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KLARICID XL 500 MG TABLETS

Active substance(s): CLARITHROMYCIN / CLARITHROMYCIN / CLARITHROMYCIN

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MKP-00105-2015

XL 500 mg
tablets
®

(Clarithromycin)

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 the leaflet. See section 4.
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 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 tablets.
• 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 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)
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 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

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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)
• 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.

POSITION ONLY

PATIENT INFORMATION LEAFLET
ON

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.

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MKP-00105-2015_d1

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.
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 StevensJohnson 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 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
• acne
• 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),

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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 levels of certain cells or products
found in the blood
Reporting side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
5. How to store Klaricid XL tablets
Keep this medicine out of the
sight and reach of children
Do not use these tablets after their
use-by (exp) date which is printed
on the blister pack.
Do not store above 30°C. Store in
the original package.
Do not throw away any medicines
via wastewater or household
water. Ask your pharmacist how
to throw away medicines you no
longer use. These measures will help protect the
environment.
6. Contents of the pack and other
information
What Klaricid XL tablets contain
Each Klaricid XL tablet contains 500 mg of the
active ingredient clarithromycin.
The other ingredients are: citric acid, sodium
alginate, sodium, calcium alginate, lactose,
povidone, talc, stearic acid, magnesium stearate,
methyl hydroxypropyl cellulose, polyethylene
glycol 400, macrogol 8000, titanium dioxide
(E171), sorbic acid, quinoline yellow dye (E104).
What Klaricid XL tablets look like and contents
of the pack
Klaricid XL tablets are yellow, oval, modified
release tablets.
Klaricid XL tablets are available in blister packs or
bottles containing 7 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder - BGP
Products Ltd., Abbott House, Vanwall
Business Park, Vanwall Road, Maidenhead,
Berkshire, SL6 4XE, UK.
Manufacturer - AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
This leaflet was last revised in July 2015

MKP-00105-2015

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MKP-00105-2015_d1

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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.

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