Ofloxacin 400mg Tablets
E
E
Package leaflet: Information for the user
OFLOXACIN 200 mg TABLETS OFLOXACIN 400 mg TABLETS
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 See
section 4._
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
This medicine contains an active ingredient called 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.
• skin and soft tissue. Soft tissue is underneath the skin and includes muscle.
2. What you need to know before you take Ofloxacin Tablets Do not take Ofloxacin Tablets :
• if you are allergic to ofloxacin or any of the other ingredients 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 a history of tendonitis (inflammation and swelling of the tendons) which can affect area such as the wrist or the achilles tendon.
• if you suffer from fits (epilepsy)
• if you are pregnant or breast-feeding (see 'Pregnancy and breast feeding' section below)
• if you are under the age of 18 or are still growing
• if you have a problem with your red blood cells known as 'glucose-6-phosphate dehydrogenase deficiency'
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 Tablets if:
• you have liver or kidney problems
• you have heart disease or problems with your heartbeat
• you are taking medicines that can affect your heart (see section Other medicines and Ofloxacin Tablets)
• you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart)
• you have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
• you have a very slow heart rhythm (called 'bradycardia')
• you have a weak heart (heart failure)
• you have a history of heart attack (myocardial infarction)
• you are female or elderly
• you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Ofloxacin Tablets)
• you have or have ever had any mental health problems
• you suffer from a condition called myasthenia gravis, which causes muscle weakness and excessive muscle fatigue
• you have been told by your doctor that you can not tolerate some sugars.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ofloxacin tablets.
There have been very rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) with the use of Ofloxacin tablets.
Symptoms of which may include: flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. If you develop any of the above you must stop taking your medicine and inform your doctor straight away (see Section 4). Ofloxacin tablets are not recommended if you have a suspected MRSA infection. While being treated with Ofloxacin tablets, avoid strong sunlight and do not use
sun lamps or solariums, as your skin may be more sensitive to light. If you experience pain in your fingers or toes whilst being treated with Ofloxacin tablets, tell your doctor or nurse immediately.
Other medicines and Ofloxacin Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ofloxacin and some other medicines can affect the way each other work.
In particular, tell your doctor if you are taking the following medicine:
• Methotrexate used for rheumatism or cancer 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
The following medicines can change the way Ofloxacin work or Ofloxacin may change the way some of these medicines work:
• Medicines used to stop your blood from dotting
• Medicines used for high blood pressure
• Medicines that contain iron (for anaemia) or zinc
• Medicines that help put you to sleep (anaesthetics)
• Water tablets (diuretics) such as furosemide
• Antacids that contain magnesium or aluminium - used for indigestion
• Glibenclamide - used for diabetes
• Probecenid - used for gout
• Cimetidine - used for stomach ulcers or indigestion
• Sucralfate - used for stomach ulcers
The following medicines, when taken with Ofloxacin, can increase the chance of you getting side effects:
• Other antibiotics (such as erythromycin, azithromycin or clarithromycin)
• Medicines for depression (such as amitriptyline, clomipramine or imipramine)
• Theophylline - used for breathing problems
• Medicines used to control your heartbeat (such as amiodarone, quinidine, procainamide, or disopyramide)
• Non steroidal anti-inflammatory drugs (NSAIDs) - used for pain relief and inflammation (such as ibuprofen, diclofenac or indometacin)
• Corticosteroids - used for inflammation
• Antipsychotics - used to treat psychiatric disorders such as schizophrenia and bipolar disorder.
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 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• 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.
