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Clarithromycin 125mg/5ml Oral Suspension

Generic Name: Clarithromycin

Information For The User

What Clarithromycin 125mg/5ml Oral Suspension Is And What It Is Used For

Clarithromycin 125mg/5ml oral suspension contains clarithromycin. Clarithromycin belongs to 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 and infections of the skin and the layers of flesh just under the skin.

Clarithromycin 125mg/5ml oral Suspension is used in children 6 months to 12 years old.

Before You Give Clarithromycin 125mg/5ml Oral Suspension

Do not give Clarithromycin 125mg/5ml Oral Suspension to your child:

  • If your child has ever had an allergic reaction to clarithromycin or to any other macrolide antibiotic (such as erythromycin or azithromycin) or to any of the other ingredients in the suspension listed at the end of the leaflet (an allergic reaction may include rash, itching, swelling of face, lips, or hands/feet or breathing difficulties).
  • Is your child taking ergot derivatives such as ergotamine tablets or inhalers (used for treatment of migraine).
  • Is your child taking terfenadine or astemizole (used for treatment of allergies), cisapride (used for treatment of digestive problems) or pimozide (used for treatment of mental illnesses).Clarithromycin must not be taken with any of these medicines because there is a risk that very serious disturbances in the rhythm of the heart could occur.
  • If your child has phenylketonuria. Clarithromycin suspension contains aspartame, which is a source of phenylalanine. This means that the suspension is not recommended for children who have phenylketonuria.
  • If your child has a serious problem with kidney(s)/liver.
  • If your child has or has ever had problems with his/her heart rhythm.
  • If your child has low blood potassium levels. Excessive diarrhoea can cause low potassium levels in the blood.

Take special care with Clarithromycin 125mg/5ml Oral Suspension:

  • If your child has or ever had problems with their liver or their kidneys.
  • If your child is allergic to lincosamide (e.g. lincomycin or clindamycin) antibacterial Agents.
  • If your child is suffering from a condition known as myasthenia gravis.

Taking other medicines

Please inform your doctor or pharmacist if your child is taking, or has recently taken, any other medicines, including any that were obtained without a prescription.

Care is needed if your child is taking:

  • Warfarin (a medicine that is used to stop blood clotting)
  • Theophylline (an anti-asthma medicine)
  • Ciclosporin, tacrolimus or sirolimus (used following organ transplants)
  • Digoxin (used for treatment of heart failure)
  • Disopyramide (used for treatment of certain abnormal heart rhythms)
  • Midazolam, triazolam or alprazolam (used as tranquilizers)
  • Phenytoin, carbamazepine or Phenobarbital (used for treating epilepsy)
  • St. John’s Wort (a herb used for medicinal purposes, including treatment of depression)
  • Insulin and antidiabetic medicinal products (used for treatment of diabetes)
  • Rifampicin or Rifabutin (an antibiotic used for treating certain infections)
  • Lovastatin or simvastatin (used for lowering blood cholesterol levels)
  • Zidovudine, Ritonavir or Efavirenz (used for treating Human Immunodeficiency Virus [HIV] infections)

Giving Clarithromycin 125mg/5ml Oral Suspension with food and drink

Clarithromycin 125mg/5ml Oral Suspension may be given with or without food Pregnancy and breast-feeding.

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.

If your daughter is of child-bearing age you should speak to your doctor before giving this product if pregnancy is known or suspected.

Ask the doctor or pharmacist before giving any medicine.

Driving and using machines

Clarithromycin is known to cause dizziness, vertigo, confusion, and disorientation. This may affect your 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.

Important information about some of the ingredients of Clarithromycin 125mg/5ml oral Suspension.

Clarithromycin suspension contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

If you have been told by the doctor that your child has an intolerance to some sugars, contact the doctor before giving this medicinal product This product contains 6 g of sucrose per 10ml dose. This should be taken into account in patients with diabetes mellitus.

