FLOXIMOX 400MG FILM COATED TABLETS… broad spectrum antibacterial agent

FLOXIMOX tablets are used in adults for the treatment of infections of the lungs, airways and sinuses. In women FLOXIMOX tablets can be used to treat a condition called ” pelvic inflammatory disease” which is an infection of the female upper genital tract. In certain infections, you may require treatment with antibiotic IV injection followed by a course of FLOXIMOX tablets e.g. severe and complicated skin and skin structure infections, complicated abdominal infections.

FLOXIMOX tablets contain the active ingredient ” moxifloxacin “, which is an antibiotic belonging to a group of medicines called fluoroquinolones. These antibiotics work by killing the bacteria that are causing your infection. FLOXIMOX tablets will not work against infections caused by viruses such as colds or the flu. FLOXIMOX tablets are available by prescription only.

HOW TO TAKE FLOXIMOX

Trade Name Form Active Ingredients Strength Company
FLOXIMOX Film Coated Tablets Moxifloxacin  400 mg per tablet Benta pharma industries- Lebanon
FLOXIMOX 400 mg film coated tablets
FLOXIMOX 400 mg film coated tablets

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How much to take: Your doctor or pharmacist will tell you how much and how often you should take FLOXIMOX . It is important that you take the full course of treatment that your doctor has prescribed for you. The usual adult dosage for FLOXIMOX tablets for most infections is one 400 mg tablet once daily for 5 to 10 days. However, some types of infections may require longer treatment.Your doctor will determine the duration of time that you take the tablets depending on the type of infection you have. You should not exceed the dose your doctor has prescribed for you. The risk of heart rhythm problems may increase with an increase of the dose.

How to take it: Swallow the tablet whole with water. Do not chew the tablet.

When to take it: FLOXIMOX tablets are usually taken once a day. Take your tablet at the same time each day. It can be taken with or without food. It is advisable to drink fluids liberally.

Do not take FLOXIMOX at the same time as taking antacids (containing magnesium, calcium, or aluminium), multivitamins (containing iron or zinc), sucralfate (a medicine to treat stomach ulcers) or didanosine (a medicine to treat viral infections). Taking these medicines at the same time as FLOXIMOX can interfere with the absorption of FLOXIMOX tablets and reduce their effectiveness in fighting the infection. You must take FLOXIMOX at least 2 hours before, or 4 hours after taking any of these medicines.

How long to take it : The length of treatment with FLOXIMOX tablets may vary depending on the type of infection. The usual duration of treatment is from five to ten days, but can be longer. Your
doctor will determine the duration of time that you need to take the tablets.

If you forget to take it: If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose): Immediately telephone your doctor, or the Poisons Information Centre. if you think you or anyone else may have taken too much FLOXIMOX . Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

FLOXIMOX 400 mg tablets- FAQs

When is the best time to take moxifloxacin? It is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take FLOXIMOX . Take FLOXIMOX at around the same time every day.

Is FLOXIMOX (moxifloxacin) stronger than Augmentin (amoxicillin)? Your doctor will decide the appropriate antibiotic for you based on the type of microbe, and the sensitivity of the microbe to the antibiotic. In the MOSAIC study, which compared moxifloxacin with a basket of comparators (amoxicillin, clarithromycin or cefuroxime), moxifloxacin resulted in superior clinical cure rates overall, as well as higher bacteriological success rates in patients with a confirmed bacterial pathogen.

Is FLOXIMOX sulfa based? FLOXIMOX (Moxifloxacin) is in an entirely different drug class that is NOT structurally similar to sulfa antibiotics.

I have a penicillin allergy, can I take this medication? Yes. FLOXIMOX (Moxifloxacin) is also in an entirely different drug class that is NOT structurally similar to penicillin antibiotics.

Can I take FLOXIMOX with milk? Do not take dairy products, antacids or vitamins containing iron, magnesium, calcium or zinc, within 2 hours before or after taking this medicine.

Is FLOXIMOX a good antibiotic? FLOXIMOX ( Moxifloxacin) is an antibacterial medicine. This means that it stops infections caused by germs (bacteria). It works by killing the germs that are causing the infection. Moxifloxacin is prescribed to treat bacterial infections such as bronchitis, pneumonia, sinusitis, and pelvic inflammatory disease.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLOXIMOX .

All medicines can have side effects. Sometimes they are serious; most of the time they are not. You may need to stop taking the tablets or have medical treatment if you get some of the
serious side effects. Do not be alarmed by the following lists of side effects. You may not experience any of them. Tell your doctor if you notice any of the following and they
worry you( These are the more common side effects of FLOXIMOX . They are usually mild and short-lived):

  • headache
  • dizziness or lightheadedness
  • nausea, vomiting
  • stomach pains, diarrhoea
  • thrush in the mouth (sore creamy-yellow raised patches in mouth) or in the vagina (itching, burning or thick white discharge).

Tell your doctor immediately, or go to the Accident and Emergency department at your nearest hospital if you notice any of the following(These are serious side effects. If you have them, you may need urgent medical attention or hospitalisation.):

  1. allergic reactions such as skin rashes, swelling of the face, lips, mouth or throat.
  2. palpitations or fainting spells.
  3.  watery or bloody diarrhoea, even if it occurs several weeks after finishing your tablets.
  4. pain, swelling or rupture of a tendon.
  5. fits (seizures, convulsions).
  6. pain, burning, tingling, numbness or weakness that starts or worsens on FLOXIMOX .
  7. changes in your mood or thoughts that worry you.
  8. sudden stomach, chest or back pain.

In isolated instances, some serious adverse drug reactions may be long-lasting (> 30 days) and disabling; such as tendinitis, tendon rupture, musculoskeletal disorders, and other reactions affecting the nervous system including psychiatric disorders and disturbance of senses.

FLOXIMOX may cause rapid and severe inflammation of the liver, which can lead to lifethreatening liver failure including fatal cases. Tell your doctor immediately if you suddenly feel unwell or sick and develop symptoms such as:

  • yellowing of the skin and in the whites of your eyes, also called jaundice.
  • pain in liver area.
  • dark urine.
  • itchy skin.
  • tendency to bleed.

If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions contact your doctor immediately before you continue the treatment. Tell your doctor or pharmacist
if you notice anything that is making you feel unwell.

Contraindications

Do not take this medicine and tell your doctor if:

  • You are allergic (hypersensitive) to FLOXIMOX or any of the other ingredients of FLOXIMOX 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 FLOXIMOX tablets. You should not take fluoroquinolone/quinolone
antibacterial medicines, including FLOXIMOX 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 FLOXIMOX 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 FLOXIMOX 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 FLOXIMOX , 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 FLOXIMOX 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 FLOXIMOX 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 FLOXIMOX 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 FLOXIMOX therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking FLOXIMOX 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 FLOXIMOX tablets, contact your doctor immediately.

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

While being treated with FLOXIMOX 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 FLOXIMOX 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 FLOXIMOX tablets.

-- Arabic Information
FLOXIMOX 400MG FILM COATED TABLETS- Arabic Information

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