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KLARICID XL 500MG MODIFIED RELEASE TABLETS

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Ref: 1549/230317/1/F

®

Klaricid XL 500mg Modified-Release Tablets
(clarithromycin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
* If you get 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 XL 500mg Modified-Release Tablets, but will
be referred to as Klaricid XL tablets throughout the rest of this leaflet.
What is in this leaflet
1

What Klaricid XL tablets are and what they are used for

2

What you need to know before you take Klaricid XL tablets

3

How to take Klaricid XL tablets

4

Possible side effects

5

How to store Klaricid XL tablets

6

Contents of the pack and other information

1

What Klaricid XL tablets are and what they are
used for

Each Klaricid XL tablet contains 500 mg of the active ingredient
clarithromycin.
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. cellulitis, folliculitis or
erysipelas.
Klaricid XL Tablets are used in adults and children 12 years and older.

2

What you need to know before you take 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
tablets.
* are taking medicines called ergot alkaloid tablets (e.g. ergotamine or
dihydroergotamine) 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. Consult your doctor for advice on
alternative medicines.
* are taking other medicines which are known to 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).
* are taking oral midazolam (a sedative)
* have abnormally low levels of potassium in your blood (hypokalaemia).
* have severe liver disease with kidney disease.
* or someone in your family has a history of heart rhythm disorder
(ventricular cardiac arrhythmia, including torsades de pointes) or
abnormality of electrocardiogram (ECG), electrical recording of the heart)
“long QT syndrome”.
* are taking medicines called ticagrelor or ranolazine (for heart attack,
chest pain or angina)
* are taking colchicine (usually taken for gout)
Take special care with Klaricid XL tablets
* If you have abnormally low levels of magnesium in your blood
(hypomagnesaemia) consult your doctor before taking these tablets.
Klaricid XL tablets are not suitable for use in children under 12 years of
age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Klaricid XL tablets
* if you have heart problems (e.g. heart disease, heart failure, an unusually
slow heart rate, or low levels of magnesium in the blood)
* 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
lactose

Other medicines and Klaricid XL tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other 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). 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.
* nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower
blood glucose levels)
* glicazide or glimepiride (sulphonylureas used in the treatment of type ll
diabetes)
* theophylline (used in patients with breathing difficulties such as asthma)
* triazolam, alprazolam or intravenous or oromucosal 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)
* quetiapine or other antipsychotic medicines
* other macrolide medicines
* lincomycin and clindamycin (lincosamides - a type of antibiotic)
Klaricid does not interact with oral contraceptives.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist before taking this
medicine as the safety of Klaricid XL tablets in pregnancy and breast-feeding
is not known.
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.

3

How to take 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.
Check with your doctor or pharmacist if you are not sure.
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.
If you stop taking Klaricid XL tablets
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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Ref: 1549/230317/1/B

®

Klaricid XL 500mg Modified-Release Tablets
(clarithromycin)
Patient Information Leaflet (continued)
4

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 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 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).
* 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 (may affect up to 1 in 10 people) include;
* difficulty sleeping
* changes in sense of taste
* headache
* widening of blood vessels
* stomach problems such as feeling sick, vomiting, stomach pain,
indigestion, diarrhoea
* a change in the way your liver works
* skin rash
* increased sweating
Uncommon side effects (may affect up to 1 in 100 people) include:
* high temperature
* swelling, redness or itchiness of the skin
* oral or vaginal ‘thrush’ (a fungal infection)
* inflammation of the stomach and intestines
* decrease of the levels of blood platelets (blood platelets help stop
bleeding)
* decrease in white blood cells (leukopenia)
* decrease in neutrophils (neutropenia)
* stiffness
* chills
* increase of eosinophils (white blood cells involved in immunity)
* exaggerate immune response to a foreign agent
* lack or loss of appetites
* anxiety, nervousness,
* drowsiness, tiredness, dizziness, or shaking
* involuntary muscle movements
* vertigo
* ringing in the ears or hearing loss
* chest pain or changes in heart rhythm such as palpitations or an irregular
heartbeat
* asthma: lung disease associated with tightening of air passages, making
breathing difficult
* nose bleeds
* blood clot that causes sudden blockage in a lung artery (pulmonary
embolism)
* inflammation of the lining of the gullet (oesophagus) and lining of the
stomach
* anal pain
* inflammation of the tongue, mouth and lips
* bloating, constipation, wind, burping
* dry mouth
* situation where the bile (fluid made by the liver and stored in the
gallbladder) cannot flow from the gallbladder to the duodenum
(cholestasis)
* inflammation of the liver
* inflammation of the skin characterized by the presence of the bullae which
are filled with fluid, itchy and painful rash.
* muscle spasms, muscle pain or loss of muscle tissue. If you suffer from
myasthenia gravis (a condition in which the muscles become weak and tire
easily), clarithromycin may worsen these symptoms.
* raised abnormal kidney and liver function blood test and raised blood tests.
* feeling weak, tired and having no energy

Not known side effects (frequency cannot be estimated from the available
data):
* inflammation of the colon
* bacterial infection of the outer layers of the skin
* reduction in the level of certain blood cells (which can make infections
more likely or increased the risk of bruising or bleeding)
* swelling of the lips and eyes
* confusion, loss or bearings, hallucinations (seeing things), change in sense
of reality or panicking, depression, abnormal dreams or nightmares and
mania (feeling of elation or over-excitement)
* convulsion (fits)
* paraesthesia, more commonly known as ‘pins’ and ‘needles’
* loss of taste or smell or inability to smell properly
* type of heart rhythm disorder (Torsade de piontes, ventricular tachycardia)
* loss of blood (haemorrhage)
* inflammation of the pancreas
* discolouration of the tongue or teeth
* changes 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)
* Steven-Johnson syndrome: skin condition that causes painful blistering
and sore of the skin and mucous membranes, especially in the mouth
* rare allergic skin reactions which causes severe illness with ulceration of
the mouth, lips and skin which causes severe illness which rash, fever and
inflammation of internal organs (DRESS)
* acne
* 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)
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.

5

How to store Klaricid XL tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 30°C.
Store in the original package to protect from light.
Do not use this medicine after the expiry date which is stated on the blister
label or carton. The expiry date refers to the last day of that month.
If your medicine becomes discoloured or shows 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 no longer required.
These measures will help to protect the environment.

6

Contents of the pack and other information

What Klaricid XL tablets contain:
Each modified release tablet contains 500mg clarithromycin.
The other ingredients are: citric acid, sodium calcium alginate, lactose
monohydrate, povidone, talc, stearic acid, magnesium stearate,
hypromellose, macrogol 400, macrogol 8000, titanium dioxide (E171),
sorbic acid and quinoline yellow aluminium lake.
What Klaricid XL tablets look like and contents of the pack
Klaricid XL tablets are yellow, oval, tablets.
Klaricid XL tablets are available in blister packs of 7 tablets.
Manufacturer and Licence Holder
Manufactured by AbbVie S.r.l., Campoverde di Aprilia (LT), Italy, and
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/1549 Klaricid XL 500mg Modified-Release Tablets

Klaricid XL is a registered trademark of Abbott Laboratories.
Revision date: 23/03/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527
505414 to obtain the leaflet in a
format suitable for you.

Expand Transcript

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.

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