Oflovir 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

OFLOVIR 200 mg film-coated tablets

Ofloxacin

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What OFLOVIR is and what it is used for
2. What you need to know before taking OFLOVIR
3. How to take OFLOVIR
4. Possible side effects
5. How to store OFLOVIR
6. Contents of the pack and other information

1. What OFLOVIR is and what it is used for

Ofloxacin is an antibiotic that belongs to the quinolone group.

It works by eliminating bacteria that cause infections.

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

• Prostatitis

• Cervical and urethral infections

• Epididymitis (infection of the epididymis, a structure part of the testicle)

• Traveller's diarrhoea

• Female reproductive tract infections (Pelvic Inflammatory Disease)

2. What you need to know before starting to take OFLOVIR

Do not take OFLOVIR:

• If you are allergic to ofloxacin, to other quinolones (the group of antibiotics to which ofloxacin belongs), or to any of the other components of this medicine (listed in section 6).

• If you have episodes of epilepsy or are prone to seizures due to any brain damage.

• If you have previously experienced tendon damage or disease following treatment with quinolones.

• If the patient is a child or a young person who is still growing.

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

Warnings and precautions

Before starting to take this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Oflovir, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this is your case, you must inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Oflovir:

If you experience an allergic reaction (signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue), you should contact your doctor immediately.

If you develop severe, persistent and/or bloody diarrhoea during or after treatment with OFLOVIR, as this may be due to a special type of colitis called pseudomembranous colitis (an intestinal infection that may cause stomach pain, fever and diarrhoea), which can be serious. In this case, you should contact your doctor immediately.

If you are predisposed to epileptic seizures, caused by brain injury or because you are being treated with anti-inflammatory drugs (such as fenbufen) or theophylline. In these cases, OFLOVIR should only be administered with extreme caution.

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

If you have a history of abnormal heart rhythm. This medicine should be taken with caution if you were born with or have a family history of QT interval prolongation (seen on ECG, an electrical recording of your heart), 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 weak heart (heart failure), have a history of heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may result in abnormal changes in the ECG (see section "Taking other medicines").

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

If you have impaired liver function, only use Oflovir under medical supervision.

If you have renal impairment, your doctor will need to adjust your dose.

If you are taking medicines to thin your blood (so-called vitamin K antagonists, e.g., warfarin), your doctor should monitor your coagulation tests (prothrombin time/INR), as these may be increased.

If you are a diabetic patient taking medicines to lower blood glucose or insulin, your doctor should monitor your blood glucose levels.

During treatment with this medicine, we recommend you avoid exposure to UV radiation and do not excessively expose yourself to sunlight; if you do, you should adequately protect your skin.

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

If you experience any changes 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 enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

If you have previously experienced 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 autoimmune inflammatory disease), vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

If you feel sudden, severe pain in your chest, abdomen or back, go immediately to an emergency service.

During treatment with this medicine

• Rarely, joint pain and swelling and inflammation and 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping treatment with Oflovir. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking ofloxacin, contact your doctor and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

• Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in feet and legs or in hands and arms. If this occurs, stop taking ofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• If you feel sudden, intense pain in the abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. The risk may increase if you are receiving systemic corticosteroid treatment.

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

Severe, disabling, long-lasting and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Oflovir, 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 decreased vision, taste, smell or hearing, depression, memory impairment, severe fatigue and serious sleep disorders.

Children and adolescents

Children and adolescents who are still growing should not take this medicine.

Taking OFLOVIR with other medicines:

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

In particular, inform your doctor if you are taking any of the following medicines:

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 antibiotics (belonging to the macrolide group), some antipsychotics.

Taking these medicines simultaneously with ofloxacin may reduce the effect of ofloxacin; therefore, it is recommended not to take them within two hours before or after taking ofloxacin:

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

Taking these medicines together with ofloxacin may cause seizures:

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

Taking these medicines with ofloxacin may increase the likelihood of experiencing adverse effects:

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

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

• Anticoagulant medicines (coumarin derivatives), glibenclamide (a medicine for the treatment of diabetes).

Urine tests

Taking ofloxacin may affect the results of certain urine tests. If you are to have a urine test, it is important that you inform your doctor that you are taking Oflovir.

Before starting to take this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including ofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this is your case, you must inform your doctor as soon as possible.

Pregnancy, lactation 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 medicine.

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

Since ofloxacin is excreted in breast milk, breastfeeding must be discontinued during treatment with OFLOVIR.

Driving and using machines

Treatment with OFLOVIR may impair your ability to drive or operate machinery, as it may cause dizziness, drowsiness and visual disturbances. The risk increases if alcoholic beverages are consumed simultaneously. Therefore, do not drive or operate dangerous machinery if you are in any of the situations described above.

OFLOVIR contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take OFLOVIR

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

OFLOVIR tablets should be taken whole, without chewing, with plenty of fluid (half a glass or 1 glass). The tablets may be taken on an empty stomach or with food.

It is important that the time intervals between doses are approximately equal.

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

The dose depends on the location and type of infection.

