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CLARITHROMYCIN 250MG/5ML ORAL SUSPENSION

Active substance(s): CLARITHROMYCIN

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What is in this leaflet
1. What Clarithromycin Oral Suspension is and
what it is used for
2. What you need to know before you give
Clarithromycin Oral Suspension
3. How to give Clarithromycin Oral Suspension
4. Possible side effects
5. How to store Clarithromycin Oral Suspension
6. Contents of the pack and other information
1. What Clarithromycin Oral Suspension is and
what it is used for
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 [particularly inflammation of middle ear
(otitis media)] and infections of the skin and the
layers of flesh just under the skin.
Clarithromycin Oral Suspension is used in children
6 months to 12 years old.
2. What you need to know before you give
Clarithromycin Oral Suspension
Do not give Clarithromycin Oral Suspension,if
your child:
- is allergic to clarithromycin,other macrolide
antibiotics such as erythromycin or azithromycin,
or any of the other ingredients of this medicine
(listedin section 6).
- has abnormally low levels of potassium or
magnesium in your blood (hypokalaemia or
hypomagnesaemia)
- has severe liver disorders combined with kidney
disorders
- has special cardiac arrhythmia (so-called QT
prolongation or torsade des pointe)
- is taking:
• ergotamine-like drugs (usually used for
migraine)
• medicines called terfenadine or astemizole (for
hay fever or allergies) or cisapride or pimozide
tablets as combining these drugs can
sometimes cause serious disturbances in heart
rhythm. Consult your doctor for advice on
alternative medicines.
• other medicines which are known to cause
serious disturbances in heart rhythm
• ticagrelor or ranolazine (for heart attack, chest
pain or angina)
• colchicine (usually taken for gout)
• lovastatin, simvastatin or atorvastatin
(treatments to lower cholesterol).
If any of the above applies to your child, consult your
doctor for advice on alternative medicines.
Warnings and precautions
Talk to your doctor or pharmacist before giving
Clarithromycin Oral Suspension, if your child:
• has a liver or kidney disorder
• is resistant to other antibiotics such as clindamycin, lincomycin
• has a heart disorder
• has hypomagnesaemia (low blood magnesium)
• is taking anticoagulants, e.g. warfarin (medicines to thin blood). Your child`s prothrombin
time should be monitored frequently.
• is taking medicines, which can impair hearing
e.g. aminoglycosides. Your doctor should check
your child`s ability to hear, if necessary.
• istaking medicines to lower blood sugar. Their
effect might be increased by clarithromycin.
• has pneumonia, as the causing bacteria
(Streptococcus pneumoniae) might be resistant
against clarithromycin.
• has pharyngitis and there is no hypersensitivity
or another contraindication to take penicillins.
If the bacteria are resistant against erythromycin A.
They might be resistant against clarithromycin, too.
If any of the above applies to your child, speak to
your doctor.
Stop giving Clarithromycin Oral Suspension and tell
your doctor, if your child:
• develops severe diarrhoea during or after
treatment with Clarithromycin Oral Suspension.
Medicines that prevent peristalsis (bowel
movement) such as antidiarrhoeal treatments
should be avoided.
• develops yellowing of skin (jaundice), skin
irritation, dark urine, tender abdomen, or loss of
appetite. These are signs that your child's liver
may not be working properly.
• develops another infection.
Other medicines and Clarithromycin Oral
Suspension
Tell your doctor or pharmacist if your child is
given,has recently been given or might be given any
other medicines.
Do not give Clarithromycin Oral Suspension to your
child and talk to your doctor, if your child if is
receiving any of the following:
- astemizole or terfenadine (for hay fever or
allergy)
- cisapride (for stomach disorders)
- pimozide (for mental disorders)
- ergotamine or dihydroergotamine (for migraine)
- ticagrelor or ranolazine (for heart attack, chest
pain or angina)
- colchicine (usually taken for gout)
- lovastatin, simvastatin or atorvastatin
(treatments to lower cholesterol [a type of fat] in
blood).
Also see section 'Do not give Clarithromycin Oral
Suspension, if your child'.
Your doctor may need to control blood levels or
effects, or adjust the dosage, or interrupt (for some
time) the treatment, if Clarithromycin Oral Suspension is used at the same time with medicines containing one of the substances listed below:
- digoxin (for heart failure)
- quinidine or disopyramide (for heartbeat disorders)
- midazolam (sedatives/sleeping pills)
- triazolam(sleeping pills)
- alprazolam (for anxiety)
- verapamil, diltiazem or amlodipine (medicine
against high blood pressure)

