Ofloxacin 400mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER OFLOXACIN 200 mg TABLETS OFLOXACIN 400 mg TABLETS (Ofloxacin)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 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 Tablets are and what are they used for
2. What you need to know before you take Ofloxacin Tablets
3. How to take Ofloxacin Tablets
4. Possible side effects
5. How to store Ofloxacin Tablets
6. Contents of the pack and other information
1. What Ofloxacin Tablets are and what are they used for
The name of your medicine is Ofloxacin 200mg or 400mg Tablets which will be referred to as Ofloxacin Tablets throughout this leaflet.
The active ingredient is ofloxacin.
Ofloxacin belongs to a group of medicines called fluoroquinolones which are used for treating bacterial infections. Ofloxacin is used to treat a variety of infections in adults including elderly which include infections of:
♦ the urinary tract (e.g. kidneys and bladder)
♦ the respiratory tract (e.g. lungs and chest)
♦ the genital tract (male and female sex organs) This includes gonorrhea which is a sexually transmitted infection that can affect both men and women.
♦ the skin and layers beneath the skin (soft tissue) such as leg ulcers
2. What you need to know before you take Ofloxacin Tablets
Do not take Ofloxacin Tablets :
♦ if you have ever been told you are allergic to ofloxacin or any of the other ingredients (these are listed in section 6 for information on the ingredients)
♦ if you have ever had an allergic reaction to another antibiotic such as Ciprofloxacin or Norfloxacin
♦ if you have a history of tendonitis (inflammation and swelling of the tendons) which can affect area such as the wrist or the archilles tendon.
♦ if you suffer from fits (epilepsy)
♦ if you are pregnant or might become pregnant
♦ if you are breast feeding
♦ if you are under the age of 18
♦ if have a problem with your red blood cells known as 'glucose-6 dehydrogenase deficiency'
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 before taking Ofloxacin Tablets:
♦ if you have heart problems
Caution should be taken when using this kind of medicine, if you are 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 low 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 Tablets').
♦ if you have ever had seizure or fit
♦ if you have kidney or liver disease
♦ if you have diabetes
♦ if you or a member of your family has porphyria or problem with their metabolism called glucose-6-phosphate dehydrogenase deficiency (G6PD)
♦ if you or a member of your family have mental or psychiatric illness
♦ if you develop sensory or sensorimotor peripheral neuropathy (Damage to the nerves which may cause pain, burning sensation, weakness, tingling or numbness in arms, hands, legs or feet). Your healthcare provider may decide to discontinue ofloxacin to prevent the development of an irreversible condition.
♦ if you are sensitive to sunlight.
♦ if you have MRSA infections.
♦ if you have urinary tract infections.
♦ if you have skin or mucosal reactions.
♦ if your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
♦ if you suffer from a condition called myasthenia gravis (muscle weakness)
♦ if you are on prolonged ofloxacin therapy (Patient taking ofloxacin for long term should consult their healthcare provider on regular basis)
Tell your doctor if you are undergoing any medical tests as ofloxacin may interfere with the results.
Children and Adolescents
Ofloxacin is not indicated for use in children or growing adolescents.
Other medicines and Ofloxacin Tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 (e.g amitriptyline, doxepin and imipramine), some antimicrobials (that belong to the group of macrolides e.g erythromycin, azithromycin, clarithromycin and dinithromycin), some antipsychotics e.g clozapine.
Do not take ofloxacin at the same time of the day as these tablets:
♦ antacids (for indigestion) that contain magnesium or aluminium, zinc or iron tablets. These medicines will reduce the amount of ofloxacin in your blood
♦ sucralfate (for ulcers), as ofloxacin will not work properly if taken with sucralfate
Ofloxacin Tablets should be taken 2 hours before taking the above mentioned preparations.