• If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
• When taking Ofloxacin, if your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
When to take your medicine
• 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
How much to take
• Your doctor will decide on how many Ofloxacin tablets you should take
• The dose will depend on the type of infection you have
430 mm
140 mm
SAME SIZE ARTWORK Front
The recommended dose for adults, including the elderly, is between 200 mg and 800 mg each day. The dose depends on the location and type of infection:
• Kidney or bladder infections (urinary tract): 200 to 800 mg
each day
• Chest or lung: 400 to 800 mg each day
• Male or female sex organ infections (genital tract): 400 mg
each day
• Gonorrhoea: a single dose of 400 mg
• Skin and soft tissue infections: 400 to 800 mg each day Kidney or liver problems:
Your doctor may give you a lower dose if you have kidney or liver problems.
Use in Children and adolescents
This medicine should not be given to children or adolescents. 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.
If you take more Ofloxacin Tablets then you should
If you take more Ofloxacin tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling confused or dizzy, loss of consciousness, fits, feeling sick or blood in your stools.
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 Keep taking Ofloxacin tablets until your doctor tells you to stop. Do not stop taking Ofloxacin tabletsjust because you feel better. If you stop, your infection may get worse again. If you have any further questions on the use of this product, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, this medicine 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
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:
Very Rare (affects less than 1 in 10,000 people)
• An uneven or fast heartbeat, you may also feel faint
• Watery 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 (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) which may include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals. Symptoms may include flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. If you develop any of the above you must stop taking this medicine and inform your doctor straight away.
• 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)
• Indigestion, flatulence (passing wind), constipation
• Fever, pain (back, chest, limbs)
• Severe abdominal pain (pancreatitis)
• Impaired hearing
• Inflammation of the eye (uveitis)
• Skin redness with extensive scaling (exfoliative dermatitis)
• 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
• Liver problems
• Problems with eye sight
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/yellowcard. 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 that 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 glycolate, 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.
Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Ofloxacin 200mg Tablets; PL 17907/0024 Ofloxacin 400mg Tablets; PL 17907/0025 This leaflet was last revised in October 2016 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.
V9 06-10-16 D1
430 mm
140 mm
SAME SIZE ARTWORK back
Package leaflet: Information for the user_
OFLOXACIN 200 mg TABLETS OFLOXACIN 400 mg TABLETS
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 See
section 4._
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
This medicine contains an active ingredient called 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.
• skin and soft tissue. Soft tissue is underneath the skin and includes muscle.
2. What you need to know before you take Ofloxacin Tablets Do not take Ofloxacin Tablets :
• if you are allergic to ofloxacin or any of the other ingredients 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 a history of tendonitis (inflammation and swelling of the tendons) which can affect area such as the wrist or the achilles tendon.
• if you suffer from fits (epilepsy)
• if you are pregnant or breast-feeding (see 'Pregnancy and breast feeding' section below)
• if you are under the age of 18 or are still growing
• if you have a problem with your red blood cells known as 'glucose-6-phosphate dehydrogenase deficiency'
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 Tablets if:
• you have liver or kidney problems
• you have heart disease or problems with your heartbeat
• you are taking medicines that can affect your heart (see section Other medicines and Ofloxacin Tabbts)
• you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart)
• you have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
• you have a very slow heart rhythm (called 'bradycardia')
• you have a weak heart (heart failure)
• you have a history of heart attack (myocardial infarction)
• you are female or elderly
• you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Ofloxacin Tablets)
• you have or have ever had any mental health problems
• you suffer from a condition called myasthenia gravis, which causes muscle weakness and excessive muscle fatigue
• you have been told by your doctor that you can not tolerate some sugars.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ofloxacin tablets.
There have been very rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) with the use of Ofloxacin tablets.
Symptoms ofwhich may include: flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. If you develop any of the above you muststop taking your medicine and inform your doctor straight away (see Section 4). Ofloxacin tablets are not recommended if you have a suspected MRSA infection. While being treated with Ofloxacin
tablets, avoid strong sunlight and do not use sun lamps or solariums, as your skin may be more sensitive to light. If you experience pain in your fingers or toes whilst being treated with Ofloxacin tablets, tell your doctor or nurse immediately.
Other medicines and Ofloxacin Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ofloxacin and some other medicines can affect the way each other work.
