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CLARITHROMYCIN 500 MG FILM COATED TABLETS

Active substance(s): CLARITHROMYCIN

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Package leaflet: Information for the user
Clarithromycin 250 mg Film-Coated Tablets
Clarithromycin 500 mg Film-Coated Tablets
Clarithromycin
Read all of this leaflet carefully before you start using this medicine becuase it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them,
even if their signs of illness 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 this leaflet. See section 4.

What is in this leaflet
1. What Clarithromycin is and what it is used for
2. What you need to know before you use Clarithromycin
3. How to use Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other information

1.
What Clarithromycin is and what it is used for
• Clarithromycin belongs to a group of drugs called macrolide antibiotics.
• Clarithromycin is used to treat a range of infections such as:
• chest infections e.g. bronchitis and pneumonia
• throat and sinus infections e.g. sinusitis and pharyngitis
• skin and soft tissue infections
• Helicobacter pylori infection associated with duodenal ulcer.
2. What you need to know before you use Clarithromycin film coated tablets
Do not take Clarithromycin
• if you are allergic to Clarithromycin, other macrolide antibiotic (e.g. erythromycin,
azithromycin) or any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or
cisapride or pimozide tablets as combining these drugs can sometimes cause serious
disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.
• if you have been told by your doctor that you have abnormally low levels of potassium in your
blood (hypokalaemia)
• if you or someone in your family has a history of heart rhythm disorders (ventricular cardiac
arrhythmia, including torsade de pointes) or abnormality of electrocardiogram (ECG, electrical
recording of the heart) called “long QT syndrome”
• if you are taking ergotamine-like drugs (usually used for migraine)
• if you are taking cholesterol-lowering drugs (lovastatin or simvastatin)
• if you have heart problems such as abnormal heart rhythm
• if you have severe liver problems in combination with kidney problems
• if you are taking ticagrelor (a blood-thinning drug)
uk-pil-clean-00289-0457-0458




if you are taking ranolazine (used to treat angina)
if you are taking colchicine (used to treat gout)

Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin if you
• are allergic to the antibiotics lincomycin or clindamycin
• have liver problems
• have kidney problems
• have heart problems
• have, or are prone to, fungal infections (e.g. thrush)
• have muscle problems known as myasthenia gravis
• taking drugs that lower your blood sugar (oral hypoglycaemic agents) or insulin
• have abnormally low levels of magnesium in your blood (hypomagnesaemia)
• have an imbalance in other salts in your blood (electrolytes)
• are taking other medicines which are known to cause serious disturbances in heart rhythm (for
the medicines terfenadine, astemizole, cisapride, and pimozide: see ‘Do not take
Clarithromycin’)
Other medicines and Clarithromycin
Tell your doctor or pharmacist if you are taking,have recenty taken or might take any other
medicines.
Do not take Clarithromycin if you are taking
• ergotamine or dihydroergotamine (to treat migraines)
• terfenadine or astemizole (used to treat hay fever and other allergies)
• pimozide (used to treat mental disorders)
• cisapride (used to treat stomach problems)
• simvastatin or lovastatin (used to lower cholesterol)
• other macrolides e.g. erythromycin or azithromycin
• ticagrelor (a blood-thinning drug)
• ranolazine (used to treat angina)
• colchicine (used to treat gout)
Talk to your doctor if you are taking any of the following
• coumarin anticoagulants used to thin your blood, e.g. warfarin
• medicines used to treat an abnormal heart beat, e.g. disopyramide or quinidine
• medicines used to treat heart failure, e.g. digoxin
• medicines used to treat epilepsy, e.g. phenytoin, valproate or carbamazepine
• medicines to treat certain mental illness e.g. quetiapine



















theophylline, used to treat asthma
benzodiazepines used as medicines that make you sleepy, e.g. alprazolam, midazolam or
triazolam
phenobarbital, used as a sedative and anti-convulsant
rifabutin, rifampicin, rifapentine or aminoglycosides (e.g. gentamicin), used to treat some
infections
ciclosporin, tacrolimus or sirolimus, used following organ transplant
medicines used to lower cholesterol, e.g. atorvastatin or rosuvastatin
ritonavir, atazanavir, etravirine, saquinavir, efavirenz, nevirapine or zidovudine, used to treat
HIV infected patients
St John’s Wort, used to treat depression
sildenafil, tadalafil, vardenafil, used to treat erection problems
cilostazol (a treatment for leg cramps)
methylprednisolone (used to treat inflammation)
vinblastine (a cancer treatment)
omeprazole, used to treat indigestion
tolterodine, used for urinary frequency
itraconazole or fluconazole, used in fungal infections
Calcium channel blockers e.g verapamil, amlodipine, diltiazem (used to treat high blood
pressure or heartbeat disorders)
drugs that lower your blood sugar (oral hypoglycaemic agents e.g. nateglinide, repaglinide) or
insulin

