ciprofloxacino SUN with food and drinks

Although you take Ciprofloxacino with meals, you should 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 ingredient.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using Ciprofloxacino during pregnancy.

Do not take Ciprofloxacino during breastfeeding, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.

Driving and operating machinery

Ciprofloxacino may reduce your alertness. You may experience some neurological effects. Therefore, make sure you know how you react to Ciprofloxacino before driving a vehicle or operating a machine. If in doubt, consult your doctor.

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

Your doctor will explain exactly how much Ciprofloxacino 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 your dose may need to be adjusted.

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

1. Swallow the tablets with a large amount of liquid. Do not chew the tablets, as their taste is unpleasant.
2. Try to take the tablets at the same time each 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 Ciprofloxacino tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (for example, orange juice fortified with calcium).

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

If you take more Ciprofloxacino 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 Ciprofloxacino 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 the missed dose.

Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacino SUN

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Stop taking ciprofloxacin and seek medical attention 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) linked to antibiotic use (can be fatal in rare cases) (see section 2: Warnings and precautions)
• liver disorders, jaundice (icterus colestático), 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 disease) (see section 2: Warnings and precautions)
• small pinpoint hemorrhages 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 wall (vasculitis)
• pancreatitis, including symptoms such as severe upper abdominal pain, often with nausea and vomiting
• muscle pain and/or weakness, joint inflammation and pain, increased muscle tone and cramps, tendon inflammation or tendon rupture, particularly affecting the Achilles tendon – see section 2.

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

• abnormally fast heart rate, irregular heart rhythm that can put the patient's life at risk, alteration of heart rhythm (denominated "prolongation of the QT interval", seen in ECG, heart electrical activity)
• unusual sensation of pain, burning, tingling, numbness or 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

Occasional:may affect up to 1 in 100 people

• superinfections caused by fungi
• elevated eosinophil count, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disturbances
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) 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 unwell (asthenia) or fever
• increased alkaline phosphatase levels in the blood (a blood substance)

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

• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), increased or decreased levels of blood clotting factor (thrombocytes)
• increased blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicides) or hallucinations
• sensation of 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, hearing deterioration
• increased heart rate (tachycardia)
• blood vessel expansion (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthma-like symptoms
• light sensitivity (see section 2)
• renal insufficiency, blood or crystals in the urine (see section 2), urinary tract inflammation
• fluid retention or excessive sweating
• increased amylase levels in the blood (a blood substance)

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

• a type of severe 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, attempts, or completed suicides) (see section 2)
• migraine, coordination disorders, gait instability (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure and pseudotumor cerebri
• color vision distortions
• liver cell death (hepatic necrosis), which very rarely leads to liver insufficiency with risk of death

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

• pustular rash
• influence on blood coagulation (in patients treated with vitamin K antagonists)
• feeling extremely excited (mania) or sensation of great optimism and hyperactivity (hypomania),
• a hypersensitivity reaction called DRESS (skin rash with eosinophilia and systemic symptoms)
• Syndrome associated with deficient water secretion and low sodium concentrations (SIADH, in English).
• Loss of consciousness due to severe decrease in 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 or permanent adverse reactions (even months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, unusual sensations such as pinching, tingling, itching, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory and 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 insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects:

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

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date that appears on the blister or packaging, after “CAD”: 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 drains or in the trash. Dispose of the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medications that you no longer need. By doing so, you will help protect the environment.

Ciprofloxacino SUN Composition

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 Ciprofloxacino SUN and packaging contents

Ciprofloxacino SUN 500 mg is presented in the form of coated tablets, white, round, marked 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 packaging with 1, 8, 10, 14, 16, 20, 28, 32, or 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible 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

Last review date of this leaflet: October 2020

Advice on prescription/medical 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.

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

• the dose
• the antibiotic plan
• the duration of treatment

Consequently, in order to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.
2. Follow the prescription strictly.
3. Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; it may not be adapted to 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 Medical Devices (AEMPS)http://www.aemps.gob.es