Amoxicillin Granules for Oral Suspension: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

^PrAMOXICILLIN 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

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 ^PrAMOXICILLIN 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:

^PrAMOXICILLIN contains the active ingredient called amoxicillin.

What the important nonmedicinal ingredients are:

^PrAMOXICILLIN also contains the following non-medicinal ingredients:

250 mg and 500 mg capsules: Colloidal Silicon Dioxide, EGC Size #2 or Size #0, Dry-Flo Starch, Magnesium stearate, Sodium lauryl sulfate, Talc

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

125 mg/5 mL and 250 mg/5 mL Granules for Oral Suspension : Artificial Cherry Raspberry 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, FD&C Red #40, Natural & Artificial Strawberry Flavor, Mannitol 2080, Nipagin-M Sodium, Nipasol-M Sodium, Sodium Citrate, Sucrose, Xanthan Gum

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 forms it comes in:

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

• ^PrAMOXICILLIN 250 mg Capsules in # 1 capsules with opaque scarlet cap and yellow body
• ^PrAMOXICILLIN 500 mg Capsules in #0 capsules with opaque scarlet cap and yellow body
• ^PrAMOXICILLIN 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
• ^PrAMOXICILLIN 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
• ^PrAMOXICILLIN Granules for Oral Suspension 125 mg/5 mL and 250 mg/5 mL

• ^PrAMOXICILLIN Sugar-Reduced Granules for Oral

  Suspension 125 mg/5 mL and 250 mg/5 mL

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 ^PrAMOXICILLIN 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 AMOXICILLIN.

As the safety of AMOXICILLIN in the treatment of infections in pregnancy is not established, your doctor will determine if AMOXICILLIN 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. warfarin).

Before taking ^PrAMOXICILLIN 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.

For the oral suspension, please administer using the syringe provided by your pharmacist to ensure the correct dose is given.

Overdose:

In case of drug overdose, 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, ^PrAMOXICILLIN may cause unwanted reactions, so called side effects. Most patients do not experience side effects from ^PrAMOXICILLIN. 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 ^PrAMOXICILLIN and call your healthcare professional immediately.

This is not a complete list of side effects. For any unexpected

effects while taking ^PrAMOXICILLIN contact your doctor or pharmacist.

HOW TO STORE IT

Do not take ^PrAMOXICILLIN past the expiry date shown on the pack.

Store your ^PrAMOXICILLIN as follows:

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

Granules for oral suspension: store at room temperature between 15⁰C and 30⁰C. Keep bottle tightly closed.

Reconstituted Solution: The reconstituted solution is stable for 14 days under refrigeration (between 2⁰C - 8⁰C) or 7 days at room temperature (between 15⁰C and 30⁰C).

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 of children.

REPORTING SUSPECTED 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:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at: 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  -Fax toll-free to 1-866-678-6789, or

  -Mail to: Canada Vigilance Program

  Health Canada

  Postal Locator 0701E

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at:

www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of the side effects, contact your health professional. 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 Sivem Pharmaceuticals ULC. at:

1-855-788-3153

or

by written request at:

4705 Dobrin Street

Saint-Laurent, Quebec H4R 2P7

or at:

www.sivem.ca

Last revised: July 4, 2014