Ofloxacin 400mg Tablets
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PACKAGE LEAFLET: INFORMATION FORTHE USER
OFLOXACIN 200 mg TABLETS
OFLOXACIN 400 mg TABLETS
(ofloxacin)
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. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Ofloxacin is and what it is used for.
2. What you need to know before you take Ofloxacin.
3. How to take Ofloxacin.
4. Possible side effects.
5. How to store Ofloxacin.
6. Contents of the pack and other information.
1. WHAT OFLOXACIN IS AND WHAT IT IS USED FOR
Ofloxacin belongs to a group of medicines called
quinolones. Ofloxacin is an antibiotic that can be
used to treat a variety of different infections. These
include infections of:
• the chest (respiratory system) such as pneumonia and bronchitis
• the bladder and kidneys (urinary tract)
• the male and female genital organs when the infections involve the cervix (neck of the womb in women) and the lower genital organs in men. Ofloxacin can be used to treat both gonorrhoea and some other genital infections.
• medicines to control your blood sugar e.g. glibenclamide as the amount of these medicines in the blood may increase and have a greater effect
• drugs that may affect your kidney function e.g. Cimetidine, Probenicid and Methotrexate as they can increase the level of Ofloxacin in the blood
• medicines to thin your blood, e.g. Warfarin. Taking these with Ofloxacin can increase the time it takes for your blood to clot.
• if you are taking Didanosine (a medicine used to treat HIV infections), you should not take the chewable, buffered tablets until at least two hours after taking Ofloxacin
• water tablets (diuretics) such as furosemide
• medicines used for high blood pressure
• medicines that help put you to sleep (anaesthetics)
• sucralfate used for stomach ulcers.
Ofloxacin with food and drink
Ofloxacin can be taken with or without food. The tablets should not be taken within two hours of taking iron tablets, antacids, or sucralfate, as these medicines can stop Ofloxacin from working properly.
Pregnancy and breast-feeding
Do not take Ofloxacin if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. If you become pregnant while taking Ofloxacin, stop taking the tablets and contact your doctor immediately. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Taking Ofloxacin may make you feel sleepy, dizzy or could affect your eyesight. Do not drive or use machines until you know how this medicine affects you. Drinking alcohol may make these symptoms worse.
Ofloxacin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ofloxacin.
3. HOWTOTAKE OFLOXACIN
2. WHAT YOU NEEDTO KNOW BEFOREYOUTAKE OFLOXACIN
Do not take Ofloxacin:
• If you are allergic 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 another quinolone antibiotic e.g. ciprofloxacin or norfloxacin.
• If you suffer from epilepsy or are at risk of fits.
• If you have a history of inflammation and swelling of the tendons (tendonitis).
• If you suffer from or there is a family history of glucose-6-phosphate dehydrogenase deficiency (an inherited disorder that affects the red blood cells)
• If you are pregnant or might become pregnant.
• If you are breast-feeding.
• If you are under the age of 18 years, or you are over 18years but thinkyou are still growing.
Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Ofloxacin tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ofloxacin if any of the following apply:
• you have or have ever had a history of mental illness
• you have problems with your liver or kidneys
• you have an illness of the nervous system called 'myasthenia gravis' (muscle weakness)
• if you developed severe diarrhoea
• if you are diabetic or suffer from low blood sugar _ • if you are taking anticoagulants e.g. warfarin.
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 oryou are taking other medicines that result in abnormal ECG changes (see section Other medicines and Ofloxacin).
When taking Ofloxacin, avoid strong sunlight and do not use sun lamps or solaria.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The length of your treatment will depend on how serious your infection is.
The medicine is usually taken for 5 to 10 days and treatment should not be longer than 2 months.
Doses up to 400 mg are taken as a single dose in the morning. Higher doses should be taken in two doses, one in the morning and one in the evening.
