Ofloxacin 400mg Tablets
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Pharma code 570
OFLOXACIN 200 mg and 400 mg TABLETS
PACKAGE LEAFLET INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Ofloxacin is and what it is used for
2. Before you take Ofloxacin
3. How to take Ofloxacin
4. Possible side effects
5. How to store Ofloxacin
6. Further information
WHAT OFLOXACIN IS AND WHAT IT IS USED FOR
Ofloxacin belongs to a group of antibacterial medicines known as fluoroquinolones.
Ofloxacin is used to treat infections of:
• the bladder or the kidneys
• the lungs, including pneumonia
• the skin and soft tissue
• the male and female genital organs when the infections involve the cervix (neck of the womb) in women and the genital organs in men. Ofloxacin can be used to treat both gonorrhoea and some other genital infections.
BEFORE YOU TAKE OFLOXACIN
Do NOT take Ofloxacin if you:
• are allergic (hypersensitive) to ofloxacin or any of the other ingredients of this medicine
• 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.
• have a history of inflammation of the tendons (tendonitis) when you have taken fluoroquinolone antibiotics in the past
• have epilepsy or have you ever had a seizure or fit
• suffer from glucose-6-phosphate dehydrogenase deficiency (this is an inherited disorder that affects the red blood cells), If Ofloxacin is taken the red blood cells may break down causing anaemia and jaundice
• are pregnant or breast-feeding
• are under the age of 18, or are over 18 years old but think you are still growing
• have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Ofloxacin is not suitable for people who have inherited disorders that give them problems when they take these sugars.
Take special care with Ofloxacin 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 Taking other medicines).
Tell your doctor before you start to take this medicine if you:
• suffer from or have a history of mental illness
• 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.
• have an illness of the nervous system called myasthenia gravis (a disorder in which the muscles are weak and tire easily)
• are elderly or have been prescribed corticosteroids (used to treat asthma and other chronic lung diseases) as this may cause swelling and pain of your tendons
• are diabetic
• are taking fenbufen or other NSAIDS, vitamin K antagonists
• are taking theophylline.
While you are taking Ofloxacin
• you may experience severe, sudden allergic reaction (an anaphylactic reaction/shock). Even with the first dose, there is a chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, stop taking Ofloxacin and contact your doctor immediately
• you may experience psychiatric reactions after first administration of Ofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ofloxacin. If this happens, stop taking Ofloxacin and contact your doctor immediately
• you may experience symptoms of liver problems such as loss of appetite, yellowing of the skin or whites of the eyes, dark urine, itching or tenderness of the stomach, Ofloxacin should be stopped immediately
• diarrhoea may develop while you are on antibiotics, including Ofloxacin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ofloxacin treatment will have to be stopped immediately, as this can be life-threatening
• pain and swelling in the joints, and tendonitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. At the first sign of any pain or inflammation Oflaxacin should be stopped
• tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin
• 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
• 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 than 2 weeks.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• anticoagulants (tablets that stop your blood clotting, e.g. warfarin), as bleeding times may be longer
• antacids, sucralfate, didanosine, aluminium, iron, magnesium or zinc preparations (see section 3, How to take)
• medicines to control your blood sugar (e.g. glibenclamide), as concentrations of these medicines in the blood may be increased and they may have a greater effect
• theophylline or non-steroidal anti-inflammatory drugs (NSAIDs), 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 they 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-arrhythmic (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, procainamide), tricyclic antidepressants e.g. amitriptyline, clomipramine, some antimicrobials (that belong to the group of macrolides e.g. erythromycin or azithromycin), some antipsychotics.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Ofloxacin with food and drink
Do not drink alcohol while taking Ofloxacin as it may make any side effects worse.
Important information about some of the ingredients of Ofloxacin
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.
Pregnancy and breast-feeding
Do not take Ofloxacin if you are pregnant, think you may be pregnant, or are breast-feeding.
Driving and using machines
Ofloxacin may make you feel sleepy, dizzy or could affect your eyesight, which may impair your ability to concentrate. If affected do not drive or operate machinery.
HOW TO TAKE OFLOXACIN
Always take Ofloxacin exactly as your doctor has told you. You should 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 together once a day or half the dose 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.
The tablets should be swallowed preferably with a drink of water. Ofloxacin tablets may be taken before or with food.
The usual dose is:
Adults (including the elderly):
Your dose will depend on the type and severity of infection you have. The dosage range is 200 mg to 800 mg a day.
• To treat simple bladder or kidney infections
The usual dose is 200 mg or 400 mg of Ofloxacin a day. Treatment usually lasts for 3 days. To treat kidney infections, your doctor may increase the dose to 400 mg twice a day and you may need to take Ofloxacin for 7-10 days
• 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 a day, taken for 7-10 days
• To treat lung infections
The usual dose is 400 mg of Ofloxacin a day. If necessary, your doctor may increase this to 400 mg twice a day. Treatment may last from 7-10 days
• To treat skin and soft tissue infections
The usual dose is 400 mg of Ofloxacin twice a day. Treatment may last from 7-10 days.
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Children and adolescents:
Ofloxacin Tablets should not be given to children or growing adolescents. Patients with kidney or liver problems:
Your doctor may tell you to take a lower dose of Ofloxacin than the usual dose.
