Klacid P125 Granules for Reconstitution 125 G Granules

    Klacid P125 Granules for Reconstitution 125 G Granules

    S4

    API: Clarithromycin | Company: Abbott

    1. What Klacid P is and what it is used for.

    Klacid P is an antibiotic belonging to a group called macrolides. Antibiotics stop the growth of bacteria (which cause infections). Its use is described below.

    Klacid P is used to treat infections such as:

    1. Throat and sinus infections
    2. Chest infections, such as bronchitis and pneumonia
    3. Skin and tissue infections
    4. Ear infections particularly inflammation of the middle ear (acute otitis media)

    2. What you need to know before you take/use Klacid P.

    Do not give Klacid P to your child:

    • if you have been told that he or she is allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the medicine.
    • Do not give your child ergotamine or dihydroergotamine tablets or let them use ergotamine inhalers for migraine while taking Klacid P. Consult your doctor, pharmacist or other health care professional for advice on alternative medicines.
    • Do not give your child terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride or pimozide tablets while taking Klacid P, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor, pharmacist or other health care professional for advice on alternative medicines.
    • Do not take colchicines (usually taken for gout), while receiving Klacid P, as this can also cause serious side effects.

    If your child has any liver or kidney problems, speak to your doctor before giving them this medicine.

    Safety and efficacy in infants less than 6 months of age have not been established.

    Take special care with Klacid P:

    • If your child has any liver or kidney problems, speak to your doctor before giving them this medicine.
    • If your child develops severe or prolonged diarrhoea during or after receiving Klacid P, tell your doctor immediately.

    3. How to take/use Klacid P.

    The usual doses of Klacid P are given below:

    Dosage based on Body Weight

    Dosage in mls (spoonsful) twice daily

    Weight (kg)Age (years)125 mg/5ml250 mg/5ml
    8 - 111 - 2 *2,5 ml (0,5)--
    12 - 192 - 4 *5,0 ml (1)2,5 ml (0,5)
    20 - 294 - 8 *7,5 ml (1 ½ )3,75 ml (0,75)
    30 - 408 - 12 *10,0 ml (2)5,0 ml (1)

    * Approximate ages.

    Always give Klacid P exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are not sure how the dose has been worked out for your child. Doctors may sometimes prescribe higher or lower doses than these. If this applies to your child then you should discuss it with your doctor or pharmacist.

    Klacid P should be given twice a day, once in the morning and again in the early evening. It can be given at mealtimes if this is most convenient. You should shake the bottle well before using and close it tightly afterwards. Klacid P is usually given for 5 to 10 days.

    Do not stop giving this medicine because your child feels better. It is important to give the medicine for as long as the doctor has told you to, otherwise the problem might come back.

    If you forget to give Klacid P:

    If you forget to give your child a dose of medicine, give this missed dose as soon as you remember and then continue dosing as normal. Do not give more Klacid P in one day than your doctor tells you to. If you are concerned about having missed one or more doses of medicine, consult your doctor or pharmacist.

    If you give more Klacid P than you should:

    If you accidentally give your child more Klacid P in one day than your doctor has told you to, or if your child accidentally swallows some extra medicine, seek medical advice urgently - in the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. An overdose of Klacid P is likely to cause vomiting and stomach pains, and there is a possibility of allergic reactions.

    4. Possible side effects.

    Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

    Klacid P can sometimes cause stomach problems such as vomiting, stomach pain or diarrhoea. If your child develops severe or prolonged diarrhoea, which may have blood or mucous in it, during or after receiving Klacid P, consult your doctor immediately.

    Your child may complain of having a funny taste in their mouth, or a change in their sense of taste and smell, while taking Klacid P. However, these are only temporary effects and they should not stop taking the medicine because of them. Very rarely, the teeth become discoloured, but in most cases this can be removed by professional dental cleaning. There have also been reports of Klacid P causing the tongue to swell or darken, sore mouth or tongue and ‘thrush’ in the mouth.

    If your child has a blood test whilst taking Klacid P he/she may be found to have raised liver enzymes. These levels usually return to normal, and your child is unlikely to show any symptoms. However, Klacid P can rarely cause jaundice and other liver or gall bladder disorders, which can be severe or even fatal in extremely rare circumstances. If your child is generally unwell or develops yellow skin and/or eyes, or pale stools with dark urine, consult you doctor immediately.

    Kidney problems, including raised levels of protein normally excreted by the kidneys and rarely kidney failure, have also been reported. Occasionally, a blood test may also show low levels of white blood cells.

    Allergic reactions including rashes have been reported with Klacid P. In very rare cases, difficulty in breathing, fainting and swelling of the face and throat can occur which may need emergency treatment. Allergic rashes may range in severity from mild, itchy skin eruptions to a rarer, more serious condition called Stevens-Johnson syndrome (which causes severe illness with ulceration of the mouth, lips and skin) or toxic epidermal necrolysis (which causes severe illness and sloughing of the skin).

    There have been a few reports of dizziness, loss of bearings, ‘ringing’ in the ears, difficulty in sleeping, depression, hallucinations (seeing things), bad dreams, confusion, change in sense of reality and panicking. These effects are usually short-lived and soon disappear. Very rarely, fainting due to low blood sugar, and mood and behavioural disorders have been reported, which in severe cases have required hospitalisation. Very rarely, some patients may experience unexpected bruising and their blood may take longer to clot after a cut to the skin. Changes in heart rhythm, inflammation of the pancreas and convulsions have also been reported rarely. There have been rare reports of loss of sense of smell and of hearing loss with Klacid P, which is a temporary effect and is usually reversible on stopping treatment. Consult your doctor if your child develops any of these problems or has any other unexpected or unusual symptoms.

    5. How to store Klacid P.

    Do not use this medicine after its ‘use - by’ (expiry) date, which is printed on the label. If the suspension is out of date, return it to your pharmacist and, if necessary, get a new prescription from your doctor.

    Store at room temperature (below 25°C). Store in the original package. Store all medicines out of reach of children – keep this medicine in a safe place where children cannot reach it.

    After reconstitution, Klacid P must be used within 14 days of you receiving the bottle from the pharmacist. If your doctor decides to stop your child’s treatment with Klacid P, return any remaining suspension to a pharmacist.

    Important Disclaimer

    The Klacid P125 Granules for Reconstitution 125 G Granules professional information leaflet below is the property of Abbott and is provided on Somayeza 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. Somayeza 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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