Active substance: CLARITHROMYCIN

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Read this entire leaflet carefully before you give
this medicine to your child.
Ÿ this leaflet. You may need to read it again.
Ÿ have further questions, please ask your
If you
doctor or your pharmacist.
Ÿ medicine has been prescribed for your child
personally and you should not pass it on to
others. It may harm them, even if their
symptoms are the same.
Ÿ of the side effects gets serious, or if you
If any
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Clarithromycin 125mg/5ml or
250mg/5ml Oral Suspension is and what it is
used for
2. Before you take Clarithromycin 125mg/5ml
or 250mg/5ml Oral Suspension
3. How to take Clarithromycin 125mg/5ml or
250mg/5ml Oral Suspension
4. Possible side effects
5. How to store Clarithromycin 125mg/5ml or
250mg/5ml Oral Suspension
6. Further information
Clarithromycin is part of a group of antibiotics called
macrolides. Clarithromycin works by destroying
some types of bacteria that cause certain infections.
Clarithromycin may be used to treat infections that
are caused by bacteria in the chest, throat, sinuses
and ear and infections of the skin and the layers of
flesh just under the skin.
Clarithromycin 125mg/5ml or 250mg/5ml oral
suspension is used in children 6 months to 12 years
125mg/5ml or 250mg/5ml ORAL SUSPENSION
Do not give Clarithromycin 125mg/5ml or
250mg/5ml Oral Suspension to your child if the
answer to any of the following questions for
your child is “YES”. If you are unsure about
anything or have any questions, please ask
your doctor, nurse or pharmacist before you
give clarithromycin to your child.
- Has your child ever been allergic
(hypersensitive) to clarithromycin, other
macrolides (similar antibiotics) or any of the
other ingredients of Clarithromycin oral
suspension (see list of ingredients in section 6).
An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips,
throat or tongue. Does your child:
- have hypokalaemia (low blood potassium)
- have severe liver disorders combined with
kidney disorders
- have special cardiac arrhythmia (so-called QT
prolongation or torsade des pointe)
- Is your child taking ergotamine-like drugs
(usually used for migraine), cisapride (used for
heartburn), pimozide (for mental illness),
astemizole or terfenadine (for hayfever),
lovastatin, simvastatin or atorvastatin
(treatments to lower cholesterol), drugs that
prevent peristalsis (bowel movement) such as
antidiarrhoea treatments.
Take special care with Clarithromycin
125mg/5ml or 250mg/5ml Oral Suspension if
your child
- develop severe diarrhoea during or after
treatment with Clarithromycin Oral Suspension
– stop taking the suspension and tell your doctor
- develops another infection – stop taking the
suspension and tell your doctor
- have a liver or kidney disorder
- are allergic to other antibiotics such as
clindamycin, lincomycin
- have a heart disorder
- have hypomagnesiaemia (low blood
- have Myasthenia gravis disease (a disease
causing muscle weakness)
- take anticoagulants, e. g. warfarin (medicines to
thin your blood). Your child`s prothrombin time
should be monitored frequently.
- take medicines, which can impair hearing e.g
aminoglycosides. Your doctor should check
your child`s ability to hear, if necessary.
- take medicines to lower your blood sugar. Their
effect might be increased by Clarithromycin.
- have pneumonia, as the causing bacteria
(Streptococcus pneumoniae) might be resistant
against clarithromycin.
- have pharyngitis and there is no hypersensitivity
or another contraindication to take penicillins.
- take colchicine, you should be monitored for
symptoms of colchicine toxicity, as
clarithromycin might increase its blood levels.
If the bacteria are resistant against erythromycin A.
They might be resistant against clarithromycin, too.
If you are pregnant, please inform your doctor.
If any of the above applies to your child, speak
to your doctor.
Taking other medicines
Please inform your doctor or pharmacist if your child
is taking, or has recently taken, any other
medicines, including any that were obtained without
a prescription.
Please talk to your doctor before giving this
medicine to your child if he/she is receiving any of
the following
astemizole or terfenadine (for hay fever or
cisapride (for stomach disorders)
pimozide (for mental disorders)
ergotamine type drugs (for migraine)
Your doctor may need to control blood levels or
effects, or to adjust the dosage, or to interrupt (for
some time) the treatment if Clarithromycin Oral
Suspension is used at the same time with
medicines containing one of the substances listed
- digoxin (for heart failure)
- quinidine or disopyramide (for heartbeat
- midazolam (sedatives/sleeping pills)
- triazolam, temazepam, nitrazepam, lorazepam
(sleeping pills)
- alprazolam (for anxiety)

