Mylan-Ciprofloxacin (Mylan Pharmaceuticals, 750 mg): Uses, Side Effects and Dosage

What is MYLAN-CIPROFLOXACIN used for?

MYLAN-CIPROFLOXACIN is used to treat certain types of bacterial infections.

Serious Warnings and Precautions

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

How does MYLAN-CIPROFLOXACIN work?

MYLAN-CIPROFLOXACIN is an antibiotic that kill the bacteria causing the infection.

What are the ingredients in MYLAN-CIPROFLOXACIN?

Medicinal ingredients: ciprofloxacin as ciprofloxacin hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide NF, corn starch NF, crospovidone NF, magnesium stearate NF, microcrystalline cellulose NF, opadry II white Y-22-7719, and pregelatinized starch NF. The colour, Opadry II White Y-22-7719, contains hydroxypropyl methylcellulose, titanium dioxide, polydextrose, triacetin, and polyethylene glycol.

MYLAN-CIPROFLOXACIN comes in the following dosage forms:

MYLAN-CIPROFLOXACIN tablets: 250 mg, 500 mg and 750 mg.

MYLAN-CIPROFLOXACIN 250 mg: each white, round, biconvex, film-coated tablet is embossed with “CF 250” on one side and “G” on the other side. HDPE bottles of 100's.

MYLAN-CIPROFLOXACIN 500 mg: each white, capsule-shaped, biconvex, film-coated tablet is embossed with “CF 500” on one side and “G” on the other side. Unit dose packages of 10 (cartons of 100's), and HDPE bottles of 100's and 500's.

MYLAN-CIPROFLOXACIN 750 mg: each white, capsule-shaped, biconvex, film-coated tablet is embossed with “CF 750” on one side and “G” on the other side. HDPE bottles of 100's.

Do not use MYLAN-CIPROFLOXACIN if:

• you are allergic to ciprofloxacin or other quinolone antibiotics.
• you are allergic to any other ingredient in these products (see “What are the ingredients in MYLAN-CIPROFLOXACIN Tablets?”).
• you are taking tizanidine (ZANAFLEX®). Side effects such as drowsiness, sleepiness and low blood pressure may occur.
• are currently taking agomelatine^a. Agomelatine concentrations may increase and may cause further side effects such as liver toxicity.

^a Currently not marketed in Canada

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

• have a history of seizures.
• have an irregular heart rhythm (such as QT prolongation).
• have low potassium blood levels.
• have liver or kidney disease or damage.

• are pregnant, planning to become pregnant, breast feeding or planning to breast feed.

• 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).

Other warnings you should know about:

While taking MYLAN-CIPROFLOXACIN:

• 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 MYLAN-CIPROFLOXACIN:

• Theophylline or VIDEX® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including MYLAN-CIPROFLOXACIN, and theophylline.
• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take MYLAN-CIPROFLOXACIN:”).
• Antidiabetic agents (such as glyburide, glibenclamide, glimepiride, insulin); the combination of any of these agents with ciprofloxacin may cause lower blood sugar.
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDS).
• Caffeine (such as coffee) and other xanthine derivatives (such as pentoxifylline).
• Certain heart medications known as antiarrhythmics (such as quinidine, procainamide, amiodarone, sotalol).

• Other medications including:

  • oral anticoagulants (like warfarin and acenocoumarol),
  • phenytoin, duloxetine, methylxanthines, sevelamer,
  • sucralfate, clozapine, ropinirole, lidocaine, sildenafil, probenecid,
  • methotrexate, metoclopramide, cyclosporine, lanthanum carbonate, zolpidem.

How to take MYLAN-CIPROFLOXACIN:

• MYLAN-CIPROFLOXACIN should be taken as prescribed at almost the same times each day with food or on an empty stomach.

• MYLAN-CIPROFLOXACIN should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, MYLAN-CIPROFLOXACIN may be taken with a meal that contains these products (see “The following may interact with MYLAN-CIPROFLOXACIN”).
• You should avoid excessive caffeine consumption while taking MYLAN-CIPROFLOXACIN.
• You should drink lots of water while taking MYLAN-CIPROFLOXACIN.
• Swallow the MYLAN-CIPROFLOXACIN tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

• If you are taking the following medicines, take them at least 2 hours before or 6 hours after MYLAN-CIPROFLOXACIN:

  • antacids or mineral supplements containing magnesium or aluminium
  • sucralfate
  • supplements containing iron or zinc
  • any product (supplement or food) with more than 800 mg calcium
• Do not use MYLAN-CIPROFLOXACIN for another condition or give it to others.

You should take MYLAN-CIPROFLOXACIN for as long as your doctor prescribes it, even after you start to feel better. Stopping an antibiotic too early may result in failure to cure your infection.

Usual dose:

Your doctor (healthcare provider) will tell you how much of the medicine to take and for how long.

This information does not take the place of discussions with your doctor or health care professional about your medication or treatment.

Overdose:

Missed Dose:

Should you forget to take it at the usual time, you may take your dose later in the day. Do not take more than two doses of MYLAN-CIPROFLOXACIN per day, even if you missed a dose.

What are possible side effects from using MYLAN-CIPROFLOXACIN?

All medicines, including MYLAN-CIPROFLOXACIN, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking MYLAN-CIPROFLOXACIN. 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 MYLAN-CIPROFLOXACIN 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 face, lips, tongue or throat
   • difficulty breathing
   • irregular or rapid heartbeat, or fainting spells
2. b) you have sunburn-like skin reaction when exposed to sunlight or ultraviolet light.
3. c)

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

   • rest
   • avoid physical exercise
4. d)

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

   • pain, burning, tingling, numbness or weakness
5. e)

   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.

1. f)

   you have mental problems such as:

   • confusion, headache, shaking
   • hallucinations, depression, agitation
   • difficulty sleeping, anxiety, nervousness, suicidal thoughts

Contact your doctor if you have suicidal thoughts.

Other side effects include:

• your eyesight worsens or changes. See your doctor or eye specialist right away.
• nausea, dizziness, unsteady walk
• gas, cramping, feeling unwell,
• loss of hearing, problems of smell and taste, loss of appetite
• migraine, sweating

• worsening of myasthenia gravis (a muscle disease) with symptoms such as:

  • weakness
  • difficulty walking, swallowing, drooping eyelids

Do not use MYLAN-CIPROFLOXACIN if you have this condition.

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

Serious side effects and what to do about them

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

Storage:

Store between 15^oC and 30^oC.

Keep out of reach and sight of children.

If you want more information about MYLAN-CIPROFLOXACIN:

• 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; or by calling 1-800-575-1379
• This document can be found at: www.mylan.ca.

Etobicoke, Ontario M8Z 2S6

Last Revised: August 09, 2017

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