Augmentin BD Tablets

    Augmentin BD Tablets

    S4
    PDF Leaflet Revision Date: 13 January 2021

    API: Amoxicillin, Clavulanic Acid | Company: Gsk

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Used to treat bacterial infections in children.

    Dosage (summary)

    Dosage determined by doctor; typically given with food.

    Special Populations

    • Children under 2 years
    • Liver impairment
    • Kidney impairment
    • Phenylketonuria (PKU)

    Pregnancy & Breastfeeding

    Consult healthcare provider if pregnant or breastfeeding.

    Key Drug Interactions

    • Allopurinol
    • Probenecid
    • Anticoagulants (e.g., warfarin)
    • Mycophenolate mofetil

    Contraindications

    • Allergy to amoxicillin or beta-lactam antibiotics
    • History of jaundice or liver disease with AUGMENTIN

    Common side effects

    • Rash
    • Diarrhea
    • Nausea
    • Vomiting
    • Headache
    • Dizziness

    Counselling Points

    • Complete the full course of treatment
    • Monitor for allergic reactions
    • Maintain hydration

    Serious warnings

    • Serious allergic reactions
    • Convulsions
    • Severe diarrhea
    • Liver dysfunction
    Important Disclaimer

    The Augmentin BD Tablets professional information leaflet below is the property of Gsk and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4. Possible side effects

    AUGMENTIN can cause side effects. Not all side effects reported for AUGMENTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

    If your child has any of the following symptoms after taking AUGMENTIN, STOP giving it and tell your doctor immediately, or take them to the accident and emergency department of your nearest hospital:

    • sudden wheeziness, shortness of breath, or chest tightness
    • swelling of the face, lips, tongue, or other parts of the body
    • suddenly feeling faint, especially upon standing up
    • convulsions (fits or seizures)
    • yellowing of the skin and/or eyes, or dark coloured urine. These symptoms may be accompanied by itching, fever, nausea, vomiting, loss of appetite and feeling generally unwell. These symptoms may not occur until several weeks after the end of treatment and can be severe
    • blood in the urine which may be associated with a rash, fever, joint pain, or a reduction in passing water (urination)
    • severe diarrhoea, which may be bloody, or contain mucus, and which may be accompanied by stomach cramps
    • a rash with blisters that may cause the skin to peel, flake, or bleed.
    • unusual tiredness, headaches, being short of breath when exercising, dizziness, looking pale, and yellowing of the skin and/or eyes. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AUGMENTIN. You may need urgent medical attention or hospitalisation.

    Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

    • fever, severe chills, sore throat or mouth ulcers. Unusual joint pains especially if accompanied by a rash
    • the tongue may change colour to yellow, brown or black, and it may have a hairy appearance
    • inflammation of the protective membrane surrounding the brain (aseptic meningitis)
    • flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
    • bleeding, or bruising, more easily than usual
    • a rash where the spots (usually 0,5 cm to 2 cm in size) have a pink/red ring around the edge and a darker centre. These are all serious side effects. You may need urgent medical attention.

    Tell your doctor if you notice any of the following:

    • mild rash, itching or hives (itchy lumps)
    • indigestion
    • headache
    • dizziness
    • diarrhoea (loose, or watery bowel movements)
    • nausea (feeling sick)
    • vomiting (being sick)
    • thrush (a fungal infection). In babies this can look like a severe nappy rash. Older children may experience itching and burning around the genital area (private parts) with the presence of a thick, white discharge. Babies and children can also develop thrush in their mouth. This appears as painful white patches on the inside of their mouth and on their tongue.

    Symptoms such as indigestion, feeling sick and being sick can often be avoided by giving AUGMENTIN at the beginning of a meal. Childrenu2019s teeth can become discoloured while using AUGMENTIN. This is less likely to happen if they clean their teeth thoroughly and any discolouration can usually be removed by brushing. If the discolouration does not disappear, ask your doctor or dentist for advice. Not all side effects reported for AUGMENTIN are included in this leaflet. Should your childu2019s general health worsen or if he/she experiences any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

    Reporting of side effects: If you get side effects, talk to your doctor or pharmacist nurse. You can also report side effects to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AUGMENTIN.

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