Patient Medication Information: uses, side effects, how to take - Sandoz Amoxicillin (Sandoz Canada, 125 mg, 250 mg)
What is Sandoz Amoxicillin used for?
Sandoz 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.
How does Sandoz Amoxicillin work?
Sandoz 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. Sandoz Amoxicillin does not kill viruses.
What are the ingredients in Sandoz Amoxicillin?
Medicinal ingredients: amoxicillin (as amoxicillin trihydrate)
Non-medicinal ingredients:
125 mg / mL, 250 mg / mL suspension: the suspension contains the non-medicinal ingredients: artificial flavor ( Flavor Refraichissement, Flavor Strawberry, Flavor Raspberry, FD&C red #40, Xanthan Gum, sodium benzoate, sodium citrate, Citric Acid anhydrous, Silicon Dioxide, Sucrose, refined and powdered.
If you are on a special diet, or if you are allergic to any substance, ask your doctor or healthcare professional whether any of these ingredients may cause a problem.
Sandoz Amoxicillin comes in the following dosage forms:
Sandoz Amoxicillin Suspension
After reconstitution, each ml of suspension contains amoxicillin trihydrate equivalent to 25 or 50 mg of amoxicillin, respectively. The reconstituted suspension is stable for 14 days at room temperature and if refrigerated. Available in bottles of 100 and 150 mL (reconstitution volume).
Do not use Sandoz Amoxicillin if:
- You have any allergies to this drug or to its ingredients (See “What are the ingredients in Sandoz 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).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz 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 Sandoz 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 Sandoz Amoxicillin.
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 Sandoz 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 Sandoz Amoxicillin.
How to take Sandoz Amoxicillin:
Antibacterial drugs like Sandoz Amoxicillin treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, Sandoz Amoxicillin should be used exactly as directed. Misuse or overuse of Sandoz Amoxicillin could lead to the growth of bacterial that will not be killed by Sandoz Amoxicillin (resistance). This means that Sandoz 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 Sandoz 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 Sandoz 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.
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.
Tell your doctor if your condition does not improve.
Overdose:
| If you think you have taken too much Sandoz 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.
What are possible side effects from using Sandoz Amoxicillin?
These are not all the possible side effects you may feel when taking Sandoz Amoxicillin. If you experience any side effects not listed here, contact your healthcare professional.
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 | ||
| 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). | √ | ||
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 | ||
| 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.
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. |
Storage:
Powder: Store at room temperature 15-30°C. Protect from light and moisture. Keep bottle tightly closed.
Reconstituted Suspension: 14 days under refrigeration (2°C to 8°C) and at room temperature (20ºC to 25ºC). Protect from light. Keep bottle tightly closed.
Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist.
If you want more information about Sandoz 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062
Date of Revision: MAY 13, 2024