Clarithromycin 500 Mg Film-Coated Tablets
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 taking this medicine because 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 take Clarithromycin
3. How to take 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 medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria that cause infections.
Clarithromycin is used in the treatment of following infections:
• Chest infections such as bronchitis and pneumonia
• Throat and sinus infections
• Skin and tissue infections
• Helicobacter pylori infection associated with duodenal ulcer
2. What you need to know before you take Clarithromycin Do not take Clarithromycin if :
• you are allergic to clarithromycin, other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6).
• you have a history of certain abnormal heart rhythms (ventricular arrhythmia, including torsades de pointes) or changes in the heart activity as measured in the electrocardiogram called “QT prolongation”,
• you suffer from severe liver failure and kidney problems at the same time,
• you have low levels of potassium in the blood (a condition known as hypokalaemia)
• you are taking any of the following medicines
- ergotamine, dihydroergotamine (medicines to treat migraine)
- astemizole, terfenadine (used for allergies)
- cisapride (gastric medicine)
- pimozide (antipsychotic),
- lovastatin, simvastatin (medicines to lower cholesterol),
- colchicines (medicine to treat gout),
- ticagrelor or ranolazine (medicines to prevent stroke or heart attack).
Consult your doctor before taking this medicine if any of the above cases apply to you, or have applied
to you in the past.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin:
• if you have or have had an allergic reaction to certain other antibiotics (lincomycin and clindamycin). There is a risk of an allergic reaction to Clarithromycin as well (crosshypersensitivity)
• if you have reduced liver or kidney function,
• if you have, or have had, heart problems
• if you are pregnant (see section “Pregnancy, breast-feeding and fertility”)
• if your blood magnesium level have previously been low.
• if you develop severe or prolonged diarrhea (pseudomembranous colitis) during or after taking Clarithromycin, consult your doctor immediately. Inflammation of the colon (Pseudomembranous colitis) has been reported with nearly all antibacterial medicines including clarithromycin.
• if you have used clarithromycin before on several occasions or for a long time.
• Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen.
• if you take combination a combination of clarithromycin and benzodiazepines, such as alprazolam, triazolam and midazolam (see section “Other medicines and Clarithromycin”)
• if you take other drugs which affect your auditory function. Loss of hearing will be checked during and after treatment.
• if you have myasthenia gravis (a disease affecting muscle functions), symptoms may become more severe if clarithromycin is used.
• In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
• Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see section “Do not take Clarithromycin if”). Caution should be exercised when using clarithromycin with other statins.If you also use oral anticoagulants besides clarithromycin. There is a risk of serious bleeding.
• Tell your doctor immediately if you suspect that during prolonged or repeated use of clarithromycin you (or your child) have developed a new infection. This may be a superinfection by micro-organisms which are not susceptible to clarithromycin.
If any of these apply to you, consult your doctor before taking Clarithromycin tablets.
Other medicines and Clarithromycin
T ell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Certain other medicines may affect the effectiveness of Clarithromycin or vice-versa.
Clarithromycin may increase the effect of the following medicines:
• astemizole, terfenadine (antiallergic), pimozide (antipsychotic), cisapride (gastric medicine), ergotamine, dihydroergotamine (migraine medicines), lovastatin, simvastatin (medicines to lower cholesterol) (see “Do not take Clarithromycin”)
• alprazolam, triazolam, midazolam (hypnotics)
• atorvastatin, rosuvastatin (cholesterol lowering agents)
• warfarin, phenprocoumon (blood thinners): concomitant use may increase the risk of bleeding. Checking of the blood clotting should be more frequent if Clarithromycin used concomitantly.
• Nateglinide, repaglinide or insulin (antidiabetics)
• carbamazepin, phenytoin, valproate (medicines to treat epilepsy)
• cilostazol (used to improve circulation in the legs)
• colchicine (to treat gout)
• cyclosporine, sirolimus, tacrolimus (immunosuppressants)
• digoxin, verapamil, quinidine, disopyramide (heart medicines), concomitant use of clarithromycin and these agents may cause cardiac arrhythmias.
• methylprednisolone (a cortisone to treat inflammation)
• omeprazole (gastric medicine)
• rifabutin (antibiotic)
• sildenafil, tadalafil, vardenafil (medicines to treat erectile dysfunction)
• theophylline (antiasthmatic)
• tolterodine (to treat overactive bladder syndrome)
• vinblastine (medicine for cancer therapy)
• medicines with the risk to affect hearing, especially aminoglycosides (group of antibiotics that are given to vein)
Both, the effect of Clarithromycin and the effect of the following medicines may be increased when taken together:
• atazanavir, saquinavir (medicines to treat HIV)
• itraconazole (medicine to treat fungal infections)
If your doctor has specifically recommended to take Clarithromycin and any of the above mentioned medicines at the same time, your doctor may need to monitor you more closely.
Clarithromycin may weaken the effect of following medicines:
• zidovudine ((used to treat HIV infection). In order to avoid this you should leave a 4 hour interval between taking these medicines.
The following medicines may weaken the effect of Clarithromycin:
• rifampicin, rifabutin, rifapentine (antibiotics)
• efavirenz, nevirapine, etravirine (medicines to treat HIV)
• phenytoin, carbamazepine, phenobarbitone (antiepileptic)
• St John’s Wort (a herbal product used to treat depression)
The following medicines may strengthen the effect of Clarithromycin:
• ritonavir (antiviral)
• fluconazole (medicine to treat fungal infections)
The use of clarithromycin at the same time as digoxin, quinidine, disopyramide or verapamil (heart medicines), or other macrolide antibiotics may cause cardiac arrhythmia.
