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Clarithromycin 250mg and 500mg film-coated tablets

In this leaflet:

1.    What Clarithromycin tablets are and what they are used for

2.    Before you take Clarithromycin tablets

3.    How to take Clarithromycin tablets

4.    Possible side effects

5.    How to store Clarithromycin tablets

6.    Further information

1. What Clarithromycin tablets are and what they are used for

Clarithromycin is an antibiotic belonging to a group called the macrolides. Antibiotics stop the growth of bacteria which cause infections.

Clarithromycin tablets are used to treat infections such as:

•    Chest infections such as bronchitis and pneumonia

•    Throat and sinus infections

•    Skin and tissue infections

•    Helicobacter pylori infection associated with duodenal ulcer.

2. Before you take Clarithromycin tablets

Do not take Clarithromycin tablets if:

•    you are allergic (hypersensitive) to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin or any of the other ingredients in the tablets (see section 6)

•    you are taking the following medicines:

o ergotamine or dihydroergotamine tablets (for migraines)

o cisapride (for stomach disorders), pimozide (for some mental illnesses), terfenadine and astemizole (for hay fever or allergy) as combining these drugs with clarithromycin can sometimes cause serious disturbances in heart rhythm, lovastatin or simvastatin (for high cholesterol) or other macrolide antibiotics o ticagrelor or ranolazine (to prevent blood clotting) o colchicine (for gout) or

o you are taking any other medicines which are known to cause serious disturbances in heart rhythm

Consult your doctor or pharmacist for advice on alternative medicines

•    you or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”

•    you have low levels of potassium or magnesium in your blood (hypokalaemia or

hypomagnesaemia)

•    you have severe liver failure.

If you are unsure, talk to your doctor or pharmacist.

Check with your doctor or pharmacist before taking Clarithromycin tablets if you:

•    have liver or kidney problems.

•    coronary heart disease or severe cardiac insufficiency.

•    (bradycardia) slow heart beat.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Consult your doctor if you are taking any of the following medicines:

•    medicines for epilepsy (e.g. carbamazepine, phenobarbital, or phenytoin)

•    theophylline (helps breathing)

•    warfarin (blood thinner)

•    triazolam or midazolam (sedatives)

•    disopyramide, digoxin or calcium channel blockers (heart drugs)

•    statins (for high cholesterol) particularly atorvastatin and rosuvastatin

•    fluconazole, clindamycin, rifabutin, rifampicin, aminoglycosides (for treatment of some infections)

•    medicines for HIV (e.g. efavirenz, nevirapine, zidovudine, etravirine or ritonavir)

•    ciclosporin, sirolimus or tacrolimus (for organ transplants)

•    terfenadine or astemizole (for hay fever or allergy)

•    omeprazole (for stomach disorders)

•    insulin or oral anti-diabetics (for diabetes)

•    St John’s wort (herbal remedy)

•    cilostazol (for intermittent claudication)

•    methylprednisolone (for inflammatory disorders)

•    sildenafil (for erectile dysfunction)

•    vinblastine (to treat some cancers).

Pregnancy and Breast-feeding

If you are pregnant, may be pregnant or breast-feeding check with your doctor or pharmacist before taking Clarithromycin tablets.

Driving and using machines

Clarithromycin tablets may make you feel confused, disorientated, dizziness or spinning sensation. Make sure you are not affected before you drive or operate machinery.

3. How to take Clarithromycin tablets

Always take Clarithromycin tablets exactly as your doctor has told you. If you are unsure check with your doctor or pharmacist.

For chest, throat or sinus infections and skin and soft tissue infections:

Adults and children over 12 years: 250mg twice a day for 7 days. In severe infections, your doctor may increase the dose to 500mg twice a day.

Children under 12 years: Not recommended.

If you have severe kidney problems your doctor may give you a different dose.

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 Clarithromycin tablets are taken with one or two other drugs.

These combinations are 500mg Clarithromycin twice a day plus one of the following:

a.    Amoxicillin 1000mg and lansoprazole 30mg twice a day for 7 to 14 days.

b.    Metronidazole 400mg and lansoprazole 30mg twice a day for 7 days.

c.    Amoxicillin 1000mg or metronidazole 400mg taken twice a day and omeprazole 40mg once a day for 7 days.

d.    Amoxicillin 1000mg taken twice a day and omeprazole 20mg once a day for 10 days.

e.    OR Clarithromycin 500mg taken three times a day for 14 days together with omeprazole 40mg taken once a day.

