•    loss of taste or smell or inability to smell properly

•    joint pain

•    muscle spasms, muscle pain or loss of muscle tissue. If your child suffers from myasthenia gravis (a condition in which the muscles become weak and tire easily) or rhabdomyolysis (a condition which causes the breakdown of muscle tissue), clarithromycin may worsen these symptoms

•    chest pain or changes in heart rhythm such as palpitations

•    a change in the levels of products made by the liver, inflammation of the liver or an inability of the liver to function properly (you may notice yellowing of the skin, dark urine, pale stools or itchiness of the skin)

•    a change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs or ankles or problems with urination)

•    a change in the levels of certain cells or products found in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Klaricid Paediatric Suspension contains:

Each 5ml of suspension contains 250 mg of clarithromycin.

Other ingredients are: sucrose, carbomers (carbopol 974P), povidone K90, hypromellose phthalate, castor oil, silicon dioxide, xanthan gum, fruit punch flavour, potassium sorbate, citric acid, maltodextrin, titanium dioxide.

What Klaricid Paediatric Suspension looks like and contents of the pack

Klaricid Paediatric Suspension is white to off-white granules for reconstitution which forms a white suspension when reconstituted with water. It is available as plastic bottle of granules, when reconstituted contains 70 ml of suspension.

Manufacturer and Licence Holder

This medicine is manufactured by Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, UK and is procured from within the EU. Product Licence Holder LTT Pharma Limited, B98 0RE. Repackaged by Lexon (UK) Limited Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 33723/0205

Klaricid is a registered trademark of Abbott Laboratories.

Revision date: 12/10/15

PATIENT INFORMATION LEAFLET    ^Ref ltt⁰²⁰⁵^⁰^^

Klaricid® 250mg/5ml Paediatric Suspension

(clarithromycin)

Read all of this leaflet carefully before you give this medicine to your child because it contains important infromation.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.

•    If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

Your medicine is called Klaricid 250mg/5ml Paediatric Suspension and will be referred to as Klaricid Paediatric Suspension throughout the rest of this leaflet.

What is in this leaflet:

1.    What Klaricid Paediatric Suspension is and what it is used for

2.    What you need to know before giving Klaricid Paediatric Suspension

3.    How to give Klaricid Paediatric Suspension

4.    Possible side effects

5.    How to store Klaricid Paediatric Suspension

6.    Content of the pack and other information

2. WHAT YOU NEED TO KNOW BEFORE GIVING KLARICID PAEDIATRIC SUSPENSION

1. WHAT KLARICID PAEDIATRIC SUSPENSION IS AND WHAT IT IS USED FOR

5. HOW TO STORE KLARICID PAEDIATRIC SUSPENSION

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not refrigerate or freeze.

•    Keep container tightly closed.

•    Klaricid Paediatric Suspension must be used within 14 days of you receiving the bottle from the pharmacist.

•    Do not take this medicine after the expiry date shown on the carton and bottle label. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Blind or partially sighted?

Is this leaflet hard to see or read? Phone LTT Pharma Limited,

Tel: 01527 505414 for help.

Each 5ml spoonful of Klaricid Paediatric Suspension contains 250mg of the active ingredient clarithromycin.

Klaricid belongs to a group of medicines called macrolide antibiotics.

Antibiotics stop the growth of bacteria (bugs) that cause infections.

It is used to treat infections such as:

1.    Chest infections, such as bronchitis and pneumonia

2.    Throat and sinus infections

3.    Skin and tissue infections

4.    Ear infections particularly inflammation of the middle ear (acute otitis media).

Klaricid Paediatric Suspension is used in children 6 months to 12 years old.

Do not give Klaricid Paediatric Suspension to your child if they;

•    are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Klaricid Paediatric Suspension.

•    are taking medicines called ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.

•    are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride (for stomach disorders) or pimozide (for mental health problems)

as combining these drugs can sometimes cause serious disturbances in heart rhythm.

•    are 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).

•    have low levels of potassium in the blood (a condition known as hypokalaemia).

•    have severe liver disease with kidney disease.

•    have an irregular heart rhythm.

•    are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina)

•    are taking colchicine (usually taken for gout)

Warning and precautions

Talk to your doctor or pharmacist before giving Klaricid Paediatric Suspension:

•    if your child has any liver or kidney problems

•    if your child has, or is prone to, fungal infections (e.g. thrush)

•    if your child has been told that they have an intolerance to any sugars as Klaricid Paediatric Suspension contains sucrose.

