CIPROFLOXACIN VIR PHARMA 750 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Vir Pharma 750 mg film-coated tablets EFG

Ciprofloxacin

Read the entire leaflet carefully before starting to use this medication.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given 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 leaflet. See section 4.

Contents of the leaflet:

1. What Ciprofloxacin Vir Pharma is and what it is used for
2. What you need to know before taking Ciprofloxacin Vir Pharma
3. How to take Ciprofloxacin Vir Pharma
4. Possible side effects
5. Storage of Ciprofloxacin Vir Pharma
6. Package contents and additional information

1. What Ciprofloxacin Vir Pharma is and what it is used for

Ciprofloxacin Vir Pharma is an antibiotic belonging to the fluoroquinolone family. The active ingredient is ciprofloxacin. Ciprofloxacin works by eliminating the bacteria that cause infections. It only works against 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 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 Vir Pharma is used in adults to treat the following bacterial infections:

• Respiratory tract infections.
• Prolonged or recurrent ear or sinus infections.
• Urinary tract infections.
• Testicular infections.
• Male and female genital tract 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 bacteria 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 Vir Pharma.

Children and adolescents

Ciprofloxacin Vir Pharma 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 those that have reached the kidneys (pyelonephritis).
• Inhalation exposure to anthrax.

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

2. What you need to know before taking Ciprofloxacin Vir Pharma

Do not take Ciprofloxacin Vir Pharma

If you are allergic to the active ingredient, other quinolones, or any of the other components of Ciprofloxacin Vir Pharma (listed in section 6).

If you are taking tizanidine (see section 2: Use with other medications).

Warnings and precautions

Before starting this medication

Do not take antibacterial medications containing fluoroquinolones or quinolones, including Ciprofloxacin Vir Pharma, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Before taking Ciprofloxacin Vir Pharma

Consult your doctor or pharmacist before starting treatment if:

• You have had kidney problems, as your treatment may need to be adjusted.
• You suffer from epilepsy or other neurological conditions.
• You have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin Vir Pharma.
• You suffer from severe myasthenia (a type of muscle weakness).
• You have a history of abnormal heart rhythms (arrhythmias).

During treatment with this medication

Inform your doctor immediately if any of the following situations occur whiletakingCiprofloxacin Vir Pharma. Your doctor will decide if it is necessary to interrupt treatment with Ciprofloxacin Vir Pharma:

• 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 symptoms such as chest tightness, dizziness, nausea, or fainting, or experience dizziness when standing up. If this happens, do not take any more Ciprofloxacin Vir Pharma and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medications containing fluoroquinolones or quinolones, including Ciprofloxacin Vir Pharma, 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 pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, numbness, 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 side effects after taking Ciprofloxacin Vir Pharma, 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.

• If you experience joint pain and swelling or tendon inflammation or rupture, stop taking Ciprofloxacin Vir Pharma, contact your doctor, and rest the affected area. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.

• If you have epilepsy or another neurological condition, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this occurs, stop taking Ciprofloxacin Vir Pharma 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 Vir Pharma and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• You may develop diarrheawhile taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If the diarrhea becomes intense or persistent, or if you notice blood or mucus in your stool, stop taking Ciprofloxacin Vir Pharma immediately, as it can 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 changes or have any eye problems.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightwhen taking Ciprofloxacin Vir Pharma. Avoid intense sunlight or artificial UV light, such as tanning beds.

• While taking Ciprofloxacin Vir Pharma, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

• Ciprofloxacin Vir Pharma 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 Vir Pharma and consult your doctor immediately.

• Ciprofloxacin Vir Pharma may cause a decrease in white blood cell count and potentially 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 check for a possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

• Inform your doctor if you or a family member has a confirmed deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

Using Ciprofloxacin Vir Pharma with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medication. Do not take Ciprofloxacin Vir Pharma at the same time as tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin Vir Pharma).

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

Tell 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 Vir Pharma may increaseblood levels of the following medications:

• Pentoxifylline (for circulatory disorders).
• Caffeine.

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

• Antacids.
• Mineral supplements.
• Sucralfate.
• A polymeric phosphate binder (e.g., sevelamer).
• Medications or supplements containing calcium, magnesium, aluminum, or iron.

If these preparations are essential, take Ciprofloxacin Vir Pharma approximately two hours beforeor four hours aftertaking these preparations.

Taking Ciprofloxacin Vir Pharma with food and drinks

Although you can take Ciprofloxacin Vir Pharma 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 ingredient.

Pregnancy, breastfeeding, and fertility

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 Vir Pharma during pregnancy.

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

Driving and using machines:

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

3. How to take Ciprofloxacin Vir Pharma

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

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

Tell your doctor if you have kidney problems, as your treatment may need to be adjusted.

