Consumer Information for: JAMP-MOXIFLOXACIN TABLETS

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Your doctor has prescribed JAMP-MOXIFLOXACIN because you have a certain type of bacterial infection.
Antibacterial drugs like JAMP-MOXIFLOXACIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, JAMP-MOXIFLOXACIN should be used exactly as directed. Misuse or overuse of JAMPMOXIFLOXACIN could lead to the growth of bacteria that will not be killed by JAMPMOXIFLOXACIN (resistance). This means that JAMP-MOXIFLOXACIN may not work for you in the future. Do not share your medicine.

What it does

JAMP-MOXIFLOXACIN is an antibiotic. It kills many of the types of bacteria that can infect the lungs, sinuses, abdomen, and skin.

When it should not be used

Do not use JAMP-MOXIFLOXACIN if:

  • you are allergic to JAMP-MOXIFLOXACIN (moxifloxacin hydrochloride) or other quinolone antibiotics.
  • you are allergic to any other ingredient in the formulation (see “What are the ingredients in JAMPMOXIFLOXACIN Tablets?”).
What the medicinal ingredient is

400 mg of moxifloxacin as moxifloxacin hydrochloride

What the non-medicinal ingredients are

cellulose microcrystalline, croscarmellose sodium, magnesium stearate, mannitol, silica colloidal anhydrous, macrogol 40000, talc, polyvinyl alcohol, titanium dioxide, FD & C Yellow # 6/Sunset Yellow FCF Aluminum Lake, Ponceau 4R Aluminum Lake, FD&C Blue # 2/Indigo Camine Aluminum Lake and purified water.

What dosage form it comes in

JAMP-MOXIFLOXACIN tablets are available as oblong, convex-shaped, dull red film-coated tablets containing 400 mg moxifloxacin (as hydrochloride). Oblong, convex-shaped, dull red film-coated tablets engraved “Moxi” on one side and “400” on the other

Warnings and precautions

Serious Warnings and Precautions

  • Quinolone antibiotics, like JAMP-MOXIFLOXACIN, are related to disabling and possibly long lasting effects such as:
    • inflamed tendon (tendonitis), tendon rupture.
    • nerve damage (peripheral neuropathy).
    • problems in the brain such as:
    • convulsions
    • nervous breakdown
    • confusion
    • and other symptoms
  • Quinolone antibiotics, like JAMP-MOXIFLOXACIN
    • have lengthened the heartbeat (QT interval prolongation).
    • have led to serious allergic reactions, including death
    • may be related to increased tendonitis (inflamed tendon)
    • may worsen myasthenia gravis (a muscle disease)
    • may lead to seizures and nervous breakdowns. Tell your doctor if you have brain or spinal cord problems (such as epilepsy)
    • may cause liver injury which may lead to death
  • For further information and symptoms see:
    • the “To help avoid side effects and ensure proper use,…” section
    • the “What are possible side effects from using Jamp-Moxifloxacin?” section
Talk to your doctor to see if Jamp-Moxifloxacin is right for you.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Jamp-Moxifloxacin. Talk about any health conditions or problems you may have, including if you:

  • have or have a family history of irregular heart rhythm (such as QT prolongation).
  • have or have had heart problems such as heart failure, an irregular heartbeat, or a slow heartbeat.
  • have low potassium blood levels (see “The following may interact with Jamp-Moxifloxacin.”)
  • have a history of seizures.
  • are pregnant, planning to become pregnant, or if you are breast feeding.
  • are less than 18 years of age.
  • have a history of tendon problems (such as pain, swelling or rupture of a tendon) related to the use of quinolone antibiotics.
  • have myasthenia gravis (a muscle disease).
  • have diabetes as JAMP-MOXIFLOXACIN may affect blood sugar levels. JAMP-MOXIFLOXACIN may also affect blood sugar levels in those without diabetes.
Other warnings you should know about:

Blood Sugar Changes

Medicines like JAMP-MOXIFLOXACIN can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like JAMP-MOXIFLOXACIN. If you have diabetes, check your blood sugar levels often while taking JAMP-MOXIFLOXACIN.

While taking Jamp-Moxifloxacin
  • Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).
  • Contact your doctor if a sunburn or rash occurs.
  • Do not drive or use machinery if you feel dizzy or lightheaded.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication

The following may interact with JAMP-MOXIFLOXACIN

  • Antacids or vitamin/mineral supplements
  • Nonsteroidal anti-inflammatory drugs(NSAIDs)
  • Antidiabetic medicines (such as, insulin, glyburide, glibenclamide)
  • Quinidine, procainamide, amiodarone, sotalol, cisaprideb , erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).
bno longer marketed in Canada
Proper use of this medication

How to take JAMP-MOXIFLOXACIN

  • You must take JAMP-MOXIFLOXACIN exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.
  • You can take Jamp-Moxifloxacin with or without food.
  • You should drink lots of fluids while taking Jamp-Moxifloxacin.
  • If your doctor decides to stop the treatment, dispose of all unused Jamp-Moxifloxacin tablets.

