Tarivid tablets contain a medicine called” Ofloxacin”. This belongs to a group of medicines called ” Fluoroquinolone antibiotics”. It works by killing bacteria that cause infections. Tarivid tablets are used for infections of the:

Urinary tract (bladder and kidney infection).
Chest or lungs.
Genital tract infections in men and women (e.g. gonorrhoea, a sexually transmitted disease).
Skin and soft tissue. Soft tissue is underneath the skin and includes muscle.
It could also be used to prevent infections in certain groups of patients.

Your doctor will decide on how many Tarivid tablets you should take. The dose will depend on the type of infection you have. The usual 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: If you have any kidney or liver problems you may be given a lower dose.
Children and Adolescents: This medicine should not be given to children or adolescents.

Always take Tarivid tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take this medicine by mouth, Swallow the tablets whole with a drink of water, When taking Tarivid tablets, avoid:

strong sunlight and do not use sun lamps or solariums.
Medicines containing iron (for anaemia) antacids (for indigestion or heartburn) or sucralfate (for stomach ulcers) should be avoided for two hours before or after taking Tarivid 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 to take your medicine. The length of your treatment will depend on how serious your infection is. 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.

Your doctor will explain to you exactly how much Tarivid you will have to take as well as how often and for how long. This will depend on the type of infection you have Kidney or liver problems, If you have any kidney or liver problems you may be given a lower dose.

Children and Adolescents: This medicine should not be given to children or adolescents.

Elderly Patients: Blood tests to monitor kidney function should be performed in elderly patients taking Tarivid tablets and the dose of Tarivid may need to be adjusted accordingly. The risk of tendinitis and tendon rupture is increased in patients over 60 years of age.

Urine Tests: Taking Tarivid tablets 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 Tarivid tablets.

If you take more Tarivid 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, seeing things that are not there, tremor, fast irregular heartbeat, loss of consciousness, fits, feeling sick or blood in your stools.

If you forget to take Tarivid tablets: If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Tarivid tablets: Keep taking Tarivid tablets until your doctor tells you to stop. Do not stop taking Tarivid 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.

Contraindications

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to Tarivid or any of the other ingredients of Tarivid tablets. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
You have ever had swelling of the tendons (called tendinitis) which can affect areas such as the wrist or the achilles tendon.
You have epilepsy or are at risk of fits.
You have a problem with your red blood cells known as ‘glucose-6-dehydrogenase deficiency’.
You are pregnant or breast-feeding .
You are under 18 years of age or are still growing .
You have received a transplantation.
You have a rare hereditary disorder that makes you unable to tolerate the sugars lactose (lactose intolerance) or glucose (glucose intolerance).

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 Tarivid tablets. You should not take fluoroquinolone/quinolone
antibacterial medicines, including Tarivid tablets, 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.

Warnings and Precautions

Talk to your doctor or pharmacist before using Tarivid tablets if:

You have liver or kidney problems.
You are elderly.
You have heart disease or problems with your heartbeat.

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.
You are taking medicines that can affect your heart.
You have low levels of potassium or magnesium in your blood.
You are taking a medicine to reduce blood clotting known as a Vitamin K Antagonist e.g. Warfarin. Your doctor will need to monitor you closely when taking both Vitamin K Antagonists and Tarivid tablets .
You have or have ever had any mental health problems.
You have diabetes.
If you have a condition called myasthenia gravis, which causes muscle weakness and excessive muscle fatigue.
You have nerve problems (peripheral neuropathy).
You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
You have been diagnosed with leaking heart valves (heart valve regurgitation).
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]).

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 Tarivid, 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 Tarivid tablets, 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.

There have been very rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) with the use of Tarivid 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 .

Allergic (anaphylactic) reactions have been reported. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If you experience an
anaphylactic reaction, stop taking this medicine and contact your doctor straight away.

If you experience severe, persistent diarrhoea, possibly with blood in it, you may have pseudomembranous colitis (CDAD). CDAD can range from mild to life threatening in severity. If you
suspect that you have symptoms of CDAD, stop taking this medicine and contact your doctor straight away.

This medicine may trigger fits (seizures). If you have a fit (seizure), stop taking this medicine and inform your doctor straight away. Patients with a history of epilepsy should not take Tarivid tablets.

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 tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Tarivid therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Tarivid tablets, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

If you develop thoughts of harming or killing yourself, stop taking this medicine and contact your doctor straight away .

If you experience difficulties with your eyesight while taking Tarivid tablets, contact your doctor immediately.

Tarivid tablets are not recommended if you have a suspected MRSA infection.

While being treated with Tarivid tablets, avoid strong sunlight and do not use sun lamps or solariums, as your skin may be more sensitive to light.

You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this
happens, stop taking Tarivid tablets and inform your doctor immediately in order to prevent the development of potentially irreversible condition.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tarivid tablets.

Possible Side effects

Uncommon (may affect up to 1 in 100 people):

resistance of infection causing organisms to this treatment, (you may fail to respond to treatment).

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

Allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as: severe skin 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).
inflammation of the bowel, which may cause severe watery diarrhoea, which may have blood in it, possibly with stomach cramps and a high temperature.
swelling of the tendons with the following symptoms; pain, tenderness, sometimes restricted movement (tendonitis). This can lead to tendon rupture, especially of the large tendon at the back
of the ankle (Achilles tendon). The risk of this occurring is increased if you are also taking corticosteroids e.g. prednisolone.
numbness or tingling in the hands and feet or being very sensitive to touch, numbness or weakness of the arms and legs.
blurred, double or altered colour vision. If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

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.
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, agranulocytosis).
fits (seizures).
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 skin peeling on much of the body surface (toxic epidermal necrolysis).
narrowing, blockage or leakage of blood vessels, in exceptional cases leading to severe skin reactions and death of areas of the skin.
severe kidney problems, which may result in your kidneys stopping working. Signs may include a rash, high temperature, general aches and pains, or blood in the urine.
hearing problems or hearing loss.
liver problems, such as inflammation of the liver (hepatitis) or blockage in the bile duct, that may cause your eyes or skin to go yellow (jaundice) or you may notice the following symptoms; nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, light coloured bowel motions, dark coloured urine.

Not known (frequency cannot be estimated from the available data):

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).
severe depression or mental illness. Some people who are depressed think of harming or killing themselves.
a serious reduction in all types of blood cells (pancytopenia), which may result from a failure of the bone marrow to produce these.
a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome).
swelling of the lungs with the following symptoms; coughing, difficulty breathing, wheezing.
temporary paralysis or weakness of the muscles (rhabdomyolysis), disease of the muscles with the following symptoms; aching muscles, muscle tenderness or weakness, not caused by exercise.
an attack of porphyria (a rare blood pigment disorder) in patients with this disease.
muscle or ligament rupture.
inflammation of the pancreas (pancreatitis) – you may have severe pain in the stomach and back.
loss of consciousness (coma), due to a severe reduction in blood sugar levels.
inflammation of the eye (uveitis).
skin redness with excessive 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.

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.
skin rash or itching.

Rare (may affect up to 1 in 1,000 people)

loss of appetite.
fast heart beat.
drowsiness.
feeling confused or anxious, nightmares, seeing, feeling or hearing things that are not there, depression and mental illness.
changes in or loss of your sense of taste or smell.
shortness of breath or wheezing.
changes in levels of liver enzymes or bilirubin, which may be seen in blood tests.
excessive sweating and hot flushes.
changes in kidney function shown in blood tests.
feeling faint, lightheaded or dizzy, which may be due to low blood pressure.
hives (urticaria).
rash with pimples.

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