CLARITHROMYCIN 500MG MODIFIED RELEASE TABLETS

Active substance: CLARITHROMYCIN

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MKP-01950-2012

2. Before taking Klaricid XL tablets

PATIENT INFORMATION LEAFLET
ON

XL 500mg tablets
(Clarithromycin)

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 further questions, ask your doctor or your
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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
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
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. cellulites,
folliculitis or erysipelas.
Klaricid XL Tablets are used in adults and children 12 years and
older.

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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.
Klaricid XL tablets are not suitable for use in children under
12 years of age.
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 lactose.
If any of these apply to you, consult your doctor before taking
Klaricid XL tablets.
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)

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• 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 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.
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. 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.
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).
• Henoch-Schonlein purpura (a rash which appears as purple
spots on the skin).
Common side effects of Klaricid XL tablets include;
• headache
• difficulty sleeping
• changes in sense of taste

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• 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 appear.
• acne
• Henoch-Schonlein purpura (a rash which appears as purple
spots on the skin)
• 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

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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.
5. How to store Klaricid XL tablets

Keep out of reach and sight 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.

6. Further 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 1*, 7 or 14 tablets.
* The pack containing 1 tablet is a starter pack and is not a full
course of treatment.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder - Abbott Laboratories Ltd.,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer - Aesica Queenborough Limited, Queenborough,
Kent ME11 5EL, UK.
Leaflet revised February 2013.
MKP-01950-2012

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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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