The treatment combination which 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 Clarithromycin tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Clarithromycin tablets

If you forget to take a dose take another as soon as you remember, unless it is nearly time for the next dose. Do not take two doses at the same time to make up for forgotten individual doses.

If you stop taking Clarithromycin tablets

Do not stop taking Clarithromycin tablets because 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, Clarithromycin tablets can have side effects, although not everybody gets them. Contact your doctor immediately if the following side effects occur:

•    allergic reactions such as swelling of the face, lips, throat or tongue or difficulty breathing or swallowing can occur which may need emergency treatment.

•    pseudomembranous colitis (severe or prolonged diarrhoea, which may have blood or mucus in it).

•    kidney inflammation or failure (increased need to urinate at night, muscle twitching and cramps, loss of appetite, feeling or being sick, unpleasant taste in mouth) or inflammation of the pancreas (abdominal pain just below the ribs, being sick, fever and generally feeling unwell)

•    jaundice and other liver disorders (weakness, fatigue, lose weight or your appetite, stomach pains, fever or develop yellow skin or whites of the eyes), hepatitis (Inflammation of the liver causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles).

•    allergic rashes may range in severity from mild itchy skin eruptions to rarer more serious skin eruptions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS).

Tell your doctor if the following side effects occur:

Common (occurs in less than 1 in 10 users):

difficulty sleeping, changes in sense of taste, headache, diarrhoea, feeling or being sick, indigestion, stomach pain, changes in liver enzymes or increased levels of creatinine in the blood (as seen in blood tests), rash, excessive sweating, widening of the blood vessels.

Uncommon (occurs in less than 1 in 100 users):

bacterial infection of the skin, 'thrush' in the mouth , Inflammation of the stomach and intestines causing sickness and diarrhoea, infections, vaginal infections, changes in some blood cells (if you notice that you are bruising easily or have frequent nose bleeds, or you have more sore throats and infections than usual tell your doctor who may want to give you a blood test), loss of appetite, decreased appetite, anxiety, nervousness, loss of consciousness, difficulty controlling movement/jerky movements, dizziness, shaking, drowsiness, ‘spinning’ sensation, difficulty hearing, 'ringing' in the ears, asthma, nosebleeds, blood clot on lungs causing chest pain and breathlessness, acid reflux, gastritis (feeling or being sick, diarrhoea), rectal pain, swollen tongue, mouth or stomach, constipation, dry mouth, belching, wind, blocked or obstructed bile flow, feeling unwell, weakness, tiredness, fever, chills, blistering of the skin, itching, Itchy skin rash caused by allergic reaction- pale or red irregular raised patches with severe itching (hives), rash, the presence of macules and papules, spasms of the muscles, stiffness of the muscles, tendons, ligaments and bones, muscle pain, chest pain, changes in levels of chemicals in the blood (seen in blood tests), increase in liver enzymes (as seen in blood tests).

Other (how often these side effects happen is not known)

Skin infections, mental disorders, hallucinations (seeing things), bad dreams, feeling elated or overexcited, which causes unusual behaviour (manic reactions), fits, confusion, disorientation, change in sense of reality and panicking, depression, inability to taste, changes in sense of smell, ‘pins and needles’, hearing loss which is usually reversible on stopping treatment, changes in heart rhythm (palpitations, an abnormally fast, slow or irregular pulse, dizziness or feeling faint, shortness of breath, chest pains), bleeding, discolouration of the tongue, teeth discolouration (but in most cases this can be removed by professional dental cleaning), yeast infection of the mouth, abnormal muscle breakdown which can lead to kidney problems, muscle diseases in which inflammation and degenerative changes occur, acne, muscle or joint pain, changes in urine colour.

If you notice any of these side effects, they get worse, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

Keep out of the reach and sight of children.

Do not store above 30⁰C.

Do not use Clarithromycin tablets after the expiry which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 tablets contain

•    The active ingredient (the ingredient that makes the medicine work) is clarithromycin. Each tablet either contains 250mg or 500mg of the active ingredient.

•    The other ingredients are: microcrystalline cellulose, croscarmellose sodium, pregelatinised maize starch, povidone, talc, magnesium stearate, colloidal anhydrous silica, titanium dioxide (E171), polydextrose, hypromellose, triacetin, macrogol, quinoline yellow (E104).

What Clarithromycin tablets look like and contents of the pack

Clarithromycin tablets are yellow, oval, film coated, biconvex tablets.

Clarithromycin tablets are available as blister packs of 14 tablets.

Marketing Authorisation Holder

Actavis Group hf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.

Manufacturer

Actavis, Barnstaple, EX32 8NS, UK

Revision date: April 2016