RAFLOX film coated tablet contain a medicine called levofloxacin which belongs to an antibiotics group called "quinolone". It works by killing the bacteria that cause infections in your body. Used in adults 18 years or older.                                                                               

Therapeutic indications:

RAFLOX tablets can be used to treat infections of the:

· Nasal sinuses.

· Lungs, in people with long-term breathing problems or pneumonia.

· Urinary tract, including your kidneys or bladder.

· Prostate gland, where you have a long lasting infection.

· Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’.

In some special situations, RAFLOX may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.

Sometimes infections are caused by viruses rather than by bacteria. Example include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including RAFLOX, do not kill viruses.

A. Do not take this medicine and tell your doctor if:

·  You are allergic to levofloxacin, or any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of RAFLOX tablets (listed in section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

· You have ever had epilepsy.

·  You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’.

·  You are a child or a growing teenager.

·  You are pregnant, might become pregnant or think you may be pregnant.

· You are breast-feeding.

·  If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking RAFLOX tablets.

B. Warnings and precaution:

Talk to your doctor or pharmacist before taking RAFLOX if:

· You are 60 years of age or older.

· You are using corticosteroids, sometimes called steroids (see section “Other medicines and RAFLOX”).

· You have ever had a fit (seizure).

· You have had damage to your brain due to a stroke or other brain injury.

· You have kidney problems.

· You have something known as ‘glucose – 6 – phosphate dehydrogenase deficiency’. You are more likely to have serious problems with your blood when taking this medicine.

· You have ever had mental health problems.

· You have ever had Heart problems: Caution should be taken when using RAFLOX, 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 Other medicines and RAFLOX).

· If you have experienced a previous episode of aortic dissection (a tear in the aorta wall).

·  If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or atherosclerosis).

· You are diabetic.

·  You have ever had liver problems.

· You have myasthenia gravis.

·  If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.

Other warnings:

· RAFLOX may rarely cause pain and inflammation in tendons. Particularly if you are elderly or taking steroid medicines (such as cortisone or hydrocortisone). If you have any problems with your tendons whilst or shortly after taking RAFLOX, seek medical advice at once and rest the affected limb (leg or arm). Do not take the next dose of RAFLOX unless your doctor tells you to. In such as cases, you experience swelling or pain in the area of affected tendon. It may be necessary to stop treatment

·  If you start having severe, persistent and/or bloody diarrhea during or after treatment with RAFLOX, tell your doctor immediately. This could mean you have serious inflammation of your bowel (pseudomembranous colitis), which can sometimes occur after antibiotic treatment. You may need to stop taking levofloxacin and your doctor may give you another medicine.

· Whilst taking RAFLOX you are advised to stay out of strong sunlight. This is because some patients may become more sensitive to light whilst taking RAFLOX and get a sun-burn like reaction.

· RAFLOX should be discontinued if the patient experiences symptoms Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’.

· RAFLOX is not an optimal therapy for most severe cases of Pneumococcal pneumonia.

· Infections got from a hospital during treatment due to P.aeruginosa may require combination therapy.

· RAFLOX is not effective against infections caused by MRSA. In infections suspicious for MRSA levofloxacin should be combined with an agent approved to treat MRSA infections.

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

C. Other medicines and RAFLOX:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those obtained without a prescription.

In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with RAFLOX tablets:

· Corticosteroids: used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons.

· Warfarin: used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

· Theophylline: used for breathing problems. You are more likely to have a fit (seizure) if taken with RAFLOX.

· Non-steroidal anti-inflammatory drugs (NSAIDS): used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with RAFLOX.

·  Ciclosporin: used after organ transplants. You may be more likely to get the side effects of Ciclosporin.

·   Medicines known to affect the way your heart beats: This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine and amiodarone), Tricyclic antidepressants (such as amitriptyline and imipramine), Macrolide antibiotics (such as erythromycin, azithromycin and clarithromycin) and Anti-psychotic medicines.

· Probenecid (used for gout) and Cimetidine (used for ulcers and heartburn).

Do not take RAFLOX tablets at the same time as the following medicines. Either 2 hours before or 2 hours after taking these products:

·  Iron tablets (for anemia), multivitamin, or other product that has magnesium, aluminum, iron or zinc.

·  Magnesium or aluminum-containing antacids (for acid or heartburn).

·  Sucralfate (for stomach ulcers).

·   Didanosine antiviral drug for HIV.

This is because it can affect the way RAFLOX tablets work.

Urine tests for opiates:

Urine tests may show ‘false positive’ results for strong painkillers called ‘opiates in people taking RAFLOX (levofloxacin) tablets. If your doctor is due to take a urine test, tell him you are taking RAFLOX tablets.

Tuberculosis tests:

This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.

Taking RAFLOX with food and drink:

Take without regard to meals. Take with plenty of water. Taking this product with orange juice can result in reduced quinolone plasma levels.

D. Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be a pregnant or planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

E. Driving and using machines:

You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

Always take RAFLOX tablets exactly as your doctor has told you. 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

• The tablets may be taken during meals or at any time between meals

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for 2 days after you stop taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

• Make sure you use high factor sun cream.

• Always wear a hat and clothes which cover your arms and legs.

