The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0141 .
Clarithromycin 250 mg/5 ml granules for oral suspension
Clarithromycin 250 mg/5 ml granules for oral suspension
1. What Clarithromycin is and what it is used for
2. What you need to know before you take Clarithromycin
3. How to take Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other information
Clarithromycin contains the active substance clarithromycin.
Clarithromycin belongs to a group of medicines called macrolide antibiotics. It stops the growth of certain bacteria.
Clarithromycin is used to treat:
Clarithromycin is used in children 6 months to 12 years old.
Talk to your doctor or pharmacist before taking Clarithromycin:
Your child should not take Clarithromycin if they are taking any of the medicines listed in the section above “Do not give Clarithromycin to your child”.
Tell your doctor or pharmacist if your child is taking, have recently taken or might take any of the following medicines as their dose may need to be changed or they may need to have regular tests performed:
Please tell your doctor if your daughter (of childbearing age) is taking oral contraceptive pills and diarrhoea or vomiting occurs, as they may need to take extra contraceptive precautions such as using a condom.
The safety of clarithromycin in pregnancy and breast-feeding is not known. As clarithromycin may be given to girls of childbearing age you should talk to your doctor before giving this medicine if pregnancy is known or suspected.
There are no data available on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.
5 ml suspension contains 2889 mg sucrose. This should be taken into account in patients with diabetes mellitus.
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.
This medicine contains 1 mg aspartame in each 5 ml suspension which is equivalent to 0.2 mg/ml.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially “sodium-free”.
This medicine contains 10 mg sodium benzoate in each 5ml suspension which is equivalent to 2 mg/ml.
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dosage is based on body weight.
The recommended doses of Clarithromycin 250 mg/5 ml granules for oral suspension are given below:
Children who weigh less than 8 kg should be given a dose of 0.15 ml/kg twice a day. Doctors may sometimes prescribe higher or lower doses than these.
Clarithromycin 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.
Method of administration
For oral use after reconstitution. Instructions for reconstitution, see below.
Shake the suspension well before each use and replace the cap firmly after use.
Duration of treatment
Clarithromycin is usually given for 5 to 10 days.
Instructions for Reconstitution
Step-A Remove bottle from the box.
Step-B Invert the bottle and shake it to loosen the powder until no powder is adhered to the bottom. Check them by holding the bottle upside down against light. Open the cap as instructed below, open the seal by lifting the tab and then peel off (See Figure 2).
Step-C Slowly add water up to ring mark. If necessary, hold the bottle against light in order to be able to recognize the correct filling level better. Close the bottle. Invert and shake well for about 1 minute until no powder is adhered to the bottom (See Figure 3). Check them by holding the bottle upside down against light. Leave the suspension to settle and if it is necessary to add more water as to make it up to the ring mark, follow step D.
Step-D If necessary, add water again to make up level up to ring mark. If necessary, hold the bottle against light in order to be able to recognize the correct filling level better. Close the bottle. Invert and shake well until no powder is adhered to the bottom (See Figure 4). Check them by holding the bottle upside down against light.
Clarithromycin is supplied with an oral syringe with an adapter for the bottle to help you measure the right amount of medicine to give to your child. Please follow instructions given below carefully.
1. To open the bottle 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 oral 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 oral syringe into the hole in the adaptor.
5. Turn the bottle upside down. Keep hold of the bottle in one hand and the oral syringe in the other.
6. Hold the barrel of the oral 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 oral syringe from the adaptor.
8. Put the oral syringe tip into your child’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 oral syringe onto a spoon for your child to take the medicine from.
9. Replace the cap on the bottle of medicine.
10. Wash the oral syringe in warm soapy water and rinse well. Hold the oral syringe under water and move the plunger up and down several times to make sure the inside of the barrel is clean. Store the oral syringe in a hygienic place with the medicine.
Clarithromycin can cause a bitter after-taste. This can be avoided by eating some food or drinking juice or water soon after intake of the suspension.
Alternatively, the following amounts of water for the respective pack sizes can be added to the bottle once:
Pack Volume of water to be added
50 ml Bottle 27 ml
60 ml Bottle 33 ml
70 ml Bottle 38 ml
100 ml Bottle 54 ml
140 ml Bottle 76 ml
Close the bottle and shake vigorously.
If you accidently give your child more Clarithromycin 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 Clarithromycin is likely to cause vomiting and stomach pains.
If you forget to give your child a dose of medicine, give one as soon as you remember. Do not give more Clarithromycin 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
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 bottle or carton. The expiry date refers to the last day of that month.
Store below 30°C. Do not refrigerate or freeze the reconstituted suspension.
Discard the unused portion after 14 days.
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.
The active substance is clarithromycin.
Each 5 ml of the reconstituted suspension contains 250 mg clarithromycin.
The other ingredients are methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent, macrogol 1500, talc, carbomer, silica colloidal anhydrous, sucrose, aspartame (E951), xanthan gum (E415), monosodium citrate, sodium benzoate (E211), titanium dioxide (E171), peppermint flavour (containing modified food starch) and flavour tutti frutti (containing waxy maize maltodextrin, nature-identical flavouring substances, propylene glycol (E1520), modified waxy maize starch (E1450), and artificial flavouring substances).
Granules for oral suspension
Clarithromycin is a white to off-white granular powder.
The following pack sizes are available:
1 bottle with 34.72 - 38.37 g granules for preparation of 50 ml oral suspension or
1 bottle with 41.66 - 46.04 g granules for preparation of 60 ml oral suspension or
1 bottle with 48.61 - 53.72 g granules for preparation of 70 ml oral suspension or
1 bottle with 69.44 - 76.75 g granules for preparation of 100 ml oral suspension or
1 bottle with 97.21 - 107.44 g granules for preparation of 140 ml oral suspension.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany CLARITHROMYCIN BASICS 250 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen
Italy Claritromicina SUN
Poland Klabax EC
Romania Klabax 250mg/5ml granule pentru suspensie orală
United Kingdom Clarithromycin 250 mg/5ml granules for oral suspension
This leaflet was last revised in July 2022.