Skip to Content

UK Edition. Click here for US version.

KLARICID XL 500 MG TABLETS

Active substance(s): CLARITHROMYCIN

PDF options:  View Fullscreen   Download PDF

PDF Transcript

MKP-00707-2017

®

XL 500mg
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 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 disorders (ventricular cardiac
arrhythmia, including torsades de pointes)
or abnormality of electrocardiogram (ECG,
electrical recording of the heart) called “long QT
syndrome”.
• are taking medicines called ticagrelor or
ranolazine (for heart attack, chest pain or
angina)
• are taking colchicine (usually taken for gout)
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
abnormally low levels of magnesium in the
blood (hypomagnesaemia))
• 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
Children
Klaricid XL tablets are not suitable for use in
children under 12 years of age.
Black - Cutting Die

Other medicines and Klaricid XL tablets
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 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, or any other anticoagulant (for blood
thinning)
• 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 rhabdomyolysis
(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)
• gliclazide or glimepiride (sulphonylureas used in
the treatment of type II diabetes)
• theophylline (used in patients with breathing
difficulties such as asthma)
• triazolam, alprazolam or intravenous or
oromucosal midazolam (sedatives)
• cilostazol (for poor circulation)
• 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)
Please tell your doctor if you are taking oral
contraceptive pills and diarrhoea or vomiting
occurs, as you may need to take extra
contraceptive precautions such as using a condom.
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.
Klaricid XL tablets contain lactose
This medicine contains lactose, which is a type of
sugar. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.
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 recommended 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

FRONT

MKP-00707-2017_d4

pharmacode
reading direction

PATIENT INFORMATION LEAFLET
ON

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.
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, tongue, lips, eyes 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 have inflammation
and not be working properly.
• severe skin reactions such as painful
blistering of the skin, mouth, lips, eyes and
genitals (symptoms of a rare allergic reaction
called Stevens-Johnson syndrome/toxic
epidermal necrolysis)
• a red, scaly rash with bumps under the skin
and blisters (symptoms of exanthematous
pustulosis). The frequency of this side effect
is not known (cannot be estimated from the
available data).
• rare allergic skin reactions which cause
severe illness with ulceration of the mouth,
lips and skin which causes severe illness
with rash, fever and inflammation of internal
organs (DRESS).
• muscle pain or weakness known as
rhabdomyolysis (a condition which causes
the breakdown of muscle tissue which can
result in kidney damage).
Other side effects
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
• 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)
• exaggerated immune response to a foreign
agent
• lack or loss of appetite
• 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 bleed
• 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

• 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 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
increase the risk of bruising or bleeding)
• confusion, loss of 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
pointes, ventricular tachycardia)
• loss of blood (haemorrhage)
• inflammation of the pancreas
• discolouration of the tongue or teeth
• 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
or pharmacist. 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 or
search for MHRA Yellow Card in the Google
Play or Apple App Store. By reporting side
effects you can help provide more information
on the safety of this medicine.
5. How to store Klaricid XL tablets
Keep this medicine out of 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
waste. 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,
hypromellose, polyethylene glycol, titanium
dioxide, sorbic acid, quinoline yellow (E104
aluminium lake).
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 - Mylan
Products Ltd., 20 Station Close, Potters Bar,
Herts, EN6 1TL, 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 February 2018

MKP-00707-2017

Black - Cutting Die

BACK

MKP-00707-2017_d4

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide