Patient Medication Information: uses, side effects, how to take - Sandoz Amoxi-Clav Tablet
Serious Warnings and Precautions
Hypersensitivity: Serious allergic reactions including death and severe skin adverse reactions have been reported in patients taking antibiotics, including amoxicillin, one of Sandoz Amoxi-Clav Tablet's medicinal ingredients. See ‘Serious side effects and what to do about them’ Table.
What is Sandoz Amoxi-Clav Tablet used for?
Sandoz Amoxi-Clav Tablet is an antibiotic used to treat bacterial infections.
Antibacterial drugs like Sandoz Amoxi-Clav Tablet treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Sandoz Amoxi-Clav Tablet should be taken exactly as directed. Misuse or overuse of Sandoz Amoxi-Clav Tablet could lead to the growth of bacteria that will not be killed by Sandoz Amoxi-Clav Tablet (resistance). This means that Sandoz Amoxi-Clav Tablet may not work for you in the future. Do not share your medicine.
How does Sandoz Amoxi-Clav Tablet work?
Sandoz Amoxi-Clav Tablet’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
What are the ingredients in Sandoz Amoxi-Clav Tablet?
Medicinal ingredients: amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium).
Non-medicinal ingredients: crospovidone (875 mg / 125 mg only), ethylcellulose, hydroxypropyl methlycellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, talc, titanium dioxide and triethyl citrate.
Sandoz Amoxi-Clav Tablet comes in the following dosage forms:
Sandoz Amoxi-Clav Tablets: 500 mg / 125 mg and 875 mg / 125 mg of amoxicillin / clavulanic acid.
Do not use Sandoz Amoxi-Clav Tablet if:
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
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:
- 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.
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 Amoxi-Clav Tablet:
- Allopurinol or probenecid (for treatment of gout).
- Anticoagulants (used to prevent blood clots) such as warfarin.
- Mycophenolate mofetil (suppressed the immune system).
- Methotrexate (used to treat conditions such as cancer and severe psoriasis).
How to take Sandoz Amoxi-Clav Tablet:
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
Amoxi-Clav 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 dose is one Sandoz Amoxi-Clav Tablet (500 mg / 125 mg) every 12 hours. For more severe infections and infections of the lower respiratory tract, your healthcare professional may prescribe one Sandoz Amoxi-Clav Tablet (875 mg / 125 mg) every 12 hours or one Sandoz Amoxi-Clav Tablet (500 mg / 125 mg) every 8 hours.
Children weighing more than 38 kg should be dosed according to adult recommendations.
Patients with kidney problems:
If you have kidney problems, your doctor may adjust your dose.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Amoxi-Clav Tablet, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you or your child 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.
What are possible side effects from using Sandoz Amoxi-Clav Tablet?
These are not all the possible side effects you may have when taking Sandoz Amoxi-Clav Tablet. If you experience any side effects not listed here, tell your healthcare professional.
- very common side effect in adults can be diarrhea (loose, or watery bowel movements).
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
uncommon side effects can be:
- Indigestion and headache
- Mild skin rash or itching
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
Sandoz Amoxi-Clav Tablet can cause abnormal urine tests (for glucose) results or blood test (for pregnancy) results. If you are getting blood or urine tests done, let the healthcare professional know that you are taking Sandoz Amoxi-Clav Tablet.
| 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 | ||
| RARE | |||
| Blood problems, with symptoms such as bleeding, or bruising, more easily than usual | ✓ | ||
| 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 | ✓ | ||
| VERY RARE | |||
| Allergic reactions: difficulty breathing, fever, hives (itchy and red bumps on skin), itching, rash, swelling of your tongue or throat | ✓ | ||
Central Nervous System (fits or seizures) problems such as convulsions (aseptic meningitis) inflammation of the protective membrane surrounding the brain | ✓ | ||
| Clostridium difficile colitis (bowel inflammation): with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✓ | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe life-threatening reaction): flu-like symptoms with fever, rash, swelling of the face or glands | ✓ | ||
| Kidney problems with symptoms such as blood in the urine which may be associated with a rash, | ✓ | ||
| 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 | ||
| fever, joint pain, or a reduction in passing water (urination) | |||
| 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 | ✓ | ||
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 | ✓ | ||
Vasculitis (blood vessel inflammation): red or purple raised spots on the skin, fatigue, fever, numbness or weakness | ✓ | ||
| UNKNOWN FREQUENCY | |||
Cardiovascular Kounis syndrome: chest pain which can be a sign of a potentially serious allergic reaction | ✓ | ||
| Drug-induced enterocolitis syndrome: repetitive vomiting (1 to 4 hours after taking Sandoz Amoxi-Clav Tablet), stomach pain, abnormal drowsiness, diarrhea and low blood pressure. These can be a sign of a serious allergic reaction | ✓ | ||
| Linear IgA disease: rash with blisters arranged in a circle with central crusting or like a string of pearls | ✓ | ||
| Symmetrical drug-related intertriginous and flexural | ✓ | ||
| 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 | |
| exanthema (SDRIFE): a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, and neck | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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. |
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Storage:
Store at 15° - 25°C, protected from moisture and protected from light.
Keep out of reach and sight of children.
If you want more information about Sandoz Amoxi-Clav Tablet:
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