CLARITHROMYCIN 500MG TABLETS

Active substance: CLARITHROMYCIN

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250mg Tablets
500mg Tablets

MKP-01949-2012

PATIENT INFORMATION LEAFLET
ON

(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 tablets are and what they are used for
2. Before taking Klaricid tablets
3. Taking Klaricid tablets
4. Possible side effects
5. How to store Klaricid tablets
6. Further information
1. What Klaricid tablets are and what they are used for
Each Klaricid tablet contains 250 mg or 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 tablets are used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Helicobacter pylori infection associated with duodenal ulcer

MKP-01949-2012_d2

Klaricid Tablets are indicated in adults and children 12 years
and older.

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)
unless your doctor has prescribed it for you to treat
Helicobacter pylori infection associated with duodenal ulcer
• 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)

2. Before taking Klaricid tablets
Do not take Klaricid 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 disorders) 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 tablets are not suitable for use in children under
12 years of age.
Take special care with Klaricid 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 any of these apply to you, consult your doctor before
taking Klaricid tablets.

Klaricid does not interact with oral contraceptives.

Taking other medicines
You should not take Klaricid tablets if you are taking any
of the medicines listed in the section above “Do not take
Klaricid tablets if you;”

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
tablets as the safety of Klaricid tablets in pregnancy and
breast-feeding is not known.

Tell your doctor if you are taking any of the following
medicines as your dose may need to be changed or you may

FRONT

Driving and Using Machines:
Klaricid 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 tablets
Do not give these tablets to children under 12 years. Your
doctor will prescribe another suitable medicine for your child.
Always take Klaricid tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure. The usual dose is;
For chest infections, throat or sinus infections and skin
and soft tissue infections:
Usual dose of Klaricid tablets for adults and children over 12
years is 250 mg twice daily for 6 to 14 days, e.g. one 250
mg tablet in the morning and one in the early evening. Your
doctor may increase the dose to 500 mg twice daily in severe
infections.
Klaricid tablets should be swallowed with at least half a glass
of water.
For the treatment of Helicobacter pylori infection
associated with duodenal ulcers:
There are a number of effective treatment combinations
available to treat Helicobacter pylori in which Klaricid tablets
are taken together with one or two other drugs.
These combinations include the following and are usually
taken for 6 to 14 days:
a) One Klaricid 500 mg tablet taken twice a day together with
amoxycillin, 1000 mg taken twice a day plus lansoprazole, 30
mg twice a day.
b) One Klaricid 500 mg tablet taken twice a day together with
metronidazole, 400 mg taken twice a day plus lansoprazole,
30 mg twice a day.
c) One Klaricid 500 mg tablet taken twice a day together with
amoxycillin, 1000 mg taken twice a day or metronidazole,
400 mg taken twice a day plus omeprazole, 40 mg a day.

d) One Klaricid 500 mg tablet taken twice a day together with
amoxycillin, 1000 mg taken twice a day plus omeprazole, 20
mg taken once a day.
e) One Klaricid 500 mg tablet taken three times a day
together with omeprazole 40 mg taken once a day.
The treatment combination that you receive may differ slightly
from the above. Your doctor will decide which treatment
combination is the most suitable for you. If you are unsure
which tablets you should be taking or how long you should be
taking them for, please consult your doctor for advice.
If you take more Klaricid tablets than you should
If you accidentally take more Klaricid 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 tablets is likely to cause vomiting and stomach
pains.
If you forget to take Klaricid tablets
If you forget to take a Klaricid tablet, take one 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 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 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.

MKP-01949-2012_d2

• 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 may
be 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).

• ringing in the ears or hearing loss
• vertigo
• paraesthesia, more commonly known as ‘pins and needles’
• 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 puffiness in the face, abdomen, thighs or ankles or
problems with urination)
• low blood sugar levels
• a change in the levels of certain cells or products found in
the blood.

Common side effects of Klaricid 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. 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
• 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)

6. Further information
What Klaricid tablets contain
Each Klaricid tablet contains 250 mg or 500 mg of the active
ingredient clarithromycin.
The other ingredients are; Yellow colour E104,
croscarmellose sodium, starch*, microcrystalline cellulose,
silica gel, povidone, stearic acid, magnesium stearate,
talc, hypromellose, propylene glycol, sorbitan monoleate,
hydroxypropyl cellulose, titanium dioxide, vanillin, and sorbic
acid (* 250 mg tablet only).
What Klaricid tablets look like and contents of the pack
Klaricid tablets are yellow, oval and film-coated.
Klaricid 250 mg tablets are available as a single calendar
pack containing 14 tablets.
Klaricid 500 mg tablets are available as calendar packs
containing 14 and 20 tablets; or in a bottle of 100 tablets
(hospitals only).
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 in February 2013.

Consult your doctor immediately if you develop any of these
problems or have any other unexpected or unusual symptoms.
5. How to store Klaricid tablets
Keep out of reach and sight of children
Do not use these tablets after their use-by (exp)
date that is printed on the box and indented on the
blister strip.
Keep these tablets in a dry, safe place, protected
from light.
MKP-01949-2012

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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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