Patient Leaflet Updated 06-Jun-2022 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Clarithromycin 125mg/5ml & 250mg/5ml Oral Suspension
Clarithromycin 125 mg/5 ml Oral Suspension
Clarithromycin 250 mg/5 ml Oral Suspension
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
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.
If any of the above applies to your child, consult your doctor for advice on alternative medicines.
Talk to your doctor or pharmacist before giving Clarithromycin Oral Suspension, if your child:
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:
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 is receiving any of the following:
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:
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.
Please tell your doctor if your child is taking oral contraceptive pills and diarrhoea or vomiting occurs, as they may need to take extra contraceptive precautions such as using a condom.
Clarithromycin Oral Suspension may be taken with or without food.
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.
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/she drives, uses machines, or engages in any other activity that could be dangerous if he/she is not alert.
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.
Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria.
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 125 mg/5 ml Oral Suspension to be given either with the spoon or with the pipette are shown below:
Children weighing 8 – 11 kg (approximate age 1 – 2 years) to be given:
Children weighing 12 – 19 kg (approximate age 3 – 6 years) to be given:
Children weighing 20 – 29 kg (approximate age 7 – 9 years) to be given:
Children weighing 30 – 40 kg (approximate age 10 – 12 years) to be given:
The usual doses of Clarithromycin 250 mg/5 ml Oral Suspension to be given either with the spoon or with the pipette are shown below:
Children weighing 8 – 11 kg (approximate age 1 – 2 years) to be given:
Children weighing 12 – 19 kg (approximate age 3 – 6 years) to be given:
Children weighing 20 – 29 kg (approximate age 7 – 9 years) to be given:
Children weighing 30 – 40 kg (approximate age 10 – 12 years) to be given:
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 500 mg 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.
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 the 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.
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 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 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.
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 a forgotten dose.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happens, stop using Clarithromycin Oral 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):
Frequency not known (frequency cannot be estimated from the available data):
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):
Uncommonly reported (may affect up to 1 in 100 people):
Frequency not known (frequency cannot be estimated from the available data):
These side effects are serious. Your child may need medical attention.
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):
Uncommonly reported (may affect up to 1 in 100 people):
Frequency 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 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.
Each 5 ml of the constituted suspension contains clarithromycin 125 mg or 250 mg.
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 Tutti Frutti flavours.
Clarithromycin 125 mg/5 ml or 250 mg/5 ml 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 available.
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This leaflet was last revised in March 2022.
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