Treatment usually lasts from 5 to 21 days, but may be longer for severe infections. Take the tablets exactly as your doctor has indicated. If you have doubts about how many Ciprofloxacin Vir Pharma 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 plenty of liquid. Do not chew the tablets, as they have an unpleasant taste. The score line is only for breaking the tablet if you find it difficult to swallow whole.
2. Try to take the tablets at the same time every day.
3. You can take the tablets with or between meals. The calcium in your meal will not seriously affect the absorption of the medication. However, do nottake Ciprofloxacin Vir Pharma 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 Ciprofloxacin Vir Pharma.

If you take more Ciprofloxacin Vir Pharma than you should

If you take more than the prescribed amount, seek medical help immediately. Consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20. If possible, bring the tablets or the box to show the doctor.

If you forget to take Ciprofloxacin Vir Pharma

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 treatment with Ciprofloxacin Vir Pharma:

It is essential to 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 Adverse Effects

Like all medicines, Ciprofloxacin Vir Pharma can cause adverse effects, although not all people will experience them.

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

Frequent Adverse Effects(likely to occur in 1 to 10 out of every 100 people):

• Nausea, diarrhea.
• Pain in the joints in children.

Uncommon Adverse Effects(likely to occur in 1 to 10 out of every 1,000 people):

• Fungal superinfections.
• A high concentration of eosinophils, a type of white blood cell.
• Lack of appetite (anorexia).
• Hyperactivity or agitation.
• Headache, dizziness, sleep problems, or taste disorders.
• Vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence.
• An increase in the amount of certain substances in the blood (transaminases and/or bilirubin).
• Skin rash, itching, or hives.
• Pain in the joints in adults.
• Impaired kidney function.
• Pain in muscles and bones, feeling of discomfort (asthenia), or fever.
• An increase in alkaline phosphatase in the blood (a blood-determined substance).

Rare Adverse Effects(likely to occur in 1 to 10 out of every 10,000 people):

• Inflammation of the intestine (colitis) associated with the use of antibiotics (can be fatal in very rare cases) (see section 2. Be especially careful with Ciprofloxacin Vir Pharma).
• Changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood coagulation factor quantities (thrombocytes).
• Allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema).
• Increased blood sugar (hyperglycemia).
• Confusion, disorientation, anxiety reactions, unusual dreams, depression, or hallucinations.
• Feeling of tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2. Be especially careful with Ciprofloxacin Vir Pharma), 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-like symptoms.
• Liver disorders, jaundice (cholestatic jaundice), hepatitis.
• Sensitivity to light (see section 2. Be especially careful with Ciprofloxacin Vir Pharma).
• Muscle pain, joint inflammation, increased muscle tone, or muscle cramps.
• Kidney failure, blood or crystals in the urine (see section 2. Be especially careful with Ciprofloxacin Vir Pharma), inflammation of the urinary tract.
• Fluid retention or excessive sweating.
• Abnormal coagulation factor levels (prothrombin) or increased amylase enzyme concentrations.

Very Rare Adverse Effects(likely to occur in less than 1 out of every 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 amount 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. Be especially careful with Ciprofloxacin Vir Pharma).
• Severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death – serum sickness) (see section 2. Be especially careful with Ciprofloxacin Vir Pharma).
• Mental disorders (psychotic reactions) (see section 2. Be especially careful with Ciprofloxacin Vir Pharma).
• Migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure).
• Visual color distortions.
• Inflammation of the blood vessel walls (vasculitis).
• Pancreatitis.
• Death of liver cells (liver 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 of the long tendon in the back of the ankle (Achilles tendon) (see section 2. Be especially careful with Ciprofloxacin Vir Pharma), worsening of myasthenia gravis symptoms (see section 2. Be especially careful with Ciprofloxacin Vir Pharma).

Unknown Frequency(cannot be estimated from available data):

• Nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs.
• Severe heart rhythm disorders, irregular heart rhythm (Torsades de Pointes).

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, prickling, 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.

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 leaflet. 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 Vir Pharma

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

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ciprofloxacin Vir Pharma

The active ingredient is Ciprofloxacin. Each tablet contains 750 mg of ciprofloxacin (as hydrochloride).

The other components (excipients) are: Microcrystalline cellulose, cornstarch, sodium potato carboxymethyl starch, talc, magnesium stearate, anhydrous colloidal silica, disodium edetate, hypromellose, titanium dioxide (E171), and polyethylene glycol 400.

Appearance of the Product and Package Contents

Ciprofloxacin Vir Pharma 750 mg are film-coated tablets, white, oblong, and scored.

Each package contains 14 tablets.

Marketing Authorization Holder and Manufacturer:

Date of the Last Revision of this Leaflet: July 2022

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 may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective. 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 program,
• The treatment duration.

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 completing a treatment, return all unused medicines to the pharmacy, to ensure they are disposed of correctly.

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