Ofloxacin 400 mg tablets – patient leaflet, side effects, dosage

1) What Ofloxacin is and what it is used for

Ofloxacin belongs to a group of antibacterial medicines known as fluoroquinolones.

Ofloxacin is an antibiotic that can be used to treat infections of:

• the bladder or the kidneys (urinary tract)
• the lungs and chest, including pneumonia and bronchitis
• the male and female genital organs. Ofloxacin can be used to treat gonorrhoea and some other genital infections.

2) What you need to know before you take Ofloxacin

Ofloxacin is not suitable for everyone. If you are not sure about anything, ask your doctor or pharmacist before you start to take Ofloxacin.

Do not take Ofloxacin:

• if you are allergic (hypersensitive) to Ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you have previously had an allergic reaction to a quinolone antibiotic. If you have had a reaction to any type of antibiotic in the past, check with your doctor before taking Ofloxacin
• if you have a history of inflammation of the tendons (tendinitis) when you have taken fluoroquinolone antibiotics in the past
• if you have epilepsy or have ever had a seizure or fit
• if you are pregnant or breast-feeding
• if you are under the age of 18, or if you are over 18 but think you are still growing.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Ofloxacin:

• if you suffer from or have a history of mental illness
• if you have problems with your liver or kidneys. Make sure you tell your doctor about any liver or kidney problems before you start taking Ofloxacin because the dose may need to be lowered
• if you have an illness of the nervous system called myasthenia gravis (a disorder in which the muscles are weak and tire easily) as this medicine can make the symptoms worse
• if you have heart problems. Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Ofloxacin)
• if you are prescribed corticosteroids (used to treat asthma and other chronic lung diseases) as this may increase the risk of swelling and pain of your tendons
• if you are diabetic
• if you have a condition which makes you likely to have fits (convulsions)
• if you have a problem with your red blood cells called “glucose-6-phosphate-dehydrogenase deficiency”
• if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm)
• if you have experienced a previous episode of aortic dissection (a tear in the aorta wall)
• if you have been diagnosed with leaking heart valves (heart valve regurgitation).
• if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels (hyperglycaemia), or lowering of your blood sugar levels below normal levels, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Ofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

While you are taking Ofloxacin

• do not expose yourself to long periods in strong sunlight whilst taking these tablets. Use a sun protection cream if you cannot avoid strong sunlight.
• do not use a sun-lamp or solarium.
• you may be more susceptible to infection with other organisms and if severe or bloody diarrhoea develops, bowel inflammation (pseudomembraneous colitis) is suspected, treatment should be discontinued.

• let your doctors know you are taking Ofloxacin if you are undergoing any medical tests, as it may interfere with the results.

  Your doctor may want to monitor you with blood tests if you are taking Ofloxacin for longer period.

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of

  • age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of the tendons may occur within the first 48 hours of treatment and even up to several months after stopping Ofloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Ofloxacin, contact your doctor and rest the painful area.

Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and / or weakness especially in the feet and lets or hands and arms. If this happens, stop taking Ofloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
• If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
• If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

Prolonged, disabling and potentially irreversible serious side effects

Fluoroquinolone/quinolone antibacterial medicines, including Ofloxacin, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Ofloxacin, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

Other medicines and Ofloxacin:

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

Tell your doctor if you are taking any of the following:

• Medicines that stop your blot clotting (anticoagulants), such as warfarin, as bleeding times may be longer
• antacids (medicines for an upset stomach), sucralfate, didanosine, aluminium, iron, magnesium or zinc preparations (see section 3, How to take Ofloxacin).
• medicines to control your blood sugar (e.g. glibenclamide), as concentrations of these medicines in the blood may be increased and cause a greater fall in the blood sugar levels.
• theophylline (used for breathing problems) or non-steroidal anti-inflammatory drugs (NSAIDs used for pain relief and inflammation) e.g. ibuprofen, diclofenac or fenbufen, as some people have fits when these are taken with Ofloxacin
• drugs that may affect your kidney function (e.g. cimetidine, furosemide, probenecid or methotrexate), as these can sometimes increase blood levels of Ofloxacin.
• you must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Taking Ofloxacin in combination with antacids, sulcrate, aluminium, iron, magnesium or zinc preparations:

Take Ofloxacin at least two hours before taking any of the above medicines otherwise Ofloxacin may not work as well.

