PATIENT INFORMATION LEAFLET

ON

KLARICID PAEDIATRIC SUSPENSION

(Clarithromycin)

Please read this leaflet carefully before you give this medicine to your child. It gives a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

 

What's in your child's medicine?

The name of your child's medicine is Klaricid Paediatric Suspension. Each 5 ml spoonful or individual sachet contains 125 mg clarithromycin as the active ingredient.

Other ingredients include: sucrose, carbopol 974P, povidone K90, hydroxypropylmethylcellulose phthalate, castor oil, silicon dioxide, xanthan gum, fruit punch, potassium sorbate, citric acid, maltodextrin, titanium dioxide and water.

Klaricid Paediatric Suspension is an off-white colour and is available in bottles of 70 and 100 ml and in single dose sachets.

Klaricid is an antibiotic belonging to a group called macrolides. Antibiotics stop the growth of bacteria (bugs) which cause infections. Its use is described below.

 

Manufacturer's Name and Address

Product Licence Holder and Manufacturer: Abbott Laboratories Ltd., Oueenborough, Kent, ME11 5EL

 

What is Klaricid Paediatric Suspension used for?

It is used to treat infections such as:

  1. Throat and sinus infections
  2. Chest infections such as bronchitis and pneumonia
  3. Skin and tissue infections
  4. Ear infections particularly inflammation of the middle ear (acute otitis media)

 

Before giving Klaricid Paediatric Suspension

Do not give Klaricid Paediatric Suspension to your child if you have been told that he or she is allergic to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin.

Do not give your child ergotamine or dihydroergotamine tablets e.g. Cafergot or let them use ergotamine inhalers for migraine while taking Klaricid Paediatric Suspension.

Do not give your child terfenadine or astemizole tablets for hay fever or allergies while taking Klaricid, as these drugs can interact. Consult your doctor or pharmacist who can advise you on alternative medicines for allergy which you can take instead.

If your child has any liver or kidney problems speak to your doctor before giving them this medicine.

If your child develops severe or prolonged diarrhoea during or after receiving Klaricid Paediatric Suspension tell your doctor immediately.

Tell your doctor if your child is taking any of the following drugs: digoxin (heart drug), warfarin (blood thinner), ergotamine or dihydroergotamine (for migraine), carbamazepine (drug for epilepsy). terfenadine or astemizole (for allergies and hay fever) or theophylline (helps breathing).

The safety of Klaricid Paediatric Suspension in pregnancy and breast feeding is not known. As Klaricid Paediatric Suspension may be given to girls of child-bearing age you should speak to your doctor before giving this product if pregnancy is known or suspected.

 

Giving Klaricid Paediatric Suspension

The usual doses of Klaricid Paediatric Suspension are given overleaf:

Dosage based on body weight

     

Number of 5 ml

Weight

Age

Dosage in mls

spoonfuls or sachets

(kg)

(years)

(twice daily)

(twice daily)

8-11

1-2

2.5

1/2

12-19

3-6

5

1

20-29

7-9

7.5

1 1/2

30-40

10-12

10

2

 

Children who weigh less than 8 kg should be given a dose of 0.3 ml/kg twice daily. Check with your doctor or pharmacist if you are not sure how the dose has been worked out for your child. Doctors may sometimes prescribe higher or lower doses than these. If this applies to your child then you should discuss it with your doctor or pharmacist.

Klaricid Paediatric Suspension 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 most convenient. You should shake the bottle well before using and close it tightly afterwards. The sachet should be reconstituted by cutting along the dotted line, emptying the contents of the sachet into a glass and half filling the sachet with cold water. Add to the glass and stir thoroughly before taking. Klaricid Paediatric Suspension is usually given for 5 to 10 days.

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 in one day than your doctor tells you to.

Do not stop giving this medicine because your child feels better. It is important to give the medicine for as long as the doctor has told you to, otherwise the problem may come back.

If you accidentally give your child more Klaricid Paediatric Suspension in one day than your doctor has told you to, or if your child accidentally swallows some extra medicine, seek medical advice urgently. An overdose of Klaricid Paediatric Suspension is likely to cause vomiting and stomach pains.

 

What problems can Klaricid Paediatric Suspension cause?

Klaricid Paediatric Suspension can sometimes cause stomach problems such as feeling sick, vomiting, stomach pain or diarrhoea. If your child develops severe or prolonged diarrhoea during or after receiving Klaricid Paediatric Suspension consult your doctor immediately. Headache can also occur rarely.

Your child may complain of having a funny taste in their mouth whilst taking Klaricid Paediatric Suspension. Sometimes the tongue darkens in colour. However these are only temporary effects and you should not stop giving the medicine because of them. There have also been reports of Klaricid Paediatric Suspension causing a swollen tongue or a sore mouth.

If your child has a blood test whilst taking Klaricid Paediatric Suspension he/she may be found to have raised liver enzymes. These levels will soon return to normal and your child is unlikely to show any symptoms. However, Klaricid Paediatric Suspension can rarely cause jaundice and other liver disorders, so if your child is generally unwell or develops yellow skin and/or eyes, consult your doctor immediately.

Allergic reactions including rashes have been reported with Klaricid Paediatric Suspension. In very rare cases, difficulty of breathing, fainting and swelling of the face and throat can occur which may need emergency treatment. Allergic rashes may range in severity from mild itchy skin eruptions to a rarer, more serious condition which may cause ulceration of the mouth, lips and skin.

There have also been a few reports of dizziness, difficulty sleeping, hallucinations (seeing things), bad dreams, confusion and panicking. These effects are short-lived and soon disappear. Very rarely, mood and behavioural disorders have been reported, which in severe cases have required hospitalisation. Consult your doctor if your child develops any of these problems or has any other unexpected or unusual symptoms.

 

How should Klaricid Paediatric Suspension be stored?

Do not use this medicine after its use-by (exp) date which is printed on the label or on the sachet. If the suspension is out of date, return it to your pharmacist and, if necessary, get a new prescription from your doctor.

Keep this medicine in a safe place at room temperature (15-30°C), where children cannot reach it. Klaricid Paediatric Suspension must be used within 14 days of you receiving it from the pharmacist. Single dose sachets should not be used after their expiry date.

If your doctor decides to stop your child's treatment with Klaricid Paediatric Suspension, return any remaining suspension or sachets to a pharmacist.

REMEMBER this medicine is for your child. NEVER give it to someone else. The medicine may harm them, even if their symptoms are the same.

If you have any questions about your child's treatment which are not answered by this leaflet, ask your doctor or pharmacist.

This leaflet applies only to Klaricid Paediatric Suspension and was prepared in October 1995.