Examples of other medicines which can affect ofloxacin are:
♦ anti-coagulants (stop blood clotting) e.g. warfarin. Taking these with ofloxacin can increase the time it takes for your blood to clot
♦ Medicines used for diabetes (to lower your blood sugar levels) e.g. glibenclamide, as ofloxacin may cause your blood sugar levels to fall even further
♦ non-steroidal anti-inflammatory drugs (NSAIDs - to relieve pain and inflammation) e.g. aspirin, fenbufen or theophylline (for asthma). These could make you more likely to have fits if you take them with ofloxacin
♦ diuretics (to increase urine output) e.g. furosemide
♦ drugs used for gout e.g. probenecid
♦ drugs used for ulcers e.g. cimetidine
♦ corticosteroids used for inflammation
♦ methotrexate a medicine used for arthritis and cancer treatment Ofloxacin Tablets with food, drink and alcohol
Do not drink alcohol while taking Ofloxacin Tablets. This is because it may make you feel dizzy or sleepy.
Pregnancy, breast-feeding and fertility
Do not take this medicine if you are pregnant, think you have become pregnant, intend to become pregnant whilst taking these tablets or are breast-feeding or are planning to breast-feed.
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 any other medicines.
Driving and using machines:
Ofloxacin can make you feel sleepy, dizzy or cause problems with your eyesight. Do not drive or use machines until you know how this medicine affects you.
| 3. How to take Ofloxacin Tablets |
Always take Ofloxacin Tablets exactly your doctor has told you. Check with your doctor or pharmacist if you are not sure.
♦ Swallow the tablets whole with a drink of water
♦ The length of your treatment will depend on how serious your infection is.
♦ The medicine is usually taken for 5-10 days and treatment should not be longer than 2 months.
♦ When taking Ofloxacin Tablets, avoid strong sunlight and do not use sun lamps and solaria.
♦ Medicines containing iron (for anaemia), antacids (for indigestion or heartburn), or sucralfate (for stomach ulcers) should be avoided for two hours before and after taking Ofloxacin Tablets.
♦ Depending on the severity of your infection, your doctor will decide how many Ofloxacin tablets you should take.
♦ If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
The recommended dose is:
Adults:
♦ The usual dose ranges from 200mg and 800mg daily, depending on the condition being treated. Up to 400mg may be given as a
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single dose; however larger doses should be given as two divided doses.
♦ For lower urinary tract infection (e.g. cystitis): 200-400mg daily.
♦ For upper urinary tract infection (e.g. kidney functions): 200400mg daily, increasing if necessary to 400mg twice daily.
♦ For lower respiratory tract infection (e.g. bronchitis): 400mg daily, increasing if necessary to 400mg twice daily.
♦ For uncomplicated urethral and cervical gonorrhoea (an example of a sexually transmitted disease): a single dose of 400mg.
♦ For non gonococcal urethritis and cervicitis (an example of a sexually transmitted disease): 400mg daily in single or divided doses.
♦ For skin and soft tissue infections: 400 mg twice daily.
Kidney or liver problems:
Your doctor may give you a lower dose if you have kidney or liver problems.
Use in Children and adolescents
Do not take Ofloxacin if you are under 18 years old.
If you take more Ofloxacin Tablets then you should:
You may become confused and dizzy, you may have a seizure or fit, your heartbeat may become rapid, and you may faint. You may also feel sick or have blood in your stool.
Tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take Ofloxacin Tablets If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Ofloxacin Tablets:
Your doctor will tell you how long you must take your tablets for. Take all the tablets that have been prescribed for you, even if you start to feel better. Do not suddenly stop taking this medicine without talking to your doctor first. Your symptoms may start to improve before the infection is completely treated. If you stop taking the tablets too soon, your symptoms may return. If you have any further questions on use of this medicine, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, Ofloxacin tablets can cause side effects, although not everybody gets them.
Stop taking Ofloxacin tablets and see a doctor or go to a hospital straight away if:
♦ You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
♦ You have skin or mucosal reactions.
