CLARITHROMYCIN 500 MG TABLETS

Active substance: CLARITHROMYCIN

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clarithromycin 250 mg Tablets
Clarithromycin 500 mg 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 any 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 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 Clarithromycin is and what it is used for
2.
Before you take Clarithromycin
3.
How to take Clarithromycin
4.
Possible side effects
5.
How to store Clarithromycin
6.
Further information
1.

WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR

Clarithromycin is an antibiotic used to treat a variety of different infections. These include infections of the
skin and soft tissue or the respiratory system (nose, throat, chest, lungs). Clarithromycin can also be used
(along with other medicines) to treat the infection H. pylori in patients with duodenal ulcers.
2.

BEFORE YOU TAKE CLARITHROMYCIN

Do not use Clarithromycin if you







are allergic (hypersensitive) to clarithromycin or a similar antibiotic such as erythromycin, or any of
the other ingredients of this medicine
are already taking any of the following medicines:
o ergotamine or dihydroergotamine (for migraine)
o cisapride (for stomach disorders)
o pimozide (for psychiatric conditions)
o terfenadine or astemizole (for hay fever or allergy)
o lovastatin or simvastatin (for high cholesterol)
have a history of QT prolongation, ventricular cardiac arrhythmia including torsades de pointe
have hypokalaemia
have severe liver failure in combination with kidney problems

Take special care with Clarithromycin
You should tell your doctor before taking this medicine if you:
 have heart, kidney or liver problems
 have myasthenia gravis (a disease causing muscle weakness)
 hypomagnesia (low magnesium levels)
 coronary heart disease, severe cardiac insufficiency or bradycardia (slow heart beat)
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Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription, or the following:
 digoxin, quinidine, verapamil or disopyramide (heart drugs)
 warfarin or other drugs to thin the blood
 ergotamine or dihydroergotamine (for migraine)
 carbamazepine, phenobarbitol, valproate or phenytoin (drugs for epilepsy)
 theophylline (helps breathing)
 terfenadine or astemizole (for hay fever or allergy)
 triazolam, alprazolam or midazolam (sedatives)
 simvastatin, lovastatin,atorvastatin, rosuvastatin or cerivastatin (for high cholesterol)
 cisapride (for stomach disorders)
 ciclosporin, sirolimus or tacrolimus (immune suppressant)
 pimozide (for psychiatric conditions)
 zidovudine, ritonavir, atazanavir, saquinavir, nevirapine or efavirenz (anti-viral agent (anti-HIV
drug)
 rifabutin, rifapentine or rifampicin (for treatment of some infections)
 fluconozole or itraconazole (antifungal)
 omeprazole, ranitidine and antacids (for heartburn and stomach ulcers)
 St Johns wort (for depression)
 other antibiotics such as erythromycin
 colchicine (usually taken for gout)
 insulin or oral anti-diabetic drugs (to reduce blood sugar levels)
 cilostazole (to improve blood circulation)
 methylprednisolone (anti-inflammatory)
 sildenafil, tadalafil or vardenafil (for erectile dysfunction)
 vinblastine (an anti-cancer drug)
 tolterodine (for urinary incontinence)
 aminoglycosides (antibiotics)
Pregnancy and breast-feeding
Clarithromycin should not be given to pregnant or breast-feeding mothers unless the benefits to the mother
outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine.
Do not breast-feed your baby, as small amounts of clarithromycin can pass into breast milk.
Driving and using machines
Do not drive or operate machinery if you feel dizzy, confused or disorientated while taking this medicine.
3.

HOW TO TAKE CLARITHROMYCIN

Always take Clarithromycin exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
 The tablets should be swallowed whole with some liquid.
 Tablets can be taken with or without food
 500 mg tablets should not be halved
The usual dose is:

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To treat a respiratory, skin or soft tissue infection
Adults, Elderly and children over 12 years old
The usual dose is 250 mg twice a day for 7 days. For severe infections your doctor may increase the dose to
500 mg twice a day for up to 14 days.
Children (under 12 years old)
Do not give this medicine to children under 12 years old.
To treat H. pylori infection in adults with duodenal ulcers
Clarithromycin is usually combined with other medicines to treat H.pylori infection in adults with duodenal
ulcers. The dose and how often you take it will depend on the other medicines your doctor gives you. It is
important to take your medicine as advised by your doctor.
If you take more Clarithromycin than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any
remaining tablets with you. Symptoms of overdose include feeling or being sick, diarrhoea, indigestion or
stomach pains.
If you forget to take Clarithromycin
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Clarithromycin
Keep taking your medicine until the course is finished. Do not stop taking your medicine just because you
feel better. If you stop too soon the infection may come back again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Clarithromycin can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Clarithromycin and tell your doctor immediately or go to
your nearest hospital emergency department:
 Allergic reactions such as skin rashes or swelling of the face, lips, tongue and/or throat which
may cause difficulty breathing or swallowing
 Severe pain in the abdomen and back caused by inflammation of the pancreas
 Severe diarrhoea with blood in the stools
 Liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the
eyes (jaundice), feeling sick, weight loss which can lead to liver failure
 Severe skin reactions, blistering of the skin, mouth, eyes and genitals
These side effects are rare but serious. You may need medical attention.
Common side effects (affecting fewer than 1 in 10 people):
 feeling or being sick, diarrhoea, indigestion or stomach pains
 painful, sore mouth or tongue
 headache
 smell alteration or taste disturbance, i.e. metallic or bitter taste
 changes in blood urea nitrogen levels.
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difficulty sleeping
rash
increased perspiration
altered liver function tests.
oral thrush

Uncommon side effects (affecting fewer than 1 in 100 people):












change in your creatinine or blood sugar levels (you may look pale and feel faint)
painful joints or muscles
feeling dizzy, vertigo, feeling anxious, shaking, drowsiness
loss of appetite or weight loss, constipation, dry mouth, flatulence, feeling bloated or burping
skin rash or itching
liver problems which may cause dark urine, pale stools,
weakness, fatigue, chills, chest pain
yeast infections in the mouth or vagina
ringing in the ears, hearing loss which is reversible on stopping treatment
change in some blood cells (you may notice that you are bruising easily or have frequent nose
bleeds, or more sore throats and infections than usual tell your doctor who may give you a blood
test)
changes in heart rhythm (palpitations, abnormally fast, slow or irregular pulse, shortness of breath,
chest pain)

Very rare side effects (affecting fewer than 1 in 10,000 people):
 numbness, prickling or tingling sensation in arms and legs
 nightmares
 severe pain in the abdomen and back caused by inflammation of the pancreas
 low sugar (glucose) levels in the blood in patients treated with antidiabetic medicinal products
(including insulin) you may experience sweating, weakness, hunger, dizziness, trembling, headache,
flushing or paleness, numbness, having a fast, pounding heart beat.
Other possible side effects (how often these side effects occur is not known):
 hallucinations, abnormal dreams, depression, convulsions, feeling disorientated or confused, mental
illness or depersonalisation
 kidney failure (you may notice a change in your urine function)
 hearing loss
 muscular weakness
 change in urine colour
 acne
 infections of skin
 change in colour of tongue or teeth
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5.

HOW TO STORE CLARITHROMYCIN

This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Clarithromycin after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Clarithromycin contains
The active substance is clarithromycin.
The other ingredients are Microcrystalline Cellulose, Pregelatinised Starch, Croscarmellose Sodium,
Povidone, Colloidal Silicon Dioxide, Stearic Acid, Magnesium Stearate. The coating includes Hypromellose
(E464), Hydroxypropyl Cellulose (E463), Titanium Dioxide (E171), Propylene Glycol (E1520), , Vanillin,

Quinoline Yellow Lake (E104)
What Clarithromycin looks like and contents of the pack
Your medicine comes as a yellow, oval shaped, film coated tablet and is available in two strengths. The 250
mg tablets are marked ‘C250’ on one side and ‘G’ on the other and the 500 mg tablets are marked ‘C500’ on
one side and ‘G’ on the other.
Clarithromycin is available in blisters and plastic bottles of 4, 6, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 42,
50, 60, 100, 250, 500 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar,
Herts,
EN6 1TL
UK.
Manufacturer
Gerard Laboratories, Unit 35, Baldoyle Industrial Estate, Grange Road, Dublin 13, Eire.

Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom
Czech Republic
Greece
Hungry
Italy
Slovakia

Clarithromycin
Klaritromycin Mylan
Clarithromycin/Generics TAB
Klarigen
Claritromicina Mylan Generics
Klaritromycin Mylan

This leaflet was last approved in 09/2011

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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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