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CLARIE XL 500MG PROLONGED RELEASE TABLETS
Active substance(s): CLARITHROMYCIN CITRATE / CLARITHROMYCIN CITRATE / CLARITHROMYCIN CITRATE
231-30-90212-E LEA CLARITHROMYCIN 500MG TAB TUK
1 August 2016
as these medicines may cause narrowing of the blood vessels leading to a
restriction of blood supply to body tissues
• lovastatin or simvastatin (cholesterol-lowering drugs),
as these medicines may lead to pain or weakness in muscles, or abnormal
Package leaflet: Information for the user
muscle breakdown which can lead to kidney problems
Read all of this leaflet carefully before you start taking this medicine because it contains
• colchicine (a treatment for gout),
important information for you.
as clarithromycin may lead to increased concentrations of this drug in your
• Keep this leaflet. You may need to read it again.
body, increasing the risks of side effects and leading to potential toxicity
• If you have any further questions, ask your doctor or pharmacist.
• ticagrelor (a blood-thinning drug)
• This medicine has been prescribed for you only. Do not pass it on to others. It may
• ranolazine (used to treat angina).
harm them, even if their signs of illness are the same as yours.
doctor may need to control blood levels or effects, to adjust the dosage, or to
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible
interrupt (for some time) the treatment if clarithromycin is used at the same time with
side effects not listed in this leaflet. See section 4.
medicines containing one of the substances listed below:
What is in this leaflet
• digoxin (for heart failure) as it may cause an irregular heart beat. Clarithromycin may
also lead to increased concentrations of this drug in your body, increasing the risk of
1. What Clarie XL is and what it is used for
2. What you need to know before you take Clarie XL
• quinidine or disopyramide (for heartbeat disorders) as these medicines may cause you
3. How to take Clarie XL
to experience a life-threatening irregular heart beat
4. Possible side effects
• midazolam (sedatives/sleeping pills), triazolam (sleeping pills) or alprazolam (for
5. How to store Clarie XL
anxiety) as these medicines may cause sleepiness or confusion
6. Contents of the pack and other information
• ritonavir, atazanavir, saquinavir (HIV treatments) as this may lead to increased
concentrations of either these medicines or clarithromycin in your body, increasing the
What Clarie XL is and what it is used for
risks of side effects
efavirenz, nevirapine, etravirine (HIV treatments) as these medicines may lead to
Clarie XL contains the active ingredient clarithromycin. Clarithromycin is an antibiotic,
decreased concentrations of clarithromycin in your body, altering the effectiveness of
which can be used to treat the following bacterial infections:
• Community-acquired pneumonia (infection of the lungs, developed outside of
• zidovudine (HIV treatment) as clarithromycin may lead to decreased absorption of this
hospitals or extended-care facilities)
drug in your body, altering the effectiveness of the drug
• Short-term worsening of chronic bronchitis caused by bacterial infection
• rifabutin, rifampicin, rifapentine (antibiotics) as these medicines may lead to decreased
• Bacterial sinusitis (infection of the sinuses)
concentrations of clarithromycin in your body, altering the effectiveness of your drug
• Bacterial pharyngitis and tonsillitis (infection of the throat or tonsils)
• warfarin or acenocoumarol (blood thinners) as these medicines may alter the rate at
• Skin and soft tissue infections (mild to moderate severity)
which your blood clots which might result in toxic effects
• cholesterol-lowering drugs (atorvastatin, rosuvastatin) as these medicines may lead to
What you need to know before you take Clarie XL
pain or weakness in muscles, or abnormal muscle breakdown which can lead to kidney
problems. Clarithromycin may also lead to increased concentrations of these drugs in
Do not take Clarie XL
your body, increasing the risks of side effects
• if you are allergic to clarithromycin, other macrolides (similar antibiotics), or any of
• itraconazole or fluconazole (used in fungal infections) as this may lead to increased
the other ingredients of this medicine (listed in Section 6). An allergic reaction may
concentrations of either these medicines or clarithromycin in your body, increasing the
include rash, itching, difficulty breathing or swelling of the face, lips, throat or
risks of side effects
The following medicines, for which clarithromycin may lead to increased concentrations
• if you are taking medicines called terfenadine or astemizole (for hay fever or
allergies) or cisapride (for stomach disorders) or pimozide (for mental illness) tablets of these drugs in your body, increasing the risks of side effects:
as combining these drugs can sometimes cause serious disturbances in heart
• valproate, phenytoin or carbamazepine (for epilepsy)
rhythm. Consult your doctor for advice on alternative medicines.