The recommended doses of Ofloxacin are as follows:
Adults (including the elderly)
The dose to be taken will depend on the location and the type of infection to be treated. For most infections the recommended dose is between 200 mg and 400 mg of Ofloxacin daily, preferably in the morning. For more severe infections your doctor may increase the dose to 400 mg of Ofloxacin twice daily (morning and evening).
The recommended doses for different infections are shown below. However, your doctor may decide you need a different dose.
To treat simple urine infections
The recommended dose is 200 mg or 400 mg of Ofloxacin daily.
To treat complicated upper urinary tract infections
The recommended dose is 200 mg to 400 mg of Ofloxacin daily. If necessary, your doctor may increase this to 400 mg twice a day.
To treat kidney infection
The dose may be increased to 400 mg to be taken twice a day.
To treat gonorrhoea of the lower genital organs only
A single dose of 400 mg of Ofloxacin in the morning is usually enough. To treat other infections of the lower genital organs for which Ofloxacin is a suitable antibiotic, the dose is usually 400 mg each day.
To treat a chest or lung infection
The recommended dose is 400 mg of Ofloxacin daily. If necessary, your doctor may increase this to 400 mg twice a day.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ofloxacin tablets.
Other medicines and Ofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have kidney or liver problems
Your doctor may give you a lower dose of Ofloxacin. It is recommended that the dose should not exceed 400 mg Ofloxacin daily.
Use in children and adolescents
Children or adolescents under 18 years of age should not take these tablets.
• 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.
Tell your doctor if you are taking any of the
following medicines:
• medicines that contain iron (for anaemia) or zinc
• antacids used for indigestion that contain magnesium or aluminium
• painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) e.g. Ibuprofen or Diclofenac as these could make you more prone to fits if taken with Ofloxacin
Urine tests
Taking Ofloxacin may affect the results of some urine tests. If you are going to have a urine test, it is important to tell your doctor you are taking Ofloxacin.
Route and method of administration:
• For oral use. You should swallow these tablets whole with water. Do not chew them.
• The tablets can be taken with or without food and can be divided into equal doses.
• If you are taking iron tablets (for anaemia), antacids (for indigestion or heartburn) or sucralfate (for stomach ulcers), it is important not to take these two hours before or after taking Ofloxacin tablets.
If you take more Ofloxacin than you should
If you take more tablets than you should you may become confused and dizzy or lose consciousness, you may have a seizure or fit, and you may feel sick or have blood in your stools. Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.
If you forget to take Ofloxacin
If you forget to take a dose take it as soon as you remember unless it is nearly time foryour next dose. Do not take a double dose to make up for the one you have missed.
If you stop taking Ofloxacin
Your doctor will tell you how long you need to take your tablets for. Do not suddenly stop taking this medicine without talking to your doctor first. If you stop, your infection may get worse again. If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or go to your nearest hospital casualty department straight away if you have any of the following serious side effects; these effects are rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people) or not known (frequency cannot be estimated from the available data) because you may need medical attention:
• you have an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:
* rash
* swelling of the face, lips, mouth, tongue or throat (angioedema)
* anaphylactic shock (sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing)
• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson Syndrome)
• a widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
• abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation ofQT interval', seen on ECG, electrical activity of the heart)
• severe depression or mental illness. Some people who are depressed think of harming or killing themselves.
• tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon), particularly if you are also taking corticosteroids e.g. prednisolone
• a liver inflammation (hepatitis) with the following symptoms: nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine
• fits (seizures)
• lack of white blood cells with the following symptoms: fever, severe chills, sore throat or mouth ulcers (agranulocytosis).
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
Uncommon (may affect up to 1 in 100 people):
• feeling sick (nausea) or being sick (vomiting), diarrhoea or stomach pains
• irritated or burning eyes
• headaches, sleep disturbances including difficulty sleeping (insomnia)
• feeling dizzy, having spinning sensations
• agitation, feeling restless
• cough and inflamed sore nose or throat (nasopharyngitis)
• fungal infection or resistance to this treatment
• skin rash or itching.