- verapamil (medicine against high blood
- tolterodine (medicine to treat urinary
- St. John's Wort (herbal product used for
- cyclosporin, tacrolimus or sirolimus (help
prevent rejection after a transplant)
- theophylline (for asthma)
- efavirenz, ritonavir, zidovudine, nevirapine,
atazanavir or saquinavir (HIV treatments)
- rifampicin, rifabutin or rifapentine (antibiotics)
- fluconazole, itraconazole (antifungal medicine)
- oral anticoagulants such as warfarin (blood
- simvastatin, atorvastatin, cerivastatin or
lovastatin (cholesterol-lowering drugs)
- omeprazole (for ulcers)
- phenytoin, carbamazepine, valproate or
phenobarbital (for epilepsy)
- insulin or other diabetes medicines, e. g.
- colchicines (for gout)
- sildenafil, tadalafil and vardenafil (for erectile
- cilostazol (for poor circulation)
- methylprednisolone (a steroid)
- vinblastine (for treatment of cancer).

not be removed.
3. Take the syringe 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 syringe into the hole in
the adaptor.
5. Turn the bottle upside down. Keep hold of the
bottle in one hand and the syringe in the other.
6. Hold the barrel of the syringe steady and slowly,
pull the plunger down until you see the medicine
fill the barrel to the mark which matches the
number of ml that you need to give to your child.
7. Turn the bottle the correct way up. Keeping hold
of the barrel, remove the whole syringe from the
8. Put the syringe tip into your baby's mouth. Drip
the medicine in by pushing down the plunger
gently while still holding the barrel. Don't hurry
your child, allow time for him or her to swallow
the medicine slowly. Alternatively, empty the
measured dose from the syringe onto a spoon
for your child to take the medicine from.
9. Replace the cap on the bottle of medicine.
10.Wash the syringe in warm soapy water and rinse
well. Hold the syringe under water and move the
plunger up and down several times to make sure
the inside of the barrel is clean. Store the syringe
in a hygienic place with the medicine.

Other side effects
Tell your doctor as soon as possible if your child
develop any of the following:

It may still be all right for you to be given
Clarithromycin Oral Suspension and your doctor
will be able to decide what is suitable for you or your
Taking Clarithromycin Oral Suspension with
food and drink
Clarithromycin Oral Suspension may be taken with
or without food.
Pregnancy and Breast-feeding
The safety of clarithromycin in pregnancy and
breast-feeding is not known and it is not usually
given during pregnancy or breastfeeding unless it is
considered very necessary. If your daughter is of
childbearing age you should speak to your doctor
before giving this product if pregnancy is known or

Clarithromycin oral suspension can cause a bitter
aftertaste. This can be avoided by drinking juice or
water soon after intake of the suspension.

Administering the dose of the suspension

Driving and using machines
Clarithromycin is known to cause dizziness, vertigo,
confusion, and disorientation. This may affect your
ability to drive and use machines. Make sure you
know how you react to clarithromycin before you
drive, use machines, or engage in any other activity
that could be dangerous if you are not alert.
Important information about some of the
ingredients of CLARITHROMYCIN 125mg/5ml
or 250mg/5ml ORAL SUSPENSION
This medicinal product contains sucrose. If you
have been told by your doctor that your child has an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
This medicinal product also contains aspartame,
which is a source of phenylalanine. It may be
harmful for people with phenylketonuria.
125mg/5ml or 250mg/5ml ORAL SUSPENSION
Always give this medicine as instructed by your
doctor. Do not give more than the doctor told you to.
If you have any questions, please ask your doctor or
pharmacist before you give clarithromycin to your
The dose of clarithromycin depends on your child's
weight in kilograms and is usually approximately 7.5
mg for each kilogram body weight given twice each
day, usually in the morning and in the evening. The
suspension can be given with or without food.
Clarithromycin suspension is usually given for 5 to
10 days. Your doctor will tell you how long to give
clarithromycin. Do not stop giving the suspension
before your doctor tells you to, even if your child
feels better, because the symptoms may return.
Clarithromycin 125mg/5ml or 250mg/5ml Oral
Suspension will be supplied with an oral dosing
spoon or pipette (syringe) to help you measure the
right amount of medicine to give to your child. Your
doctor or pharmacist will advise you whether it is
better to use the spoon or the pipette to give the right
dose. Make sure that you are clear about this before
you start to give the suspension.
The usual doses of Clarithromycin 125mg/5ml Oral
Suspension to be given either with the spoon or with
the pipette are shown below:

