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Details for: APO-CEPHALEX

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00768723APO-CEPHALEXCEPHALEXIN (CEPHALEXIN MONOHYDRATE)250 MGTABLETORAL
00768715APO-CEPHALEXCEPHALEXIN (CEPHALEXIN MONOHYDRATE)500 MGTABLETORAL
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Summary Reports

Summary Safety Review - Beta-lactam antibiotics - Assessing the potential risk of severe skin side effects

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • APO-CEPHALEX is used to treat certain bacterial infections in the:
    • respiratory tract;
    • ear (otitis media);
    • genitals and urinarytract;
    • bones and joints;
    • skin and soft tissue.
  • Antibacterial drugs like APO-CEPHALEX treat only bacterial infections. They do not treat viral infections, such as the commoncold.

What it does

APO-CEPHALEX is an antibiotic that:

  • Stops the growth of bacteria
  • Kills bacteria

When it should not be used

  • you are allergic to cephalexin, cephalosporin antibiotics or to any of the other ingredients in APO-CEPHALEX
What the medicinal ingredient is

Cephalexin

What the non-medicinal ingredients are

Colloidal silicon dioxide, FD&C yellow #6, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, and titanium dioxide.

What dosage form it comes in

250 mg Tablets: Supplied in bottles of 100 and 1000 Tablets.
500 mg Tablets: Supplied in bottles of 100 and 500 Tablets.

Warnings and precautions

  • you are allergic to or react badly to penicillins or other antibiotics.
  • you have intestinal or bowl problems.
  • you have kidneyproblems.
  • you are pregnant or plan to bepregnant.
  • you are breast-feeding or plan tobreast-feed.

Other warnings that you should know about:

  • Using antibiotics like APO-CEPHALEX may cause with Clostridium difficile-associated disease (CDAD). See “Serious side effects and what to do about them”, below.
  • APO-CEPHALEX may interfere with some blood and urine test results. Talk to your doctor if you are given a blood or urine test while takingAPO-CEPHALEX.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

Proper use of this medication
  • Take APO-CEPHALEX orally on an empty stomach.
  • Although you may feel better early in treatment, APO-CEPHALEX should be used exactly as directed.
  • Misuse or overuse of APO-CEPHALEX could lead to the growth of bacteria that will not be killed by APO-CEPHALEX (resistance). This means that APO-CEPHALEX may not work for you in the future.
  • Do not share your medicine.

Usual Dose

Adult

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 1 g/day in divided doses every 6 hours

Children

The recommended daily dosage for children is 25 to 50 mg/kg/day in divided doses every 6 hours.

Overdose

If you think you have taken too much APO-CEPHALEX, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Symptoms of oral overdose may include:

  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • bloody urine

Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-CEPHALEX. If you experience any side effects not listed here, contact your healthcare professional.

You may experience diarrhea, nausea, vomiting, loose stools, abdominal pain, diaper rash, inflammation of the vagina or discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations or symptoms that you do not understand. You should tell your health professional for of any of these symptoms as soon as possible.

Vertigo (loss of balance or unsteadiness), tinnitus (ringing in the ears), hearing loss and behavioural changes in young children have been reported.

APO-CEPHALEX may also cause effects such as yellowing of the whites of the eyes or skin (jaundice) or the inflammation of the liver (hepatitis).

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
RARE
Symptoms of a severe bowel condition (Clostridium difficile colitis):
  • persistent diarrhea
  • bloody or waterydiarrhea
  • abdominal or stomach pain/cramping
  • blood/mucus in stool
   
Severe skin reactions:
  • skin rash, which mayblister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge)
  • widespread rash with blisters and skin peeling on much of the body surface particularly around the mouth,nose, eyes and genitals.
   
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
  • Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish)
  • Swelling and redness of eyes or face
  • Flu-like feeling, fever, chills, body aches, swollen glands, cough
  • Shortness of breath, chest pain or discomfort
   

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.

How to store

Tablets:
Store at room temperature (15°C to 30°C) in a tightly closed container. Dispense in a light-resistant container, as prolonged exposure to light may cause fading of the coating.

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

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: September 16, 2020.

Date modified: