KLARICID PAEDIATRIC SUSPENSION 250MG/5ML

Active substance: CLARITHROMYCIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Clarithromycin
SOLID 1000556092

PATIENT INFORMATION LEAFLET
ON

PAEDIATRIC SUSPENSION
250MG/5ML

1000006640

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 250mg/5ml is and what it is
used for
2. What you need to know before giving Klaricid Paediatric
Suspension 250mg/5ml
3. How to give Klaricid Paediatric Suspension 250mg/5ml
4. Possible side effects
5. How to store Klaricid Paediatric Suspension 250mg/5ml
6. Content of the pack and other information
1. What Klaricid Paediatric Suspension 250mg/5ml is and
what it is used for
Each 5ml spoonful of Klaricid Paediatric Suspension 250mg/5ml
contains 250mg 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.
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 250mg/5ml is used in children 6
months to 12 years old.

1000006640_d7

This information is confidential

2. What you need to know before giving Klaricid Paediatric
Suspension 250mg/5ml
Do not give Klaricid Paediatric Suspension
250mg/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 250mg/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 250mg/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 250mg/5ml contains
sucrose.
Other medicines and Klaricid paediatric Suspension
250mg/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))
• St John’s Wort (a herbal product used to treat depression)
• aminoglycosides (a group of antibiotic to treat certain bacteria
for example gentamicin, neomycin)
Klaricid does not interact with oral contraceptives.
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 childbearing age you should speak to your doctor before giving this
medicine if pregnancy is known or suspected.

FRONT

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 250mg/5ml
Always give Klaricid Paediatric Suspension 250mg/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 250mg/5ml are
given below:
Dosage based on body weight
Weight (kg)
Age (years)
Dosage in mls (twice daily)
8-11
1-2
1.25
12-19
3-6
2.5
20-29
7-9
3.75
30-40
10-12
5
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. Turn the bottle back the right way up.

Clarithromycin
SOLID 1000556092

v1.0

8. Keeping hold of the barrel, remove the whole pipette from the
bottle.
9. 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.
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.
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.
If you stop giving Klaricid Paediatric Suspension 250mg/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
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).
• 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 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
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 250mg/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.
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.
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 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. 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.

1000006640

1000006640_d7

This information is confidential

BACK

Expand view ⇕

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.

Hide
(web4)