Administration of water or juice after medicine
If you have the impression that the effect of
clarithromycin suspension is too strong or too weak,
talk to your doctor or pharmacist.
If you forget to take or to give clarithromycin
suspension to your child at the right time, give it
as soon as you remember. However, if it is almost
time for the next dose, skip the missed dose and
give the next dose when it is due. Do not give a
double dose to make up for forgotten individual
If you take or give your child more
clarithromycin suspension than your doctor
has told you to, or if your child has accidentally
swallowed some extra medicine, consult your
doctor or go to the nearest hospital emergency
department immediately. Take this leaflet or bottle of
suspension with you so the doctor will know what
your child has taken.
Like all medicines, clarithromycin can have side
effects, although not everybody gets them.

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



The usual doses of Clarithromycin 250mg/5ml Oral
Suspension to be given either with the spoon or with
the pipette are shown below:

Approximate Dose in millilitres Number of 5ml
spoonfuls to
Age (years) of suspension
(twice daily)
using the

be given
twice daily


1 -2



12 - 19

3 -6



20 - 29

7 -9



30 - 40

10 - 12



If your child weighs less than 8 kilograms, your
doctor will calculate the dose for your child and this
will be written on the pharmacist's label.
In the treatment of severe infections, doses up to
500mg clarithromycin twice daily have been used.
Your doctor may prescribe a lower dose if your child
has mild to moderate kidney or liver problems.
Clarithromycin 125mg/5ml or 250mg/5ml Oral
Suspension is supplied with an oral dosing spoon or
pipette (syringe). If you use the pipette, please
follow instructions given below carefully. After use of
the spoon or syringe, wash in warm soapy water
and rinse well.
1. Remove the child-proof cap from the bottle by
pushing down on the cap while turning it
2. Take the plastic circular adaptor from the carton
and push this into the neck of the bottle. This
should fit tightly and once it is in place it should

Commonly reported (less than 1 in 10, but more
than 1 in 100):
- increased sweating (hyperhidrosis)
- widening of blood vessels
- sleeplessness (insomnia)
- headache
- change in the sense of smell,
- nausea (feeling sick), vomiting, stomach pain,
indigestion, diarrhoea
- altered taste (for example metallic or loose
stools bitter taste).
Uncommonly reported (less than 1 in 100, but more
than 1 in 1,000):
- belching
- spinning sensation
- inflammation of the food pipe (oesophagitis),
stomach (gastritis), in the mouth or the tongue
- mouth ulcers and cold sores
- constipation, dry mouth, winds, abdominal
- pain in the rectum
- nausea, fever, feeling of weakness, chest pain,
chills, tiredness, pain in joints and muscle
- raised blood urea nitrogen or creatinine (waste
- decreased appetite (anorexia)
- anxiety, nervousness, dizziness, screaming
- generally feeling unwell
- hearing impaired, tinnitus (ringing in the ears)
- infection of vagina
- thrush (fungal infection)
- nose bleed.
Not known (cannot be estimated from available
- abnormal urine colour
- generally feeling unwell
- tongue discoloration
- tooth discoloration
- pain or weakness in muscles (myopathy)
- loss of taste functions of the tongue (ageusia)
- inability to perceive smells
- depression, hallucinations, psychosis
(abnormal thoughts), disorientation (not
knowing where you are), depersonalization (out
of body feeling), bad dreams, confusion.
In case of injectable clarithromycin, pain and
inflammation at the site of injection has also been

Very serious side effects

If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

If any of the following happen, stop using
clarithromycin suspension and tell your childs
doctor immediately or go to the casualty
department at your nearest hospital:

125mg/5ml or 250mg/5ml ORAL SUSPENSION

All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your
doctor straight away if your child gets
- any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body)
- rare skin condition with severe blisters and
bleeding in the lips, eyes, mouth, nose and genitals
- red raised skin rash, bullae on the skin.
These side effects are rare but serious. Your child
may need medical attention.

