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

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

MYLAN-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 MYLAN-MOXIFLOXACIN if you are allergic to moxifloxacin, other quinolone antibiotics or to any nonmedicinal ingredient in this product (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

MYLAN-MOXIFLOXACIN tablets contain 400 mg of moxifloxacin as moxifloxacin hydrochloride.

What the nonmedicinal ingredients are:

MYLAN-MOXIFLOXACIN tablets are composed of the following non-medicinal ingredients: croscarmellose sodium, copovidone, iron oxide red, isopropyl alcohol, lecithin (soya), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.

What dosage forms it comes in:

MYLAN-MOXIFLOXACIN tablets are available as pink, film-coated, capsule shaped, biconvex, beveled edge tablets debossed with M on one side of the tablet and MOI on the other side.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Moxifloxacin hydrochloride has been shown to lengthen the heartbeat on an electrocardiogram test (QT interval prolongation).
Serious hypersensitivity (allergic) reactions, sometimes fatal, have been reported in some patients receiving quinolone therapy, including moxifloxacin

hydrochloride.
If you have myasthenia gravis, treatment with moxifloxacin hydrochloride may make your condition worse. Do not use moxifloxacin hydrochloride if you have this condition.
Quinolones, including moxifloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. Speak to your doctor to determine if this medication is suitable for you.
Seizures and toxic psychoses may occur with quinolone therapy. Tell your doctor if you have any central nervous
system problems (ie, epilepsy). Your doctor will determine whether you should use this medication.
Moxifloxacin hydrochloride can cause liver injury which may be fatal.

See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

BEFORE you use MYLAN-MOXIFLOXACIN talk to your doctor or pharmacist if any of the following apply to you:

Some people are born with a rare condition which results
in lengthening of the heartbeat on an electrocardiogram test (QT interval prolongation). If you or any of your family members have this condition, you should inform your health care professional.
You should avoid taking MYLAN-MOXIFLOXACIN with certain medicines used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, or sotalol. Inform your health care professional if you are taking a heart rhythm drug.
You have or have had heart problems such as heart failure, an irregular heartbeat, or a slow heartbeat.
Some medicines such as cisapride^a, erythromycin, antipsychotics and tricyclic antidepressants may also produce an effect on an electrocardiogram test. These may increase the risk of abnormal heartbeats when taken with MYLAN-MOXIFLOXACIN. For this reason, it is important to let your health care provider know all of the medicines that you are using (including non-prescription medicines).
You should avoid MYLAN-MOXIFLOXACIN if your doctor has told you that the amount of potassium in your blood is low. Low potassium can sometimes be caused by medicines called diuretics such as furosemide and hydrochlorothiazide. If you are taking a diuretic medicine you should speak with your health care professional.
If you have a history of seizures, notify your doctor before you start taking this drug.
You should tell your doctor if you are allergic to any of
the quinolone drugs or any of the non-medicinal ingredients in MYLAN-MOXIFLOXACIN.
Moxifloxacin hydrochloride may be associated with allergic (hypersensitivity) reactions, even after a single dose. Stop taking the drug at the first sign of a skin rash or other signs of an allergic reaction and tell your doctor.
Please tell your doctor if you are pregnant, planning to become pregnant, or if you are breast feeding. MYLAN-MOXIFLOXACIN is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
MYLAN-MOXIFLOXACIN is not recommended for persons less than 18 years of age.
You should not use MYLAN-MOXIFLOXACIN if you have a history of tendon problems associated with the use of a quinolone antibiotic.
You have a condition known as myasthenia gravis. With this condition, your muscles get weaker with physical activity and improve after periods of rest.
You have diabetes and are taking anti-diabetic medications. MYLAN-MOXIFLOXACIN may interfere with blood sugar levels. MYLAN-MOXIFLOXACIN may also interfere with blood sugar levels in those without diabetes.

^ano longer marketed in Canada

INTERACTIONS WITH THIS MEDICATION

Talk to your doctor before taking any of the following medications as drug interactions and side effects may occur and they may not be suitable for you. See WARNINGS AND PRECAUTIONS and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Drugs that may interact with MYLAN-MOXIFLOXACIN include:

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

^bno longer marketed in Canada

PROPER USE OF THIS MEDICATION

Usual adult dose:

