Tuesday, October 25, 2016

Clarithromycin 250mg & 500mg Tablets





Clarithromycin 250mg and 500mg film-coated tablets




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, please ask your doctor or your pharmacist.

  • This medicine has been prescribed for you personally and you should 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 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





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





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)

  • are taking the following, you should consult your doctor for advice on alternative medicines:

    • ergotamine or dihydroergotamine tablets (for migraines).

    • cisapride (for stomach disorders), pimozide (for some mental illnesses), terfenadine and astemizole (for hay fever or allergy) or other macrolide antibiotics, as combining these drugs with clarithromycin can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.

    • colchicine (for gout).





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



  • have liver or kidney problems.




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:



  • carbamazepine or phenytoin (drugs for epilepsy)

  • theophylline (helps breathing)

  • warfarin (blood thinner)

  • ergotamine or dihydroergotamine (for migraine)

  • triazolam or midazolam (sedatives)

  • disopyramide or digoxin (heart drugs)

  • simvastatin or lovastatin (for high cholesterol)

  • pimozide (for some mental illnesses)

  • zidovudine, rifabutin, rifampicin or ritonavir (for treatment of some infections)

  • ciclosporin or tacrolimus (for organ transplants)

  • terfenadine or astemizole (for hay fever or allergy)

  • cisapride (for stomach disorders)

  • colchicine (for gout).




Pregnancy and Breastfeeding



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





Driving and using machines



Clarithromycin tablets may make you feel confused, disorientated or dizzy, cause fits, panicking or changes in sense of reality or seeing things that are not there. Make sure you are not affected before you drive or operate machinery.






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 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.






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 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).

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




Tell your doctor if the following side effects occur:



  • stomach problems such as feeling or being sick, stomach pain, indigestion or diarrhoea.

  • headache.

  • changes in liver enzymes or increased levels of creatinine in the blood (as seen in blood tests).

  • swelling or discolouration of the tongue, sore mouth and ‘thrush’ in the mouth.

  • dizziness, ‘pins and needles’, ‘spinning’ sensation, ‘ringing’ in the ears, difficulty sleeping, hallucinations (seeing things), bad dreams, fits, confusion, disorientation, change in sense of reality and panicking.

  • changes in sense of taste and smell.

  • teeth discolouration, but in most cases this can be removed by professional dental cleaning.

  • hearing loss which is usually reversible on stopping treatment.

  • 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) or low blood sugar (muscle weakness, confusion, sweating).

  • changes in heart rhythm (palpitations, an abnormally fast, slow, or irregular pulse, dizziness or feeling faint, shortness of breath, chest pains).

  • muscle or joint pain.



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.





How to store Clarithromycin tablets



Keep out of the reach and sight of children.



Do not store above 30°C.



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.





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

Reykjavíkurvegur 76-78

220 Hafnarfjordur

Iceland





Manufacturer




Actavis

Barnstaple

EX32 8NS

UK





Revision date: August 2008






Actavis

Barnstaple

EX32 8NS

UK



50222883






No comments:

Post a Comment