• cilostazol (a treatment for leg cramps)
• if you or someone in your family has a history of heart rhythm disorders (ventricular • methylprednisolone (used to treat inflammation)
cardiac arrhythmia, including torsade de pointes) or abnormality of
• sildenafil, tadalafil, vardenafil (treatment for erection problems)
electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome” • vinblastine (a cancer treatment)
• if you have severe kidney problems
• tolterodine (used for urinary frequency)
• if you are taking ticagrelor (a blood-thinning drug)
• eletriptan (used for migraine)
• if you are taking ranolazine (used to treat angina)
• aprepitant (used to prevent nausea and vomiting after chemotherapy)
• if you are taking ergotamine-like drugs (usually used for migraine)
• halofantrine (used to treat malaria)
• if you are taking cholesterol-lowering drugs (lovastatin or simvastatin)
• omeprazole (for indigestion)
• if you have abnormally low levels of potassium in your blood (hypokalaemia)
• ziprasidone (for schizophrenia)
• if you have severe liver problems in combination with kidney problems
• ciclosporin, tacrolimus, sirolimus (to help prevent rejection after a transplant)
• if you are taking colchicine (used to treat gout)
• theophylline (for asthma)
Warnings and precautions
Other interactions include:
Talk to your doctor or pharmacist before taking Clarie XL if you:
• St John’s Wort (herbal product to treat depression).
• suffer from problems with your kidneys
• Drugs that lower your blood sugar, e.g. insulin, nateglinide, repaglinide.
• suffer from problems with your liver
• Aminoglycosides (antibiotics) e.g. gentamicin
• suffer from problems with your heart
• Calcium channel blockers e.g verapamil, amlodipine, diltiazem (used to treat high
• are pregnant or breast-feeding
blood pressure or heartbeat disorders)
• are taking drugs called triazolam or midazolam (usually taken for sedation or
It may still be all right for you to take the tablets and your doctor will be able to decide
what is suitable for you.
• are taking aminoglycosides (antibiotic drugs)
Clarie XL with food and drink
• are taking cholesterol-lowering drugs (statins)
• are taking drugs that lower your blood sugar (oral hypoglycaemic agents) or insulin This medicine should be taken with food.
• are taking blood thinners (oral anticoagulants like warfarin)
Pregnancy and breast-feeding
• have muscle problems known as myasthenia gravis
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
• have abnormally low levels of magnesium in your blood (hypomagnesaemia)
a baby, ask your doctor or pharmacist for advice before taking this medicine.
• are taking other medicines which are known to cause serious disturbances in heart
rhythm (for the medicines terfenadine, astemizole, cisapride, and pimozide: see ‘Do Small amounts of clarithromycin can pass into breast milk.
not take Clarie XL’’).
Clarie XL should not be given to pregnant or breast-feeding mothers unless the benefits
to the mother outweigh the risks to the baby.
Other medicines and Clarie XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
Driving and using machines
other medicines, including medicines obtained without a prescription.
Clarie XL may cause dizziness. If affected you should not drive or use machines.
You should not be given Clarie XL if you are taking any one of the following medicines
Clarie XL contains lactose.
(see section “Do not take Clarie XL”)
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
• terfenadine or astemizole (for hay fever or allergy),
• cisapride (for stomach disorders),
How to take Clarie XL
• pimozide (for mental illness),
as these medicines may cause you to experience a life-threatening irregular
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• ergotamine type drugs (usually used for migraine, eg ergotamine or
Clarie XL 500 mg
Prolonged Release Tablets
TEVA UK Ref:
231-30-90212-E LEA CLARITHROMYCIN 500MG TAB TUK
1 August 2016
Very rare: may affect up to 1 in 10,000 people
Your tablets must be swallowed whole and not chewed. Clarie XL should
• Nervous system disorders: paraesthesia (tingling or numbness of
be taken with food.
Adults and children over 12 years
Not known: frequency cannot be estimated from the available data
The recommended dose is one tablet (500 mg) once daily.
• Infections: pseudomembranous colitis (infection of the bowel),
Your doctor may increase the dose to two tablets daily (1000 mg) in more
erysipelas or erythrasma (infections of the skin)
• Blood disorder: agranulocytosis (severe reduction in white blood cells
Your dose must be taken at the same time every day.
with an increased risk of infection), thrombocytopenia (reduction in
The usual duration of treatment is 6 to 14 days.
blood platelets, which increases risk of bleeding or bruising)
Children under 12 years
• Immune system disorders: Anaphylactic reaction (severe allergic reaction),
Clarie XL is not suitable for children under 12 years of age. Your doctor can advise you of
angioedema (swelling of the face, lips and tongue)
other clarithromycin medicines which may be more suitable for children in this age group,
• Metabolism and nutrition disorder: hypoglycaemia (low blood sugar)
such as clarithromycin suspension.
• Psychiatric disorder: mania, abnormal dreams, confusional state, , depersonalization
(out of body feeling), disorientation (not knowing where you are), hallucination,
If you take more Clarie XL than you should
If you take more tablets than you should contact your doctor or hospital immediately. If
Nervous system disorders: fits, loss of taste, smell alteration, loss of ability to smell
you take too many tablets it may cause gastrointestinal symptoms such as vomiting and
• Ear and labyrinth disorders: irreversible hearing loss
• Heart disorders: heart rhythm disturbances, life-threatening irregular heart beat
If you forget to take Clarie XL
• Vascular disorders: Bleeding
If you forget to take your tablet, take one as soon as you remember. Do not take a double
• Digestive system disorders: pancreatitis (inflammation of the pancreas),
dose to make up for a forgotten dose.
discolouration of tongue and teeth
If you stop taking Clarie XL
• Liver, gall bladder and bile duct disorders: Jaundice hepatocellular (yellowing of the
You should take the tablets for as long as your doctor has told you to even if the
skin and whites of the eyes), liver failure
symptoms disappear, otherwise your infection might come back.