You must take MYLAN-MOXIFLOXACIN exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE. The recommended adult dose of MYLAN-MOXIFLOXACIN is one 400 mg tablet once a day.
MYLAN-MOXIFLOXACIN may be taken with or without food.
Do not crush or chew MYLAN-MOXIFLOXACIN tablets. Swallow each one whole with a drink of water.
You should drink lots of fluids while taking MYLAN-MOXIFLOXACIN.
Avoid excessive sunlight or artificial ultraviolet light (eg, sunlamps) during treatment with MYLAN-MOXIFLOXACIN and for one day following completion of treatment. If a sunburn- like reaction or skin eruptions occur, contact your doctor.
MYLAN-MOXIFLOXACIN may cause dizziness and lightheadedness. You should know how you react to this drug before you operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
If you are taking antacids or vitamin/mineral supplements while on MYLAN-MOXIFLOXACIN treatment, you should take MYLAN-MOXIFLOXACIN at least 4 hours before or 8 hours after taking a mineral supplement or a vitamin supplement that also contains minerals, or an antacid containing magnesium or aluminium.
The usual length of treatment with MYLAN-MOXIFLOXACIN is 5-10 days. During the course of treatment, all tablets must be taken to make sure that all bacteria have been killed. CONTINUE TAKING THE TABLETS UNTIL THEY ARE FINISHED, EVEN IF YOU BEGIN TO FEEL BETTER.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, 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.

Stopped Treatment:

If your doctor decides to stop the treatment, do not keep any left over medicine unless your doctor tells you to. Please discard all unused MYLAN-MOXIFLOXACIN tablets.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Although most people do not have a problem with side effects when taking MYLAN-MOXIFLOXACIN, all medicines can cause unwanted side effects. Discontinue your medicine and contact your doctor at the first sign of rash, hives or skin eruptions, a rapid heartbeat, difficulty in breathing or swallowing or any other symptom of an allergic reaction. Do not take any more medicine unless your doctor tells you to do so. Your doctor may decide to stop your treatment.

Contact your health care professional and stop taking the drug if you develop an irregular heartbeat or have fainting spells.

Quinolones, a class of antibiotics including MYLAN-MOXIFLOXACIN, have been rarely associated with inflammation of the tendons. If you experience pain, swelling or rupture of a tendon, you should stop taking MYLAN-MOXIFLOXACIN (moxifloxacin hydrochloride), rest, avoid physical exercise and call your health professional.

Treatment with a quinolone antibiotic, including MYLAN-MOXIFLOXACIN (moxifloxacin hydrochloride), may worsen muscle weakness in persons with myasthenia gravis. If you have myasthenia gravis, do not use MYLAN-MOXIFLOXACIN.

Quinolones, including moxifloxacin, have been rarely associated with other central nervous system events including confusion, tremors, headache, hallucinations, depression, agitation, insomnia, anxiety, nervousness and suicidal thoughts. If you have suicidal thoughts,contact your doctor.

Neuropathy (problems in the nerves) has been reported in patients receiving quinolones, including MYLAN-MOXIFLOXACIN. If neuropathy symptoms occur such as pain, burning, tingling, numbness, or weakness, you should stop taking MYLAN-MOXIFLOXACIN and contact your doctor immediately

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking MYLAN-MOXIFLOXACIN and contact your healthcare professional immediately.

If your eyesight worsens or changes in any way consult your doctor and eye specialist immediately.

Other possible side effects which may occur with MYLAN-MOXIFLOXACIN are nausea, diarrhea and dizziness. Some people may have other side effects. If you notice any unusual effects, check with your doctor or pharmacist. If you feel worse or you think your condition is not improving while taking MYLAN-MOXIFLOXACIN, contact your doctor as soon as possible.

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
	Symptom / effect	Talk to your doctor or pharmacist		Stop taking drug and seek immediate emergency medical attention
Rare
Irregular heartbeat or fainting spells			✓
Nervous system side effects: seizures/ convulsions confusion tremors hallucinations depression symptoms of neuropathy, numbness, tingling, pain, burning or weakness			✓
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			✓
Liver problems with symptoms such as yellowing of the skin and eyes, nausea, abdominal pain, dark urine, and pale stools			✓

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

Symptom / effect

Talk to your doctor or pharmacist

Stop taking drug and seek immediate emergency medical attention

Symptoms of a severe bowel condition:

persistent diarrhea
bloody or watery diarrhea
abdominal or stomach pain/cramping
blood/mucus in stool

✓

Very rare

Symptoms of hypoglycemia such as fatigue, dizziness, sweating or shaking

✓

This is not a complete list of side effects. For any unexpected effects while taking MYLAN-MOXIFLOXACIN, contact your doctor or pharmacist.

HOW TO STORE IT

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

MYLAN-MOXIFLOXACIN tablets should be stored between 15°C and 30°C. Do not freeze the tablets.

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
  Health Canada, Postal Locator 1908C Ottawa, ON
  K1A 0K9
  Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

(http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php)

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

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Prepared on: November 15, 2016

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca

Rx or OTC	Prescription (Rx)?
DIN	02406136
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	MYLAN PHARMACEUTICALS ULC
Current status	Cancelled Pre Market
Current status date	January 11, 2017

Mylan-Moxifloxacin: Uses, Side Effects and Dosage