Patient Information Leaflet

OFLOVIR 200 mg Film-Coated Tablets

Ofloxacin

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What OFLOVIR is and what it is used for

2. What you need to know before you start taking OFLOVIR

3. How to take OFLOVIR

4. Possible side effects

5. Storage of OFLOVIR

6. Contents of the pack and additional informationl

Ofloxacino is an antibiotic that belongs to the quinolones group.

It acts by eliminating the bacteria that cause infections.

OFLOVIR is indicated for the treatment of the following bacterial infections:

• Respiratory tract infections, including pneumonia and bronchitis

-Skin and soft tissue infections

• Urinary tract infections

• Prostate infections

• Cervical and urethral infections

• Epididymitis (a structure that is part of the testicle)

• Traveler's diarrhea

• Female reproductive system infections (Pelvic inflammatory disease)

Do not take OFLOVIR:

-If you are allergic to ofloxacin, to other quinolones (a group of antibiotics to which ofloxacin belongs

or to any of the other components of this medication (listed in section 6).

- If you have episodes of epilepsy or have a tendency to have seizures as a result of some brain damage

-If you have suffered any damage or disease in the tendons after administration of quinolones.

-If the patient is a child or young person in growth age.

-If you are pregnant or breastfeeding (see sections “Pregnancy and Breastfeeding”).

Warnings and precautions

Before starting to take this medication

Do not take antibacterial medications that contain fluoroquinolones or quinolones, including Oflovir, if you have experienced a severe adverse reaction with a quinolone or fluoroquinolone in the past. If this is the case, you must inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Oflovir:

If you have an allergic reaction (the symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue) you must consult your doctor immediately.

If you have intense, persistent, and/or bloody diarrhea during or after treatment with OFLOVIR, as it may be due to a special type of colitis called pseudomembranous colitis (a bowel infection that can cause stomach pain, fever, and diarrhea), which can be severe. In this case, you must consult your doctor immediately.

If you have a predisposition to having seizures, caused by brain damage or because you are being treated with anti-inflammatory medications (such as phenbufeno) or theophylline. In these cases, OFLOVIR should only be administered with maximum caution.

If you have a history of psychotic disorders, as they may progress to thoughts of self-harm or suicide, including attempted suicide.

If you have a history of abnormal heart rhythm. This medication should be taken with caution if you were born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), have electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman or elderly or are taking other medications that can result in abnormal ECG changes (see section Taking other medications).

If you have a family or personal history of deficiency in the enzyme glucose-6-phosphate dehydrogenase (congenital or acquired metabolic disorder).

If you have liver damage, use Oflovir only under the supervision of a doctor.

If you have kidney insufficiency, as your doctor will have to adjust your dose.

If you are taking medications to clarify your blood (called vitamin K antagonists, for example, warfarin), your doctor must control your coagulation tests (prothrombin time/INR), as they may be increased.

If you are a diabetic patient taking medications to reduce blood glucose or insulin. Your doctor must control your blood glucose levels.

During treatment with this medication, we recommend avoiding exposure to UV radiation and not exposing yourself excessively to sunlight, if you do, you should protect your skin properly.

If you have myasthenia gravis, it may worsen your condition, so OFLOVIR should be used with caution.

If you experience any alteration in your vision or have any eye problems, consult an ophthalmologist immediately.

If you are being treated with OFLOVIR for a prolonged period, your doctor will perform periodic checks of kidney, liver, and blood function.

If you have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).

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 or personal 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 vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

If you experience a sudden and intense pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may be increased if you are receiving systemic corticosteroids.

During treatment with this medication

• In rare cases, you may experiencejoint pain and swelling, inflammation, and tendon rupture.The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Oflovir. At the first sign of joint pain or inflammation, stop taking oflovir, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• In rare cases, you may experiencenerve damage symptoms (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in feet and legs or hands and arms. If this happens, stop taking oflovir and inform your doctor immediately to prevent the development of a potentially irreversible condition.

• If you experience a sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may be increased if you are receiving systemic corticosteroids.

• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone-containing antibacterial medications, including Oflovir, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or weakness (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

Children and adolescents

Children and adolescents in growth age should not take this medication.

Taking OFLOVIR with other medications:

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

Particularly inform your doctor if you are taking any of the following medications:

Medications that can alter your heart rhythm: medications belonging to the anti-arrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibiotics (belonging to the macrolide group), some antipsychotics.