• Skin disorders: Stevens-Johnson syndrome or toxic epidermal necrolysis (severe
peeling and blistering of the skin), drug rash with eosinophilia (type of white blood
If you have any further questions on the use of this medicine, ask your doctor or
cells increase) and systemic symptoms (DRESS), acne
• Musculoskeletal disorders: Rhabdomyolysis (pain or weakness in muscles, or
abnormal muscle breakdown which can lead to kidney problems), myopathy
Possible side effects
• Kidney disorders: kidney failure, interstitial nephritis (inflammation of the kidneys)
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Abnormal laboratory test results: International normalised ratio increased and
prothrombin time prolongation (increased blood clotting time), urine colour
If any of the following happens, tell your doctor immediately:
• Swelling of the lips, face and neck leading to severe difficulty in swallowing or
breathing, skin flushing and/or dizziness or fainting (severe allergic reaction)
You may get side effects which you are not aware of, such as changes in the number of
• Severe or prolonged diarrhoea which may contain blood or mucous
certain blood cells, other blood components or liver enzymes. Your doctor may choose to
• Blistering of the skin, mouth, eyes or genitals (Stevens-Johnson syndrome)
do blood tests to check this.
These are rare but serious side effects. You may need urgent medical attention or
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
The following side effects have been reported:
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
Common: may affect up to 1 in 10 people
By reporting side effects you can help provide more information on the safety of this
• Psychiatric disorders: difficulty in sleeping
• Nervous system disorders: headache, taste disturbance, taste perversion
• Digestive system disorders: abdominal (tummy) pain, diarrhea, indigestion, feeling
• Liver, gall bladder and bile duct disorders: altered liver function tests
• Skin disorders: rash, increased sweating
• Kidney disorders: increased levels of urea (a measure of nitrogen) in the blood
• Vascular disorders: widening of blood vessels
Uncommon: may affect up to 1 in 100 people
• Infections: gastroenteritis (inflammation of stomach and intestines), fungal infection,
vaginal bacterial or fungal infection, skin inflammation
• Blood disorders: leucopenia and neutropenia (reduction in the number of white
blood cells, which makes infections more likely), eosinophilia (blood disorder),
thrombocythaemia (increase in blood platelets, which increases risk of bleeding or
• Immune system disorders: allergic reactions ranging from urticaria (nettle rash),
mild skin eruptions and angioedema (swelling of the hands and face) to anaphylaxis
(severe allergic reaction), hypersensitivity
• Metabolism and nutrition disorders: anorexia (loss of appetite), decreased appetite
• Psychiatric disorders:, nervousness, anxiety
• Nervous system disorders: dizziness, tremor (shaking), sleepiness, loss of
consciousness, movement disorder
• Ear and labyrinth disorders: tinnitus (ringing in the ears), vertigo (spinning
sensation), hearing impaired
• Heart disorders: heart rhythm disturbances, palpitations (sensations of irregular
and/or forceful beating of the heart), ECG abnormalities
• Respiratory disorders: shortness of breath or other problems with breathing
including asthma, nose bleed
• Digestive system disorders: constipation, dry mouth, belching, flatulence (wind),
gastrooesophageal reflux disease, inflammation or ulceration of the mouth e.g.
mouth ulcers and cold sores, inflammation of the tongue, inflammation of the
oesophagus and stomach lining, rectal pain, bloating
• Liver, gall bladder and bile duct disorders: liver dysfunction or hepatitis
(inflammation of the liver), cholestasis (obstruction of bile) with or without jaundice
(yellowing of the skin and whites of the eyes), increased liver enzymes in blood.
• Skin disorders: redness of skin, scaling, itching, rash with raised bumps, rash with
pus, dry skin or eczema, nettle rash
• Musculoskeletal disorders: joint or muscle pain, muscle stiffness
• Kidney disorder: altered kidney function or blood tests
• General disorders: feeling of weakness or discomfort, lethargy, general
feeling of being unwell, chest pain or any other pain, chills, tiredness, fever
• Abnormal laboratory test results:, altered liver function tests or blood tests,
How to store Clarie XL
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the label after Exp. The
expiry date refers to the last day of that month.
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.
Content of the pack and other information
What Clarie XL contains:
• The active substance is Clarithromycin citrate equivalent to clarithromycin 500mg.
• The other ingredients are: lactose monohydrate, hypromellose, hypromellose
phthalate, talc, magnesium stearate, macrogol, quinoline yellow aluminium lake
(E104), titanium dioxide (E171).
What Clarie XL looks like and contents of the pack
Clarie XL tablets are yellow, oblong prolonged-release tablets.
Your tablets come in blister packs in pack sizes of 7 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder is:
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG,
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in: July 2016
Code : PB/Drugs/1807-B
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.