Consumer Information for: AG-AMOXICILLIN

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

AG-AMOXICILLIN is used to treat bacterial infections, such as:

  • infections of upper respiratory tract (ear, nose, tonsils and throat);
  • infections of lower respiratory tract (bronchi and lungs)
  • urinary tract infections
  • infections of the skin
  • Gonorrhea

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

What it does

Amoxicillin interferes with the synthesis of the bacterial cell wall, contributing to bacterial death.

When it should not be used

You should not take AG-AMOXICILLIN if:

  • you have ever had an unusual hypersensitivity or allergic reaction to penicillin or to any other component of this product
  • have infectious mononucleosis (suspected or confirmed)
What the medicinal ingredient is

AG-AMOXICILLIN contains the active ingredient called amoxicillin

What the non-medicinal ingredients are

AG-AMOXICILLIN also contains the following non-medicinal ingredients:

250 mg and 500 mg capsules: Magnesium stearate, talc, gelatin

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

AG-AMOXICILLIN is available as capsules, 250 mg in # 1 capsules with red cap and white body, 500 mg in #0 capsules with red cap and white body

Warnings and precautions

Serious and occasionally fatal allergic (hypersensitivity) reactions have been reported in patients on penicillin therapy (see Side Effects and Serious Side Effects)

BEFORE you use AG-AMOXICILLIN talk to your doctor or pharmacist if:

  • you have previous hypersensitivity reactions to penicillins and other allergens
  • you have any allergies to this drug or its ingredients or components of the container
  • you are taking anticoagulants – please advise of any signs of bleeding including prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeds from gums brushing, unusual bleeding or bruising, red or brown urine or red or black stools
  • you have kidney problems. Your doctor may monitor your kidney and liver functions during prolonged therapy with AG-AMOXICILLIN.

As the safety of AG-AMOXICILLIN in the treatment of infections in pregnancy is not established, your doctor will determine if AGAMOXICILLIN treatment is suitable for you.

Interactions with this medication

As with other medicines, interactions with other drugs are possible. Therefore, do not take any other medicines unless you have discussed the matter with your physician or your pharmacist.

Talk to your doctor before taking the following drugs, as there may be interactions:

  • methotrexate (anti-cancer agent), probenecid (gout treatment), tetracyclines (antibiotics), oral contraceptives, anticoagulants (e.g. warfain).

    • Before taking AG-AMOXICILLIN make sure your doctor knows about all the medications you are taking, including those not prescribed by your doctor. It may be necessary to change the dose, take other precautions, or perhaps stop one of the medicines. This applies to both prescription and non-prescription medicines.

    Proper use of this medication

    Usual Dose

    It is very important that you take this medicine exactly as your doctor tells you in order to get the best results and reduce the chance of side effects.

    Infections of upper respiratory tract (ear, nose, tonsils and throat) and Infections of urinary tract The usual dosage for the treatment of upper respiratory tract and urinary infections is one 250 mg tablet every 8 hours for adults.

    For children under 20 kg, the dose should be calculated by your doctor considering 20 mg/kg/day in divided doses every 8 hours. In severe infections the recommended dose for adults is 500 mg every 8 hours and for children under 20 kg, 40 mg/kg/day in divided doses every 8 hours. For children over 20 kg, the adult dose should be used.

    Infections of lower respiratory tract (bronchi and lungs) The recommended dose for adults is 500 mg every 8 hours and for children 40 mg/kg/day in divided doses every 8 hours. The children's dosage should not exceed that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.

    Overdose

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

    Hemodialysis would be the proper treatment in case of severe overdose.

    Activated charcoal may be administered to aid in the removal of unabsorbed drug. General supportive measures are recommended.

    Missed Dose

    Try to take your dose as per your doctor’s recommendations. If you/your child miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

    Side effects and what to do about them

    Like all medicines, AG-AMOXICILLIN may cause unwanted reactions, so called side effects. Most patients do not experience side effects from AG-AMOXICILLIN. Examples of occasional side effects include:

    • Nausea
    • Vomiting and diarrhea
    • Skin rashes

    If you suffer severe, persistent diarrhea (bloody or watery), with or without fever, abdominal pain and vomiting, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking AG-AMOXICILLIN and call your healthcare professional immediately.

    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
    Common
    Allergic reactions Skin rash, skin eruption or other effect on the skin or eyes     ✔
    Uncommon
    Gastrointestinal (nausea, vomiting, diarrhea, bloody stool)     ✔
    Serious Allergic Reactions - anaphylaxis – (swollen nose, eyes, throat, difficulty breathing, and serious skin reactions such as blistering, peeling skin, rash)     ✔
    Kidney disorder (excretion of crystals in the urine – crystalluria)     ✔
    Liver disorder yellowing of the skin and eyes (Jaundice), abdominal pain, nausea, cytolytic hepatitis (destruction of liver cells)     ✔
    Oral (glossitis – black “hairy” tongue and stomatitis, tooth discoloration in children (brown, yellow or gray staining)   ✔  
    Central Nervous System (dizziness, anxiety, insomnia, confusion, behavioral changes   ✔  
    Blood problems such as leukopenia (low white blood cell count), neutropenia (low blood cell count )   ✔  

    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

    Do not take AG-AMOXICILLIN past the expiry date shown on the pack.

    Store your AG-AMOXICILLIN as follows: Store in original package at 250C with excursions permitted to 15°C - 30°C.

    Always remember This medicine has been prescribed to you for your current medical problem only. Do not give it to other people.

    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:

    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 document plus the full Product Monograph prepared for health professionals can be found by contacting the sponsor Angita Pharma Inc. at:

    1-866-399-9091
    This leaflet was prepared by Angita Pharma Inc.

    Last revised: June 26, 2018

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