Consumer Information for: AURO-CEPHALEXIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

What is Auro-Cephalexin used for?

  • Auro-Cephalexin is used to treat certain bacterial infections in the:
    • respiratory tract;
    • ear(otitis media);
    • genitals and urinary tract;
    • bones and joints;
    • skin and soft tissue.
  • Antibacterial drugs like Auro-Cephalexin treat only bacterial infections. They do not treat viral infections, such as the common cold.
What it does

Auro-Cephalexin is an antibiotic that:

  • Stops the growth of bacteria
  • Kills bacteria
When it should not be used

Do not use Auro-Cephalexin if:

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

Medicinal ingredients: Cephalexin (cephalexin monohydrate)

What the non-medicinal ingredients are

Non-medicinal ingredients:
Sucrose, Silicon Dioxide, Sodium benzoate, Xanthum gum, Artificial cherry flavour, FD & C Red. 40.

What dosage form it comes in
Warnings and precautions

Serious Warnings and Precautions

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

  • you are allergic to or react badly to penicillins or other antibiotics.
  • you have intestinal or bowel problems.
  • you have kidney problems.
  • you are pregnant or plan to be pregnant.
  • you are breast-feeding or plan to breast-feed.

Other warnings that you should know about:

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

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

How to take Auro-Cephalexin:

  • Take Auro-Cephalexin orally on an empty stomach.
  • Although you may feel better early in treatment, Auro-Cephalexin should be used exactly as directed.
  • Misuse or overuse of Auro-Cephalexin could lead to the growth of bacteria that will not be killed by Auro-Cephalexin (resistance). This means that Auro-Cephalexin 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

Symptoms of oral overdose may include:

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

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

Side effects and what to do about them

These are not all the possible side effects you may feel when taking Auro-Cephalexin. 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.

Auro-Cephalexin 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 watery diarrhea
  • abdominal or stomach
  • pain/cramping
  • blood/mucus in stool
     ✔
Severe skin reactions:
  • skin rash, which may blister, 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

Store dry powder between 15°C and 25°C. Protect from light and humidity.
After Reconstitution: The reconstituted formulation is stable for 14 days under refrigeration (2 - 8°C). Do not freeze. Keep well closed. Shake well before using. Keep out of reach and sight of children.

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 for information on how to report online, by mail or by fax; or
  • Call 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.

More information

If you want more information about Auro-Cephalexin:

  • Talk to your doctor or pharmacist.
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website; or by calling 1-855-648-6681.

This leaflet was prepared by

Auro Pharma Inc.
3700 Steele Avenue West, Suite #402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Revision: June 25, 2020

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