Medication Guide App

KLACID XL 500MG TABLETS

Active substance: CLARITHROMYCIN

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Klaricid XL 500mg Tablets/
Klacid XL 500mg Tablets
(clarithromycin)
Your medicine is known by either of the above names but will be referred
to as Klaricid XL Tablets throughout this leaflet.
Patient Information Leaflet

Klaricid XL Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

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 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.
 If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

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)
 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)
 efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (antiviral 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.

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.

2) 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.
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;”

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are breastfeeding, 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)
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

 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
 Do not use after the expiry date printed on the carton, label or blister
strip.
 Do not store above 30C. Store in the original package.
 Keep out of the sight and reach of children
 If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
 If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of down the drain or with household
rubbish. Ask your pharmacist how to dispose of any medicines no longer
required. These measures will help to protect the environment.

6) Further information
What Klaricid XL Tablets contains:
Each contains 500mg of the active ingredient clarithromycin in a modified
release formulation.
Each tablet also contains anhydrous citric acid, sodium alginate, sodium
calcium alginate, lactose, povidone K30, talc, stearic acid, magnesium
stearate, hypromellose, macrogol, titanium dioxide (E171), sorbic acid, and
quinoline yellow aluminium lake (E104).
What Klaricid XL Tablets looks like and contents of the pack
The tablets are ovaloid shaped, film coated yellow tablet with no markings.
Klaricid XL Tablets are available as blister packs of 14 or 6 tablets.

Other less common side effects include:
 swelling, redness or itchiness of the skin. Sometimes brown scales may
appear.
 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
 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)
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)

PL 10383/1308

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Abbot S.p.A., 04010 Campoverde di
Aprilia, Italy. and is procured from within the EU and repackaged by the
Product Licence holder Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 10.01.2013

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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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