Other interactions include:
• any beta lactam antibiotics
• ziprasidone (an antipsychotic drugs)
• eletriptan (used for migraine)
• halofantrine (used to treat malaria)
• aprepitant (used to prevent vomiting during chemotherapy)
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.
If you are pregnant or breast-feeding do not take Clarithromycin before consulting your doctor.
Driving and using machines
Clarithromycin has generally no effect on the ability to drive or use machines. However, if side effects, such as dizziness, confusion and disorientation, your reaction may be adversely affected. Use caution when driving or operating machinery until you know how you react to this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Clarithromycin can be taken with or without food.
The usual dosage instructions are given below:
Dosage in adults and adolescents (children over 12 years old):
The usual dose is 250 mg twice daily. Your doctor may increase the dose to 500 mg twice daily in severe infections. Treatment will last for between 6 and 14 days and should be continued at least for two days after symptoms have subsided.
Use in H. pylori infections:
In adult patients with gastro-duodenal ulcers due to H. pylori infection, Clarithromycin as part of the “first line triple therapy” is given in a dosage of 500 mg twice daily.
Patients with kidney problems:
If you have severe kidney problems your doctor may need to reduce your dose by half, i.e. once daily and restrict treatment to 14 days at the most.
Use in Children
Children under 12 years old:
Clarithromycin in the form of tablet is not suitable for children under 12 years of age or having less than 30 kg body weight. Your doctor will prescribe another suitable medicine for your child.
If you have the impression that the effect of Clarithromycin is too strong or too weak, talk to your doctor or pharmacist.
If you take more Clarithromycin than you should
If you (or some one else) swallow a lot of the tablets all together, contact your nearest hospital causality department or your doctor immediately. 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.
An overdose is likely to cause vomiting and stomach pains.
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 tablet. Take the remaining doses at the correct time.
If you stop taking Clarithromycin
Do not stop taking your medicine because you are feeling better. If the use of Clarithromycin is stopped too early, possibly not all infective bacteria are killed and the infection may return.
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:
If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:
• allergic reactions such as sudden difficulty in breathing, speaking and swallowing
• extreme dizziness or fainting
• severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs
Contact your doctor if the following symptoms develop:
• diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. Your doctor may discontinue treatment. Do not take medicines that reduce bowel movements.
• Liver function with following possible symptoms
- loss of appetite
- yellowing of the skin or whites of the eyes (jaundice),
- pale stools, dark urine
- Itchy rash
- Abdominal pain
• P alpitations or irregular heartbeat
• severe pain in the abdomen and back, caused by pancreas inflammation
Other possible side effects:
Common (may affect up to 1 in 10 people):
• difficulty sleeping
• headache
• changes in sense of taste
• abdominal pain, nausea, vomiting, diarrhoea, indigestion
• abnormal liver function test results
• skin rash
• excessive sweating.
Uncommon (may affect up to 1 in 100 people):
• yeast infections (candidiasis) (eg: in the mouth)
• infections of the vagina
• reduction in the level of certain white blood cells, which can make infections more likely (leucopenia and neutropenia)
• increased number of certain white blood cells (eosinophilia)
• loss of appetite
• anxiety, dizziness, chills
• spinning sensation
• impaired hearing, ringing in the ears (tinnitus)
• palpitations
• inflammation of the stomach, mouth and tongue
• Flatulence, constipation and indigestion
• dry mouth
• problems with the bile flow (cholestasis)
• increase of liver enzymes in the blood
• itching, hives
• muscle pain
• generally feeling unwell
• weakness
• chest pain
• chills
• fatigue
Frequency not known [frequency cannot be estimated from the available data]:
• Inflammation of the gut with severe diarrhea called Pseudomembranous collitus,
• a type of skin infection marked by red skin eruptions, chills and fever (erysipelas), acne
• severe reduction of white blood cells associated with sudden high fever, severe sore throat and mouth ulcers (agranulocytosis)
• unusual bruising or bleeding caused by low blood platelets
• Serious allergic reaction which causes swelling of the face or throat (angioedema)
• psychosis, a feeling of loss of identity
• confusion, change in sense of reality or panicking,
• depression, nightmares, disorientation, hallucinations
• convulsions
• disturbed sense of smell, loss of sense of smell or taste
• deafness
• tingling or numbness in the hands or feet
• difficulty with your blood clotting
• discoloration of the teeth and tongue
• acne
• pain or weakness in muscles
• Inflammation of the kidneys, renal failure
• abnormal urine colour.
Clarithromycin may worsen the symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily) in patients who already suffer from this condition.
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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 contains
• The active substance is clarithromycin.
250mg
Each film-coated tablet contains 250 mg clarithromycin 500mg
Each film-coated tablet contains 500 mg clarithromycin.
• The other ingredients are:
cellulose microcrystalline, croscarmellose sodium, silica, colloidal anhydrous, magnesium stearate, povidone, hypromellose, propylene glycol, titanium dioxide (E 171), hydroxy propyl cellulose, vanillin, sorbic acid and iron oxide yellow (E 172).
What Clarithromycin looks like and contents of the pack
Film-coated tablet.
250mg
Light yellow coloured, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side.
500mg
Light yellow coloured, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘63’ on the other side.
Clarithromycin film-coated tablets are available in blister packs of:
250mg:
1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 24, 28, 30, 32, 40, 42, 45, 49, 50, 56, 60, 72, 75, 90, 100,
120, 140, 250, 500 or 1000 film coated tablets.
500mg:
1, 2, 4, 5, 6, 7, 8 10, 12, 14, 15, 16, 18, 20, 21, 24, 28, 30, 32, 42, 45, 49, 50, 56, 60, 70, 84, 90, 100,
140, 168, 250, 500 or 1000 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
AP L Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000, Malta