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

- bacterial infections of the skin (erysipelas,
- liver failure (particularly in patients with liver
disease or patients taking other medicine that
may be harmful for the liver), jaundice (yellowing
of the skin or eyes)
- changes in heartbeat rhythm (torsade de points)
- increased heart rate (tachycardia)
- inflammation of the pancreas (combined with
severe pain in the upper abdominal region
radiating to the back, along with nausea and
- inflammation of kidneys (combined with blood in
the urine, fever, and pain in the sides),
- severely reduced kidney function (renal failure)
- hypoglycaemia (abnormally low blood sugar
indicated by feeling hungry, sweating, dizziness,
heart palpitation) particularly after taking antidiabetic medicine
- deafness
- convulsions (fits)
- abnormally low counts of blood platelets (which
may cause bruising of the skin or increased
tendency to bleed)
- bleeding (haemorrhage)
- long bleeding and blood clotting time
- diarrhoea (see also 'Take special care with
Clarithromycin Oral Suspension)
- abnormal muscle breakdown, which can lead to
kidney problems (rhabdomyolysis).

Serious side effects
Tell your doctor immediately or go to the
casualty department at your nearest hospital if
you notice any of the following:
Commonly reported (less than 1 in 10, but more
than 1 in 100):
- abnormal liver test results
- rash.
Uncommonly reported (less than 1 in 100, but more
than 1 in 1,000):
- hepatitis (inflammation of the liver), cholestasis
(bile disorder)
- hot, tender and red skin, sometimes with fever
and chills (cellulitis)
- mild to severe nausea, vomiting, cramps,
diarrhoea. These symptoms may be due to
inflammation of the stomach and intestines,
usually caused by a virus
- frequent infections such as fever, severe chills,
sore throat or mouth ulcers. These symptoms
may be due to low count of white blood cells
- increase in some white blood cells
- increase platelet counts (thrombocythemia)
- loss of consciousnees; uncontrollable twitching,
jerking or writhing movements; drowsiness;
shaking or tremors
- heart attack, dangerously fast heart beat, ECG
changes, extra heart beats, palpitations
- breathlessness, wheezing, a cough sometimes
brought on by exercise, and a feeling of
tightness in the chest (asthma)
- blood clot in the lungs which causes chest pain
and breathlessness
- changed blood levels of albumin, globuline and
diverse enzymes (alkaline phosphatase, lactate
Not known (cannot be estimated from available

Do not store above 25°C. Do not refrigerate or
freeze. Keep the bottle tightly closed.
Keep clarithromycin suspension out of the reach
and sight of children.
Do not give after the expiry date on the labelling.
Discard unused portion after 14 days or return to
your pharmacist, who will dispose of it.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
The active substance is clarithromycin. Other
ingredients are microcrystalline cellulose,
hypromellose, hydroxypropyl cellulose,
croscarmellose sodium, alginic acid, methacrylic
acid-ethyl acrylate copolymer (1:1) dispersion 30%,
macrogol 1500, talc, carbomer (Carbopol 974 P),
colloidal anhydrous silica, sucrose, aspartame
(E951), xanthan gum, monosodium citrate, sodium
benzoate (E211), titanium dioxide(E171), sodium
chloride, Peppermint and Tutti Frutti flavours.
Clarithromycin 125mg/5ml or 250mg/5ml Oral
Suspension is white to off-white granular powder
forming a white to off-white suspension on
constitution with water. The resulting suspension
has a sweet taste and fruity flavour.
The suspension is available in bottles of 50, 60, 70,
100 and 140 ml. Not all the pack sizes may be
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
United Kingdom
Ranbaxy Ireland Limited,
Spafield, Cork Road,
Cashel, Co. Tipperary,
Republic of Ireland
This leaflet was last revised in July 2012.

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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.