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Ref: LTT167/041113/1/F


Klaricid XL 500mg Modified Release Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is known as Klaricid XL 500mg Modified Release Tablets but
will be referred to Klaricid XL tablets throughout the leaflet.
In this leaflet:
1 What Klaricid XL tablets are and what they are used for
2 Before taking Klaricid XL tablets
3 Taking Klaricid XL tablets
4 Possible side effects
5 How to store Klaricid XL tablets
6 Further information


What Klaricid XL tablets are and what they are used

Each Klaricid XL tablet contains 500 mg of the active ingredient
Klaricid belongs to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klaricid XL tablets are used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Mild to moderate skin and tissue infections, e.g. cellulites, folliculitis or

Taking other medicines
You should not take Klaricid XL tablets if you are taking any of the medicines
listed in the section above “Do not take Klaricid XL tablets if you;”
Tell your doctor if you are taking any of the following medicines as your dose
may need to be changed or you 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)
* 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 (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)
Klaricid XL does not interact with oral contraceptives.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are breast-feeding,
consult your doctor before taking Klaricid XL tablets as the safety of Klaricid
XL tablets in pregnancy and breast-feeding is not known.

Klaricid XL Tablets are used in adults and children 12 years and older.


Before taking Klaricid XL tablets

Do not take Klaricid XL tablets if you;
* know that you are allergic to clarithromycin, other macrolide antibiotics
such as erythromycin or azithromycin, or any of the other ingredients in the
* 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 problems) 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
* have severe liver disease with kidney disease.
* have an irregular heart rhythm.
Klaricid XL tablets are not suitable for use in children under 12 years of
Take special care with Klaricid XL tablets;
* if you have any liver or kidney problems
* if you have, or are prone to, fungal infections (e.g. thrush)
* if you are pregnant or breast feeding
* if you have an intolerance to any sugars as Klaricid XL tablets contain
If any of these apply to you, consult your doctor before taking Klaricid XL

Driving and Using Machines:
Klaricid XL tablets may make you feel dizzy or drowsy. If they affect you in
this way do not drive, operate machinery or do anything that requires you to
be alert.

Taking Klaricid XL Tablets

Do not give these tablets to children under 12 years. Your doctor will
prescribe another suitable medicine for your child. Always take Klaricid XL
tablets exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
You may initially be given a pack containing one Klaricid XL tablet so that
you can start your treatment straight away.
This one tablet is not a full course of treatment. You should also receive a
prescription for the rest of the tablets that you need.
The usual dose of Klaricid XL tablets for adults and children over 12 years is
one 500 mg tablet once a day for 6 to 14 days. Your doctor may increase the
dose to two 500 mg tablets daily in severe infections.
Klaricid XL tablets should be taken with food and must be swallowed whole
and not chewed.
If you take more Klaricid XL tablets than you should
If you accidentally take more Klaricid XL tablets in one day than your doctor
has told you to, or if a child accidentally swallows some tablets, contact your
doctor or nearest hospital emergency department immediately. An overdose
of Klaricid XL tablets is likely to cause vomiting and stomach pains.
If you forget to take Klaricid XL tablets
If you forget to take a dose of Klaricid XL tablets, take it as soon as you
remember. Do not take more tablets in one day than your doctor has told
you to.
Do not stop taking Klaricid XL tablets, even if you feel better. It is important
to take the tablets for as long as the doctor has told you to, otherwise the
problem might come back.

Ref: LTT0167/041113/1/B


Klaricid XL 500mg Modified Release Tablets
Patient Information Leaflet (continued)

Possible side effects

Like all medicines, Klaricid XL tablets can cause side effects although not
everybody gets them.
If you suffer from any of the following at any time during your treatment
STOP TAKING your tablets 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 Klaricid XL
tablets, 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 you 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 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).
* Henoch-Schonlein purpura (a rash which appears as purple spots on the
Common side effects of Klaricid XL tablets 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 your liver works
* skin rash
* increased sweating
Other less common side effects include:
* swelling, redness or itchiness of the skin. Sometimes brown scales may
* acne
* Henoch-Schonlein purpura (a rash which appears as purple spots on the
* 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
* rectal pain
* 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’
* nose bleeds
* 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
* muscle pain or loss of muscle tissue. If you suffer 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)
* low blood sugar levels
* a change in levels of certain cells or products found in the blood
Consult your doctor immediately if you develop any of these problems or
have any other unexpected or unusual symptoms.

Reporting of side effects
If you get and 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
By reporting side effects, you help provide more information on the safety of
this medicine.


How to store Klaricid XL tablets

* Do not store light. 30°C. Store in the original package.
* Protect use this medicine after the expiry date shown on the carton label
Do not
* or blister strip.
If your doctor
taking this medicine, return
* tablets to yourtells you to stopsafe disposal. Only keep thisany unusedif
pharmacist for

your doctor tells you to.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.


Further information

What this medicine contains:
Each modified release tablet contains 500mg of the active ingredient
Other ingredients: citric acid, sodium alginate, sodium calcium alginate,
povidone, talc, stearic acid, magnesium stearate, hypromellose,
macrogol 400, macrogol 8000, titanium dioxide (E171), sorbic acid,
quinoline yellow dye (E104) and lactose monohydrate.
What this medicine looks like and contents of the pack
Klaricid XL tablets are yellow, oval, modified release tablets.
Klaricid XL tablets are available in calendar blister pack of 7.
Manufacturer and Licence Holder
This medicine is manufactured Aesica Queenborough Limited,
Queenborough, Kent, ME11 5EL, UK and procured from within the EU.
Product licence holder: LTT Pharma Ltd, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcs, B98 0RE. Repackaged by Lexon (UK) Ltd,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.


PL 33723/0167

Klaricid XL 500mg Modified Release Tablets

Klaricid XL is a registered trademark of Abbott Laboratories.
Revision date: 04/11/13

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.