KLARICID PAEDIATRIC SUSPENSION 250MG/5ML

Active substance: CLARITHROMYCIN

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PATIENT INFORMATION LEAFLET
ON

PAEDIATRIC SUSPENSION
250MG/5ML

Klaricid belongs to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) that cause infections.
It is used to treat infections such as:
1. Chest infections, such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Ear infections particularly inflammation of the middle ear (acute
otitis media).

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Klaricid Paediatric Suspension 250mg/5ml is used in children 6 months Tell your doctor if your child is taking any of the following medicines
as their dose may need to be changed or they may need to have
to 12 years old.
regular tests performed:
• digoxin, quinidine or disopyramide (for heart problems)
2. Before giving Klaricid Paediatric Suspension 250mg/5ml
• warfarin (for thinning the blood)
• carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)
Do not give Klaricid Paediatric Suspension
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors,
(Clarithromycin)
250mg/5ml to your child if they;
commonly known as statins, and used to lower levels of cholesterol
Read all of this leaflet carefully before you give this medicine to
(a type of fat) in the blood)
your child.
• are allergic to clarithromycin, other macrolide antibiotics such as
• colchicine (usually taken for gout)
• Keep this leaflet. You may need to read it again.
erythromycin or azithromycin, or any of the other ingredients of
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used
• If you have further questions, ask your doctor or your pharmacist.
Klaricid Paediatric Suspension 250mg/5ml.
to lower blood glucose levels)
• This medicine has been prescribed for your child. Do not pass it on
• are taking medicines called ergotamine or dihydroergotamine
• theophylline (used in patients with breathing difficulties such as
to others. It may harm them, even if their symptoms are the same as
tablets or use ergotamine inhalers for migraine.
asthma)
your child’s.
• are taking medicines called terfenadine or astemizole (widely taken
• triazolam, alprazolam or midazolam (sedatives)
• If any of the side effects gets serious, or if you notice any side
for hay fever or allergies) or cisapride (for stomach disorders) or
• cilostazol (for poor circulation)
effects not listed in this leaflet, please tell your doctor or pharmacist.
pimozide (for mental health problems) as combining these drugs can • omeprazole (for treatment of indigestion and gastric ulcers)
sometimes cause serious disturbances in heart rhythm.
• methylprednisolone (a corticosteroid)
In this leaflet:
• are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, • vinblastine (for treatment of cancer)
1. What Klaricid Paediatric Suspension 250mg/5ml is and what it is
commonly known as statins, used to lower levels of cholesterol (a
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
used for
type of fat) in the blood).
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir,
2. Before giving Klaricid Paediatric Suspension 250mg/5ml
• have low levels of potassium in the blood (a condition known as
saquinavir (anti-viral drugs used in the treatment of HIV)
3. Giving Klaricid Paediatric Suspension 250mg/5ml
hypokalaemia).
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in
4. Possible side effects
• have severe liver disease with kidney disease.
the treatment of certain bacterial infections)
5. How to store Klaricid Paediatric Suspension 250mg/5ml
• have an irregular heart rhythm.
• tolterodine (for overactive bladder)
6. Further information
• verapamil (for high blood pressure)
Take special care with Klaricid Paediatric Suspension 250mg/5ml; • sildenafil, vardenafil and tadalafil (for impotence in adult males or for
1. What Klaricid Paediatric Suspension 250mg/5ml is and what
• if your child has any liver or kidney problems
use in pulmonary arterial hypertension (high blood pressure in the
it is used for
• if your child has, or is prone to, fungal infections (e.g. thrush)
blood vessels of the lung))
• if your child has been told that they have an intolerance to any
• St John’s Wort (a herbal product used to treat depression)
Each 5ml spoonful of Klaricid Paediatric Suspension 250mg/5ml
sugars as Klaricid Paediatric Suspension 250mg/5ml contains
contains 250mg of the active ingredient clarithromycin.
sucrose.
Klaricid does not interact with oral contraceptives.
If any of these apply to your child, consult your doctor before giving
your child Klaricid Paediatric Suspension 250mg/5ml.
Taking other medicines
You should not give your child Klaricid Paediatric Suspension
250mg/5ml if they are taking any of the medicines listed in the section
above “Do not give Klaricid Paediatric Suspension 250mg/5ml to
your child if they;”

Pregnancy and breast-feeding
The safety of Klaricid Paediatric Suspension 250mg/5ml in pregnancy
and breast-feeding is not known. As Klaricid Paediatric Suspension
250mg/5ml may be given to girls of child-bearing age you should
speak to your doctor before giving this medicine if pregnancy is
known or suspected.