Taking Ofloxacin in combination with antacids, sucralfate, didanosine, 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.
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. An overdose is likely to cause dizziness, confusion, fits, loss of consciousness, nausea and severe stomach problems. 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 dose.
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 product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Ofloxacin can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor
immediately or go to the casualty department at your nearest hospital:
• 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
• 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
• tendon discomfort, including inflammation and rupture, particularly if you are elderly or also taking corticosteroids e.g. prednisolone
• fits, agitation, nightmares, anxiety, depression, hallucinations, feeling of wanting to harm yourself and other disturbances of the mind, confusion, ringing in the ears, unsteadiness, shaking, disturbance of sensation, numbness, pins-and-needles, blurred, double or odd colour vision problems, problems with or loss of hearing, taste or smell
• diarrhoea containing blood.
These are very serious but very rare or rare side effects. You may
need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate frequencies shown:
Common (affecting fewer than one person in 10 but more than one person in 100):
• stomach upsets.
Uncommon (affecting fewer than one person in 100 but more than one person in 1000):
• fungal infection, resistance to pathogens
• headache, dizziness, sleep disturbances and restlessness
• eye irritation, vertigo, cough, inflammation of nose
• feeling sick or being sick, diarrhoea, stomach pain
• rashes, itching.
Rare (affecting fewer than one person in 1000 but more than one person in 10,000):
• serious allergic reaction which causes difficulty in breathing, dizziness, swelling of the face or throat
• loss of appetite
• feeling confused or anxious, nightmares, seeing things that are not there, depression
• sleepiness
• numbness
• changes in or loss of your sense of taste or smell
• drowsiness
• visual disturbances such as double vision or blurred vision
• faster heart rate (tachycardia)
• low blood pressure
• difficulty in breathing or wheezing, shortness of breath
• inflammation of bowel, which may cause bleeding
• impairment of liver function with abnormal liver blood test results
• hives (nettle rash)
• menstrual disturbance (such as hot flushes), excessive sweating, rash
• inflammation of tendons
• increased creatinine levels in the blood.
• abnormal dreams or mental illness
• a disorder of the nerves which can cause weakness, tingling or numbness
• fits (convulsions)
• impairment of voluntary movement i.e. tremors, tics. Changes in muscle tone, slowness of movement
• an allergic reaction in the eye or on the skin around the eye
• ringing in the ears, problems hearing or loss of hearing
• failure to circulate blood around the body
• flushing
• severe diarrhoea containing blood and/or mucus (antibiotic associated diarrhoea)
• jaundice (yellowing of the skin), severe liver damage
• serious illness with blistering of the skin, rash on exposure to strong sunlight, skin discolouration, peeling or detachment of nails, blisters, blisters with bleeding, ulcers, flushing, widespread red rashes, small lumps in the skin that can form ulcers and scabs, bleeding into the skin and other organs (drug eruption)
• bruise like rash
• inflammation of blood vessels, often with skin rash
• muscle weakness, joint and muscle pain
• swelling or discomfort in your tendons such as in the achilles tendon, which may occur within 48 hours of treatment
• effects on kidney function, which may lead to kidney failure
• unbalanced walk.
Other side effects
• severe reduction in the number of white blood cells which makes infections more likely
• an impairment in blood cell production which can result in anaemia, reduced ability to fight infection and bruising or bleeding
• low blood sugar levels (especially in diabetics)
• severe depression or mental illness. Some people who are depressed think of harming or killing themselves
• 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)
• inflammation of the lungs which causes breathlessness, cough and raised temperature (allergic pneumonitis)
• severe shortness of breath
• inflammation of liver, which may be severe
• serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• acute generalised exanthematous pustulosis (red swollen area with numerous small pustules)
• pain or muscle weakness, abnormal muscle breakdown which can lead to kidney problems
• muscle tear, muscle rupture
• inflammation of the kidney which can cause swollen ankles or high blood pressure
• ofloxacin may trigger an attack of porphyria in susceptible patients.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE OFLOXACIN
Keep out of the reach and sight of children. Keep the container in the outer carton supplied to protect these tablets from light. Do not transfer them to another container. Do not use Ofloxacin after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.
FURTHER INFORMATION
What Ofloxacin tablets contain:
• The active ingredient is Ofloxacin.
• The other ingredients are lactose monohydrate, pregelatinised starch, hypromellose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (El71), macrogol 3000 and triacetin.
What Ofloxacin tablets look like and contents of the pack:
• The 200 mg tablets are white, round, film-coated tablets, scored on both sides. One side of the tablet is marked "FXN" on one side of the breakline and "200" on the other side.
• The 400 mg tablets are white, oval, film-coated tablets marked 'FXN 400' on one side and scored on the other side.
• The 200 mg and 400 mg tablets are available in pack sizes of 5, 10, 20 and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: March 2011 PL 00289/0353-0354
Very rare (affecting fewer than one person in 10,000):
• anaemia (reduction in red blood cells causing pale or yellow skin, unusual tiredness or weakness)
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TEVA UK LIMITED
• other blood disorders when the numbers of different types of cells in the blood may fall. Symptoms can include fever, chills, sore throat, ulcers in the mouth and throat, unusual bleeding or unexplained bruising
• increase in blood sugar levels (especially in diabetics)