Patient Medication Information: uses, side effects, how to take - Amoxicillin (Sivem Pharmaceuticals, Granules For Suspension)

Serious Warnings and Precautions

Some people taking penicillin antibiotics like AMOXICILLIN (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 AMOXICILLIN.

What is AMOXICILLIN used for?

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 AMOXICILLIN work?

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. AMOXICILLIN does not kill viruses.

What are the ingredients in AMOXICILLIN?

Medicinal ingredients: amoxicillin (as amoxicillin trihydrate)

Non-medicinal ingredients:

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

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.

AMOXICILLIN comes in the following dosage form:

AMOXICILLIN Granules for Oral Suspension 250 mg/5 mL

Do not use AMOXICILLIN if:

You have any allergies to this drug or to its ingredients (See “What are the ingredients in 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 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 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 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 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 AMOXICILLIN.

How to take AMOXICILLIN:

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

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

Overdose:

If you think you, or a person you are caring for, have taken too much AMOXICILLIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or 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 AMOXICILLIN?

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

AMOXICILLIN can 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

Serious side effects and what to do about them
Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Only if severe	In all cases
COMMON
Anxiety		✓
Change in tooth color in children (brown, yellow or gray staining)		✓
Dizziness (light headedness)		✓
Glossitis (Black “hairy” tongue)		✓
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 panting			✓
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: 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: persistent nausea/vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine.			✓
RARE
Confusion or changes in behavior		✓
Insomnia (difficulty falling asleep)		✓
Hypersensitivity vasculitis (Inflammation of the blood vessels): rash, red spots, hives, and blisters on the lower part of the body			✓
Severe skin reactions (that may also affect other organs): Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish) Swelling and redness of eyes or face Flu-like feeling, fever, chills, body aches, swollen glands, cough Shortness of breath, chest pain or discomfort Feeling thirsty, urinating less often, less urine			✓
NOT KNOWN
Anemia (lack of red blood cells): fatigue, headache, pale skin, irregular heart beats, chest pain, cold hands, dizziness, leg cramps			✓
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.			✓
Drug-induced enterocolitis syndrome: repetitive vomiting (1 to 4 hours after taking amoxicillin containing drug products), stomach pain, abnormal drowsiness, diarrhea and low blood pressure. These can be a sign of a serious allergic reaction			✓
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, fever			✓
Kounis syndrome (heart problems caused by an allergic reaction): 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			✓
Linear IgA disease: rash with blisters arranged in a circle with central crusting or like a string of pearls	✓
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness			✓
Yeast infection / Thrush (fungal infection affecting the mouth, throat, stomach, urinary tract or vagina): thick white patches in the mouth, tongue or on the throat, sore throat. Itching, burning, rash, soreness or discomfort or discharge from the vagina.		✓

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:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

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

Once mixed, the oral suspension will last for 14 days at room temperature (between 15⁰C and 30⁰C).

Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist.

Keep out of reach and sight of children.

If you want more information about AMOXICILLIN:

Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sivem.ca; or by calling 1-855-788-3153.

Rx or OTC	Prescription (Rx)?
DIN	02401541
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Amoxicillin (amoxicillin trihydrate) 250 MG
Dosage form(s)	Granules For Suspension
Route(s) of administration	Oral
Drug class (WHO ATC)	J Antiinfectives for systemic use J01 Antibacterials for systemic use J01C Beta-lactam antibacterials, penicillins J01CA Penicillins with extended spectrum J01CA04 Amoxicillin
Company	SIVEM PHARMACEUTICALS ULC
Current status	Marketed
Current status date	February 14, 2013

Amoxicillin (Sivem Pharmaceuticals, Granules For Suspension): Uses, Side Effects and Dosage