Patient Medication Information: uses, side effects, how to take - PMS-Cephalexin - Tab 500mg
What is pms-CEPHALEXIN used for?
x pms-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.
x Antibacterial drugs like pms-CEPHALEXIN treat only bacterial infections. They do not treat viral infections, such as the common cold.
How does pms-CEPHALEXIN work?
pms-CEPHALEXIN is an antibiotic that:
x Stops the growth of bacteria
x Kills bacteria
What are the ingredients in pms-CEPHALEXIN?
Medicinal ingredients: Cephalexin
Non-medicinal ingredients:
250 mg Tablets: Glycerin, Hydroxypropyl Methylcellulose, Starch, Magnesium Stearate, Methyl Cellulose, Pregelatinized Maize Starch, Red Iron Oxide, Sodium Starch Glycolate, Stearic Acid Powder, Talc, Titanium Dioxide and Yellow Iron Oxide.
500 mg Tablets: Glycerin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Methyl Cellulose, Povidone, Red Iron Oxide, Sodium Starch Glycolate, Talc, Titanium Dioxide and Yellow Iron Oxide.
pms-CEPHALEXIN 125: 125 mg / 5 mL Oral Solution: FD&C Red No. 40, Imitation Guarana Flavour, Methylcellulose, Sodium Lauryl Sulfate, Sucrose Fine Granulated and Sucrose Silicone. pms-CEPHALEXIN 250: 250 mg / 5 mL Oral Solution: FD&C Yellow No. 6, Imitation Guarana Flavour, Methylcellulose, Sodium Lauryl Sulfate, Sucrose Fine Granulated and Sucrose Silicone.
pms-CEPHALEXIN comes in the following dosage forms:
250 mg Tablets: Supplied in bottles of 100 and 500 Tablets.
500 mg Tablets: Supplied in bottles of 100 and 250 Tablets.
pms-CEPHALEXIN 125: 125 mg / 5 mL Oral Suspension: Supplied in 100 and 200 mL bottles. pms-CEPHALEXIN 250: 250 mg / 5 mL Oral Suspension: Supplied in 100 and 200 mL bottles.
Do not use pms-CEPHALEXIN if:
x you are allergic to cephalexin, cephalosporin antibiotics or to any of the other ingredients in pms-CEPHALEXIN
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-CEPHALEXIN. Talk about any health conditions or problems you may have, including if you:
x you are allergic to or react badly to penicillins or other antibiotics.
x you have intestinal or bowl problems.
x you have kidney problems.
x you are pregnant or plan to be pregnant.
x you are breast-feeding or plan to breast-feed.
Other warnings that you should know about:
x Using antibiotics like pms-CEPHALEXIN may cause with Clostridium difficile-associated disease (CDAD). See “Serious side effects and what to do about them”, below. x Pms-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 pms-CEPHALEXIN.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take pms-CEPHALEXIN:
x Take pms-CEPHALEXIN orally on an empty stomach.
x Although you may feel better early in treatment, pms-CEPHALEXIN should be used exactly as directed.
x Misuse or overuse of pms-CEPHALEXIN could lead to the growth of bacteria that will not be killed by pms-CEPHALEXIN (resistance). This means that pms-CEPHALEXIN may not work for you in the future.
x 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:
x nausea
x vomiting
x abdominal pain
x diarrhea
x bloody urine
If you think you have taken too much pms-CEPHALEXIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using pms-CEPHALEXIN?
These are not all the possible side effects you may feel when taking pms-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.
pms-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 | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
Symptoms of a severe bowel condition (Clostridium difficile colitis): x persistent diarrhea x bloody or watery diarrhea x abdominal or stomach pain/cramping x blood/mucus in stool | ¥ | ||
Severe skin reactions: x 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) x widespread rash with blisters and skin peeling on much of the body surface particularly around the mouth, nose, eyes and genitals. | ¥ | ||
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:
x Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
x 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:
Tablets:
Store between 15°C and 30°C. Keep tightly closed.
Oral Suspension:
Store dry powder between 15°C and 30°C. Suspension may be kept for 14 days in a refrigerator without significant loss of potency.
Keep tightly closed. Shake well before using.
If you want more information about pms-CEPHALEXIN:
x Talk to your healthcare professional
x Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the manufacturer at 1-888-550-6060.
Pharmascience Inc.
Montréal, Quebec
H4P 2T4