Novamoxin (Teva Canada, 125 mg): Uses, Side Effects and Dosage

What is NOVAMOXIN used for?

NOVAMOXIN 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 NOVAMOXIN work?

NOVAMOXIN 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. NOVAMOXIN does not kill viruses.

What are the ingredients in NOVAMOXIN?

Medicinal ingredients: amoxicillin (as amoxicillin trihydrate)

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)

125 mg and 250 mg tablets: Artificial Cherry Flavor, Aspartame, Colloidal Silicon Dioxide, Dipac White (Compressible Sugar), D&C Red #30 AL Lake, FD&C Red #40 Lake, Magnesium Stearate, Mannitol, Microcrystalline Cellulose

125 mg/5 mL and 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

125 mg/5 mL and 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

For 125 mg/5 mL Sugar-Reduced Granules for Oral Suspension: FD&C Red #40 & Natural & Artificial Strawberry Flavor

For 250 mg/5 mL Sugar-Reduced Granules for Oral Suspension: 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.

NOVAMOXIN comes in the following dosage forms:

NOVAMOXIN is available in four different forms, such as capsules, chewable tablets, Granules for Oral Suspension and Sugar-Reduced Granules for Oral Suspension

• NOVAMOXIN 250 mg Capsules in # 2 capsules with opaque scarlet cap and yellow body
• NOVAMOXIN 500 mg Capsules in #0 capsules with opaque scarlet cap and yellow body
• NOVAMOXIN 125 mg Tablets are a rose coloured, mottled, oval shaped, single-scored compressed tablet with cherry flavour, engraved ‘NOVO’ with scoreline on one side and ‘125’ on the other side
• NOVAMOXIN 250 mg Tablets are a rose coloured, mottled, oval shaped, single-scored compressed tablet with cherry flavour, engraved ‘NOVO’ with scoreline on one side and ‘250’ on the other side
• NOVAMOXIN Granules for Oral Suspension 125 mg/5 mL and 250 mg/5 mL
• NOVAMOXIN Sugar-Reduced Granules for Oral Suspension 125 mg/5 mL and 250 mg/5 mL

Do not use NOVAMOXIN if:

• You have any allergies to this drug or to its ingredients (See “What are the ingredients in Novamoxin?”).
• 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 NOVAMOXIN. 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 Novamoxin?”.
• 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 NOVAMOXIN.

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 NOVAMOXIN:

• 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 NOVAMOXIN.

How to take NOVAMOXIN:

Antibacterial drugs like NOVAMOXIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, NOVAMOXIN should be used exactly as directed. Misuse or overuse of NOVAMOXIN could lead to the growth of bacterial that will not be killed by NOVAMOXIN (resistance). This means that NOVAMOXIN 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 NOVAMOXIN.

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 Novamoxin 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 Novamoxin between meals with a glass of water. Tell your doctor if your condition does not improve.

Overdose:

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 NOVAMOXIN?

These are not all the possible side effects you may feel when taking NOVAMOXIN. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects and what to do about them

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

Storage:

For Capsules and Tablets: store between 15⁰C and 30⁰C. Blister strips should be stored between 15⁰C and 25⁰C and protected from high humidity.

Granules for oral suspension: store at room temperature between 15⁰C and 30⁰C. 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 NOVAMOXIN:

• 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 (http://hc-sc.gc.ca/index-eng.php); ; the manufacturer’s website www.tevacanada.com, or
• by calling 1-800-268-4127 ext. 3.
• By e-mail: : druginfo@tevacanada.com
• Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada

M1B 2K9

www.tevacanada.com

Last revised: March 20, 2020