Usual Dose

  • Take one 400 mg JAMP-MOXIFLOXACIN tablet once a day.
  • Swallow each JAMP-MOXIFLOXACIN tablet whole with a drink of water. Do not crush or chew JAMP-MOXIFLOXACIN tablets.
  • If you are taking antacids or vitamin/mineral supplements which contain magnesium or aluminium, take JAMP-MOXIFLOXACIN at least 4 hours before or 8 hours after taking the supplement or antacid.
  • Your doctor has decided on the best dose for you and for how long based on your needs.
  • The usual length of treatment with JAMP-MOXIFLOXACIN is 5-10 days. IT IS IMPORTANT TO COMPLETE THE FULL LENGTH OF TREATMENT, EVEN IF YOU BEGIN TO FEEL BETTER.

Overdose

If you think you have taken too much JAMP- MOXIFLOXACIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre, even if there are no symptoms.

Missed Dose

If you forget to take a dose, take another as soon as you remember. Take the next dose 24 hours later. Do not take two doses in any 24 hour period.

Side effects and what to do about them

All medicines, including JAMP-MOXIFLOXACIN, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking Jamp-Moxifloxacin. If you have any side effects not listed here or if conditions worsen or do not improve then:

  • contact your healthcare professional.
  • see the “To help avoid side effects and ensure proper use, …” section.
Stop taking Jamp-Moxifloxacin and contact your doctor if:
  1. you have symptoms of an allergic reaction such as:
  • rash, hives, blistering or other skin reaction
  • swelling of the mouth, throat, limbs
  • difficulty breathing
  • irregular or rapid heartbeat, or fainting spells
  • you have pain, swelling or rupture of a tendon. You should:
    • rest
    • avoid physical exercise
  • you have neuropathy (damage to the nerves) with symptoms such as:
    • pain, burning, tingling, numbness or weakness
  • you have severe diarrhea (bloody or watery) with or without:
    • fever
    • stomach pain or tenderness
    You may have Clostridium difficile colitis (bowel inflammation). See your doctor right away. Other side effects include:
    • your eyesight worsens or changes. See your doctor or eye specialist right away.
    • nausea, dizziness
    • worsening of myasthenia gravis (a muscle disease) with symptoms such as:
      • weakness
      • difficulty walking, swallowing, drooping eyelids
      Do not use JAMP-MOXIFLOXACIN if you have this condition.
      mental problems such as:
      • confusion, headache,shaking
      • hallucinations, depression, agitation
      • difficulty sleeping, anxiety, nervousness, suicidal thoughts
      • Contact your doctor if you have suicidal thoughts.
      Self-Limiting Side Effects:
      • feeling lightheaded
      • insomnia (difficulty sleeping)
      • nightmares

    Serious side effects, how often they happen and what to do about them
    Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
    Rare
    Irregular heartbeat or fainting spells     ✔
    Mental health problems:
    • anxiety
    • confusion
    • depression
    • feeling agitated
    • restless or nervous
    • suicidal thoughts or actions
    • hallucinations
    • inability to think clearly or pay attention
    • memory loss
    • paranoia or loss of touch with reality
    		     ✔
    Neurological problems:
    • seizures/convulsions
    • tremors
    		   ✔  
    Nervous system side effects:
    • symptoms of neuropathy (damage to the nerves): numbness, tingling, pain, burning or weakness
    		     ✔
    Rise in the pressure within your skull:
    • blurred or double vision
    • headaches
    • nausea
    		   ✔  
    Tendon pain, inflammation, or rupture     ✔
    Symptoms of an allergic reaction (which may lead to death):
    • rash
    • hives
    • rapid heartbeat
    • difficulty breathing
    • difficulty swallowing
    • swelling of face, lips, or tongue
    		     ✔
    Liver problems with symptoms such as yellowing of the skin and/or eyes, nausea, abdominal pain, dark urine, and pale stools     ✔
    Symptoms of a severe bowel condition (Clostridium difficile colitis):
    • persistent diarrhea
    • bloody or watery diarrhea
    • abdominal or stomach pain/cramping
    • blood/mucus in stool
    		     ✔
    Very Rare
    Hypoglycemia (low blood sugar) such as:
    • change in mood
    • change in vision
    • confusion
    • dizziness
    • fast heartbeat
    • feeling faint
    • headache
    • hunger
    • shaking
    • sweating
    • weakness
    		   ✔  
    How to store

    AMP-MOXIFLOXACIN tablets should be stored:

    • at room temperature (15°C - 30°C)
    • in a tightly closed container away from heat and direct light.
    Do not freeze the tablets.

    Keep out of reach and sight of children.
    Reporting side effects

    Reporting Side Effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

    If you want more information about JAMP-MOXIFLOXACIN:

    • Talk to your healthcare professional
    • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); or by calling the sponsor at: 1-866-399-9091
    This leaflet was prepared by:
    Jamp Pharma Corporation
    1310 rue Nobel, Boucherville
    Québec, Canada, J4B 5H3

    Last revised: July 8, 2019

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