Stop taking Ofloxacin tablets and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Veiy Rare (affects less than 1 in 10,000 people)
♦ An uneven or fast heartbeat, you may also feel faint
♦ Wateiy diarrhoea, which may have blood in it, possibly with stomach cramps and a high temperature
♦ Fits
♦ Hearing problems or hearing loss
♦ Liver problems that may cause your eyes or skin to go yellow (jaundice)
♦ Severe skin rashes which may include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals
♦ Skin rashes caused by strong sunlight
♦ Feeling faint, light-headed or dizzy, due to low blood pressure
♦ Muscle weakness, joint and muscle pains
♦ Feeling weak or irritable, sweating and/or trembling. This could be due to lowering of blood sugar levels
♦ Feeling thirsty and passing water more often than usual. This could be due to a raise in blood sugar levels
♦ Swelling or discomfort in your tendons, such as in the achilles tendon
♦ Severe inflammation of the kidneys, which may result in your kidneys stop working. Signs may include a rash, high temperature and general aches and pains
♦ Severe depression or mental illness
Some people who are depressed think of harming or killing themselves Rare (affects less than 1 in 1000 people)
♦ Numbness or tingling in the hands and feet or being very sensitive to touch
Frequency not known (cannot be estimated from the available data)
♦ Heart problems:
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)
♦ increase in blood sugar level, decrease in blood sugar level with coma
♦ nervousness, involuntary movements, loss of taste functions, loss of consciousness, hearing impaired,
♦ inflammation of pancreas, flatulence, indigestion, constipation,
♦ inflammation of mouth and lips.
♦ inflammation of joints, ligament rupture
♦ fever, weakness and pain in back, chest and extremeties.
Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Uncommon (affects less than 1 in 100 people)
♦ Feeling or being sick, diarrhoea or stomach pains
♦ Headaches, sleeping problems, feeling dizzy or restless
♦ Skin rash or itching
Rare (affects less than 1 in 1000 people)
♦ Loss of appetite
♦ Feeling confused or anxious, nightmares, seeing things that are not there, depression and mental illness, feeling drowsy, trembling, problems in walking due to poor muscle control
♦ Changes in eyesight
♦ Changes in or loss of your sense of taste or smell
♦ Changes in levels of liver enzymes shown in blood tests
♦ A general feeling of being unwell
Very Rare (affects less than 1 in 10,000 people)
♦ Feeling tired, faint, dizzy and having pale skin. These could be signs of anaemia
♦ You may bruise more easily than usual. This could be because of a blood problem called 'thrombocytopenia'
♦ Cough or shortness of breath, caused by lung inflammation
It is possible that Ofloxacin may trigger an attack of porphyria (a rare illness which affects the metabolism) in some patients.
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/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
| 5. How to store Ofloxacin Tablets |
♦ Keep this medicine out of the sight and reach of children.
♦ Do not store above 250C. Store in the original package.
♦ Do not use the tablets after the expiry date stated on the carton. The expiry date refers to the last date of the month.
♦ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information |
What Ofloxacin Tablets contain:
♦ Each tablet contains either 200mg or 400mg of the active ingredient, ofloxacin.
♦ The other ingredients are microcrystalline cellulose, sodium starch glycollate, hydroxypropyl cellulose, magnesium stearate, opadry Y-1-7000 white (containing hypromellose, macrogol 400, titanium dioxide (E171)).
What Ofloxacin Tablets look like and contents of the pack:
♦ The 200mg tablets are white capsule shaped and scored on both sides with 'BL' and '200' embossed on one face of the tablet.
♦ The 400mg tablets are white capsule shaped and scored on both sides with 'BL' and '400' embossed on one face of the tablet.
♦ Ofloxacin 200mg Tablets are available in blister packs of 10, 20 and 100 tablets. While, Ofloxacin 400mg Tablets are available in blister packs of 5, 10 and 50 tablets.
♦ Not all packs may be marketed.
Name and address:
Telephone:
Fax:
E-mail:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom 0044 (0)1442 200922 0044 (0)1442 873717 info@bristol-labs.co.uk
Ofloxacin 200mg Tablets; PL 17907/0024 Ofloxacin 400mg Tablets; PL 17907/0025 This leaflet was last revised in August 2014
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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