The simultaneous taking of these medications with ofloxacin may result in a decrease in the effect of ofloxacin, so it is recommended not to take them during the two hours before and after taking ofloxacin:

• Antacids containing magnesium or aluminum, sucralfate (used for stomach ulcers).
• Medications containing iron or zinc.
• Didanosine.

The simultaneous taking of these medications with ofloxacin may result in seizures.

• Non-steroidal anti-inflammatory medications used to reduce pain and inflammation (phenbufeno) and theophylline, used to treat respiratory problems.

The simultaneous taking of these medications with ofloxacin may increase the risk of adverse effects:

• Medications that are eliminated by tubular renal excretion such as probenecid (used to treat gout), cimetidine (used for stomach ulcers), furosemide (a diuretic), and methotrexate (used to treat rheumatism or cancer).

When taken with ofloxacin, the effect of these medications may be increased:

• Anticoagulant medications (cumarinic derivatives), glibenclamide (medication for the

treatment of diabetes).

Urine analysis

The taking of Oflovir may affect the results of some urine tests. If you are to have a urine test, it is essential to inform your doctor that you are taking Oflovir.

Before starting to take this medication

Do not take antibacterial medications that contain fluoroquinolones or quinolones, including Oflovir, if you have experienced a severe adverse reaction with a quinolone or fluoroquinolone in the past. If this is the case, you must inform your doctor as soon as possible.

Pregnancy, lactation, and fertility

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

OFLOVIR should not be taken during pregnancy or in women at risk of becoming pregnant.

Since ofloxacin is excreted in milk, breastfeeding should be interrupted during the

OFLOVIR treatment.

Driving and operating machinery

The treatment with OFLOVIR may alter your ability to drive or operate machinery, as it may cause dizziness, drowsiness, and visual disturbances. The risk increases if you consume alcohol simultaneously. Therefore, do not drive or operate hazardous machinery if you are in any of the situations described above.

OFLOVIR contains lactose.

If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken as directed by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

OFLOVIR tablets should be taken without chewing, accompanied by a sufficient amount of liquid (half a glass or 1 glass). The dose can be taken on an empty stomach or with meals.

It is essential that the time intervals between doses are almost identical.

Your doctor will inform you of the duration of your treatment with OFLOVIR, depending on the type and severity of your infection. Do not stop treatment prematurely, as the infection may not be fully cured, and you may become ill again.

The dose depends on the location and type of infection.

Generally, the following dosage is recommended:

• Respiratory infections: 200-400 mg twice a day

-Skin and soft tissue infections: 400 mg twice a day

• Urinary tract infections: 200 mg twice a day

• Prostate infections: 200 mg twice a day

• Cervical and urethral infections: 200 mg twice a day or 400 mg once a day

• Epididymal infection: 200 mg twice a day

• Traveler's diarrhea: 200 mg twice a day

• Female reproductive system infections: 400 mg twice a day

Do not expose your skin directly to the sun or ultraviolet (UVA) lamps while taking this medication, as your skin will become much more sensitive to the sun and may burn, itch, or even blister. If you do, you should protect your skin properly.

Patients with kidney or liver problems

If you have liver or kidney problems, your doctor may prescribe a lower dose.

Patients of advanced age

The dose will be adjusted in these patients, taking into account their age and renal and hepatic function.

Use in children and adolescents

OFLOVIR is not indicated for children or adolescents.

If you take more OFLOVIR than you should

If you have taken more ofloxacino than you should, consult your doctor, pharmacist, or call theToxicological Information Service, phone: 91 5620420, indicating the medication and the amount taken.

The most important symptoms that may arise as a result of excessive administration of ofloxacino (among others) are those localized in the central nervous system, such as, for example, disorientation, dizziness, confusion, and seizures, as well as gastrointestinal discomfort, such as, for example, nausea and lesions (erosions (shallow ulcer)) of the gastrointestinal mucosa or injuryto the stomach or duodenum when it is eroded by stomach acid or duodenal juices.

If you forget to take OFLOVIR

If you forget to take a dose, take the tablet as soon as possible and continue treatment as prescribed. However, when it is close to the next dose, it is better not to take the missed dose and take the next one at the scheduled time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with OFLOVIR

Take OFLOVIR until your doctor tells you to stop. Do not stop taking OFLOVIR because you feel better. If you stop, your infection may worsen again.