Other medicines and Klaricid paediatric Suspension

Tell your doctor if your child is taking 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 (for thinning the 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 rhabdomyolosis (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.

•    muscle spasms, muscle pain or loss of muscle tissue. If your child suffers from myasthenia gravis (a condition in which the muscles become weak and tire easily) or rhabdomyolysis (a condition which causes the breakdown of muscle tissue), clarithromycin may worsen these symptoms

•    chest pain or changes in heart rhythm such as palpitations

•    a change in the levels of products made by the liver, inflammation of the liver or an inability of the liver to function properly (you may notice yellowing of the skin, dark urine, pale stools or itchiness of the skin)

•    a change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs or ankles or problems with urination)

•    a change in the levels of certain cells or products found in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Clarithromycin contains:

Each 5ml of suspension contains 250 mg of clarithromycin.

Other ingredients are: sucrose, carbomers (carbopol 974P), povidone K90, hypromellose phthalate, castor oil, silicon dioxide, xanthan gum, fruit punch flavour, potassium sorbate, citric acid, maltodextrin, titanium dioxide.

What Clarithromycin looks like and contents of the pack

Clarithromycin is white to off-white granules for reconstitution which forms a white suspension when reconstituted with water. It is available as plastic bottle of granules, when reconstituted contains 70 ml of suspension.

Manufacturer and Licence Holder This medicine is manufactured by Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, UK and is procured from within the EU. Product Licence Holder LTT Pharma Limited, B98 0RE. Repackaged by Lexon (UK) Limited Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 33723/0205

Revision date: 12/10/15

PATIENT INFORMATION LEAFLET    ^Ref ltt°²°^5/i²i°i^5/2/f

Clarithromycin 250mg/5ml Granules for Oral Suspension

Read all of this leaflet carefully before you give this medicine to your child because it contains important infromation.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.

•    If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

Your medicine is called Clarithromycin 250mg/5ml Granules for Oral Suspension and will be referred to as Clarithromycin throughout the rest of this leaflet.

What is in this leaflet:

1.    What Clarithromycin is and what it is used for

2.    What you need to know before giving Clarithromycin

3.    How to give Clarithromycin

4.    Possible side effects

5.    How to store Clarithromycin

6.    Content of the pack and other information

5. HOW TO STORE CLARITHROMYCIN

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not refrigerate or freeze.

•    Keep container tightly closed.

•    Clarithromycin must be used

within 14 days of you receiving the bottle from the pharmacist.

•    Do not take this medicine after the expiry date shown on the carton and bottle label. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Blind or partially sighted?

Is this leaflet hard to see or read? Phone LTT Pharma Limited,

Tel: 01527 505414 for help.

1. WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR

Each 5ml spoonful of Clarithromycin contains 250mg of the active ingredient clarithromycin.

Clarithromycin belongs to a group of medicines called macrolide antibiotics.

Antibiotics stop the growth of bacteria (bugs) that cause infections.

It is used to treat infections such as:

1.    Chest infections, such as bronchitis and pneumonia

2.    Throat and sinus infections

3.    Skin and tissue infections

4.    Ear infections particularly inflammation of the middle ear (acute otitis media).

Clarithromycin is used in children 6 months to 12 years old.

2. WHAT YOU NEED TO KNOW BEFORE GIVING CLARITHROMYCIN Do not give Clarithromycin to your child if they;

•    are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Clarithromycin.

•    are taking medicines called ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.

•    are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride (for stomach disorders) or pimozide (for mental health problems)

as combining these drugs can sometimes cause serious disturbances in heart rhythm.

•    are 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).

•    have low levels of potassium in the blood (a condition known as hypokalaemia).

•    have severe liver disease with kidney disease.

•    have an irregular heart rhythm.

•    are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina)

•    are taking colchicine (usually taken for gout)

Warning and precautions

Talk to your doctor or pharmacist before giving Clarithromycin

•    if your child has any liver or kidney problems

•    if your child has, or is prone to, fungal infections (e.g. thrush)

•    if your child has been told that they have an intolerance to any sugars as Clarithromycin contains sucrose.

Other medicines and Clarithromycin

Tell your doctor if your child is taking 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 (for thinning the 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 rhabdomyolosis (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.