- tolterodine (medicine to treat urinary incontinence)
- St. John's Wort (herbal product used for depression)
- cyclosporin, tacrolimus or sirolimus (help prevent
rejection after a transplant)
- theophylline (used in patients with breathing
difficulties such as asthma)
- efavirenz, ritonavir, zidovudine, nevirapine,
atazanaviror saquinavir (anti-viral drugs used in
the treatment of HIV)
- rifampicin, rifabutin or rifapentine (antibiotics
used in the treatment of certain bacterial
infections)
- fluconazole, itraconazole (antifungal medicine)
- oral anticoagulants such as warfarin (blood
thinner). Your child`s prothrombin time should be
monitored frequently
- rosuvastatin (cholesterol-lowering drugs).Statins
can cause rhabdomyolosis (a condition which
causes the breakdown of muscle tissue which
can result in kidney damage).Signs of myopathy
(muscle pain or muscle weakness) should be
monitored.
- omeprazole (for treatment of indigestion and
gastric ulcers)
- phenytoin, carbamazepine, valproate or
phenobarbital (for epilepsy)
- insulin or other diabetes medicines, e.g.
repaglinide, nateglinide (used to lower blood
glucose levels)
- sildenafil, tadalafil and vardenafil (for impotence
in adult males or for use in high blood pressure in
the blood vessels of the lungs)
- cilostazol (for poor circulation)
- methylprednisolone (a corticosteroid)
- vinblastine (for treatment of cancer)
- aminoglycosides (a group of antibiotic to treat
certain bacteria for example gentamicin,
neomycin).
It may still be all right for your child to be given
Clarithromycin Oral Suspension and your doctor
will be able to decide what is suitable for your child.

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

Administering the dose of the suspension

Administration ofwater or juice after medicine

Clarithromycin Oral Suspension with food and
drink
Clarithromycin Oral Suspension may be taken with
or without food.

If you have the impression that the effect of
clarithromycin suspension is too strong or too weak,
talk to your doctor or pharmacist.

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. As clarithromycin may
be given to girls of childbearing age, you should
speak to your doctor before giving this medicine if
pregnancy is known or suspected.

If you give more Clarithromycin Oral
Suspension than you should
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. An
overdose of Clarithromycin Oral Suspension is
likely to cause vomiting and stomach pains.

Driving and using machines
Clarithromycin is known to cause dizziness, vertigo,
confusion, and disorientation. This may affect your
child's ability to drive and use machines. Make sure
you know how your child reacts to clarithromycin
before he/shedrives, uses machines, or engages in
any other activity that could be dangerous if he/she
is not alert.

If you forget to give Clarithromycin Oral
Suspension
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
doses.

Clarithromycin Oral Suspension contains
sucrose
If you have been told by your doctor that your child
has an intolerance to some sugars, contact your
doctor before giving this medicinal product.
Clarithromycin Oral Suspension also contains
aspartame
Aspartame is a source of phenylalanine. It may be
harmful for people with phenylketonuria.
3. How to give Clarithromycin Oral Suspension
Always give this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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
child.
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.
Clarithromycin 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:
Weight
(kg)

Approximate
Age (years)

Dose in millilitres of
Number of 5ml
suspension (twice
spoonfuls to be
daily) using the ipette given twice daily

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

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

2.5
5
7.5
10

½
1

2

The usual doses of Clarithromycin 250mg/5ml Oral
Suspension to be given either with the spoon or with
the pipette are shown below:
Weight
(kg)
8 - 11
12 - 19
20 - 29
30 - 40

Approximate
Age
(years)
1-2
3-6
7-9
10 - 12

Dose in millilitres of
suspension (twice daily)
using the pipette
1.25
2.5
3.75
5.0

Number of 5ml
spoonfuls to be
given twice daily
¼
½
¾
1

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 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
anticlockwise.
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
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.

If you stop giving Clarithromycin Oral
Suspension
Do not stop giving the suspension before your
doctor tells you to, even if your child feels better,
because the symptoms may return.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
If any of the following happens, stop using
Clarithromycin Suspension and tell your child's
doctor immediately or go to the casualty department
at your nearest hospital:
Uncommonly reported (may affect up to 1 in 100
people):
- any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching
Frequency not known (frequency cannot be
estimated from the available data):
- severe or prolonged diarrhoea, which may have
blood or mucus in it. Diarrhoea may occur after
the treatment with clarithromycin (see also
Warnings and precautions).
- severe form of skin rash with flushing, fever,
blisters or ulcers (Stevens Johnson syndrome),
severe rash involving reddening, peeling and
swelling of the skin that resembles severe burns
(toxic epidermal necrolysis)
- rash fever, abnormal blood count and
inflammation of internal organs. These may be
symptoms of drug reaction with eosinophilia and
systemic symptoms (DRESS).
- jaundice (yellowing of the skin or eyes), skin
irritation, pale stools, dark urine, tender abdomen
or loss of appetite. These may be signs that your
child's liver may not be working properly.
Tell your doctor immediately or go to the casualty
department at your nearest hospital if any of the
following happens:
Commonly reported (may affect up to 1 in 10
people):
- abnormal liver test results
Uncommonly reported (may affect up to 1 in 100
people):
- heart attack, dangerously fast heartbeat, ECG
changes, extra heart beats, palpitations
- blood clot in the lungs which causes chest pain
and breathlessness
Frequency not known (frequency cannot be
estimated from the available data):
- 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
vomiting)
- inflammation of kidneys (combined with blood in
the urine, fever, and pain in the sides)
- hypoglycaemia (abnormally low blood sugar
indicated by feeling hungry, sweating, dizziness,
heart palpitation) particularly after taking antidiabetic medicinemuscle weakness, tenderness
or pain and particularly, if at the same time, your
child feels unwell or has a high temperature it
may be caused by an abnormal muscle
breakdown, which can lead to kidney problems
(rhabdomyolysis).
These side effects are serious. Your child may need
medical attention.
Other side effects
Tell your doctor as soon as possible if your child
develops any of the following:
Commonly reported (may affect up to 1 in 10 people):
- rash
- increased sweating (hyperhidrosis)