Clarithromycin with food and drink
• You can take Clarithromycin either with or without food, whichever you prefer
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 for advice before taking this medicine.
Clarithromycin should not be given to pregnant or breast-feeding mothers unless the benefits to the
mother outweigh the risks to the baby.
Small amounts of clarithromycin can pass into breast milk..
Driving and using machines
• Your tablets may make you feel sleepy, dizzy or confused. Do not drive or operate machinery if
you are affected.
Clarithromycin film coated tablets contain Tartrazine lake and Allura red lake
Tartrazine lake (E102) and Allura red lake (E129) may cause allergic reactions.
3.
How to use Clarithromycin film coated tablets
Always use this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed preferably with a glass of water.

The recommended dosage instructions are given below:
Adults including the elderly:
• For chest infections, throat or sinus infections and skin and soft tissue infections:
The recommended dose is 250 mg twice a day. Your doctor may increase the dose to 500 mg
twice a day in severe infections. The usual duration of treatment is 6 to 14 days. Treatment
should be continued for at least 2 days after you have stopped having symptoms.
Adults
• For the treatment of Helicobacter pylori infection associated with duodenal ulcers:
Clarithromycin should be taken in a dose of 500 mg twice daily in combination with other
medicines to treat Helicobacter pylori.
Your doctor will decide on the best treatment combination for you. If you are at all unsure as to
which medicine to take and when to take the medicine you must speak to your doctor.
Patients with liver or kidney problems
If you have liver or severe kidney problems your doctor may need to reduce your dose.
Clarithromycin should not be taken for more than 14 days if you have these problems.
Use in children and adolescents
Children under 12 years old
Clarithromycin is not recommended for use in children under 12 years of age, but there are other
formulations e.g oral suspensions which your doctor will prescribe for children under 12 years of
age.
Children over 12 years old
• For chest infections, throat or sinus infections and skin and soft tissue infections:
The recommended dose is 250 mg twice a day. Your doctor may increase the dose to 500 mg
twice a day in severe infections. The usual duration of treatment is 6 to 14 days. Treatment
should be continued for at least 2 days after you have stopped having symptoms.
If you take more Clarithromycin than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately.
An overdose is likely to cause vomiting and stomach pains.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Clarithromycin
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Clarithromycin
Do not stop taking your medicine because you are feeling better. It is important that you complete
your prescribed course of treatment, otherwise the problem may come back and this medicine may
be less effective next time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Stop taking Clarithromycin and tell your doctor immediately or go to the casualty department
at your nearest hospital, if the following happens:
Uncommon: may affect up to 1 in 100 people
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in
breathing, or severe skin rash or hives1
• gall bladder problems (cholestasis)4
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss
of appetite. These may be signs of hepatitis (an inflammation of the liver)4
• changes in heart beat/rhythm (an abnormally fast, slow, or irregular pulse)

Not known: frequency cannot be estimated from the available data
• Torsades de pointes, a life threatening irregular heart beat
• blistering of the skin, mouth eyes and genitals; this could be caused by Steven-Johnson
syndrome or toxic epidermal necrosis, which are serious illnesses
• pseudomembranous colitis (infection of the bowel with severe or prolonged diarrhoea,
which,may have blood or mucus in it)
• agranulocytosis (severe reduction in white blood cells with an increased risk of infection);
symptoms include high temperature, ulcers in the mouth and throat, and unexplained bruising or
bleeding
• pancreatitis – nausea, vomiting, abdominal pain and back pain
• fits
• changes in the heart rythm (ventricular tachycardia, ventricular fibrillation)
• liver failure and jaundice - yellowing of the skin and the whites of the eyes, with increased liver
enzymes in the blood

