CIPROFLOXACIN TARBIS 750 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Tarbis 750 mg film-coated tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Ciprofloxacin Tarbis and what is it used for
2. What you need to know before you take Ciprofloxacin Tarbis
3. How to take Ciprofloxacin Tarbis
4. Possible side effects
5. Storage of Ciprofloxacin Tarbis

Package contents and further information

1. What is Ciprofloxacin Tarbis and what is it used for

Ciprofloxacin Tarbis is an antibiotic that belongs to the fluoroquinolone family. The active substance is ciprofloxacin. 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 do not work for viral infections such as the flu or the common 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 any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

Adults

Ciprofloxacin is 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
• treatment of infections in patients with a very low white blood cell count (neutropenia)
• prevention of infections in patients with a very low white blood cell count (neutropenia)
• prevention of infections caused by the bacterium Neisseria meningitidis
• inhalation exposure to anthrax

In case 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, in addition to ciprofloxacin.

Children and adolescents

Ciprofloxacin is 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 exposure to anthrax

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

2. What you need to know before you take Ciprofloxacin Tarbis

Do not take Ciprofloxacin Tarbis:

• 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: Taking Ciprofloxacin Tarbis with other medications)

Warnings and precautions:

Before you start taking this medication

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

Consult your doctor or pharmacist before you start taking this medication

• if you have ever had kidney problems because your treatment needs to be adjusted
• if you have epilepsy or other neurological conditions
• if you have a history of tendon problems during previous treatment with antibiotics like ciprofloxacin
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin
• if you have severe myasthenia (a type of muscle weakness)
• if you have a history of abnormal heart rhythms (arrhythmias)
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic or peripheral 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 dissection, congenital heart valve disorders, 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, hypertension, or atherosclerosis)
• if you have been diagnosed with a heart valve disorder (regurgitation of the heart valves)
• if you or a family member has a proven deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin

During treatment with this medication

Inform your doctor immediately if any of the following situations occur while taking Ciprofloxacin Tarbis. 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, dizziness, nausea, or fainting, or experience dizziness when standing up. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medications that contain fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but severe side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes 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 Tarbis, 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.

• In rare cases, tendon pain and swelling, and tendon inflammation or rupturemay occur. The risk is higher if you are an older person (over 60 years), 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 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 any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you have epilepsyor another neurological condition, such as cerebral ischemia or infarction, you may experience side effects related to the central nervous system. 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 and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• You may experience psychiatric reactionswhen taking ciprofloxacin for the first time. If you experience depressionor psychosis, your symptoms may worsen with treatment with Ciprofloxacin Tarbis. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.

• Quinolone antibiotics may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow 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.

• Diarrheamay develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after you have stopped taking them. If the diarrhea becomes severe or persistent, or if you notice that your stools contain blood or mucus, stop taking ciprofloxacin immediately, as this can be life-threatening. Do not take medications that stop or slow down bowel movements, and consult your doctor.

• While taking ciprofloxacin, inform your doctor or laboratory staff that you are taking this medication if you need to undergo a blood or urine test.

• Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin, dark urine, itching, or stomach pain, stop taking ciprofloxacin immediately and consult your doctor.

• Ciprofloxacin may cause a decrease in your white blood cell countand 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, you should consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medication.

• 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.

• If you experience sudden and severe abdominal, chest, or back pain, which can 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 experiencing sudden onset of 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), you should inform your doctor immediately.

Taking Ciprofloxacin Tarbis with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to 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 Tarbis").

It is known that the following medications interact with ciprofloxacin in your body. If you take ciprofloxacin at the same time as these medications, this 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:

• warfarin 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin may increaseblood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

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

• antacids
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g., sevelamer)
• medications or supplements that contain calcium, magnesium, aluminum, or iron

If these preparations are essential, take Ciprofloxacin Tarbis approximately twohours before or four hours aftertaking these preparations.

Taking Ciprofloxacin Tarbis with food and drinks

Although you can take ciprofloxacin 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 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 preferable to avoid using ciprofloxacin during pregnancy. Inform your doctor if you plan to become pregnant.