Rare (may affect up to 1 in 1,000 people):
• loss of appetite
• fast heart beat
• numbness or tingling in the hands and feet or being very sensitive to touch
• drowsiness
• feeling confused or anxious, nightmares, seeing, feeling or hearing things that are not there, depression and mental illness
• blurred, double or altered colour vision
• changes in or loss of your sense of taste or smell
• shortness of breath or wheezing
• changes in levels of liver enzymes shown in blood tests
• excessive sweating and hot flushes
• changes in kidney function shown in blood tests
• feeling faint, lightheaded or dizzy due to low blood pressure
• inflammation of the bowel causing severe diarrhoea, sometimes bloody
• hives (urticaria)
• rash with pimples
• swelling of the tendons with the following symptoms: pain, tenderness, sometimes restricted movement (tendonitis).
Very rare (may affect up to 1 in 10,000 people):
• a condition in which the amount of oxygen-carrying pigment (haemoglobin) in the blood is below normal or an illness resulting from the destruction of red blood cells with the following symptoms: feeling tired, faint, dizzy, being short of breath when exercising and having pale skin.These may be signs of anaemia or haemolytic anaemia.
• uncontrolled movements, unsteadiness and shaking
• other blood disorders when the numbers of different types of cells in the blood may fall, which may cause fever, chills, sore throat, ulcers in the mouth and throat (leucopenia), unusual bleeding oryou may bruise more easily than normal (thrombocytopenia)
• increase in some white blood cells (eosinophilia)
• numbness or weakness of the arms and legs
• narrowing or blockage of blood vessels, in exceptional cases leading to severe skin reactions
• ringing in the ears (tinnitus), hearing problems or hearing loss
• joint and muscle pains
• skin rashes caused by strong sunlight
• unusual bleeding or bruising under the skin
• liver problems that may cause your eyes or skin to go yellow (jaundice)
• watery diarrhoea, which may have blood in it, possibly with stomach cramps and a high temperature
• severe inflammation of the kidneys, which may result in your kidneys stopping working. Signs may include a rash, high temperature and general aches and pains.
Not known (frequency cannot be estimated from the available data):
• it is also possible that ofloxacin may trigger an attack of porphyria (a rare blood pigment disorder) in some patients
• disease of the blood with a reduced number of red or white blood cells or platelets (bone marrow failure) with the following symptoms: tiredness, headaches, dizziness, being short of breath when exercising and looking pale
• a red, scaly rash with bumps under the skin and blisters (exanthemous pustolosis)
• swelling of the lungs with the following symptoms: coughing, difficulty breathing, wheezing
• kidney disease, sometimes with blood in the urine
• temporary paralysis or weakness of muscles (rhabdomyolysis), disease of the muscles with the following symptoms: aching muscles, muscle tenderness or weakness, not caused by exercise, muscular weakness, muscle tear, muscle rupture
• feeling weak or irritable, sweating and/or trembling.This could be due to lowering of blood sugar (glucose) levels.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOWTO STORE OFLOXACIN
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ofloxacin contains
The active substance is ofloxacin. Each film-coated tablet contains 200 mg or 400 mg ofloxacin.
The other ingredients are: maize starch, lactose anhydrous, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc and macrogol 400. The 200 mg tablets also contain croscarmellose sodium and the 400 mg tablets also contain sodium starch glycollate, yellow and black iron oxides (E172) and carnauba wax.
What Ofloxacin looks like and contents of the pack
The 200 mg tablets are white capsule-shaped film-coated tablets marked 'OF' breakline '200' on one side and 'G' on the other. The tablet can be divided into equal doses.
The 400 mg tablets are yellow capsule-shaped film-coated tablets marked 'OF' breakline '400' on one side and 'G' on the other. The tablet can be divided into equal doses.
Ofloxacin Tablets are available in blisters or plastic bottles of 5, 6, 7, 10, 12, 14, 16, 20, 24, 30, 50, 100 and 250 tablets. The 200 mg tablets are also available in blisters or plastic bottles of 8 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last
revised in: 08/2012 XXXXXXXX 10004273