PMS-Moxifloxacin (Pharmascience, 400 mg): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is pms-MOXIFLOXACIN used for?

Your doctor has prescribed pms-MOXIFLOXACIN because you have a certain type of bacterial infection.

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

How does pms-MOXIFLOXACIN work?

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

What are the ingredients in pms-MOXIFLOXACIN Tablets?

Medicinal ingredients: 400 of moxifloxacin, as moxifloxacin hydrochloride

Non-medicinal ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Stearyl Fumarate, Talc, and Titanium Dioxide.

pms-MOXIFLOXACIN comes in the following dosage forms:

Tablets: 400 mg

Do not use pms-MOXIFLOXACIN if:

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-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).
• You 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 pms-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 (e.g., pain, swelling or rupture of a tendon) related to the use of quinolone antibiotics.
• have a myasthenia gravis (a muscle disease).
• have diabetes as pms-MOXIFLOXACIN may affect blood sugar levels. pms-MOXIFLOXACIN may also affect blood sugar levels in those without diabetes.

Other warnings you should know about:

Blood sugar changes

Medicines like moxifloxacin hydrochloride 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 moxifloxacin hydrochloride. If you have diabetes, check your blood sugar levels often while taking pms-MOXIFLOXACIN.

While taking pms-MOXIFLOXACIN:

• Avoid too much sunlight or artificial ultraviolet light (e.g., 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.

The following may interact with pms-MOXIFLOXACIN include:

• antacids or vitamin/mineral supplements.
• nonsteroidal anti-inflammatory drugs (NSAIDs).
• antidiabetic medicines (e.g., insulin, glyburide, glibenclamide).
• quinidine, procainamide, amiodarone, sotalol, cisaprideb, erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).

^b no longer marketed in Canada

How to take pms-MOXIFLOXACIN:

• You must take pms-MOXIFLOXACIN exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.

• You can take pms-MOXIFLOXACIN with or without food. You should drink lots of fluids while taking pms-MOXIFLOXACIN.

• If your doctor decides to stop the treatment, dispose of all unused pms-MOXIFLOXACIN tablets.

Usual Dose:

• Take one 400 mg pms-MOXIFLOXACIN tablet once a day.
• Swallow each pms-MOXIFLOXACIN tablet whole with a drink of water. Do not crush or chew pms-MOXIFLOXACIN tablets.
• If you are taking antacids or vitamin/mineral supplements which contain magnesium or aluminum, take d take pms-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 pms-MOXIFLOXACIN is 5-10 days. IT IS IMPORTANT TO COMPLETE THE FULL LENGTH OF TREATMENT, EVEN IF YOU BEGIN TO FEEL BETTER.

Overdose:

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.

What are possible side effects from using pms-MOXIFLOXACIN?

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

These are not all the possible side effects you may feel when taking pms-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 pms-MOXIFLOXACIN and contact your doctor if:

1. a)

   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
2. b)

   you have pain, swelling or rupture of a tendon. You should:

   • rest
   • avoid physical exercise
3. c)

   you have neuropathy (damage to the nerves) with symptoms such as:

   • pain, burning, tingling, numbness or weakness
4. d)

   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 pms-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

If any of these affect you severely, tell your doctor or pharmacist.

Serious Side Effects and What to do About Them

Serious Side Effects and What to do About Them

Reporting Side Effects

Storage:

pms-MOXIFLOXACIN should be stored:

• at room temperature (between 15°C and 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.

If you want more information about pms-MOXIFLOXACIN:

• Talk to your healthcare professional.
• Finds the full product monograph that is prepared for healthcare professionals, includes this Patient Medication Information by visiting the Health Canada website https://www.canada.ca/en/health-canada.html); the manufacturer’s website (www.pharmascience.com), or by calling Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montréal, Canada

H4P 2T4

www.pharmascience.com

Last revised: May 9, 2019