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

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

Stop taking OFLOVIR and see a doctor or go to the hospital if:

- You experience an allergic reaction. Symptoms may include: skin rash, swallowing or breathing problems, inflammation of the lips, face, throat, or tongue

- You experience seizures

- You have diarrhea with blood

Inform your doctor if any of the following side effects worsen or last more than a few days:

Rare (may affect up to 1 in 100 people)

- The prolonged use of ofloxacin has been associated with the development of a fungal or bacterial superinfection

- Nausea, vomiting, diarrhea, abdominal pain

- Headache, dizziness, agitation, sleep problems

- Itching or rash

- Eye irritation, vertigo

- Cough, nasopharyngitis

Very rare (may affect up to 1 in 1,000 people)

- Allergic reactions from eye itching, throat itching, and nasal discharge to facial swelling, tongue, or throat swelling with difficulty swallowing and/or breathing

- Skin reactions (urticaria, hot flashes, excessive sweating, pustular rash)

- Loss of appetite (anorexia)

- Elevated liver enzyme levels

- Kidney function damage

- Rapid heartbeat or collapse due to low blood pressure

- Confusion, drowsiness, persistent tingling or pain in the feet and/or hands (paresthesias, hyperesthesia), visual disturbances (blurred vision, double vision, and altered color vision), taste and smell disturbances (disturbances or loss of taste and smell), balance disturbances, sleep disturbances (nightmares) or psychotic reactions (such as excitement, anxiety, depression, or hallucinations).

- Tendinitis

- Respiratory problems (shortness of breath), bronchospasm

- Intestinal inflammation

- Delirium (acute confusional state)

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

- Pseudomembranous colitis (intestinal infection that may cause stomach pain, fever, and diarrhea)

- Yellowing of the skin or white of the eyes caused by liver or blood problems; hepatitis or severe liver damage

- Seizures, tinnitus, hearing loss

- Coordination and sensitivity disturbances

- Altered blood cell levels (red blood cells, white blood cells, and platelets)

- Blisters, skin ulceration, inflammation of skin blood vessels (vasculitis), and increased skin sensitivity to light

-Severe allergic reaction that causes difficulty breathing or dizziness

- Joint pain, tendon rupture

- Kidney damage

Frequency unknown (cannot be estimated from available data)

- Psychotic disorders and depression with self-harm behavior, including suicidal thoughts or attempts

- Changes in blood glucose levels in diabetic patients

- Heart problems: irregular heartbeat, alteration of the heart rhythm (denominated prolongation of the QT interval, observed in ECG, heart electrical activity)

- Allergic reactions (e.g. Stevens-Johnson syndrome)

- Porphyria attacks in patients with porphyria (blood enzyme disorders)

- Hepatitis

- Muscle disorders (pain, weakness, tears)

- Pulmonary inflammation

- Kidney inflammation

- Eye inflammation (uveitis)

- Widespread skin redness with extensive peeling (dermatitis exfoliativa)

- Loss of appetite, yellowing of eyes and skin, dark urine, pruritus, or stomach discomfort (abdomen). These may be signs of liver problems that may include fatal liver failure.

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, abnormal sensations such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and hearing, vision, taste, and smell disturbances, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse effects:

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

No special storage conditions are required.

Keep OFLOVIR out of the sight and reach of children.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment..

Composition of Oflovir

The active ingredient is ofloxacin. Each tablet contains 200 mg of ofloxacin.

The other components (excipients) are:

Core excipients:lactose, cornstarch, sodium carboxymethylstarch from potato, anhydrous colloidal silica, magnesium stearate, gelatin.

Coating excipients: diethyl phthalate, hypromellose, opaspray K-1R-7000 (industrial methylated spirit, titanium dioxide (E-171), hydroxypropylcellulose).

Appearance of the product and contents of the packaging

OFLOVIR is presented in the form of coated, oval, scored, and white oral tablets. They are presented in packs containing 7 and 14 tablets.

Holder of the marketing authorization and responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70

28923 Alcorcón (Madrid)

Spain

Date of the last review of this leaflet:April 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices: http://www.aemps.gob.es/