•    colchicine (usually taken for gout)

•    nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)

•    theophylline (used in patients with breathing difficulties such as asthma)

•    triazolam, alprazolam or midazolam (sedatives)

•    cilostazol (for poor circulation)

•    omeprazole (for treatment of indigestion and gastric ulcers)

•    methylprednisolone (a corticosteroid)

•    vinblastine (for treatment of cancer)

•    ciclosporin, sirolimus and tacrolimus (immune suppressants)

•    etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used in the treatment of HIV)

•    rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial 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)

•    aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin) and other medicines that may be toxic to the ear

Clarithromycin does not interact with oral contraceptives.

Pregnancy and breast-feeding

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

Driving and Using Machines:

Clarithromycin may make you feel dizzy or drowsy. If they affect you or your child in this way do not drive, operate machinery or do anything that requires you to be alert.

3. HOW TO GIVE CLARITHROMYCIN

Always give Clarithromycin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how the dose has been worked out for your child.

The usual doses of Clarithromycin are given below:

Dosage based on body weight

Weight (kg)    Age (years) Dosage in mls

(twice daily)

8-11    1-2    1.25

12-19    3-6    2.5

20-29    7-9    3.75

30-40    10-12    5

Children who weigh less than 8kg should be given a dose of 0.15 ml/kg twice a day.

Doctors may sometimes prescribe higher or lower doses than these.

Clarithromycin is supplied with a pipette to help you measure the right amount of medicine to give to your child.

Please follow these instructions carefully;

1.    Remove the child-proof cap from the bottle by pushing down on the cap while turning

it anticlockwise (Fig 1).

2.    Take the plastic circular stopper 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. (Fig 2).

3.    Take the pipette 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 pipette into the hole in the stopper (Fig 3).

5.    Turn the bottle upside down. Keep hold of the bottle in one hand and the pipette in the other (Fig 4).

6.    Hold the barrel of the pipette steady and slowly, pull the plunger down until you see the liquid

fill the barrel to the mark which matches the number of ml that you need to give to your child (Fig 4).

7.    Turn the bottle back the right way up.

8.    Keeping hold of the barrel, remove the whole pipette from the bottle.

9.    The contents of the pipette can be emptied directly into your child's mouth by pushing down on the plunger while still holding the barrel. Alternatively, empty the measured dose from the pipette onto a spoon for your child to take the medicine from.

10.    Replace the cap on the bottle of medicine.

11 .Wash the pipette in warm soapy water and

rinse well. Hold the pipette under water and move the plunger up and down several times to make sure the inside of the barrel is clean. Store the pipette in a hygienic place with the medicine.

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.

You should shake the bottle well before using and replace the cap firmly after use. Clarithromycin is usually given for 5 to 10 days.

If you give more Clarithromycin than you should

If you accidentally 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 Clarithromycin

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.

If you stop giving Clarithromycin

Do not stop giving this medicine even if your child feels better. It is important to give 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clarithromycin 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:

• severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor.

•    a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that your child may have developed an allergic reaction.

•    yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite. These are signs that your child's liver may not be working properly.

•    severe skin reactions such as blistering of the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis)

•    muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).

Common side effects of Clarithromycin include;

•    headache

•    difficulty sleeping

•    changes in sense of taste

•    stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea

•    a change in the way the liver works

•    skin rash

•    increased sweating

Other less common side effects include:

•    high temperature

•    swelling, redness or itchiness of the skin. Sometimes brown scales may appear.

•    acne

•    Henoch-Schonlein purpura (a rash which appears as purple spots on the skin).

•    oral or vaginal ‘thrush' (a fungal infection)

•    reduction in the level of certain blood cells (which can make infections more likely or increase the risk of bruising or bleeding)

•    loss of appetite, heartburn, bloating, constipation, wind

•    inflammation of the pancreas

•    anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking

•    confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares

•    convulsion (fits)

•    ringing in the ears or hearing loss

•    vertigo

•    paraesthesia, more commonly known as "pins and needles"

•    leaking of blood from blood vessels (haemorrhage)

•    inflammation of the mouth or tongue

•    discolouration of the tongue or teeth

•    dry mouth

•    loss of taste or smell or inability to smell properly

•    joint pain

Ref: LTT0205/121015/2/B