Patient Medication Information: uses, side effects, how to take - Apo-Amoxi Sugar Free
What is APO-AMOXI SUGAR FREE used for?
APO-AMOXI SUGAR FREE is used to treat certain bacterial infections. It may also be used to prevent infections in:
- Mouth, nose, tonsils and throat.
- Heart.
- Emergency situation.
How does APO-AMOXI SUGAR FREE work?
APO-AMOXI SUGAR FREE 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. APO-AMOXI SUGAR FREE does not kill viruses.
What are the ingredients in APO-AMOXI SUGAR FREE?
Medicinal ingredients: amoxicillin (as amoxicillin trihydrate)
Non-medicinal ingredients: artificial banana cream flavour (250 mg/5 mL only), artificial strawberry flavour (125 mg/5 mL only), aspartame, colloidal silicon dioxide, FD&C red #40 (125 mg/5 mL only), sodium benzoate, sodium citrate, sorbitol, and xanthan gum.
Serious Warnings and Precautions
- Some people taking penicillin antibiotics like APO-AMOXI SUGAR FREE (amoxicillin) have had serious allergic reactions, including severe skin reactions and death. If you have had an allergic reaction to penicillins, cephalosporins and other allergens, tell your healthcare professional before you start treatment with APO-AMOXI SUGAR FREE.
APO-AMOXI SUGAR FREE comes in the following dosage forms:
APO-AMOXI SUGAR FREE Suspension: 125 mg / 5 mL, 250 mg / 5 mL.
Do not use APO-AMOXI SUGAR FREE if:
- You have any allergies to this drug or to its ingredients (See “What are the ingredients in APO-AMOXI SUGAR FREE?”).
- 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).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-AMOXI SUGAR FREE. 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 possible side effects from using APO-AMOXI SUGAR FREE?”.
- 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 healthcare professional about how to feed your baby while you are taking APO-AMOXI SUGAR FREE.
Other warnings you should know about:
- If you develop severe diarrhea (very loose or watery stool), tell your healthcare professional right away. Do this even if it occurs several weeks after you stopped taking APO-AMOXI SUGAR FREE. Diarrhea may mean that you have a serious condition affecting your bowel (colitis). You may need urgent medical care. Do not try to treat loose stools without first checking with your healthcare professional.
Using too much APO-AMOXI SUGAR FREE or using it in the wrong way may cause:
- more bacteria to grow.
- bacteria that will not be killed (resistance).
- it may not work for you in the future (resistance).
- Laboratory tests: Your healthcare professional will perform regular blood counts, liver and kidney function tests when you are taking APO-AMOXI SUGAR FREE.
If you are on a special diet, or if you are allergic to any substance, ask your healthcare professional whether any of these ingredients may cause a problem.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-AMOXI SUGAR FREE:
- 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 APO-AMOXI SUGAR FREE.
If you are going to have any blood or urine tests, tell your healthcare professional that you are taking APO-AMOXI SUGAR FREE. It may affect the results of test for glucose in urine and assay of estriol in pregnant women.
How to take APO-AMOXI SUGAR FREE:
- Take this medication by mouth as directed by your healthcare professional.
- Tell your healthcare professional if your condition does not improve.
Antibacterial drugs like APO-AMOXI SUGAR FREE treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, APO-AMOXI SUGAR FREE should be used exactly as directed. Misuse or overuse of APO-AMOXI SUGAR FREE could lead to the growth of bacterial that will not be killed by APO-AMOXI SUGAR FREE (resistance). This means that APO-AMOXI SUGAR FREE 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 APO-AMOXI SUGAR FREE.
Usual dose:
Adults:
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.
Children:
Your healthcare professional will tell you how much APO-AMOXI SUGAR FREE 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.
Overdose:
Symptoms of overdose may include severe dizziness.
| If you think you, or a person you are caring for, have taken too much APO-AMOXI SUGAR FREE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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.
What are possible side effects from using APO-AMOXI SUGAR FREE?
These are not all the possible side effects you may have when taking APO-AMOXI SUGAR FREE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea (feeling sick) or vomiting
- diarrhea (loose, or watery bowel movements)
- bloody stool
- black “hairy” tongue (glossitis)
- soreness of the mouth or tongue
- yeast infections (thrush) of the mouth, nails, skin, vagina, stomach or urinary tract
- change of tooth color in children (brown, yellow or gray staining)
- muscle jerks
- dizziness (light headedness)
- decreased ability to perceive and respond
- anxiety
- difficulty to fell asleep (insomnia)
- confusion or changes in behavior
- skin rash
- skin eruption or other effect on skin or eyes
- itching
- hives
- crystals in urine
APO-AMOXI SUGAR FREEcan cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
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 | ||
| UNCOMMON | |||
| Anaphylaxis (severe allergic reactions): swollen nose, eyes, throat, difficulty breathing, hay fever, skin blistering, lumpy rash (hives), peeling, fainting. | ✓ | ||
| Angioneurotic edema: Painful swelling of face, eyes, lips, tongue and/or throat, hands or feet; itchy skin rash, skin reddening, hives, stomach pain, dizziness and painting | ✓ | ||
| Erythema multiforme (severe skin reaction): 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). | ✓ | ||
| Kidney problems with symptoms such as cloudy urine, blood in the urine which may be associated with a rash, fever, joint pain, or a reduction in passing water (urination)). | ✓ | ||
| Liver problems with symptoms such as persistent nausea/vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine. | ✓ | ||
| RARE | |||
| Acute Generalised Exanthematous Pustulosis (AGEP): a red, scaly rash with bumps under the skin and blisters | ✓ | ||
| Bullous exfoliative Dermatitis: widespread red skin rash with | ✓ | ||
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 | ||
| small pus-containing blisters | |||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect more than one or more organs): fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinate less often, less urine | ✓ | ||
| Hypersensitivity vasculitis (Inflammation of the blood vessels): rash, red spots, hives, and blisters on the lower part of the body | ✓ | ||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
| ✓ | ||
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 | ||
| Stevens-Johnson syndrome (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
| Toxic Epidermal Necrolysis (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | ✓ | ||
| NOT KNOWN | |||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by bacteria): confusion, fever, nausea, fatigue, sudden headache or stiffness of your neck, sensitivity to light, vomiting | ✓ | ||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✓ | ||
| Convulsions (seizures or fits): uncontrollable shaking with or without loss of consciousness. | ✓ | ||
| Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing | ✓ | ||
| Hemolytic anemia (breakdown of red blood cells): pale skin, weakness, tiredness, shortness of breath, yellowing of your skin and/or the whites of your eyes, | ✓ | ||
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 | ||
| fever | |||
| Kounis syndrome (heart problems caused by an allergic reaction): Symptoms of anaphylaxis (see above), chest pain, chest pressure or discomfort, heart palpitations, nausea or vomiting, sweating, shortness of breath, fatigue, clammy skin, feeling anxious or faint, disorientation, upset stomach. | ✓ | ||
| Leukopenia, Neutropenia and Agranulocytosis (low levels of white blood cells): fever, chills, sore throat, faster heartbeat and breathing, other signs of infection | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 |
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| effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Powder: Store at 20°C to 25°C (Controlled Room Temperature). Protect from light and moisture. Keep bottle tightly closed.
Reconstituted Suspension: 14 days under refrigeration (2°C to 8°C) or 7 days at room temperature (20°C to 25°C). Protect from light. Keep bottle tightly closed.
Do not use after the expiry date. Generally, all expired medications should be returned to your healthcare professional.
Keep out of reach and sight of children.
If you want more information about APO-AMOXI SUGAR FREE:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.