Patient Medication Information: uses, side effects, how to take - Bio-Moxifloxacin

Serious Warnings and Precautions

Quinolone antiobiotics, like Bio-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 Bio-MOXIFLOXACIN:
- have lengthened the heartbeat (QT prolongation)
- have led to serious allergic reactions, including death
- may be related increased tendonitis (inflamed tendon)
- may worsen myasthenia gravis (a muscular disease)
- may lead to seizures and nervous breakdowns. Tell your doctor if 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 Bio-MOXIFLOXACIN?” section

Talk to your doctor to see if Bio-MOXIFLOXACIN is right for you.

ABOUT THIS MEDICATION

What is Bio-MOXIFLOXACIN used for?

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

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

How does Bio-MOXIFLOXACIN work?

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

What are the ingredient in Bio-MOXIFLOXACIN?

Medicinal ingredients Bio-MOXIFLOXACIN tablets contain 400 mg of moxifloxacin as moxifloxacin hydrochloride.

Nonmedicinal ingredients: Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose and Opadry Pink.

Bio-MOXIFLOXACIN Tablets come in the following dosage forms:

Tablets: capsule shaped dull red colored film coated tablets debossed with M400 on one side and plain on the other side.

Do not use Bio-MOXIFLOXACIN if:

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

To help avoid side effects and ensure proper use,

talk to your healthcare professional before you take Bio-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 Bio-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 Bio-MOXIFLOXACIN may affect blood sugar levels. Bio-MOXIFLOXACIN may also affect blood sugar levels in those without diabetes.

Other warnings you should know about:

Blood Sugar Changes

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

While taking Bio-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.

The following may interact with Bio-MOXIFLOXACIN:

Antacids or vitamin/mineral supplements
Nonsteroidal anti-inflammatory drugs (NSAIDs)
Antidiabetic medicines (such as, insulin, glyburide, glibenclamide)
Quinidine, procainamide, amiodarone, sotalol, cisapride^b, erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).

^bno longer marketed in Canada

How to take Bio-MOXIFLOXACIN:

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

Usual dose:

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

Overdose:

In case of drug overdosage, contact your healthcare practitioner, 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 possible. Continue with the next dose 24 hours later. Do not take two doses in any 24 hour period.

What are possible side effects from using Bio-MOXIFLOXACIN?

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

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

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
b)
you have pain, swelling or rupture of a tendon. You should:
- rest
- avoid physical exercise
c)
you have neuropathy (damage to the nerves) with symptoms such as:
- pain, burning, tingling, numbness or weakness
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 Bio-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, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
					Symptom/Effect	Talk to your healthcare professional	Stop taking drug and call your doctor or pharmacist
	Only if severe	In all cases
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 can be fatal): rash hives skin eruption rapid heartbeat difficulty breathing difficulty swallowing swelling of face, lips, or tongue				√
Symptoms of neuropathy: pain burning tingling numbness				√

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom/Effect	Stop taking drug and call your doctor or pharmacist
weakness
Liver problems with symptoms such as yellowing of the skin and eyes, nausea, abdominal pain, dark urine, and pale stools		√
Symptoms of a severe bowel condition: persistent diarrhea bloody or watery diarrhea abdominal or stomach pain/cramping blood/mucus in stool		√
Very rare
Hypoglycaemia (low blood sugar) such as change in mood change in vision confusion fast heartbeat feeling faint headache hunger dizziness shaking sweating weakness	√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

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

Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

Storage:

Keep your Bio-MOXIFLOXACIN tablets in a safe place where children cannot reach or see them.

Bio-MOXIFLOXACIN tablets should be stored at room temperature (15°C -30°C) in 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 Bio-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 (www.healthcanada.gc.ca ); or by contacting:

Biomed Pharma

+1 (888) 731-6703

info@biomed-pharma.ca

Date of preparation: September 6, 2019

Rx or OTC	Prescription (Rx)?
DIN	02447266
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Moxifloxacin (moxifloxacin hydrochloride) 400 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	J Antiinfectives for systemic use J01 Antibacterials for systemic use J01M Quinolone antibacterials J01MA Fluoroquinolone antibacterials, systemic J01MA14 Moxifloxacin
Company	BIOMED PHARMA
Current status	Cancelled Post Market
Current status date	July 19, 2022

Bio-Moxifloxacin: Uses, Side Effects and Dosage