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KLARICID PAEDIATRIC SUSPENSION 125MG/5ML

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Clarithromycin
SOLID 1000556090

PATIENT INFORMATION LEAFLET
ON
® PAEDIATRIC SUSPENSION

125mg/5ml

1000006618

v1.0

(Clarithromycin)
Read all of this leaflet carefully before you give this medicine
to your child because it contains important information.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for your child only. Do not
pass it on to others. It may harm them, even if their symptoms
are the same as your child’s.
• If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See Section 4.
What is in this leaflet:
1. What Klaricid Paediatric Suspension 125mg/5ml is and what it is
used for
2. What you need to know before giving Klaricid Paediatric
Suspension 125mg/5ml
3. How to give Klaricid Paediatric Suspension 125mg/5ml
4. Possible side effects
5. How to store Klaricid Paediatric Suspension 125mg/5ml
6. Contents of the pack and other information
1. What Klaricid Paediatric Suspension 125mg/5ml is and what
it is used for
Each 5ml spoonful of Klaricid Paediatric Suspension 125mg/5ml
contains 125 mg of the active ingredient clarithromycin.
Klaricid belongs to a group of medicines called macrolide
antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause
infections.

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This information is confidential

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).
Klaricid Paediatric Suspension 125mg/5ml is used in children 6
months to 12 years old.
2. What you need to know before giving Klaricid Paediatric
Suspension 125mg/5ml
Do not give Klaricid Paediatric Suspension
125mg/5ml to your child if they;











• are allergic to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or
any of the other ingredients of Klaricid Paediatric Suspension
125mg/5ml.
are taking medicines called ergotamine or dihydroergotamine
tablets or use ergotamine inhalers for migraine.
are taking medicines called terfenadine or astemizole (widely
taken for hay fever or allergies) or cisapride (for stomach
disorders) or pimozide (for mental health problems) as combining
these drugs can sometimes cause serious disturbances in heart
rhythm.
are taking lovastatin or simvastatin (HMG-CoA reductase
inhibitors, commonly known as statins, used to lower levels of
cholesterol (a type of fat) in the blood).
have low levels of potassium in the blood (a condition known as
hypokalaemia).
have severe liver disease with kidney disease.
have an irregular heart rhythm.
are taking medicines called ticagrelor or ranolazine (for heart
attack, chest pain or angina).
are taking colchicine (usually taken for gout)

Warning and precautions
Talk to your doctor or pharmacist before giving Klaricid Paediatric
Suspension 125mg/5ml:

• if your child has any liver or kidney problems
• if your child has, or is prone to, fungal infections (e.g. thrush)
• if your child has been told that they have an intolerance to any
sugars as Klaricid Paediatric Suspension 125mg/5ml contains
sucrose.

• St John’s Wort (a herbal product used to treat depression)
• aminoglycosides (a group of antibiotic to treat certain bacteria
for example gentamicin, neomycin)

Other medicines and Klaricid paediatric Suspension 125mg/5ml
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
regular tests performed:
• digoxin, quinidine or disopyramide (for heart problems)
• warfarin (for thinning the blood)
• carbamazepine, valproate, phenobarbital or phenytoin (for
epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors,
commonly known as statins, and used to lower levels of
cholesterol (a type of fat) in the blood). Statins can cause
rhabdomyolosis (a condition which causes the breakdown of
muscle tissue which can result in kidney damage) and signs
of myopathy (muscle pain or muscle weakness) should be
monitored.
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin
(used to lower blood glucose levels)
• theophylline (used in patients with breathing difficulties such as
asthma)
• triazolam, alprazolam or midazolam (sedatives)
• cilostazol (for poor circulation)
• omeprazole (for treatment of indigestion and gastric ulcers)
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir,
saquinavir (anti-viral drugs used in the treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used
in the treatment of certain bacterial infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or
for use in pulmonary arterial hypertension (high blood pressure in
the blood vessels of the lung))

Pregnancy and breast-feeding
The safety of Klaricid Paediatric Suspension 125mg/5ml in
pregnancy and breast-feeding is not known. As Klaricid Paediatric
Suspension 125mg/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.

FRONT

Klaricid does not interact with oral contraceptives.

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. How to give Klaricid Paediatric Suspension 125mg/5ml
Always give Klaricid Paediatric Suspension 125mg/5ml exactly as
your doctor has told you. 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 125mg/5ml are
given below:
Dosage based on body weight
Weight (kg)

Age (years)

8-11

1-2

Dosage in mls Number of 5 ml
(twice daily)
spoonfuls
(twice daily)
2.5
1/2

12-19

3-6

5

1

20-29

7-9

7.5

1 1/2

30-40

10-12

10

2

Children who weigh less than 8kg should be given a dose of
0.3 ml/kg twice a day. Doctors may sometimes prescribe higher or
lower doses than these.

Clarithromycin
SOLID 1000556090

Klaricid Paediatric Suspension 125mg/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 close it tightly
afterwards. Klaricid Paediatric Suspension 125mg/5ml is usually
given for 5 to 10 days.
If you give more Klaricid Paediatric Suspension 125mg/5ml
than you should
If you accidentally give your child more Klaricid Paediatric Suspension
125mg/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 extra medicine, contact
your doctor or nearest hospital emergency department immediately.
An overdose of Klaricid Paediatric Suspension 125mg/5ml is likely to
cause vomiting and stomach pains.
If you forget to give Klaricid Paediatric Suspension 125mg/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 125mg/5ml in
one day than your doctor tells you to.
If you stop giving Klaricid Paediatric Suspension 125mg/5ml
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.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Klaricid Paediatric Suspension
125mg/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:

v1.0

• 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).
• muscle pain or weakness known as rhabdomyolysis
(a condition which causes the breakdown of muscle tissue
which can result in kidney damage).
Common side effects of Klaricid Paediatric Suspension
125mg/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
Other less common side effects include:
• high temperature
• swelling, redness or itchiness of the skin.
• acne
• 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)
• a change in the levels of certain cells or products found in the
blood
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Klaricid Paediatric Suspension 125mg/5ml
Keep this medicine out of the sight and reach of
children
Do not use this medicine after its use-by (exp.) date
that is printed on the label.
Do not store above 25°C.
Klaricid Paediatric Suspension 125mg/5ml must be
used within 14 days of you receiving the bottle from
the pharmacist.
Do not throw away any medicines via wastewater or
household water. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help
protect the environment.
6. Content of pack and other Information
What Klaricid Paediatric Suspension 125mg/5ml contains
Each 5ml spoonful of Klaricid Paediatric Suspension 125mg/5ml
contains 125 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 125mg/5ml looks like and
contents of the pack Klaricid Paediatric Suspension 125mg/5ml
is an off-white colour and is available in bottles of 70ml and
100ml. Not all pack sizes may be marketed.
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.
This leaflet was last revised in May 2014.
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This information is confidential

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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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