Driving and Using Machines:
Klaricid Paediatric Suspension may make you feel dizzy or drowsy. If
they affect you or your child in this way do not drive, operate
machinery or do anything that requires you to be alert.
3. Giving Klaricid Paediatric Suspension 250mg/5ml
Always give Klaricid Paediatric Suspension 250mg/5ml exactly as your
doctor has told you. You should check with your doctor or pharmacist
if you are not sure how the dose has been worked out for your child.
The usual doses of Klaricid Paediatric Suspension 250mg/5ml are
given below:
Dosage based on body weight
Weight (kg)
Age (years)

Dosage in mls (twice daily)

8-11
12-19
20-29
30-40

1.25
2.5
3.75
5

1-2
3-6
7-9
10-12

Children who weigh less than 8kg should be given a dose of
0.15 ml/kg twice a day.
Doctors may sometimes prescribe higher or lower doses than these.
Klaricid Paediatric Suspension 250mg/5ml is supplied with a pipette to
help you measure the right amount of medicine to give to your child.
Please follow these instructions carefully;
1. Remove the child-proof cap from the bottle by pushing down on
the cap while turning it anticlockwise (Fig 1).
2. Take the plastic circular stopper from the carton and push this
into the neck of the bottle. This should fit tightly and once it is in
place it should not be removed. (Fig 2).
3. Take the pipette out of the carton and ensure that the plunger is
pressed down inside the barrel as far as it will go. This gets rid of
any air that may be inside the barrel.
4. Insert the nozzle of the pipette into the hole in the stopper (Fig 3).
5. Turn the bottle upside down. Keep hold of the bottle in one hand
and the pipette in the other (Fig 4).
6. Hold the barrel of the pipette steady and slowly, pull the plunger
down until you see the liquid fill the barrel to the mark which
matches the number of ml that you need to give to your child (Fig 4).

7.
8.
9.

Turn the bottle back the right way up.
Keeping hold of the barrel, remove the whole pipette from the bottle.
The contents of the pipette can be emptied directly into your
child’s mouth by pushing down on the plunger while still holding
the barrel. Alternatively, empty the measured dose from the
pipette onto a spoon for your child to take the medicine from.
10. Replace the cap on the bottle of medicine.
11. Wash the pipette in warm soapy water and rinse well. Hold the
pipette under water and move the plunger up and down several
times to make sure the inside of the barrel is clean.
Store the pipette in a hygienic place with the medicine.

Fig 1.

Fig 2.

Fig 3.

Fig 4.

Klaricid Paediatric Suspension 250mg/5ml 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 more convenient.
You should shake the bottle well before using and replace the cap
firmly after use. Klaricid Paediatric Suspension 250mg/5ml is usually
given for 5 to 10 days.

4. Possible Side Effects
Like all medicines, Klaricid Paediatric Suspension
250mg/5ml can cause side effects although not
everybody gets them.
If your child suffers from any of the following at
any time during their treatment STOP giving the
medicine and contact your doctor immediately:
• severe or prolonged diarrhoea, which may have blood or mucus in it.
Diarrhoea may occur over two months after treatment with
clarithromycin, in which case you should still contact your doctor.
• a rash, difficulty breathing, fainting or swelling of the face and throat.
This is a sign that your child may have developed an allergic
reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine,
tender abdomen or loss of appetite. These are signs that your
child’s liver may not be working properly.
• severe skin reactions such as blistering of the skin, mouth, lips, eyes
and genitals (symptoms of a rare allergic reaction called
Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Henoch-Schonlein purpura (a rash which appears as purple spots on
the skin).

