Details for: SANDOZ AMOXI-CLAV TABLET
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02482576 | SANDOZ AMOXI-CLAV TABLET | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 500 MG; 125 MG | TABLET | ORAL |
| 02482584 | SANDOZ AMOXI-CLAV TABLET | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 875 MG; 125 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Sandoz Amoxi-Clav tablet is an antibiotic used to treat bacterial infections
What it does
Sandoz Amoxi-Clav tablet’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
When it should not be used
- you or your child are allergic to:
- amoxicillin.
- beta-lactam antibiotics (such as penicillins and cephalosporins).
- any of the other ingredients of Sandoz Amoxi-Clav tablet . See What are the ingredients in Sandoz Amoxi-Clav tablet .
- you or your child have had a history of:
- jaundice (yellowing of the skin and/or eyes) or liver disease, after taking Sandoz Amoxi-Clav tablet .
- you have mononucleosis.
What the medicinal ingredient is
amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium).
What the non-medicinal ingredients are
colloidal silica, crospovidone, croscarmellose sodium, ethylcellulose, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, polysorbat 80, talc, triethyl citrate, and titanium dioxide.
What dosage form it comes in
Sandoz Amoxi-Clav Tablets : 500/125 mg and 875/125 mg of amoxicillin / clavulanic acid.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Amoxi-Clav tablet. Talk about any health conditions or problems you may have, including if you or your child:
- have had an allergic reaction (such as a rash) when taking an antibiotic.
- start to have a skin rash while taking Sandoz Amoxi-Clav tablet then:
- stop taking Sandoz Amoxi-Clav tablet .
- tell your healthcare professional right away.
- have mononucleosis.
- have liver or kidney problems.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed:
- The amoxicillin in Sandoz Amoxi-Clav tablet is passed into human breast milk. Talk about this with your healthcare professional.
- are taking a birth control pill. Birth control pills may not work as well if you take Sandoz Amoxi-Clav tablet.
Other warnings you should know about
- Sandoz Amoxi-Clav tablet treats only bacterial infections, not viral infections like the common cold.
- Although you may feel better early in treatment, use Sandoz Amoxi-Clav tablet exactly as directed.
- Using too much Sandoz Amoxi-Clav tablet or using it in the wrong way may cause:
- more bacteria to grow
- bacteria that will not be killed (resistance).
- it not to work for you in the future (resistance).
Do not share your medicine
Tell your healthcare professional about all the medicines you or your child are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- allopurinol or probenecid (for treatment of gout)
- anticoagulants (used to prevent blood clots) such as warfarin
- mycophenolate mofetil (suppressed the immune system)
Proper use of this medication
You must use the medicine as instructed by your healthcare professional. Your healthcare professional will decide how much medicine you or your child need each day, and how many days you should take it for.
Treatment normally lasts 7 to 10 days. Your healthcare professional may ask you to take Sandoz AmoxiClav tablet for 48 to 72 hours more depending on how it works for you.
It is better to take Sandoz Amoxi-Clav tablet at the same time as a meal, but it still works without food. If there is anything you do not understand please ask your healthcare professional.
Usual Dose
Adults
The usual adult does is 1 Sandoz Amoxi-Clav tablet 500 mg every 12 hours. For more severe infections and infections of the lower respiratory tract, your healthcare professional may prescribe 1 Sandoz Amoxi-Clav tablet 875 mg every 12 hours or 1 Sandoz Amoxi-Clav tablet 500mg every 8 hours.
Patients with kidney problems
If you have kidney problems, your doctor may adjust your dose.
Overdose
If you think you have taken too much Sandoz Amoxi-Clav tablet , contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you miss a dose of Sandoz Amoxi-Clav tablet, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose. Instead, continue with your next scheduled dose. Do not try to make up for the missed dose by taking double the dose next time.
Side effects and what to do about them
Using Sandoz Amoxi-Clav tablet may cause side effects:
- that are not all listed here. If not listed here, contact your healthcare professional. Side effects may also be explained in Warnings and Precautions, or if they are serious they will be listed in the Serious Side Effects Table below.
While taking Sandoz Amoxi-Clav tablet a very common side effect in adults can be diarrhea (loose, or watery bowel movements).
While taking Sandoz Amoxi-Clav tablet common side effects can be:
- a yeast infection of the nails, skin, mouth, vagina, stomach or urinary tract.
- nausea (feeling sick) or vomiting.
- diarrhea (loose, or watery bowel movements) in children.
While taking Sandoz Amoxi-Clav tablet uncommon side effects can be:
- indigestion and headache.
- mild skin rash or itching
While taking Sandoz Amoxi-Clav tablet, very rare side effects can be:
- your tongue may change colour to yellow, brown or black or look “hairy”.
- your teeth may discolour.
- to reduce or prevent discolouring, brush your teeth thoroughly.
- talk to your dentist or doctor if this does not go away.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| RARE | |||
| Erythema multiforme (allergic skin reaction): skin reaction which results in itchy reddish purple patches especially on the palms of the hands or soles of the feet | ✔ | ||
| Blood problems, with symptoms such as bleeding, or bruising, more easily than usual | ✔ | ||
| VERY RARE | |||
| Allergic reactions: difficulty breathing, fever, hives (itchy and red bumps on skin), itching, rash, swelling of your tongue or throat | ✔ | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe life-threatening reaction): flu-like symptoms with fever, rash, swelling of the face or glands | ✔ | ||
| Vasculitis (blood vessel inflammation): red or purple raised spots on the skin, fatigue, fever, numbness or weakness | ✔ | ||
| Severe skin reactions:
(Steven-Johnson syndrome
and toxic epidermal necrolysis)
blisters and peeling skin,
particularly around the mouth,
nose, eyes, and genitals; or more
severely, blisters and peeling
skin on a lot of the body; body
aches or fever (bullous exfoliative dermatitis) red itchy scaly rash with blisters and bumps under the skin (exanthemous pustulosis) widespread red skin rash with small blisters containing pus |
✔ | ||
| Central Nervous System (fits or seizures) problems such as convulsions (Aseptic meningitis) Inflammation of the protective membrane surrounding the brain | ✔ | ||
| Liver problems with symptoms such as yellowing of the skin and/or eyes, or dark coloured urine, nausea, vomiting, abdominal pain, fever or unusual tiredness | ✔ | ||
| Kidney problems with symptoms such as blood in the urine which may be associated with a rash, fever, joint pain, or a reduction in passing water (urination) | ✔ | ||
| Clostridium difficile colitis (bowel inflammation) with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
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.
How to store
Store at 15° - 25°C, protected from moisture and protected from light. Keep out of reach and sight of children.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
More information
- 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/healthcanada/services/drugs-health-products/drug-products/drug-product-database.html) ; the manufacturer’s website http://www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc. Boucherville, Quebec, J4B 1E6
Last Revised: March 20, 2020