Pregnancy, breast-feeding and fertility:

Do not take this medicine if you are pregnant, might become pregnant, think you may be pregnant or if you are breast-feeding. If you become pregnant while taking Ofloxacin, stop taking the tablets and contact your doctor immediately (see ‘Do NOT take’). Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Ofloxacin may make you feel sleepy, dizzy or could affect your eyesight and reaction time.

If affected do not drive or operate machinery. Drinking alcohol may make these symptoms worse.

Ofloxacin contains lactose:

Patients who are intolerant to lactose should note that Ofloxacin tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ofloxacin contains sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3) How to take Ofloxacin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will decide how much Ofloxacin you need to take each day and whether you can take the dose all at once or should take half in the morning and half in the evening. Your doctor will tell you how long your treatment with Ofloxacin will last. Treatment should not exceed 2 months. Return to your doctor if you still feel unwell after finishing your course of tablets. If you are taking Ofloxacin for longer periodyour doctor may carry out blood tests from time to time to check on your condition.

Swallow the tablets whole with a full glass of water. Do not chew them. Ofloxacin tablets may be taken before or during meal times.

Ofloxacin 200 mg Film-coated Tablets only:

The tablet can be divided into equal doses.

The recommended dose is:

Adults (including the elderly):

The dose to be taken will depend on the type of infection to be treated. For most infections, the recommended dose range is 200 mg to 800 mg of Ofloxacin daily.

Up to 400 mg may be given as a single dose, preferably in the morning.

The recommended doses for different infections are shown below. However, your doctor may decide you need a different dose.

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

• Keep this 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• To treat bladder or kidney infections

  The recommended dose for a simple bladder or kidney infection is 200 mg or 400 mg of Ofloxacin a day. Treatment usually lasts for 3 days. To treat complicated kidney infections, your doctor may increase the dose to 400 mg twice daily and you may need to take Ofloxacin for 7 to 10 days.

• To treat infections of the genital organs

  To treat gonorrhoea of the genital organs, a single dose of 400 mg of Ofloxacin in the morning is usually enough.

  To treat other infections of the genital organs for which Ofloxacin is a suitable antibiotic, the dose is usually 400 mg each day. Treatment may last from 7-10 days.

• To treat lung and chest infections

  The recommended dose is 400 mg of Ofloxacin daily. If necessary, your doctor may increase this to 400 mg twice a day. Treatment may last from 7-10 days. For certain types of pneumonia Ofloxacin may be taken with other medicines.

Patients with kidney or liver problems:

If you have kidney problems (whether or not you need dialysis treatments) or have severe liver problems, your doctor may tell you to take a lower dose of Ofloxacin each day.

Use in children and adolescents:

Ofloxacin Tablets should not be given to children or growing adolescents.

If you take more Ofloxacin than you should:

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

Overdose of Ofloxacin can cause dizziness, confusion, fits, loss of consciousness, nausea and there can be severe problems in the stomach. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Ofloxacin:

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct time.

If you stop taking Ofloxacin

It is important that you complete the full course of treatment as directed by your doctor even if you feel better. If you don’t do this, your symptoms may reappear.

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

4) Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens, stop taking Ofloxacin and tell your doctor immediately or go to the casualty department at your nearest hospital:

Uncommon: may affect up to 1 in 100 people

• Agitation, excessive sleepiness

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

• An allergic reaction sometimes even after taking your first dose, which may include swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, fast heart rate, low blood pressure, fever, burning of the eyes, throat irritation, coughing, wheezing, shock or blood disorders
• Tendon discomfort (usually the Achilles tendon), including inflammation and rupture, particularly if you are elderly or also taking corticosteroids e.g. prednisolone
• Fast heart beat
• Inflammation of the large intestine causing abdominal pain
• Diarrhoea if persistent, and or containing blood
• Nightmares, anxiety, depression, hallucinations, confusion, pins and needles, blurred, double or odd colour vision problems, problems with or loss of smell
• Delirium (acute confusional state)