5131371, MARKET - UK-R, SIZE: 140 x 580 MM (Folded 70x48), SPIL-DWS: 21.07.16vs/US1, OLD CODE : 5130435, ITF CODE: 05131371

-

widening of blood vessels
sleeplessness (insomnia)
headache
feeling sick(nausea), vomiting, stomach pain,
indigestion, diarrhoea
- change in the sense of taste, altered taste (for
example metallic or bitter taste)
Uncommonly reported (may affect up to 1 in 100
people):
- inflammation of the skin with blisters (dermatitis
bullous), itching of the skin, skin rash and hives
(urticaria), rash characterized by a flat, red area
on the skin that is covered with small confluent
bumps (rash maculo-papular)
- 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 count (thrombocythemia)
- raised blood urea nitrogen or creatinine (waste
products)
- changed blood levels of albumin, globulin, and
diverse enzymes (alkaline phosphatase, lactate
dehydrogenase)
- loss of consciousness; uncontrollable twitching,
jerking or writhing movements; drowsiness,
shaking or tremors
- breathlessness, wheezing, a cough sometimes
brought on by exercise, and a feeling of tightness
in the chest (asthma)spinning sensation, hearing
impaired, ringing in the ears (tinnitus)
- inflammation of the food pipe (oesophagitis),
stomach (gastritis), in the mouth or the tongue
- a burning sensation in the chest rising up to the
throat, also known as heartburn
- constipation, dry mouth, winds, abdominal
distension,belching
- pain in the rectum
- fever, feeling of weakness, chest pain, chills,
tiredness, muscle pain, muscle stiffness, muscle
spasm decreased appetite, loss of appetite
(anorexia)
- anxiety, nervousness, dizziness, screaming
- generally feeling unwell
- infection of vagina
- thrush (fungal infection)
- nose bleed
Frequency not known (frequency cannot be
estimated from the available data):
- abnormal urine colour
- bacterial infections of the skin (erysipelas)
- severely reduced kidney function (renal failure)
- deafness
- convulsions (fits)
- abnormally low counts of blood platelets (which
may cause bruising of the skin or increased
tendency to bleed)
- bleeding (haemorrhage)
- numbness and tingling in arms and legs
(paraesthesia) tooth discoloration
- pain or weakness in muscles (myopathy)
- loss of taste functions of the tongue (ageusia),
tongue discoloration
- inability to perceive smells, change in the sense
of smell
- acne
- depression, hallucinations, abnormal thoughts
(psychosis), not knowing where you are
(disorientation), out of body feeling
(depersonalization), bad dreams, confusion
- long bleeding and blood clotting time
Reporting of side effects
If your child gets any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.
5. How to store Clarithromycin Oral Suspension
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the label or carton. The expiry date
refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or
freeze. Keep the bottle tightly closed.
Discard unused portion after 14 days or return to
your pharmacist, who will dispose of it.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Clarithromycin Oral Suspension contains
Each 5ml of the constituted suspension contains
clarithromycin 125mg or 250mg.
The 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 TuttiFrutti flavours.
What Clarithromycin Oral Suspension looks
like and contents of the pack
Clarithromycin 125mg/5ml or 250mg/5ml Oral
Suspension iswhite 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
available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29.,
Tiszavasvári 4440
Hungary
Terapia S.A.
Str. Fabricii, 124,
Cluj- Napoca 400632
Romania
This leaflet was last revised in July 2016.

COLOUR : 286-U / BLACK-U

FONT SIZE : 9pt.

Read all of this leaflet carefully before you start
giving this medicine to your child because it
contains important information for your child.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for your child
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
your child.
• 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.

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
adaptor.
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.

5131371

Package leaflet: Information for the user

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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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