• oral or vaginal ‘thrush’ (a fungal infection)
• reduction in the level of certain blood cells (which can make
infections more likely or increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating, constipation, wind
• inflammation of the pancreas
• anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or
shaking
• confusion, loss of bearings, hallucinations (seeing things), change in
sense of reality or panicking, depression, abnormal dreams or
nightmares
• convulsion (fits)
• ringing in the ears or hearing loss
• vertigo
• paraesthesia, more commonly known as "pins and needles"
• leaking of blood from blood vessels (haemorrhage)
• inflammation of the mouth or tongue
• discolouration of the tongue or teeth
• dry mouth
• loss of taste or smell or inability to smell properly
• joint pain
• muscle spasms, muscle pain or loss of muscle tissue. If your child
suffers from myasthenia gravis (a condition in which the muscles
become weak and tire easily) or rhabdomyolysis (a condition which
causes the breakdown of muscle tissue), clarithromycin may worsen
these symptoms
• chest pain or changes in heart rhythm such as palpitations
• a change in the levels of products made by the liver, inflammation of
the liver or an inability of the liver to function properly (you may
notice yellowing of the skin, dark urine, pale stools or itchiness of
the skin)
• a change in the levels of products produced by the kidney,
inflammation of the kidney or an inability of the kidney to function
properly (you may notice tiredness, swelling or puffiness in the face,
abdomen, thighs or ankles or problems with urination)
• low blood sugar levels
• a change in the levels of certain cells or products found in the blood.

If you give more Klaricid Paediatric Suspension 250mg/5ml than
you should
If you accidentally give your child more Klaricid Paediatric Suspension
250mg/5ml in one day than your doctor has told you to, or if your child
accidentally swallows some extra medicine, contact your doctor or
nearest hospital emergency department immediately. An overdose of
Klaricid Paediatric Suspension 250mg/5ml is likely to cause vomiting and
stomach pains.

Common side effects of Klaricid Paediatric Suspension 250mg/5ml
include;
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick, vomiting, stomach pain,
indigestion, diarrhoea
• a change in the way the liver works
• skin rash
• increased sweating

If you forget to give Klaricid Paediatric Suspension 250mg/5ml
If you forget to give your child a dose of medicine, give one as soon as
you remember. Do not give more Klaricid Paediatric Suspension
250mg/5ml in one day than your doctor tells you to.
Do not stop giving this medicine even if 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.

Other less common side effects include:
• high temperature
• swelling, redness or itchiness of the skin. Sometimes brown scales
Consult your doctor immediately if your child develops any of these
may appear
problems or has any other unexpected or unusual symptoms.
• acne
• Henoch-Schonlein purpura (a rash which appears as purple spots on
the skin)

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5. How to store Klaricid Paediatric Suspension 250mg/5ml
Keep out of reach and sight of children
Do not use this medicine after its use-by (exp.) date that
is printed on the label.
Keep this medicine in a cool place. Do not store above
30°C. Do not refrigerate or freeze.
Klaricid Paediatric Suspension 250mg/5ml must be
used within 14 days of you receiving the bottle from the
pharmacist.
6. Further Information
What Klaricid Paediatric Suspension 250mg/5ml contains
Each 5ml spoonful of Klaricid Paediatric Suspension 250mg/5ml
contains 250 mg of the active ingredient clarithromycin.
Other ingredients are: sucrose, carbopol 974P, povidone K90,
hydroxypropylmethylcellulose phthalate, castor oil, silicon dioxide,
xanthan gum, fruit punch flavour, potassium sorbate, citric acid,
maltodextrin, titanium dioxide and water.
What Klaricid Paediatric Suspension 250mg/5ml looks like and
contents of the pack
Klaricid Paediatric Suspension 250mg/5ml is an off-white colour and
is available in bottles of 70 ml.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder - Abbott Laboratories Ltd., Abbott
House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire,
SL6 4XE, UK.
Manufacturer - Aesica Queenborough Limited, Queenborough, Kent
ME11 5EL, UK.
Leaflet revised February 2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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