In particular, tell your doctor if you are taking the following medicine:
• Methotrexate used for rheumatism or cancer 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
The following medicines can change the way Ofloxacin work or Ofloxacin may change the way some of these medicines work:
• Medicines used to stop your blood from dotting
• Medicines used for high blood pressure
• Medicines that contain iron (for anaemia) or zinc
• Medicines that help put you to sleep (anaesthetics)
• Water tablets (diuretics) such as furosemide
• Antacids that contain magnesium or aluminium - used for indigestion
• Glibenclamide - used for diabetes
• Probecenid - used for gout
• Cimetidine - used for stomach ulcers or indigestion
• Sucralfate - used for stomach ulcers
The following medicines, when taken with Ofloxacin, can increase the chance of you getting side effects:
• Other antibiotics (such as erythromycin, azithromycin or clarithromycin)
• Medicines for depression (such as amitriptyline, clomipramine or imipramine)
• Theophylline - used for breathing problems
• Medicines used to control your heartbeat (such as amiodarone, quinidine, procainamide, or disopyramide)
• Non steroidal anti-inflammatory drugs (NSAIDs) - used for pain relief and inflammation (such as ibuprofen, diclofenac or indometacin)
• Corticosteroids - used for inflammation
• Antipsychotics - used to treat psychiatric disorders such as schizophrenia and bipolar disorder.
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 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• 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.
• If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
• When taking Ofloxacin, If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
When to take your medicine
• 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
How much to take
• Your doctor will decide on how many Ofloxacin tablets you should take
• The dose will depend on the type of infection you have «
The recommended dose for adults, including the elderly, is between 200 mg and 800 mg each day. The dose depends on the location and type of infection:
• Kidney or bladder infections (urinary tract): 200 to 800 mg
each day
• Chest or lung: 400 to 800 mg each day
• Male or female sex organ infections (genital tract): 400 mg
each day
• Gonorrhoea: a single dose of 400 mg
• Skin and soft tissue infections: 400 to 800 mg each day Kidney or liver problems:
Your doctor may give you a lower dose if you have kidney or liver problems.
Use in Children and adolescents
This medicine should not be given to children or adolescents.
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.
If you take more Ofloxacin Tablets then you should
If you take more Ofloxacin tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling confused or dizzy, loss of consciousness, fits, feeling sick or blood in your stools.
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 Keep taking Ofloxacin tablets until your doctor tells you to stop. Do not stop taking Ofloxacin tablets just because you feel better. If you stop, your infection may get worse again. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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
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:
Very Rare (affects less than 1 in 10,000 people)
• An uneven or fast heartbeat, you may also feel faint
• Watery diarrhoea, which may have blood in it, possibly with stomach cramps and a high temperature
• Fils
• Hearing problems or hearing loss
• Liver problems that may cause your eyes or skin to go yellow (jaundice)
• Severe skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) which may include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals. Symptoms may include flu-like symptoms followed by a painful red or purplish rash that spreads and blisters. If you develop any of the above you must stop taking this medicine and inform your doctor straight away.
• 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 activUy of the heart)
• Indigestion, flatulence (passing wind), constipation
• Fever, pain (back, chest, limbs)
• Severe abdominal pain (pancreatitis)
• Impaired hearing
• Inflammation of the eye (uveitis)
• Skin redness with extensive scaling (exfoliative dermatitis)
• 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
• Liver problems
• Problems with eye sight
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/yellowcard. 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 that 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.
What Ofloxacin Tablets contain
• Each tablet contains either 200mg or 400mg of the active ingredient, ofloxacin.
• The other ingredients are microcrystalline cellulose, sodium starch glycolate, 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.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Ofloxacin 200mg Tablets; PL 17907/0024 Ofloxacin 400mg Tablets; PL 17907/0025 This leaflet was last revised in October 2016
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.
V7 06-10-16 D1
SAME SIZEARTWORK