How Clarithromycin 125mg/5ml Oral Suspension Is Given

Always take Clarithromycin 125mg/5ml oral suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

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 125mg/5ml 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 125mg/5ml Oral Suspension to be given either with the spoon or with the pipette are shown below:

Weight (kg) Approximate Age (years) Dose in millilitres of suspension (twice daily) using the pipette Number of 5ml spoonfuls to be given twice daily
8-11 1-2 2.5 1/2
12-19 3-6 5 1
20-29 7-9 7.5 1 ½
30-40 10-12 10 2

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 500mg clarithromycin twice daily have been used.

Your doctor may prescribe a lower dose if your child has mild to moderate kidney or liver problems.

Method and/or route(s) of administration

Clarithromycin 125mg/5ml 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 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.

Duration of treatment

Clarithromycin suspension is usually given for 5 to 10 days. Your doctor will tell you how long to give clarithromycin. 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 the impression that the effect of clarithromycin suspension is too strong or too weak, talk to your doctor or pharmacist.

If you give your child more clarithromycin suspension than your doctor has told you to, or 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.

If you forget to give clarithromycin suspension to your child at the right time, 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 forgotten individual doses.

If you have any further questions on the use of this product, ask the doctor or pharmacist.

Possible Side Effects of Clarithromycin

Like all medicines, clarithromycin can cause side effects, although not everybody gets them.

If any of the following happen, stop giving clarithromycin suspension and tell your doctor immediately or go to the emergency department at your nearest hospital. Your child may be having a serious allergic reaction to clarithromycin and may need urgent medical attention.

  • Rashes that may be lumpy, hives, itching, tightness in the chest, difficulty breathing and shortness of breath, fever or swelling of face, lips, hands / feet, fainting.
  • Severe skin rashes, with or without blisters, sores or ulcers.

You should also stop giving clarithromycin suspension and tell your doctor immediately if your child develops:

  • Severe diarrhoea (which may contain blood or mucous) along with stomach cramps
  • Any irregular or fast heart beat
  • Fits
  • Jaundice (yellowing of whites of eyes and skin)
  • Easy bruising or bleeding for a long time after minor injuries. This can be due to low numbers of a type of blood cell called platelets that help blood to clot.

Other side effects that can occur are:

  • Feeling or being sick, indigestion, pain in the belly, mild diarrhoea or loose stools, inflammation and discoloration of tongue, inflammation of the mouth, tooth discoloration (usually reversible with professional tooth cleaning)
  • White patches inside the mouth or on the tongue (oral thrush) while taking this medicine (your doctor or pharmacist will prescribe treatment for this)
  • Dizziness, unsteadiness, headache, sleep disorders, nightmares, pins and needles
  • Impaired sense of taste and smell (usually returns to normal once treatment with clarithromycin is over)
  • Ringing in the ears or some loss of hearing (usually returns to normal once treatment with clarithromycin is over)
  • Confusion, hallucinations, marked disturbances in behaviour, mood changes, loss of sense of reality, excessive anxiety, loss of bearings
  • Disturbance in the rhythm of heart
  • Severe abdominal pain accompanied by nausea and vomiting, (this may be a manifestation of inflammation of the pancreas)
  • Yellowing of whites of eyes and skin (jaundice), loss of appetite, pain in right upper abdomen, and general feeling of being unwell accompanied by nausea and vomiting (this may be a manifestation of inflammation of liver)
  • Dark discoloration of urine, bloody or cloudy urine or any change in his/her urine output.
  • Swelling of face, ankles or other parts of the body, with decrease in the amount of urine passed
  • Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections
  • Joint and muscle pains.

There may be changes in the results of certain laboratory tests

  • Abnormal liver-function tests
  • Abnormal kidney function tests
  • Decreased blood sugar
  • Altered blood cell counts

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform the doctor or pharmacist.

How To Store Clarithromycin 125mg/5ml Oral Suspension

Keep clarithromycin suspension out of the reach and sight of children.

Do not give after the expiry date on the labeling.

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.

Further Information

What Clarithromycin 125mg/5ml oral suspension contains

The active substance is clarithromycin. 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.

What Clarithromycin 125mg/5ml oral suspension looks like and contents of the pack

Clarithromycin 125mg/5ml oral suspension is white to off-white granular powderforming 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.

Marketing authorisation holder and manufacturer

Marketing authorisation holder: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

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