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 Tarbis

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. 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 of infection you have and its severity.

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

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the tablets exactly as your doctor has indicated. If you are unsure about how many ciprofloxacin tablets to take or how to take them, ask your doctor or pharmacist how many tablets to take and how to take them.

1. Swallow the tablets with a large amount of liquid. Do not chew the tablets because they have an unpleasant taste.
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 ciprofloxacin tablets with dairy products like milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

Remember to drink plenty of fluids while taking this medication.

If you take more Ciprofloxacin Tarbis than you should

If you take more than the prescribed amount, seek medical help immediately. If possible, bring the tablets or the package with you to show the doctor.

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 Tarbis

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 stop taking Ciprofloxacin Tarbis

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 fully cured, and your symptoms may worsen. You may develop resistance to the antibiotic.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Frequent Adverse Effects(may affect up to 1 in 10 people):

• nausea, diarrhea
• joint pain in children

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• fungal superinfections
• high concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disorders
• 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
• renal impairment
• muscle and bone pain, feeling of discomfort (asthenia) or fever
• increased alkaline phosphatase in blood (a blood-determined substance)

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• inflammation of the intestine (colitis) related to the use of antibiotics (can be fatal in very rare cases) (see section 2: Take special care with Ciprofloxacin Tarbis)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood coagulation factor levels (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression or hallucinations
• tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2: Take special care with Ciprofloxacin Tarbis) or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, hearing impairment
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthma symptoms
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• sensitivity to light (see section 2: Take special care with Ciprofloxacin Tarbis)
• muscle pain, joint inflammation, increased muscle tone or cramps
• renal failure, blood or crystals in the urine (see section 2: Take special care with Ciprofloxacin Tarbis), inflammation of the urinary tract
• fluid retention or excessive sweating
• abnormal levels of coagulation factor (prothrombin) or increased concentrations of amylase enzyme

Very Rare Adverse Effects(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 a risk of death, and bone marrow depression, also with a risk of death (see section 2: Take special care with Ciprofloxacin Tarbis).
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum sickness) (see section 2: Take special care with Ciprofloxacin Tarbis).
• mental disorders (psychotic reactions) (see section 2: Take special care with Ciprofloxacin Tarbis).
• migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); brain pressure (intracranial pressure).
• visual color distortions.
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• death of liver cells (hepatic necrosis), which can very rarely lead to liver failure with a risk of death
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis).
• muscle weakness, tendon inflammation, tendon rupture - especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacin Tarbis), worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacin Tarbis)

• Ciprofloxacin Tarbis), worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacin Tarbis)

Unknown Frequency(cannot be estimated from available data)

• nervous system problems such as pain, burning, tingling, numbness and/or weakness in the limbs
• serious heart rhythm disorders, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with deficient water secretion and low sodium levels (SIADH, by its English acronym)
• loss of consciousness due to a 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 (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, tingling, 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 cardiac valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ciprofloxacin Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box or blister, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ciprofloxacin Tarbis 750 mg film-coated tablets

• The active ingredient is ciprofloxacin. Each tablet contains 750 mg of ciprofloxacin (as hydrochloride).
• The other components are:
• • Core: cornstarch, microcrystalline cellulose (E-460i), silicon dioxide, crospovidone, and magnesium stearate.
  • Coating: hydroxypropyl methylcellulose (E-464) and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Film-coated tablets, the tablets are elongated and white in color.

Each package contains 14 or 500 (clinical package) film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

Spain

Manufacturer:

Labiana Pharmaceuticals, S.L.

Casanova, 27-31

08757 Corbera de Llobregat (Barcelona)

Spain

Date of the Last Revision of this Prospectus:December 2020

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

Medical Advice/Education

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

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

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

Misuse of antibiotics increases resistance. Even you can help bacteria become more resistant and, therefore, delay your recovery or decrease the effectiveness of antibiotics if you do not respect:

• the dose,
• the program
• the duration of treatment

Consequently, to maintain the effectiveness of this medicine:

1. Use antibiotics only when they are 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 finishing a treatment, return all unused medicines to the pharmacy, to ensure they are eliminated correctly.