The following dosage is generally recommended:

• Respiratory tract infections: 200–400 mg twice daily
• Skin and soft tissue infections: 400 mg twice daily
• Urinary tract infections: 200 mg twice daily
• Prostate infections: 200 mg twice daily
• Cervical and urethral infections: 200 mg twice daily or 400 mg once daily
• Epididymitis: 200 mg twice daily
• Traveller's diarrhoea: 200 mg twice daily
• Female genital tract infections: 400 mg twice daily

Do not expose your skin directly to sunlight or ultraviolet (UVA) lamps while taking this medicine, as your skin may become much more sensitive to sunlight and may burn, sting, or even blister. If exposure is unavoidable, you should adequately protect your skin.

Patients with kidney or liver problems

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

Elderly patients

Dosage in these patients will be adjusted according to age and renal and hepatic function.

Use in children and adolescents

Oflovir is not indicated for use in children or adolescents.

If you take more OFLOVIR than you should

If you have taken more ofloxacin than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 5620420, indicating the medicine and the amount taken.

Among the most important symptoms that may occur due to an overdose of ofloxacin (among others) are those affecting the central nervous system, such as, e.g., disorientation, dizziness, confusion, and seizures, as well as gastrointestinal disturbances such as, e.g., nausea and gastrointestinal mucosal lesions (erosions (shallow ulcers)), or injury to the stomach or duodenum when eroded by gastric acids or duodenal juices.

If you forget to take OFLOVIR

If you miss a dose, take the tablet as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed tablet and instead take the next dose at the scheduled time.

Do not take a double dose to make up for a missed dose.

If you stop taking OFLOVIR

Take Oflovir for as long as your doctor instructs you to continue. Do not stop taking Oflovir just because you feel better. Stopping treatment prematurely may cause your infection to worsen again.

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 may cause adverse effects, although not everyone experiences them.

Stop taking OFLOVIR and contact your doctor or go to hospital immediately if you:

• Experience an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue

• Have seizures

• Develop diarrhoea with blood

Tell your doctor if any of the following adverse effects worsen or persist for more than a few days:

Uncommon (may affect up to 1 in 100 people)

• Prolonged use of ofloxacin has been associated with the development of superinfection with fungi or resistant bacteria
• Nausea, vomiting, diarrhoea, abdominal pain
• Headache, dizziness, agitation, sleep disturbances
• Itching or rash
• Eye irritation, vertigo
• Cough, nasopharyngitis

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

• Allergic reactions ranging from eye irritation, sore throat and runny nose to swelling of the face, tongue or throat with difficulty swallowing and/or breathing
• Skin reactions (urticaria, flushing, excessive sweating, pustular rash)
• Loss of appetite (anorexia)
• Elevated liver enzyme levels
• Impaired kidney function
• Rapid heartbeat or collapse due to low blood pressure
• Confusion, drowsiness, persistent tingling or pain in the feet and/or hands (paraesthesia, hyperaesthesia), visual disturbances (blurred vision, double vision, altered colour vision), disturbances or loss of taste and smell, balance disorders, sleep disorders (nightmares), or psychotic reactions (such as excitement, anxiety, depression or hallucinations)
• Tendinitis
• Breathing problems (dyspnoea), bronchospasm
• Inflammation of the intestine
• 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 diarrhoea)

• Yellowing of the skin or whites of the eyes due to liver or blood problems; hepatitis or severe liver damage

• Seizures, ringing in the ears (tinnitus), hearing loss

• Coordination disorders, sensory disturbances

• Abnormal blood cell counts (red blood cells, white blood cells and platelets)

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

• Severe allergic reaction causing difficulty breathing or dizziness

• Joint pain, tendon rupture

• Kidney damage

Frequency not known (cannot be estimated from available data)

• Psychotic disorders and depression with self-harming behaviour, including suicidal thoughts or suicide attempts
• Changes in blood glucose levels in diabetic patients
• Heart problems: irregular heartbeat, changes in heart rhythm (known as QT interval prolongation, seen on ECG, electrical activity of the heart)
• Allergic reactions (e.g. Stevens-Johnson syndrome)
• Attacks of porphyria in patients with porphyria (disorders of blood-forming enzymes)
• Hepatitis
• Muscle disorders (pain, weakness, tears)
• Lung inflammation
• Kidney inflammation
• Eye inflammation (uveitis)
• Reddening of the skin with widespread peeling (exfoliative dermatitis)
• Loss of appetite, yellowing of eyes and skin, dark urine, itching or stomach discomfort (abdomen). These may be signs of liver problems, which could include fatal liver failure.

The use 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 pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), decreased 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 may be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects 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 OFLOVIR

No special storage conditions are required.

Keep OFLOVIR out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Oflovir

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

The other components (excipients) are:

Excipients of the core: lactose, corn starch, sodium carboxymethylstarch (potato), colloidal anhydrous 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 container

OFLOVIR is presented as white, oblong, film-coated tablets, scored on one side, for oral administration. It is available in packs containing 7 and 14 tablets.

Marketing Authorization Holder and Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

Date of the most recent review of this leaflet: June 2025

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