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

• Severe blistering, peeling of the skin, or inflammation and ulceration of the mouth, eyes, gut and genitals; these may be due to Stevens-Johnson Syndrome or toxic epidermal necrolysis, which are serious illnesses
• Fits, ringing in the ears, unsteadiness, shaking, numbness, disturbance of sensation, problems with or loss of hearing
• Other blood disorders where the numbers of different types of cells in the blood may fall. Symptoms can include weakness, fever, chills, sore throat, ulcers in the mouth and throat, unusual bleeding or unexplained bruising
• Jaundice (yellowing of the skin)

Not known: frequency cannot be estimated from the available data

• Irregular or slower heart beat, fainting
• Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
• If you are a diabetic on treatment and feel signs of low blood sugar levels – feeling weak, sweating and/or trembling
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.
• Feeling of wanting to harm yourself and other disturbances of the mind, problems with or loss of taste
• Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver
• Inflammation of pancreas causing severe abdominal pain

You may need urgent medical attention or hospitalisation. These reactions can occur in some patients after the first dose of Ofloxacin, or even after treatment has stopped.

The following side effects have been reported at the approximate frequencies shown:

Uncommon: may affect up to 1 in 10 people

• Feeling sick or being sick, diarrhoea, stomach pain, indigestion and other stomach upsets.
• Headache, dizziness, a spinning feeling (vertigo), sleep disturbances and restlessness
• Skin rashes, itching
• Irritation of the eye
• Cough, inflammation of nose and throat
• Fungal infections,
• Increases in the number of other bacteria, which may need to be treated

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

• Loss of appetite

• Low blood pressure

  • Shortness of breath, wheezing
  • Fast, irregular heart beat
  • Hot flushes, hives (called urticaria), sweating too much (hyperhidrosis), rash pustular
  • Problems with liver function with abnormal blood test results
  • Problems with kidney function with abnormal blood test results

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

• Anaemia (reduction in red blood cells causing unusual tiredness or weakness)
• Rash on exposure to strong sunlight and other severe skin reactions
• Inflammation of your tubes that carry blood around your body (vessels) due to an allergic reaction
• Discoloration, peeling or loss of nails
• Acute kidney failure
• Joint and muscle pains
• Problems moving and walking

Not known: frequency cannot be estimated from the available data

• Occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis
• It is also possible that Ofloxacin may trigger an attack of porphyria (deficiency of specific enzymes in the body which can lead to discolouration of the urine, serious skin disorders, anaemia, stomach pains and severe mental disorders) in patients who are at risk of developing this condition.
• Abnormal muscle breakdown, muscle weakness, tear, muscle rupture
• Allergic lung inflammation, severe loss of breath
• Upset stomach, excessive wind, constipation
• Feeling weak, elevate body temperature, pain (including pain in back, chest arma and legs)
• Bone marrow failure may lead to pancytopenia (a medical condition in which there is a reduction in the number of red and white blood cells as well as platelets)
• Inflammation of the eye (uveitis)
• Skin redness with extensive scaling (exfoliative dermatitis)
• Syndrome associated with impaired water excretion and low levels of sodium (SIADH)

Very rare cases of long lasting ( up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysm and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

Return to your doctor if you still feel unwell after finishing your course of tablets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5) How to store Ofloxacin tablets

• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton or blister label after ‘EXP’. The expiry date refers to the last day of that month.
• Keep the blisters in the outer carton in order to protect from light.
• Store in the original package.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6) Contents of the pack and other information

What Ofloxacin tablets contain

The active substance is ofloxacin. Each tablet contains 400mg ofloxacin.

The other ingredients are: lactose monohydrate, pregelatinised starch, hypromellose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), macrogol 3000 and triacetin.

What Ofloxacin tablets look like and contents of the pack

Ofloxacin tablets are white, oval, film-coated tablets marked ‘FXN 400’ on one side and scored on the other side.

They are available in blister packs containing 5 and 10 tablets.

PL 46420/0021 Ofloxacin 400mg Tablets POM

Who makes and repackages your medicine?

Your medicine is manufactured by Teva Pharmaceutical Works Ltd, Pallagi Street 13, H-4042 Debrecen, Hungary. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 23.03.2026

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