Details for: AMOXICILLIN
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02352710 | AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 250 MG | CAPSULE | ORAL |
| 02352753 | AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 250 MG / 5 ML | GRANULES FOR SUSPENSION | ORAL |
| 02352788 | AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 250 MG / 5 ML | GRANULES FOR SUSPENSION | ORAL |
| 02352729 | AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 500 MG | CAPSULE | ORAL |
Summary Reports
Summary Safety Review - Amoxicillin-containing Products - Assessing the Potential Risk of Aseptic Meningitis
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
AMOXICILLIN is used to treat certain bacterial infections. It may also be used to prevent infections in:
- Mouth, nose, tonsils and throat.
- Heart.
- Emergency situation.
What it does
AMOXICILLIN interferes with bacterial cell wall. This helps to:
- Stop growth of bacteria.
- Kill the bacteria.
- Reduce the infection.
Some infections are caused by viruses, such as the common cold. AMOXICILLIN does not kill viruses.
When it should not be used
Do not use AMOXICILLIN if:
- You have any allergies to this drug or to its ingredients (See “What are the ingredients in AMOXICILLIN?”).
- You have allergy to packaging components of this drug.
- You have allergy to penicillins, cephalosporins or similar antibiotics such as amoxicillin, ampicillin, cephalexin and others.
- You have a mononucleosis (either suspected or confirmed).
What the medicinal ingredient is
Medicinal ingredients: amoxicillin (as amoxicillin trihydrate)
What the non-medicinal ingredients are
Non-medicinal ingredients:
250 mg and 500 mg capsules: Colloidal Silicon Dioxide, Dry-Flo Starch, Magnesium stearate, Sodium lauryl sulfate. Gelatine Capsules (EGC Size #2) and (EGC Size #0): D&C Yellow # 10, FD & C Blue #1, FD & C Red #3, FD & C Red #40, FD & C Yellow # 6, Titanium Dioxide, Gelatin and White S-1-7085 (250 mg) / White SB-0007P (500 mg)
250 mg/5 mL Granules for Oral Suspension: Artificial Cherry Rasberry Flavor, FD&C Red #40, Silicon Dioxide, Sodium Benzoate, Sodium Citrate, Sucrose, Xanthan Gum
250 mg/5 mL Sugar-Reduced Granules for Oral Suspension: Colloidal Silicon Dioxide, Mannitol 2080, Nipagin-M Sodium, Nipasol-M Sodium, Sodium Citrate, Sucrose, Xanthan Gum, D&C Yellow #10 & Artificial Banana Flavour
If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem.
What dosage form it comes in
AMOXICILLIN is available in three different forms, such as capsules, Granules for Oral Suspension, and Sugar-Reduced Granules for Oral Suspension
- AMOXICILLIN 250 mg Capsules in #2 capsules with opaque scarlet cap and yellow body
- AMOXICILLIN 500 mg Capsules in #0 capsules with opaque scarlet cap and yellow body
- AMOXICILLIN Granules for Oral Suspension 250 mg/5 mL
- AMOXICILLIN Sugar-Reduced Granules for Oral Suspension 250 mg/5 mL
Warnings and precautions
Serious Warnings and Precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMOXICILLIN. Talk about any health conditions or problems you may have, including if you:
- have a history of hypersensitivity reactions to beta-lactams (ampicillin, piperacillin, etc). See “What are the possible side effects from using AMOXICILLIN?”.
- have been taken blood thinners (such as warfarin, etc.).
- have a history of mild diarrhea or colitis influenced by the use of antibiotics.
- have kidney problems.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. Talk to your doctor about how to feed your baby while you are taking AMOXICILLIN.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with AMOXICILLIN:
- anti-cancer drug (such as Methotrexate).
- medicines used for heartburn or gout (such as probenecid, cimetidine, etc.).
- blood thinner medications (such as warfarin, etc.) that used to thin the blood and prevent clots – may predispose you to the development of bleeding problems.
- birth control pills (it may reduce effect of contraceptives).
- antibacterial medicines (such as tetracyclines) may lower effectiveness of AMOXICILLIN.
Proper use of this medication
Antibacterial drugs like AMOXICILLIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, AMOXICILLIN should be used exactly as directed. Misuse or overuse of AMOXICILLIN could lead to the growth of bacterial that will not be killed by AMOXICILLIN (resistance). This means that AMOXICILLIN may not work in the future.
Do not share your medicine.
Ask your pharmacist about the other products you take. Some medicines will affect the way that your body absorbs AMOXICILLIN.
Usual adult dose:
For infections: 250 mg – 500 mg every 8 hours or a single dose of 3 g.
For prevention: 3 g once before procedure, then 1.5 g every 6 hours.
Usual children’s dose:
Your doctor will tell you how much AMOXICILLIN to give your child based on their weight and the severity of their infection. The children’s dose should not exceed the adult dose. For children over 20 kg, the adult dose should be used.
For the oral suspension, please administer using the syringe provided by your pharmacist to ensure the correct dose is given.
Take this medication by mouth as directed by your doctor.
Take AMOXICILLIN between meals with a glass of water.
Tell your doctor if your condition does not improve.
Overdose
If you think you have taken too much AMOXICILLIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Symptoms of overdose may include: severe dizziness.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking AMOXICILLIN. If you experience any side effects not listed here, contact your healthcare professional.
| 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 |
|---|---|---|---|
| Common | |||
| Skin rash. | ✔ | ||
| Skin eruption or other effect on skin or eyes. | ✔ | ||
| Nausea. | ✔ | ||
| Vomiting. | ✔ | ||
| Diarrhea. | ✔ | ||
| Bloody stool. | ✔ | ||
| ✔ | |||
| Black “hairy” tongue (glossitis). | ✔ | ||
| change of tooth color in children (brown, yellow or gray staining). | ✔ | ||
| Dizziness (light headness). | ✔ | ||
| Anxiety. | ✔ | ||
| Uncommon | |||
| Hives, itch. | ✔ | ||
| Red rash on the face. | ✔ | ||
| Swelling | ✔ | ||
| Anaphylaxis (severe allergic reactions such as swollen nose,eyes, throat, difficulty breathing, skin blistering, rash, peeling). | ✔ | ||
| signs of kidney problems (such as cloudy urine). | ✔ | ||
| signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine). | ✔ | ||
| Rare | |||
| Severe skin reaction (flu-like symptoms, blistering and peeling skin). | ✔ | ||
| difficulty to fell asleep (insomnia). | ✔ | ||
| confusion or changes in behavior. | ✔ | ||
| Changes in blood cell count test results. | ✔ | ||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
|
✔ | ||
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
For Capsules: store between 15°C and 30°C.
Granules for oral suspension: store at room temperature between 15°C and 30°C. Keep bottle tightly closed.
Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- 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
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 AMOXICILLIN:
- 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; the manufacturer’s website, or by contacting Sanis Health Inc. at:
1-866-236-4076
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: June 18, 2020