Other side effects:
The following side effects have been reported at the approximate frequencies shown:
Common: may affect up to 1 in 10 people
• stomach problems such as nausea, vomiting, indigestion, stomach pains, or diarrhoea
• change in sense of taste
• headache
• difficulty sleeping
• altered liver function tests
• rash, increased sweating
• widening of blood vessels (vasodilation)1
Uncommon: may affect up to 1 in 100 people
• fungal infection, vaginal infection
• blood disorders, such as a change in the number of white blood cells making infections more
likely. These may be characterised by fever chills, sore throat, ulcers in your mouth
• joint pain and muscle pain, muscle stiffness1, muscle cramps3
• increased blood clotting time3, nose bleeding2



















altered liver or kidney function tests or blood tests
nettle rash, itching, flat, red areas on the skin covered with small confluent bumps
(maculopapular rash)3 , blisters on the skin which are filled with fluid (dermatitis bullous)1
loss of appetite, decreased appetite
anxiety, nervousness3
dizziness, sleepiness, tremor (shaking), movement disorders (dyskinesia)1
vertigo (spinning sensation), ringing in the ears, hearing impaired
inflammation of the stomach lining and small intestine, heartburn2, bloating, constipation, dry
mouth, belching, flatulence (wind)4, rectal pain2
inflammation of the gullet (oesophagitis)
inflammation or ulceration of the mouth or tongue, feeling of weakness or discomfort, loss of
consciousness1, general feeling of being unwell4, chest pain, ECG abnormalities
chills, tiredness, fever3
hypersensitivity reactions (allergic reactions)
changes in the levels of several enzymes in the blood, shown by a blood test1
asthma1
cough and coughing up blood (signs of pulmonary embolism)1
cellulitis1 (a skin infection caused by bacteria)
infections3
cardiac arrest1 (a sudden stop in effective blood circulation due to the failure of the heart to
contract effectively)

Very rare: may affect up to 1 in 10,000 people
• numbness or pins-and-needles (paresthesia)
Not known: frequency cannot be estimated from the available data
• erysipelas or erythrasma (infections of the skin)
• decreased platelets count in the blood
• confusion, change in the sense of reality and feeling panicky, disorientation, hallucinations
• teeth discolouration (this can usually be corrected by professional cleaning)
• tongue discolouration
• kidney failure, kidney inflammation
• psychotic disorder (mental illness), depression, abnormal dreams, feeling elated or overexcited, which causes unusual behaviour (mania)
• loss of taste, smell alteration, loss of ability to smell
• hearing loss
• unusual bleeding or unexplained bruising
• low blood sugar levels in diabetic patients
• drug rash with eosinophilia (type of white blood cells increase) and systemic symptoms
(DRESS), acne
• myopathy (muscular weakness), rhabdomyolosis (muscle pain, breakdown of muscle fibres)
• international normalised ratio increased (increased blood clotting time), urine colour abnormal
• prothrombin time prolonged
1

Side effects reported only for the Powder for Solution for Injection formulation
Side effects reported only for the Extended-Release Tablets formulation
3
Side effects reported only for the Granules for Oral Suspension formulation
4
Side effects reported only for the Immediate-Release Tablets formulation
2

You may get side effects which you are not aware of, such as changes in the number of certain
blood cells, other blood components or liver enzymes. Your doctor may choose to do blood tests to
check this.
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
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Clarithromycin film coated tablets:

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the container in the outer carton. Do not transfer to another
container.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
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 Clarithromycin film coated Tablets contain
• The active substance is clarithromycin. Each tablet contains either 250 mg or 500 mg of
Clarithromycin.
• The other ingredients are sodium starch glycolate, microcrystalline cellulose, povidone (PVP K30), magnesium hydroxide, croscarmellose sodium, anhydrous colloidal silica, stearic acid,
magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, tartrazine
lake (E102), allura red AC lake (E129), indigo carmine lake (E132) and vanillin.
What Clarithromycin film coated tablets looks like and contents of the pack
• The 250 mg tablet is a yellow, oval shaped film-coated tablet marked with “93” on one side and
“7157” on the other.
• The 500 mg tablet is a light yellow, oval shaped film-coated tablet marked with “93” on one
side and “7158” on the other.
• The 250 mg product is available in pack sizes of 7, 8, 10, 12, 14, 14 calendar pack, 16, 20, 30,
100 and 120 tablets.
• The 500 mg product is available in pack sizes of 7, 8, 10, 14, 14 calendar pack, 16, 20, 21, 30,
42 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
TEVA UK Limited, Eastbourne, BN22 9AG.
OR*
Teva Pharmaceutical Works Private Limited Company, Debrecen, H-4042, Hungary
OR*

Merckle GmbH,
Ludwig-Merckle-Str. 3, 89143
Blaubeuren, Germany
Distributed by: TEVA UK Limited, Leeds, LS27 0JG.
This leaflet was last revised in August 2016

*Only the final site of batch release will appear on the printed version of the leaflet

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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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