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KLARICID 500 MG TABLETS

Active substance(s): CLARITHROMYCIN

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MKP-00708-2017

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PATIENT INFORMATION LEAFLET
ON

250mg Tablets
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 tablets are and what they are used for
2. What you need to know before you take Klaricid tablets
3. How to take Klaricid tablets
4. Possible side effects
5. How to store Klaricid tablets
6. Contents of the pack and other 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
Klaricid Tablets are indicated in adults and children 12 years and older.
2. What you need to know before you take 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 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 disorders) 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 cardia 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 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 tablets are not suitable for use in children under 12 years of age.
Other medicines and Klaricid Tablets
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;”
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 tablets in pregnancy and breastfeeding is not known
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. How to take 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. Check with your doctor or pharmacist if
you are not sure. The recommended 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.
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.
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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.
If you stop taking Klaricid tablets
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.
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 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 include 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 your child suffers 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 tablets
Keep this medicine out of the sight and reach 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.
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 tablets contain
Each Klaricid tablet contains 250 mg or 500 mg of the active ingredient clarithromycin.
The other ingredients are; quinolone yellow (E104 aluminium lake), sodium croscarmellose,
pregelatinized starch*, microcrystalline cellulose, silicon dioxide, povidone, stearic acid, magnesium
stearate, talc, hypromellose, propylene glycol, sorbitan monooleate, titanium dioxide, vanillin, and sorbic
acid (* 250 mg tablet only).
What Klaricid tablets look like and contents of the pack
Klaricid 250mg tablets are yellow, oval and plain or marked with “a”.
Klaricid 500 mg tablets are yellow, oval and plain.
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).
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

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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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