• Avoid sun beds.

How much to take

• Your doctor will decide on how many RAFLOX film coated tablet you should take.

• The dose will depend on the type of infection you have and where the infection is in your body.

• The length of your treatment will depend on how serious your infection is.

• If you feel the effect of your medicine is too weak or strong, do not change the dose by yourself, but ask your doctor.

Adults and the elderly with normal renal function:

Sinuses infection:

• Two tablet of 250 mg once daily.

• 500 mg, once daily.

• 750 mg, once daily.

Pneumonia:

• Two tablets of 250 mg, once or twice daily.

• 500 mg, once daily.

• 750 mg, once daily.

Lungs infection, in people with long-term breathing problems:

• Two tablets of 250 mg, once daily.

• One tablet of 500 mg, once daily.

Urinary tract infection or acute pyelonephritis:

• 750 mg, once daily.

Chronic bacterial prostatitis:

• 500 mg, once daily.

Infection of skin and underneath the skin, including muscles:

• Two tablets of 250 mg, once or twice daily.

• One tablet of 500 mg, once or twice daily.

Adults with kidney problems:

• Your doctor may need to give you a lower dose.

Children and Adolescence:

• RAFLOX must not be given to children or teenagers below 18 years.

That’s because children have a higher chance of getting bone, joint, or tendon problems such as pain or swelling while taking RAFLOX.

A. If you take more RAFLOX tablets than you should:

If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, and heart problems leading to uneven heart beats as well as feeling sick (nausea).

B. If you forget to take RAFLOX tablets:

If you forgot to take your dose, take it as soon as you remember unless it is nearly time for your next dose. Do not double-up the next dose to make up for the missed dose.

C. If you stop taking RAFLOX tablets:

Do not stop taking RAFLOX just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, RAFLOX can cause side effects, although not everybody gets them. These effects are normally mild or moderate and often disappear after a short time.

Stop taking RAFLOX and see a doctor or go to a hospital straight away if you notice the following side effect:

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

• Watery diarrhea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem.

• Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles tendon is affected most often.

• Convulsions.

Very rare (may affect up to 1 in 10,000 people)

• You have an allergic reaction. The signs may include: rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue.

• Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’.

Other:

• Severe skin rashes which may include blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals.

• Loss of appetite, skin and eyes becoming yellow in color, dark-colored urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver.

If your eyesight becomes impaired or if you have any other eye disturbances whilst taking RAFLOX and consult an eye specialist immediately.

Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:

Common (may affect up to 1 in 10 people)

• Sleeping problems.

• Headache, feeling dizzy.

• Feeling sick (nausea, vomiting) and diarrhea.

• Increase in the level of some liver enzymes in your blood.

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated.

• Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia).

• Feeling stressed (anxiety), confused, nervous, sleepy, trembling, and a spinning (vertigo).

• Shortness of breath (dyspnea).

• Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), and feeling bloated (flatulence) or constipation.

• Itching and skin rash, urticaria, sweating too much (hyperhidrosis).

• Joint pain or muscle pain.

• Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems.

• General weakness.

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

• Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia).

• Low number of white blood cells (neutropenia).

• Exaggerated immune response (hypersensitivity).

• Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have diabetes.

• Hallucinations, paranoia, and change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.

• Feeling depressed, mental problems, feeling restless (agitation), or nightmares.

• Tingly feeling in your hands and feet (paresthesia).

• Problems with your hearing (tinnitus) or eyesight (blurred vision).

• Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension).

• Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system).

• Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.

• Fever.

Other side effects include:

• Anemia: this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia).

• Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells (agranulocytosis).

• Sudden drop in blood circulation (anaphylactic shock).

• Increase of your blood sugar levels (hyperglycemia) or lowering of your blood sugar levels leading to coma (hypoglycemic coma). This is important for people that have diabetes.

• Changes in the way things smell, loss of smell or taste.

• Problems moving and walking (dyskinesia, extrapyramidal disorders).

• Temporary loss of consciousness or posture (syncope).

• Temporary loss of vision.

• Impairment or loss of hearing.

• Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart).

• Difficulty breathing or wheezing (bronchospasm).

• Allergic lung reactions.

• Pancreatitis.

• Inflammation of the liver (hepatitis).

• Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).

• Inflammation of the blood vessels due to an allergic reaction (vasculitis).

• Inflammation of the tissue inside the mouth (stomatitis).

• Muscle rupture and muscle destruction (rhabdomyolysis).

• Joint redness and swelling (arthritis).

• Pain, including pain in the back, chest and extremities.

• Attacks of porphyria in people who already have porphyria (a very rare metabolic disease).

• Persistent headache with or without blurred vision (benign intracranial hypertension).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

To report any side effect(s):

Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax:                               +966-11-205-7662

Call NPC at                    +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail:                          npc.drug@sfda.gov.sa

Website:                        www.sfda.gov.sa/npc 

Other GCC States:

Please contact the relevant competent authority

• Keep out of the reach and sight of children.

• Keep RAFLOX film coated tablets in the original strips and box in a dry place.

• Do not use this medicine after the expiry date which is stated on the carton and foil after EXP. The expiry date refers to the last day of the month.

• Don’t store above 30°C.

• 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.