Do not give Clarithromycin to your child,

• if your child is allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6).
• if your child is taking medicines called ergot alkaloid tablets (e.g. ergotamine or dihydroergotamine) or using ergotamine inhalers for migraine.
• if your child is taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride or domperidone (for stomach disorders) or pimozide (for mental health problems) as combining these medicines can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.
• if your child is taking other medicines which are known to cause serious disturbances in heart rhythm.
• if your child is 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).
• if your child is taking oral midazolam (sedatives).
• if your child has abnormally low levels of potassium or magnesium in their blood (hypokalaemia or hypomagnesaemia).
• if your child has severe liver disease with kidney disease.
• if your child or someone in their family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.
• if your child is taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).
• if your child is taking colchicine (usually taken for gout)
• if your child is taking a medicine containing lomitapide.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin:

• if your child has heart problems (e.g. heart disease, heart failure, an unusually slow heart rate).
• if your child has any liver or kidney problems
• if your child has, or is prone to, fungal infections (e.g. thrush)

Other medicines and 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:

• digoxin, quinidine or disopyramide (for heart problems)
• warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (used to thin your 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 rhabdomyolysis (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)
• gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam or intravenous or oromucosal midazolam (sedatives)
• cilostazol (for poor circulation)
• methylprednisolone (a corticosteroid)
• ibrutinib or vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral medicines used in the treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial or fungal 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)
• quetiapine or other antipsychotic medicines
• other macrolide medicines
• lincomycin and clindamycin (lincosamides – a type of antibiotic)
• hydroxychloroquine or chloroquine (for autoimmune diseases)

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Clarithromycin contains sucrose

5 ml suspension contain 3194 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.

Clarithromycin contains aspartame

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.

Clarithromycin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially “sodium-free”.

Clarithromycin contains sodium benzoate

This medicine contains 10 mg sodium benzoate in each 5ml suspension which is equivalent to 2 mg/ml.